draft environmental impact assessment...

DRAFT

ENVIRONMENTAL IMPACT ASSESSMENT REPORT

FOR

PROPOSED UNIT

(Pharmaceuticals Bulk Drug: 46..85 MT /M)

OF

M/S. ATLAS LIFESCIENCES

(Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad, Gujarat.)

PREPARED BY

BHAGWATI ENVIRO CARE PVT. LTD. [ISO 9001, ISO 14001 & OHSAS: 18001 CERTIFIED COMPANY]

CORPORATE OFFICE

28, 29, 30, Parmeshwar Estate II, Opp. HDFC Bank,

Phase I, GIDC Estate, Vatva, Ahmedabad – 382445. Gujarat, India Phone No: +91 79 29295043, 40083051/52 Fax: +91 79 40083053 , Email: [email protected] , [email protected]

URL: www.bhagwatienviro.com

mailto:[email protected]


http://www.bhagwatienviro.com/

CONTENTS

CLAUSE NO

TOPIC PAGE NO

ANN - A Executive Summary in English…………………………………………………. --

ANN – B Accreditation Certificate ………………………………………………………… --

CHAPTER-1 PREAMBLE

1 - 45

1.1 Preamble.................................................................................... 1 1.2 Identification of Project and Project Proponent………………………. 1 1.3 Objective of EIA Study………………………………………………….. 3 1.4 Location ……………………………………………………………………. 4 1.5 Study Area…………………………………………………………………. 11 1.6 Nearest Location from the Project Site……………………………… 11 1.7 Scope and methodology of EIA………………………………………. 12 1.8 Structure of EIA…………………………………………………………… 15 1.9 Approved TOR for EIA study from SEIAA, Gujarat…………… 17 1.10 Compliance of TOR……………………………………………………… 26 1.11 Regulatory Frame work………………………………………………….. 43 1.12 Photographs of the Project Site………………………… 44

CHAPTER – 2

PROJECT DESCRIPTION

46 - 136

2.1 Prelude…………………………………………………………………………….. 46 2.2 Location……………………………………………………………………………. 46 2.3 Justification of Project site……………………………………………………… 47 2.4 Promoters and their background……………………………………………….. 48 2.5 Infrastructure Facilities including Power Sources………………… 48 2.6 Land Use Breakup for Total Plot Area………………………………. 50 2.7 Product Details…………………………………………………………… 50 2.8 Packing & Final Application of Products………………………….. 53 2.9 Raw material Requirements……………………………………………. 54 2.10 Physical form & Storage of Raw Materials…………………. 56 2.11 Physical and Chemical properties of Hazardous Raw material…. 59 2.12 Manufacturing Process……………………………………………….… 60 2.13 Water Consumption & Effluent generation……………… 98 2.14 Characteristics of effluent……………………………………………… 102 2.15 Details of Effluent Treatment Plant…………………………………. 105 2.16 Flue Gas Emission…………………………………………………………….. 108 2.17 Process Gas Emission………………………………………………………… 110 2.18 Fuel Requirement…………………………………………………………....... 110 2.19 Fugitive Emission Control……………………………………………………… 111 2.20 Hazardous waste management…………………………… 112 2.21 Noise Pollution…………………………………………………………….. 113 2.22 List of Hazardous Chemicals……………………………………………. 114

2.23 Safety & Occupational measure for storage & handling of the Raw Material & product…………………………………………………………

125

2.24 Action Plan for Transportation of Raw Material & product including hazardous Chemicals…………………………………………………………

127

2.25 Details of Fire fighting system…………………………………………… 128 2.26 Cost of project…………………………………………………...... 129 2.27 Power Requirement……………………………………………………….. 130 2.28 Man Power Details………………………………………………………… 130 2.29 Green Belt Development………………………………………………..... 131 2.30 Scheme for Rain water Harvesting……………………………………… 136

CHAPTER – 3

BASELINE ENVIRONMENTAL STATUS

137 - 210

3.1 Introduction .................................................................... 137 3.2 Study Area........................................................................ 137 3.3 Environmental Standards of the Region................................ 141 3.4 Air Environment…………………………………………………………… 141 3.5 Meteorology…………………………………………………………… 152 3.6 Baseline Data………………………………………………………….. 152 3.7 Atmospheric Stability……………………………………………….. 159 3.8 Noise Environment ………………………………………………….. 160 3.9 Water Environment............................................................ 169

3.10 Land Environment……………………………………………………. 174 3.11 Types of Soil......................................................... 175 3.12 Land Use Pattern……………………………………………………… 179 3.13 Hydrogeology................................................................... 182 3.14 Ecology............................................................................ 186 3.15 Socio Economic Environment.............................................. 195 3.16 Economic Attributes………………………………………………….. 201 3.17 Availability of Basic Amenities…………………………………….. 204 3.18 Socio Economic Survey……………………………………………… 207

CHAPTER – 4

ENVIRONMENTAL IMPACTS ASSESMENTS

211 - 246

4.1 Impact Identification....................................................................... 211 4.2 Impact Prediction and assessment with mitigative

measures......................................................................... 216

4.3 Air Environment……………………………………………………………. 217 4.4 Mathematical Model for Pollutants Dispersion……………………… 219 4.5 Results of the ISCST -3 Model…………………………………………. 229 4.6 Ground level Concentration……………………………………………… 235 4.7 Assessment of Impact on Air Quality…………………………………… 236 4.8 Water Environment…………………………………………………… 240 4.9 Noise Environment…………………………………………………… 241

4.10 Land Environment……………………………………………………. 242 4.11 Ecology…………………………………………………………………. 243 4.12 Socio Economic Environment………………………………………. 243 4.13 Health & Safety………………………………………………………….. 244 4.14 Traffic Study & Its Impact……………………………………………… 244

CHAPTER – 5

ENVIRONMENTAL MONITORING PROGRAM

247 - 251

5.1 Monitoring of Environment............................................ 247 5.2 Work zone monitoring arrangement for Hazardous Chemicals…… 249 5.3 Chemicals which are exposed to workers directly or indirectly…… 250

CHAPTER – 6

ENVIRONMENTAL MANAGEMENT PLAN

252 - 294

6.1 Introduction.................................................................. 252 6.2 The EMP………………………………………………………… 252 6.3 Objectives of EMP........................................................ 253 6.4 Brief Environmental management Plant......................... 254 6.5 Environmental Management Cell……………………………. 258 6.6 Occupational Health & Safety…………………………………………… 259 6.7 Possibility of Occupational health Hazards and its preventive

measures…. 260

6.8 Details of occupational Health Surveillance Programme……………. 268 6.9 Hazardous Identification and Preventive Measures………………….. 270

6.10 Occupational Health and First Aid Measures 282 6.11 Expenditure on Enviromental Matters……………………… 284 6.12 Concept of waste minimization……………………………… 285 6.13 Checklist in the form of Do’s & Don’t………………………. 288 6.14 Socio Economic Development activity…………………….. 290 6.15 Environmental Policy 292 6.16 Infrastructure facilities to the labours during construction Phase. 293

CHAPTER – 7

ADDITONAL STUDIES

295 - 312

7.1 Public Consultation....................................................... 295 7.2 Risk Assesment............................................................ 296 7.3 Onsite & Offsite Disaster preparedness & Emergency management

plan of the Industry………………………………………………………… 299

7.4 Social Impact Assesment…………………………………..... 312

CHAPTER – 8 PROJECT BENEFITS

313

-- Project Benefits.......................................................................... 313

CHAPTER –9

SUMMARY OF ENVIONMETAL IMPACTS AND CONCLUSION

314 - 316

9.1 Air Environment……………………………………………….. 314 9.2 Water Environment……………………………………………. 314 9.3 Noise Environment……………………………………………. 315 9.4 Hazardous wastes…………………………………………….. 315 9.5 Ecology………………………………………………………….. 315 9.6 Socio Economic Environment………………………………. 316 9.7 Conclusion……………………………………………………… 316

CHAPTER – 10 PROFILE OF ENVIRONMENTAL CONSULTANTS

317 - 325

10.1 Introduction................................................................. 317 10.2 Expertise In ................................................................ 318 10.3 Laboratory Facility....................................................... 319 10.4 Treatability studies...................................................... 319 10.5 Our Team of Highly Qualified Technocrats &

Scientists……………………………………………………….. 320

10.6 List of Valuable Clients in Gujarat................................. 321 10.7 List of Valuable Clients in Himachal Pradesh……………. 323 10.8 EC Application Applied by M/s. Bhagwati Enviro Care

Pvt.Ltd…………………………………………………………… 324

10.9 Schedule II Environmental Audit carried out by M/s. Bhagwati Enviro Care Pvt.Ltd…………………………….....

325

FIGURES FIGURE

NO TOPICS PAGE NO.

CHAPTER - 1 1.1 Map of Gujarat State……................................................. 5 1.2 Map of Ahmedabad District.................................................. 6 1.3 5 Km & 10 KM radius Map of the project site…………………. 7 1.4 Plant Layout ……………………………………………………………. 8 1.5 Goggle Image of M/s. Atlas Life Sciences ……….. 9 1.6 Topography map of M/s. Atlas Life Sciences ……….. 10 1.7 Methodology of EIA study………………………………………… 14

CHAPTER-2

2.1. Water Balance Diagram.................................................. 101 2.2 Effluent Treatment Plant Flow Diagram..................................... 106

CHAPTER -3 3.1 Study Area Map of Base line Study for 5 KM Radius and 10 KM Radius with

Topo Sheet No……………………………………………….. 139

3.2 Study Area Map of Base line Study for 5 KM Radius and 10 KM Radius in Google Map……………………………………………………….

140

3.3 Sampling Locations for AAQ, Water Quality, Noise Level and Soil Analysis………………………………………………………………………..

144

3.4 Wind Rose Diagram...................................................... 154 3.5 Wind Rose Frequency Distribution Graph ………………………… 157 3.6 Geological Structure of Gujarat State................................ 174 3.7 Land use / land cover map of 10 km radius area around project site… 181 3.8 Hydro chemistry level of ground water……………………………………. 183 3.9 Status of depth to water level in Gujarat............................................... 184

3.10 Ground water Quality map of Gujarat……………………………………... 185 3.11 Forest Vegetation map of Gujarat…………………………………………. 193 3.12 National park and Sanctuaries of Gujarat………………………………… 194 3.13 Population Details…………………………………………………………… 199 3.14 Literacy Details……………………………………………………………… 199 3.15 Employment Pattern……………………………………………………….. 202

CHAPTER - 4

4.1 Isopleths of SPM..................................................................... 237 4.2 Isopleths of SO 2……………………………………………………….. 238 4.3 Isopleths of NO x……………………………………………………….. 239

CHAPTER -6

6.1 Organization Chart………………………………………………. 258

TABLES

TABLE NO.

TOPICS PAGE NO.

CHAPTER –1

1.1 Details of project Site & Nearest locations from the Site……… 11 1.2 Nearest Industries from the Project site………………………….. 12 1.3 Compliance of Terms of Reference……………………………….. 26

CHAPTER –2

2.1 Location of the project site………………………………………….......... 46 2.2 Details of Sources…………………………………………………………. 49 2.3 Land use breakup for total Plot area…………………………………….. 50 2.4 List of Product………………………………………………………………. 50 2.5 Chemical name of Product……………………………………………… 52 2.6 Packing & Final Application of Product………………………………… 53 2.7 Details of Raw Material …………………………………………………… 57 2.8 Details of water consumption & Wastewater Generation……………… 98 2.9 Productwise Water Consumption & Effluent Generation details only for

Process: Unit is in KL /Day…………… 99

2.10 Characteristics of Industrial Effluent……………………………………… 102 2.11 Streamwise and combined Characteristics of Effluent………………………… 103 2.12 Productwise Characteristics of effluent……………………………………... 104 2.13 Details of Proposed Effluent Treatment Plant Units………………… 105 2.14 Flue gas Stack details……………………………………………………. 108 2.15 Emission rate of Pollutants……………………………………………… 109 2.16 Fuel Details…………………………………………………………. 110 2.17 Fuel Characteristics………………………………………………. 110 2.18 Details of Hazardous waste………………………………………. 112 2.19 Typical Noise level of equipment………………………………. 113 2.20 List of Hazardous chemicals………………………………….. 114 2.21 Antidotes of Chemicals…………………………………………. 127 2.22 Capital Cost & Recurring cost of the project……………………….. 129 2.23 Power Requirement…………………………………………….. 130 2.24 Details of Man Power…………………………………………… 130 2.25 Budgetary Expenditure for Green Belt…………………………………………….. 133

CHAPTER – 3

3.1 Name of villages in the study area……………………………… 138 3.2 Location of ambient air quality monitoring stations…………. 142 3.3 Ambient Air quality Results (Min, Max, Avg and 98%) for Individual

Locations…………………………………………………. 143

3.4 Ambient Air Quality Analysis Report ……………………………… 146 3.5 Details of Ambient Air quality monitoring and analysis

procedure…………………………………………………………. 151

3.6 Wind Rose Frequency Distribution…………………………… 155 3.7 Wind Rose Frequency Distribution count………………………… 156 3.8 Relative Humidity 158 3.9 Hourly mixing depth over Indian Region…………………….. 159

3.10 Noise Level in the study area…………………………… 161

TABLE NO.

TOPICS PAGE NO.

3.11 Location of water quality monitoring station………………... 169 3.12 Water quality Analysis………………………………………….. 171 3.13 Analysis Results of Soil Sample……………………………………. 176 3.14 Landuse distribution in study area (10 Km Radial Zone) ……. 180 3.15 List of Commonly found flora in the study

area…………………………………………………………………….. 188

3.16 Bird species reported during the study………………………………… 190 3.17 Mammals species reported during the study…………………………….. 192 3.18 Population Details…………………………………………………… 198 3.19 Literacy Details………………………………………………………. 200 3.20 Employment pattern and Main worker Employment

pattern………………………………………………………………….. 203

3.21 Availabilities of Basic Amenities Activities…………………………………. 204 3.22 Main Commodities in the Study Area……………………………………… 206 3.23 Name of village for survey in the Study Area……………………………. 209

CHAPTER -4

4.1 Impact identification matrix………………………………………… 213 4.2 Impact Prediction Matrix……………………………………………. 214 4.3 Basis of Emission Rate calculations…………………………….. 228 4.4 The 1st highest 24 Hr average Concentration values of

SPM………………………………………………………………… 229

4.5 The 1st highest 24 Hr average Concentration values of SO x……………………………………………………………………….

231

4.6 The 1st highest 24 Hr average Concentration values of NO2……………………………………………………………………….

233

4.7 Maximum Computed Ground Level Concentration……………. 235 4.8 Traffic study………………………………………………………….. 245 4.9 Assessment of Proposed Traffic Load………………………… 246

CHAPTER – 5

5.1 Environmental Monitoring Plan........................................ 247 CHAPTER – 6

6.1 Expenditure on Environmental Matters……………………………. 284

ANNEXURES

ANNEXURE NO.

Topics

Page No.

1. RISK ASSESMENT STUDY REPORT………………………………… 326 – 400

2. NATIONAL AMBIENT AIR QUALITY STANDARDS……………………….. 402 – 403

3. ICMR STANDARD FOR DRINKING WATER………………………………. 404

4. NATIONAL AMBIENT NOISE QUALITY STANDARDS AND OSHA’S PERMISSIBLE LIMIT FOR NOISE…………………………………………..

405

5. LAND SUPPORTING DOCUMENTS……………………………………….. 406 – 409

6. UNDERTAKING OF ATLAS LIFE SCIENCES …………………………….. 410

7. UNDERTAKING OF CONSULTANT………………………………………… 411

8. MATERIAL SAFETY DATA SHEETS 412 - 711

Annexure: A

EXECUTIVE SUMMARY OF

ENVIRONMENTAL IMPACT ASSESSMENT REPORT

FOR

PROPOSED UNIT

OF

M/s. Atlas Life Sciences

(Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad, Gujarat.)

PREPARED BY

BHAGWATI ENVIRO CARE PVT. LTD. [ISO 9001, ISO 14001 & OHSAS: 18001 CERTIFIED COMPANY]

CORPORATE OFFICE

28, 29, 30, Parmeshwar Estate II, Opp. AMCO Bank,

Phase I, GIDC Estate, Vatva, Ahmedabad – 382445. Gujarat, India Phone No: +91 79 29295043, 40083051/52 Fax: +91 79 40083053 , Email: [email protected] , [email protected]

URL: www.bhagwatienviro.com



http://www.bhagwatienviro.com/

Annexure: A Executive Summary for Draft Environmental Impact Assessment Study of

M/s. Atlas Life Sciences At Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad, Gujarat. .

1. INTRODUCTION

M/s. Atlas Life Sciences is a proposed unit located at Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad, Gujarat. In proposed unit they have decided to manufacture Pharmaceuticals bulk drugs @ 46.85 MT/Month. Considering scale of unit and its categorization, according to EIA notification dated 14th September 2006, by Ministry of Environment & Forest (MoEF), Government of India, their Proposed manufacturing activity is falls under Synthetic Organic Chemicals – Schedule 5(f)) & cat -B. For that unit needs Environmental clearance from State Level Environment Impact Assessment Authority, Gandhinagar, Gujarat. In order to assess the Environmental Impacts of the New proposed project, M/s Atlas Life Sciences entrusted Bhagwati Enviro Care Pvt Ltd, Ahmedabad (NABET Accredited) to undertake Draft Environmental Impact Assessment Study for various components of the Environment viz., Air, Water, Noise, Land and Socio-economics. This Report presents base line data collected for March-April-May-2017 for Air, Water, Noise, Land etc., for identification and assessment of the impacts. Total plot area is 1321 Sq. meter. From that they had done planning for gardening and plantation for 200 Sq. Meter. The unit proposes to develop greenbelt in area of 200 m2 and it will be 15% of the total area, because there is no availability of land and unit will compensate balance greenbelt at common place of GIDC & road side.

2. DETAILS OF PRODUCT Table: 01

Product Details

Sr. No.

Name of Products CAS No. Qty. (MT/month)

1. Phenylephrine HCl 61-76-7 4.0

2. Pregabalin 148553-50-8 6.0

3. Levosulpiride 23672-07-3 1.0

4. Linezolid 165800-03-3 2.0

5. Olmesartan Medoxomil 144689-63-4 1.0

6. Gabapentin 60142-96-3 5.0

7. Levetirecetam 102767-28-2 2.0

8. Pantoprazole Sodium Monohydride

138786-67-1 3.0

9. Sucralfate 54182-58-0 10.0

10. Montelukast sodium 151767-02-1 2.0

i Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



11. Telmisartan 144701-48-4 2.0

12. Amlodipine Besylate 88150-42-9 3.0

13. Silodosin 160970-54-7 0.1

14. Olenzapine 132539-06-1 1.0

15. Glimepride 93479-97-1 2.0

16. Chlorthalidone 77-36-1 2.0

17. Tapentadol HCl 175591-09-0. 0.5

18. Voricanazole 137234-62-9 0.25

Total 46.85

3. WATER CONSUMPTION & WASTEWATER GENERATION/ DISPOSAL

Table: 02 Water Consumption and Wastewater generation

Maximum Quantity of Water Consumption

(KL/Day)

Maximum Quantity of Waste Water generation

(KL/Day) Domestic 6.0 5.0 Gardening 2.0 Nil

Industrial DM Plant 1.0 1.0 Process 1.5 0.0 Cooling 3.0 1.0 Boiler 1.5 0.2 Total 15.0 7.2

WASTEWATER MANAGEMENT • Domestic water consumption will be around 6 KLPD and sewage generated will

be disposed to soak pit via septic tank @ 5 KLPD.

• Gardening water consumption will be 2 KLPD.

• Industrial water consumption 7 KLPD and effluent generation will be 2.2 KLPD, industrial wastewater will be sent to evaporator & condensate of evaporator around 2.0 KLD will be utilized for greenbelt development.

ii Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



4. DETAILS OF AIR EMISSION

Table: 03 Flue Gas Stack Details

Sr. No.

Stack attached to

Capacity Fuel Consumption

Stack Height

(m)

APCM Fuel used

1 Boiler 1.5 TPH

2750 SCM/Day

18

---

Natural Gas

2 Thermic fluid

Heater

1 Lacs kcal/hr

250

SCM/Day

---

3 D.G.Set 25 KVA 10 Lit./hr 6 --- HSD

Process Gas Stack Details: Note: There will be no process gas emission from the manufacturing activity

Table: 04

Fuel Details

Sr.No Name of Fuel Consumption

1 Natural gas (Boiler & TFH) 3000 SCM/Day

2 Diesel (D G Set) 10 Lt/Hr

iii Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



5. DETAILS OF HAZARDOUS WASTE GENERATION & ITS MANAGEMENT

TABLE: 05 DETAILS OF HAZARDOUS WASTE GENERATION & ITS MANAGEMENT

Sr. No.

Type of Waste

Category of Waste as per HWM Rules

2008

Quantity in MT/Yr Disposal facility

1. ETP waste 34.3 0.3 Collection, Storage, Transportation & Disposal at TSDF site approved by GPCB.

2. Evaporation salt 34.3 3.0

Collection, Storage, Transportation & Disposal at TSDF site approved by GPCB.

3. Distillation residue 20.3 1.8

Collection, Storage, Transportation, Disposal at Common Haz. Waste Incineration facility (CHWIF).

4. Spent carbon I-28.2 1.2 Collection, Storage, Transportation, Disposal at Common Haz. Waste Incineration facility (CHWIF).

5. Discarded

containers/ drums

33.3 2.4 Collection, Storage and sold to approved recycler or traders.

6. Used oil 5.1 0.05 KL/Yr

Collection, Storage, Transportation & disposal by selling to Registered Recyclers.

iv Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



1. ENVIRONMENTAL PARAMETER MONITORING STUDY AREA/ STUDY PERIOD

The study area for detailed studies is an area within a radius of 10 Kms. Ambient air quality monitoring were carried out at 08 locations within the study area of 5 km aerial coverage from project site as the Center. The ground water monitoring, noise level monitoring, Soil analysis were carried out at 08 location for once in the study period. The monitoring activities were carried out at 08 sampling sites for the Month of March 2017 – May 2017.

2. AIR ENVIRONMENT

Baseline study indicates that AAQ in the surrounding study area with respect to PM2.5, PM10, SO2, NOX, and VOC are well within the stipulated permissible limits as prescribed by the latest National Ambient Air Quality (NAAQ) Standards for the respective industrial residential rural areas. Maximum evaluated 24 hourly GLC from the ISCST-3, when added to the 98-percentile concentration of each parameter monitored during March 2017 – May 2017 season of the ambient air it indicates that due to establishment of proposed project of M/s. Atlas Life Sciences, ambient air quality of the surrounding study area will be well within the NAAQ standards for the respective Industrial, residential rural areas. Company will use natural gas as a fuel. There will be process gas emission from process Reaction.

It is concluded that there will be no long term impacts on the surrounding ambient air environment.

3. WATER ENVIRONMENT

The source of water for the proposed project will be GIDC Estate, odhav. Base line data reveal that, the ground water quality is meeting with Drinking Water standards. The company proposes to use proposed source of water for both domestic as well as Industrial purpose.

• Domestic water consumption will be around 6 KLPD and sewage generated will be disposed to soak pit via septic tank @ 5 KLPD.


• Industrial water consumption 7 KLPD and effluent generation will be 2.2 KLPD, industrial wastewater will be sent to evaporator & condensate of evaporator around 2.0 KLD will be utilized for greenbelt development. It is concluded that due to zero discharge unit, there will be no significant impacts on the surrounding water environment.

v Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



4. NOISE ENVIRONMENT

Base line data indicates that noise levels in the ambient air environment are within the prescribed norms. The industry will provide adequate noise control measures such as mufflers & silencers at the air inlet/outlet, anti vibration pad for equipment with have extreme vibration etc. Ear plugs & ear muffs will be provided to the workers where noise level will remain extremely high. Thus, there will be short term, reversible impact on the noise environment due to the proposed project.

5. LAND ENVIRONMENT

Air pollution, water pollution and solid waste pollute soil and causes direct/indirect effect on soil. Since all necessary air pollution control measures have been provided and based on the results of the dispersion model for the ground level concentration of various pollutants after the commissioning of the proposed Project, there will not be any adverse impact of air pollution on soil. Industrial effluent will be treated into ETP and finally treated effluent will be evaporated. Therefore no impact on soil environment is anticipated. All necessary control measures will be provided for handling, storage and safe disposal of solid/hazardous waste, which will be generated from the proposed project. Thus, there will not be any significant impact of solid waste on the soil Environment.

6. ECOLOGY

Impacts on terrestrial ecosystem due to the operation of plant occur mainly from air emissions. Air pollutants can impact adversely on the biotic and abiotic components of the ecosystem and may include injurious effects when concentration of these pollutants exceed from permissible limit. Since the proposed activity will be carried out in proposed unit, so, there will be no adverse impact on the ecological environment of the study area. Total plot area is 1321 Sq. meter. From that they had done planning for gardening and plantation for 200 Sq. Meter. The unit proposes to develop greenbelt in area of 200 m2 and it will be 15% of the total area, because there is no availability of land and unit will compensate balance greenbelt at common place of GIDC & road side. The company will also develop plantation as per the MoEF guidelines all along the periphery of plant so that these trees perform as natural barrier for bring down the fugitive emission and also stop carryover of dust along with wind current.

vi Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



7. SOCIO-ECONOMIC ENVIRONMENT

Due to Proposed project, 10 nos. of local peoples and outside peoples will get employment during the construction phase and additional 16 peoples will be employed during the operation phase. The indirect employment will also be generated by way of transportation, shopkeepers and other casual employment for many people. Thus, the proposed project will have long term- irreversible positive impact on the employment pattern of the study area.

8. ENVIRONMENTAL PARAMETER MONITORING Environmental parameter monitoring facility of the proposed project is as given below:

S. No. Aspect Source of Impact

Monitoring Method and it’s Parameters

Frequency Executing Agency

Monitoring Agency

1.0 Construction Phase (As the construction area is small so, steel structure will be used in the existing unit, hence the impact will be very less)

1.1 Local Manpower Absorption

Construction Work

Contractor’s report No. of people working in the project

Daily Contractor Atlas Life Sciences

1.2 Air Quality transportation of construction materials

Survey & observations; Levels of SPM, RSPM, SO2 and NOx

Weekly Atlas Life Sciences

GPCB/ Recognized Env. Agency

1.3 Public Health Dust, Noise, Movement of labours

Regular medical checkup

Monthly Contractors Atlas Life Sciences

2.0 Operation Phase

2.1 Water Quality & Quantity

Surface & Ground water quality within the Project Area

Surveys, sample collection & field measurement;

Quarterly Atlas Life Sciences


2.2 Effluent Quality

Quality of Treated effluent Send to evaporator.

ETP sample collection & quality analysis

Daily (Internal); Monthly (Third Party)

Atlas Life Sciences


vii Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



S. No. Aspect Source of

Impact

Monitoring Methods and Parameters


Monitoring Agency

2.3 Air Quality Emissions from utility .

Air quality monitoring at 2-3 location within (SO2, NOx, SPM, RSPM, CO, HC, VOC) as well as stack monitoring.

Ambient -Monthly (24 hourly); Stack – Monthly (third party)

Atlas Life Sciences


2.4 Noise Level Noise level compliance with respect to industrial standards

Ambient Equivalent Sound Pressure Levels (Leq) in day and Night time at 4 to 6 location.

Monthly (Third Party) and fortnightly (internal)

Atlas Life Sciences


2.5 Biological Environment

Horticulture/ Greenbelt Development

Survival rate of plants and shrubs



2.6 Solid Waste Management

Disposal of waste

Monitoring of waste collection, segregation and disposal

Fortnightly Atlas Life Sciences


2.7 Hazardous Waste Management

Hazardous waste as required by hazardous waste authorization

Monitoring of hazardous waste collection, segreg ation, storage and disposal



Generation of used drums, bags and records of their dispatch to approved vendors.

Maintain Records Daily Atlas Life Sciences


Generation of waste oil and their treatment



viii Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



9. ADDITIONAL STUDIES

We have carried out socio-economic study of the study area to evaluate impact of proposed project on them. Since the proposed project is a small scale unit so, it is beneficial to local people.

10. ENVIRONMENTAL MANAGEMENT PLAN

The environmental management plan is the plan for effective environmental management prepared by project proponents. Environmental Management Plan of the company is given in the following table:

OPERATIONAL PHASE:

M/s. Atlas Life Sciences has planned all the necessary steps to control Water Pollution, Air Pollution, noise pollution as well as Hazardous Waste Pollution. The detailed mitigation measures planned during operation phase of the project are as follows:

Activity Environmental Impacts

Mitigation measures Remarks

Construction Phase: Erection of Plant Machineries

• Air • Noise • Socio

Economic

• Well maintained vehicles will be used.

• Metalled Road for Vehicle Movement

• Well maintained equipment will be utilized to prevent noise generation.

• Local labour will be hired for the work so that housing arrangement will be avoided.

Implementation responsibility: Atlas Life Sciences

ix Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



Activity Environmental

Impacts Mitigation measures Remarks

Manufacturing of Products

o Air o Land o Water o Noise

• Ensure proper handling of all chemical by introducing spill control procedures.

• Ensure usages of PPE’s by workers.

• Strictly following the appropriate spill control procedures.

• The charging of the hazardous chemical will be done through very carefully.

• MSDS of Raw material & products will be displayed at storage & handling area.

• Water usage will be strictly by putting water meter plant wise.

• Monitored data will be analyzed and reviewed time to time.

• Contaminated solid waste will be sent to approve TSDF Facilities.

• Storage area will be designed in line with the factory Act requirement.


x Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



Environmental Management Plan: Operation Phase:


Mitigation Measures Remarks

Operation of Thermic Fluid Heater and Boiler

• Air • Noise • Water

• Ensure proper preventive maintenance of fuel firing system and optimization of air fuel ratio.

• Ensure proper maintenance of machinery to reduce noise level

• After clean up of spillage ensure that disposed it properly.

• Provision of Adequate Stack Height.

• Ensure usage of Personal Protective Equipments.


Operation of Cooling Tower

• Air • Water • Noise

• Ensure proper maintenance of machinery to reduce noise level.

• Blow down is being sent in ETP provided within premises.

xi Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



Environmental Management Plan: Operation Phase

Storage, Handling & Transportation of Raw materials and Products

• Air • Water • Land

• Chemical to be stored in accordance with the rules and regulations of the Safety Department.

• Separate storage area for solid/liquid raw materials.

• Install proper facilities to prevent rain/storm water contamination during the storage of solid raw materials.

• Ensure disposal of used drums, bags as per the rules/regulations.


Transportation of all the raw materials, Finished products & Hazardous wastes.

Air Water Land

• Work will be given to Trained/Approved Transports for the transportation of the raw materials/products.

• TERMCARD will be followed.

• Ensure availability of MSDS of all the raw materials and finished products to the Off-site Emergency team.

Development and maintenance of green belt

• Air. • Land

Ensure development and maintenance of proper green belt as proposed.

Direct / Indirect Employment

• Socio Economic issue

Continue policy of local employment according to the skill and availability of the manpower

xii Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.



CONCLUSION The study brings out the followings: • The proposed project will have easy access to basic infrastructure facilities,

availability of land, fuel, transportation network, power availability, environmental compatibility and well developed pollution control systems.

• Environmental Impact Assessment shows that proposed project activity will not

have any significant impact on existing ambient air quality, ground water quality and noise level.

• Risk to flora, fauna and soil is negligible due to location of project activity and

proposed effective environmental management plan for management and handling of air pollution, hazardous wastes and wastewater.

• Additional greenbelt on available open land area will be further more developed

within the plant premises; there will be positive impact on the ecological environment of the study area.

• There will be Socio-economic benefits due to creation of direct/indirect

employment. Thus, it is concluded that proposed project of M/s. Atlas Life Sciences Will have negligible impact on environment and will become beneficial to the local people after implementation of the mitigation measures and environmental management plan.

xiii Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

Annexure: C

Accreditation Certificate

Accreditation Certificate of M/s. Bhagwati Enviro Care Pvt Ltd.

Draft Environmental Impact Assessment of Proposed Manufacturing unit by M/s. Atlas Life Sciences At

No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad Dist: Ahmedabad, Gujarat.

CHAPTER 1

INTRODUCTION 1.1 PREAMBLE

M/s. Atlas Life Sciences (a division of Atlas Dye chem India Pvt. Ltd.) proposed to start manufacturing of Bulk Drugs products @ 46.85 MT /Month at Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad, Gujarat. As per the EIA Notification-2006, Industry falls under the Project or Activity - 5(f) - Synthetic organic chemicals industry (dyes & dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates).

The Draft EIA studies are carried out as a part of process to obtain Environmental Clearance Certificate for the proposed project. Unit believes in sustainable development and equally concern about environment preservation and pollution control and proposes to provide adequate Environmental Management System to meet desired norms prescribed by statutory authority.

In order to assess the Environmental Impacts of the New Proposed unit, M/s. Atlas Life Sciences Entrusted Bhagwati Enviro Care Pvt Ltd, Ahmedabad (NABET Accredited) to undertake Draft Environmental Impact Assessment Study for various components of the Environment viz., Air, Water, Noise, Land and Socio-economics. This Report presents base line data collected for March - April – May 2017 for Air, Water, Noise, Land etc., for identification and assessment of the impacts.

1.2 IDENTIFICATION OF PROJECT AND PROJECT

PROPONENT

Environment Impact Assessment or EIA is a study to predict the effect of a proposed projection or its activity on the environment. It is a management tool to facilitate appropriate decision; an EIA compares various alternatives for a project and seeks to identify the one, which represents the best combination of economic and environmental costs and benefits.

It helps to identify possible environmental effects of the New Proposed project, proposes measures to mitigate adverse effects and predicts whether there will be significant adverse environmental effects, even after the mitigation is implemented. By considering environmental effects and mitigation early in the project planning cycle, environmental assessment has many benefits, such as protection of environment, optimum utilization of resources and saves

Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

1



overall time and cost of the project.

On 27th January 1994, the Union Ministry of Environment and Forests (MoEF), Government of India, under the Environmental (Protection) Act 1986, promulgated EIA Notification making Environmental Clearance (EC) mandatory for expansion or modernization of any activity or for setting up new projects listed in Schedule of the notification and its subsequent amendments.

On 14th September 2006, a new legislation was passed, which has objectives such as “To formulate a transparent, decentralized and efficient regulatory mechanism; to incorporate necessary environmental safeguards at planning stage; to involve stakeholders in the public consultation process and to identify developmental projects based on impact potential instead of the investment criteria”

The developmental activities requiring Environmental Clearance (EC) are:

• All new projects/activities listed in Schedule;

o Expansion and modernization of existing projects or activities listed in the Schedule to this Notification with addition of capacity beyond the limits specified for the concerned sector, that is, projects or activities which cross the threshold limits given in the Schedule, after expansion or modernization;

o Any change in product - mix in an existing manufacturing unit included

in Schedule beyond the specified range.

The projects or activities shall require prior environmental clearance from the concerned regulatory authority, as the Central Government in the Ministry of Environment and Forests for matters falling under Category ‘A’ in the schedule and at State level the State Environment Impact Assessment Authority SEIAA) for matters falling under Category ‘B’ in the said Schedule, before any construction work, or preparation of land by the project management except for securing the land, is started on the project or activity. As per the provisions of the new re-engineered EIA Notification of 2006, the company requires to obtain prior Environmental Clearance from the State Level Environmental Appraisal Authority or from the Ministry of Environment & Forests, New Delhi as stated in the said Notification. This project falls under Synthetic organic Chemical Industry which is listed in Schedule and falls under Clause No. 5 (f) of Category “B” (Located inside notified industrial area / estate, unit falls under small scale category, water consumption less than 25 KLPD, Fuel Consumption less than 25 MTPM, Unit not covered under MAH category) of Schedule as stated in Environmental Impact Assessment Notification published on 14th September 2006 and its vide amendment.


2



As specified in sub paragraph (ii) of paragraph 2, of the stated Notification of the Government of India, expanded / Proposed project requires prior environmental clearance from the State Level Environment Impact Assessment Authority, Gujarat as, Proposed project is located inside the notified industrial area [Clause No. 5 (f)] of Category “B”. For this the industry is required to submit an Environmental Impact Assessment Study report to State Pollution Control Board for Public hearing and Final EIA report to State Level Expert Appraisal Committee, Gujarat. Unit is located in notified industrial estate so, public hearing is not applicable. In order to assess the Environmental Impacts arising due to the proposed project, the company has appointed M/s. Bhagwati Enviro Care Pvt. Ltd., Ahmedabad to undertake the Environmental Impact Assessment for various components of the Environment.

The growing demand of the various kinds of bulk drugs in the domestic as well as international markets has provided a strong basis to M/s. Atlas Life Sciences for their proposed unit located at Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad, Gujarat.

The proposed project will help in the following aspects.

• To earn a substantial amount of foreign exchange through business development, manufacturer & sales of fine chemical products.

• To generate adequate employment for people in neighbouring areas. • To generate indirect employment.

1.3 OBJECTIVES OF EIA STUDY The project activities are listed in serial No. 5 (f) of the schedule of EIA

Notification, 2006 (synthetic Organic Chemical industries). Since the proposed project is coming up inside the notified industrial area, it is categorized as category ‘B’ and needs the Environmental clearance from State Level Environment Impact Assessment Authority, Gujarat.

The Environmental study undertaken is aimed at identifying existing

Environmental conditions, predicting Environmental impacts associated with the proposed unit and suggesting mitigation measures to mitigate the adverse Environmental impacts. The different activities that are likely to take place have been analyzed and proposed mitigation measures are assessed for their adequacy. Proposed mitigation measures have been considered where necessary.

The study also aims at reflecting the acceptability of the project to different stockholders and at incorporating the concerns rose by them into impact assesment and of the subsequent comprehensive Environmental management Plan and suggest the preventive and mitigative measures to minimize the adverse impacts on the environment and to maximize the beneficial impacts.


3



1.4 LOCATION

The Project Site is located at Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad, Gujarat. Latitude : 23°01'15.40"N Longitude : 72°39'39.72"E

Please refer Figure No. 1.1 for Map of Gujarat State.

Please refer Figure No. 1.2 for Map of Ahmedabad District.

Please refer Figure No. 1.3 for 5 km & 10 km radius map of project site.

Please refer Figure No. 1.4 for Plant Layout.

Please refer Figure No.1.5 for Google Image of M/s. Atlas Life Sciences.

Please refer Figure No.1.6 for Topography Map of M/s. Atlas Life

Sciences.


4



FIGURE NO.1.1

MAP OF GUJARAT STATE

AHMEDABAD DISTRICT


5



FIGURE NO. 1.2

MAP OF AHMEDABAD DISTRICT


6



FIGURE NO. 1.3

5 KM & 10 KM RADIOUS MAP OF THE PROJECT SITE


7



FIGURE NO.1.4 Layout Plan


8



FIGURE NO.1.5

GOOGLE IMAGE OF M/S. ATLAS LIFE SCIENCES

Latitude: 23.020944, Longitude: 72.661028


9



FIGURE NO.1.6

TOPOGRAPHY MAP OF M/S. ATLAS LIFE SCIENCES.


10



1.5 STUDY AREA

To decide whether proposed activity is likely to cause significant adverse environmental effects; the concept of EIA is practiced. Before proceeding the baseline Environmental status, it is important to know the boundary limits and framework where data can be effectively utilized in impact assessment. In keeping with the nature and size of the industry, based on our submitted TOR and additional terms of Reference Issued by State Level Expert Appraisal Committee, Gujarat the study area for detailed studies is an area within a radius of 5 Kms with the Project Site at the center. A Map of the Study Area is presented in Figure No. 1.3

1.6 NEAREST LOCATION FROM THE SITE

Table: 1.1

Nearest locations from the Site

Particulars Details

Address Plot No. C-1, 360-361, GIDC Estate, Odhav, Ahmedabad

Co-ordinates

Latitude 23°01'15.40"N (23.020944)

Longitude 72°39'39.72"E (72.661028)

Nearest Residential area Location is in the GIDC Estate & no residential area within GIDC.

Nearest Airport 6.5 km (Ahmedabad Airport)

Nearest Water Body: Creek/Nallah/ Lake/Pond/Reservoir/Canal

0.7 km Odhav Pond

Nearest National/state Highway NH-8 - 2.3 km

Nearest Railway station Nearest Railway station Kalupur-5.6 km

National Park/Wildlife Sanctuary None within 10 km radius

Note: Aerial distance is given in above table.


11



Table: 1.2 Nearest Industries from the Project Site

1.7 SCOPE & METHODOLOGY OF EIA:

An attempt has been made to carry out a Draft Environmental Impact Assessment Study for M/s. ATLAS LIFE SCIENCES The Scope of EIA adopted for M/s Atlas Life Sciences is based on the TOR approved by SEIAA, Gujarat. The copy of the same is attached here with. Under the scope of EIA, it covers:

• A brief description of project site, its surrounding environment and proposed project facilities.

• To endow with detail description of the raw materials and manufacturing process for existing and proposed products.

• Collection and Assessment of existing environmental baseline status based on the project information, field survey relating to air quality, meteorology, water quality, socio-economic aspects, flora & fauna, existing land use pattern etc. within study area.

• Identification of Impacts due to the proposed project. • Prediction and evaluation of the environmental impacts that may result from

project development. • Outline the Environmental Management Plan (EMP) to mitigate the adverse

impacts due to the proposed project. • Preparation of Risk Assessment Report.

Sr. No. Name of Industry Type of Unit

1. Jay Chemicals

Dyes & Intermediate

2. Samir Chemicals

Dyes & Intermediate

3. Samir Synthesis

Textile Processing

4. Navkar industries

Dyes Mfg

5. Vaibhav Dyestuff

Dyes Mfg

6. Indo Overseas

Dyes Mfg

7. Interseas Industries

Dyes Mfg

8.

Jacktech Hydraulics Mechanical


12



METHODOLOGY FOR EIA:

The methodology adopted for carrying out the Environmental Impact Assessment for the proposed project has been based on the Guidelines issued by Ministry of Environment and Forest (MOEF). An effective EIA calls for identification of environmental parameters likely to be impacted, depending on the activities to be carried out during construction and operation phase of the project.

• Generation and collection of baseline data for valued Environmental components as per approved TOR.

• Identification and quantification of significant Environmental impacts due to the project and associated activities.

• Evaluation of impacts due to proposed activities and preparation of an Environmental impact statement.

• Preparation of appropriate Environmental Management Plan (EMP) surrounding strategies for minimizing identified adverse impacts along with budgetary provisions to be made by the project authorities for implementation of mitigation measures.

• Delineation of post Environmental Quality Monitoring Programme (EQMP) along with organizational setup required for monitoring the effectiveness of mitigation measures.


13



Figure 1.7: Methodology of EIA Study


14



1.8 STRUCTURE OF EIA:

This EIA report has been prepared on the basis of available on-site primary data (survey/ monitoring) and secondary/literature data. The EIA report contains project features, baseline environmental setup, assessment of environmental impacts, and formulation of mitigation measures, environmental management and monitoring plan with risk & assessment Report. The report includes 10 Chapters. The structure of the EIA Report with necessary tables, drawings and annexure is as follows: Chapter 1: Introduction This chapter provides background information on need of project, need of EIA study and brief of the project. The scope and EIA methodology adopted in Preparations of EIA report have also been described in this Chapter. It also covers the identification of project & project proponent, brief description of nature, size, location of the project and its importance to the country and the region. Scope of the study details about the regulatory scoping carried out as per the generic structure given in the EIA Notification, 2006. Chapter 2: Project Description This chapter deals with the project details of the proposed products, with type of project, need for the project, location, size & magnitude of operation including associated activities required by and for the project, proposed schedule for approval and implementation, including technical details of raw material, quality and quantity etc. Chapter 3: Baseline Environmental Conditions This chapter presents the existing environmental status of the study area around the existing project including topography, drainage pattern, water environment, geological, climate, transport system, land use, flora & fauna, socio-economic aspects, basic amenities etc. Environmental assessment of the project site in regard to its capability to receive the proposed new project is also discussed in this Chapter.


15



Chapter 4: Anticipated Environmental Impacts and Mitigation

Measures This chapter describes the overall impacts of the proposed project activities and underscores the areas of concern, which need mitigation measures. It predicts the overall impact of the proposed project on different components of the environment viz. air, water, land, noise, biological, and socio-economic. Chapter 5: Environmental Monitoring Program Technical aspects of monitoring the effectiveness of mitigation measures have been given in this Chapter. Chapter 6: Environmental Management Plan This chapter details the inferences drawn from the environmental impact assessment exercise. It describes the overall impacts of the proposed activities during construction and operation phases and underscores the areas of concern, which need mitigation measures. It also provides mitigation and control measures for environmental management plan (EMP) for minimizing the negative environmental impacts and to strengthen the positive environmental impacts of the proposed project.

Chapter 7: Additional Studies This chapter deals with the Public consultation & Risk assessment carried out for the proposed manufacturing plant. Unit is located in notified area so, public consultation is not required. Chapter 8: Project Benefits This chapter deals with the benefits to the local surrounding people due to New Proposed unit. Chapter 9: Summary & Conclusion This chapter provides the summary and conclusions of the EIA study of the Proposed project with overall justification for implementation of the project and also explanation of how, adverse effects will be mitigated. Chapter 10: Disclosure of Consultants Engaged This chapter provides the disclosure of consultants engaged to carryout the EIA study along with other additional studies.


16



1.9 APPROVED TOR FOR EIA STUDY FROM SEIAA, GUJARAT.


17




18




19




20




21




22




23




24




25



1.10 COMPLIANCE OF TOR

Table: 1.3: TOR COMPLIANCE

GENERIC TERMS OF REFERENCE (TOR) IN RESPECT OF INDUSTRY SECTOR

Sr. No. TOR Compliance Status Page No. 1. Executive Summary (Generic Structure as per

Appendix III A)

Please Refer Annexure A ---

2. Introduction

i. Details of the EIA Consultant including NABET accreditation

Please Refer Annexure – B ---

ii. Information about the project proponent

Please Refer Section 2.4 of Chapter 2.

48

iii. Importance and benefits of the project

Please Refer Section 1.2 & 1.11 of Chapter 1. Section 2.3. of Chapter 2

1 43 47

3. Project Description

i. Cost of project and time of completion.

Please Refer Section 2.26 of Chapter 2. Time of Completion: 03 months after obtaining EC & CTE.

129

ii. Products with capacities for the proposed project.


50

iii. If expansion project, details of existing products with capacities and whether adequate land is available for expansion, reference of earlier EC if any.

This is Proposed Unit

iv. List of raw materials required and their source along with mode of transportation.


54

v. Other chemicals and materials required with quantities and storage capacities.

Please Refer Table 2.7 of Chapter 2.

54


26



vi. Details of Emission, effluents,

hazardous waste generation and their management.

For Air Emission: Please Refer Section 2.16 – 2.19 of Chapter 2. For Water consumption & Effluent Generation: Please Refer Section 2.13 – 2.15 of Chapter 2. For Hazardous Waste Generation: Please Refer Section 2.20 of Chapter 2.

108 – 111

98 – 105

112

vii. Requirement of water, power, with source of supply, status of approval, water balance diagram, man-power requirement (regular and contract).

Please Refer Table 2.2 of Chapter 2, For water balance Diagram, Please Refer Fig 2.1. of Chapter 2, For manpower details, Please Refer table 2.28 of Chapter 2.

49

101

130

viii. Process description along with major equipments and machineries, process flow sheet (quantities) from raw material to products to be provided.

For Process Description with Process flow diagram: Please Refer Section 2.12 of Chapter 2. For major Equipments, machineries, Please Refer Page No. 57

60

49

ix. Hazard identification and details of proposed safety systems.


270

x. Expansion/modernization Proposals:

a. Copy of all the Environmental Clearance(s) including Amendments thereto obtained for the project from MOEF/SEIAA shall be attached as an Annexure. A copy of the compliance of conditions stipulated in all the existing Environmental clearances including Amendments shall be provided. In addition, status of compliance of Consent to Operate for the ongoing /existing operation

This is Proposed Unit. ---


27



of the project from SPCB shall be attached with the EIA-EMP report.

b. In case the existing project has not

obtained Environmental clearance, reasons for not taking EC under the provisions of the EIA Notification 1994 and/or EIA Notification 2006 shall be provided. Copies of Consent to Establish/No Objection Certificate and Consent to Operate (in case of units operating prior to EIA Notification 2006, CTE and CTO of FY 2005-2006) obtained from the SPCB shall be submitted. Further, compliance report to the conditions of consents from the SPCB shall be submitted.

This is Proposed Unit. ----

4. Site Details

i. Location of the project site covering village, Taluka/Tehsil, District and State, Justification for selecting the site, whether other sites were considered.

Please Refer Fig 1.1 to 1.3 of chapter 1 For Justification for selecting the site, Please Refer Section 2.3 of Chapter 2.

5,6,7

47

ii. A Toposheet of the study area of radius of 10km and site location on 1:50,000/1:25,000 scale on an A3/A2 sheet. (Including all eco-sensitive areas and Environmentally sensitive places).

Please Refer Fig 1.6 of chapter 1

10

iii. Details w.r.t. option analysis for selection of site.

----- ----

iv. Layout maps indicating existing unit as well as proposed unit indicating storage area, plant area, greenbelt area, utilities etc.

Please Refer Fig 1.4 of chapter 1.

8

v. Photographs of the proposed and existing (if applicable) plant site. If existing, show photographs of plantation/greenbelt, in particular.


44


28



vi. Land use break-up of total land of the project site (identified and acquired), government/private - agricultural, forest, wasteland, water bodies, settlements, etc shall be included. (not required for industrial area).

Please Refer table 2.3 of Chapter 2.

50

vii. A list of major industries with name and type within study area (10km radius) shall be incorporated. Land use details of the study area.

For list of major industries, Please Refer Table 1.2 of Chapter 1. For Land Use Details, Please Refer section 3.12 of Chapter 3.

12

179

viii. Geological features and Geo-hydrological status of the study area shall be included.

For Geological features, Please Refer Section 3.10.1 of Chapter 3 and For Geo-hydrological status of the study area, Please Refer Section 3.13 of Chapter 3.

174

182

ix. Details of Drainage of the project up to 5km radius of study area. If the site is within 1 km radius of any major river, peak and lean season river discharge as well as flood occurrence frequency based on peak rainfall data of the past 30 years. Details of Flood Level of the project site and maximum Flood Level of the river shall also be provided. (Mega green field projects).

Treated effluent will be evaporated in kettle type evaporator system to achieve zero discharge. Details of rain Water harvesting are shown in Section 2.30 of Chapter 2.

----

136

x. Status of acquisition of land. If acquisition is not complete, stage of the acquisition process and expected time of complete possession of the land.

Land Supporting Document is enclosed in Annexure 08.

406 - 409

xi. R&R details in respect of land in line with state Government policy.

Not Done. ----

5. Forest and wildlife related issues (if applicable):

i. Permission and approval for the use of forest land (forestry clearance), if any, and recommendations of the State Forest Department. (If applicable).

Not Applicable ----


29



ii. Land use map based on High resolution satellite imagery (GPS) of the proposed site delineating the forestland (in case of projects involving forest land more than 40 ha).

For land Use details of the study Area, Please Refer Section 3.12 of Chapter 3.

179

iii. Status of Application submitted for obtaining the stage I forestry clearance along with latest status shall be submitted.]

Not Applicable -----

iv. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere Reserves. Migratory Corridors of Wild Animals, the project proponent shall submit the map duly authenticated by Chief Wildlife Warden showing these features vis-à-vis the project location and the recommendations or comments of the Chief Wildlife Warden-thereon.

Not Applicable. No, National Parks, Sanctuaries, Biosphere Reserves. Migratory Corridors of Wild Animals, located within 10 Km of the Study Area.

-----

v. Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the State Government for conservation of Schedule I fauna, if any exists in the study area.


vi. Copy of application submitted for clearance under the Wildlife (Protection) Act, 1972, to the Standing Committee of the National Board for Wildlife.


6. Environmental Status

i. Determination of atmospheric inversion level at the project site and site-specific micrometeorological data using temperature, relative humidity, hourly wind speed and direction and rainfall.

Please Refer Table No. 4.4, 4.5 & 4.6 of Chapter 4. Please Refer Fig No. 4.1, 4.2 & 4.3 of Chapter 4. For Micrometeorology data Please Refer Section 3.6 of Chapter 3.

229 – 234

237 – 239

152

ii. AAQ data (except monsoon) at 8 For Monitoring Station, Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

30



locations for PM10, PM2.5, SO2, NOX, CO and other parameters relevant to the project shall be collected. The monitoring stations shall be based CPCB guidelines and take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests.

Please Refer table No. 3.2 of Chapter 3. AAQ data of 8 locations is given in table No. 3.4a to 3.4e of Chapter 3.

142

146 - 150

iii. Data of all AAQ measurement for 12 weeks of all stations as per frequency given in the NAQQM Notification of Nov. 2009 along with - min., max., average and 98% values for each of the AAQ parameters from data of all AAQ stations should be provided as an annexure to the EIA Report.

AAQ data of 8 locations is given in table No. 3.4a to 3.4e of Chapter 3. Min., Max., Average and 98% values for each of the AAQ parameters from data of all AAQ stations is shown in table No. 3.3 of Chapter 3.

146 - 150

143

iv. Surface water quality of nearby River (100m upstream and downstream of discharge point) and other surface drains at eight locations as per CPCB/MoEF & CC guidelines.

Treated effluent will be evaporated in kettle type evaporator system to achieve zero discharge.

-----

v. Whether the site falls near to polluted stretch of river identified by the CPCB/MoEF & CC, if yes give details.


vi. Ground water monitoring at minimum at 8 locations shall be included.

Please Refer Table No. 3.11 of Chapter 3.

169

vii. Noise levels monitoring at 8 locations within the study area.


161

viii. Soil Characteristic as per CPCB guidelines.


176

ix. Traffic study of the area, type of vehicles, frequency of vehicles for transportation of materials, additional traffic due to proposed project, parking arrangement etc.


244

x. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study area shall be given with special reference to rare, endemic and


186


31



endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared and furnished.

No Schedule-I fauna are found within the study area.

xi. Socio-economic status of the study area.


195

7. Impact and Environmental Management Plan

i. Assessment of ground level concentration of pollutants from the stack emission based on site-specific meteorological features. In case the project is located on a hilly terrain, the AQIP Modeling shall be done using inputs of the specific terrain characteristics for determining the potential impacts of the project on the AAQ. Cumulative impact of all sources of emissions (including transportation) on the AAQ of the area shall be assessed. Details of the model used and the input data used for modeling shall also be provided. The air quality contours shall be plotted on a location map showing the location of project site, habitation nearby, sensitive receptors, if any.

Please Refer Section 4.6 of Chapter 4. For Air Quality Contours, Please refer Fig. 4.1, 4.2 & 4.3 of Chapter 4.

235

237 - 239

ii. Water Quality modeling - in case of discharge in water body

Not Applicable. ----

iii. Impact of the transport of the raw materials and end products on the surrounding Environmental shall be assessed and provided. In this regard, options for transport of raw materials and finished products and wastes (large quantities) by rail or rail-cum road transport or conveyor cum-rail transport shall be examined.


244

iv. A note on treatment of wastewater from different plant operations, extent recycled and reused for different

Please Refer Section 2.13 – 2.15 of Chapter 2.

98 - 105


32



purposes shall be included. Complete scheme of effluent treatment. Characteristics of untreated and treated effluent to meet the prescribed standards of discharge under E(P) Rules.

v. Details of stack emission and action

plan for control of emissions to meet standards.

Please Refer Section 2.16 – 2.18 of Chapter 2.

108 - 110

vi. Measures for fugitive emission control.


111

vii. Details of hazardous waste generation and their storage, utilization and management. Copies of MOU regarding utilization of solid and hazardous waste in cement plant shall also be included. EMP shall include the concept of waste-minimization, recycle/reuse/recover techniques, Energy conservation, and natural resource conservation.

For Details of hazardous waste generation and their storage, utilization and management, Please Refer Section 2.20 of Chapter 2. For, concept of waste-minimization, recycle/reuse/recover techniques, Energy conservation, and natural resource conservation - Please Refer Section 6.12 of Chapter 6.

112

285

viii. Proper utilization of fly ash shall be ensured as per Fly Ash Notification, 2009. A detailed plan of action shall be provided.

There will be no Ash generate.

----

ix. Action plan for the green belt development plan in 33 % area i.e. land with not less than 1,500 trees per ha. Giving details of species, width of plantation, planning schedule etc. shall be included. The green belt shall be around the project boundary and a scheme for greening of the roads used for the project shall also be incorporated.


131


33



x. Action plan for rainwater harvesting

measures at plant site shall be submitted to harvest rainwater from the roof tops and storm water drains to recharge the ground water and also to use for the various activities at the project site to conserve fresh water and reduce the water requirement from other sources.


136

xi. Total capital cost and recurring cost/annum for Environmental pollution control measures shall be included.

Please Refer table No.2.22 of Chapter 2.

129

xii. Action plan for post-project Environmental monitoring shall be submitted.

Please Refer table No. 5.1 of Chapter 5.

247

xiii. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency Management Plan including Risk Assessment and damage control. Disaster management plan should be linked with District Disaster Management Plan.

Please Refer Section 7.3 of Chapter 7. Risk Assessment Report is enclosed in Annexure -01.

299

326 - 400

8. Occupational health

i. Plan and fund allocation to ensure the occupational health & safety of all contract and casual workers.

Please Refer table 6.1 of Chapter 6.

284

ii. Details of exposure specific health status evaluation of worker. If the workers' health is being evaluated by pre designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far & Near vision, color vision and any other ocular defect) ECG, during pre placement and periodical examinations give the details of the same. Details regarding last month analyzed data of above mentioned parameters as per age, sex, duration of exposure and department wise.

Please Refer Section 6.7 & 6.8 of Chapter 6.

260 - 268

iii. Details of existing Occupational & Please Refer Section 6.7, 6.8, 260 - 270


34



Safety Hazards. What are the exposure levels of hazards and whether they are within Permissible Exposure level (PEL). If these are not within PEL, what measures the company has adopted to keep them within PEL so that health of the workers can be preserved.

6.9 of Chapter 6.

iv. Annual report of heath status of workers with special reference to Occupational Health and Safety.

After Proposed activity of the project, all the data of the medical checkups of workers will be kept as per Form 37.

----

9. Corporate Environmental Policy

i. Does the company have a well laid down Environmental Policy approved by its Board of Directors? If so, it may be detailed in the EIA report.


292

ii. Does the Environmental Policy prescribe for standard operating process / procedures to bring into focus any infringement / deviation / violation of the Environmental or forest norms / conditions? If so, it may be detailed in the EIA.


292

iii. What is the hierarchical system or Administrative order of the company to deal with the Environmental issues and for ensuring compliance with the Environmental clearance conditions? Details of this system may be given.

Please Refer Figure 6.1 of Chapter 6.

258

iv. Does the company have system of reporting of non compliances / violations of Environmental norms to the Board of Directors of the company and / or shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report.


292


35



10. Details regarding infrastructure

facilities such as sanitation, fuel, restroom etc. to be provided to the labour force during construction as well as to the casual workers including truck drivers during operation phase.


293

11 Enterprise Social Commitment (ESC)

i. Adequate funds (at least 2.5 % of the project cost) shall be earmarked towards the Enterprise Social Commitment based on Public Hearing issues and item-wise details along with time bound action plan shall be included. Socio-economic development activities need to be elaborated upon.

The industry will provide 2.5 % of the project cost Towards the Enterprise Commitment. Socio Economic development activities.

-----

12. Any litigation pending against the project and/or any direction/order passed by any Court of Law against the project, if so, details thereof shall also be included. Has the unit received any notice under the Section 5 of Environmental (Protection) Act, 1986 or relevant Sections of Air and Water Acts? If so, details thereof and compliance/ATR to the notice(s) and present status of the case.

No litigation pending against the project and No any direction/order passed by any Court of Law against the project.

------

13. 'A tabular chart with index for point wise compliance of above TOR.

Given herewith in Section 1.10 of Chapter 1.

26

A. Specific TOR / Additional TOR

1. A tabular chart with index for Point wise compliance of below mentioned TORs.

Given herewith in Section 1.10 of Chapter 1.

26

2. Copy of plot holding certificate obtained from GIDC Odhav.

Please Refer Annexure - 05 406 - 409

3. Exact aerial distance from the CEPI area of Vatva from the project premises.

Exact aerial distance as per the Google Earth is 5.13 km from the project boundary to last corner of last plot of GIDC Phase-IV, Vatva towards Odhav direction. Pls. refer figure 1.3, page no.7

7 Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

36



of chapter-1.

4. Present land use pattern of the study area shall be given based on satellite imagery.

For, Landuse details, Please Refer section 3.12 of chapter 3

179

5. Layout plan of the factory premises. Provision of separate entry & exit and adequate margin all-round the periphery for unobstructed easy movement of the emergency vehicle / fire tenders without reversing back. Mark the same in the plant layout.

Please Refer Figure – 1.4 of Chapter 1

8

6. Proposed monthly production of each product and product wise monthly consumption of each raw material.

For product details – Please Refer Table - 2.4 of chapter 2 For Raw Material details - Please Refer Table 2.7 of chapter 2

50

54

7. Manufacturing process along with chemical reactions, mass balance for each product.

For Manufacturing process along with chemical reactions, mass balance for each product – Please Refer section 2.12 of chapter 2

60

8. Assessment of source of the water supply With adequacy of the same to meet with the requirements for the project. Copy of permission letter obtained from the CGWA or concern authority for drawl of raw water.

Total maximum fresh water demand will be tune around 13.0 KLD which will be satisfied by the GIDC water supply, Odhav.

9. Water balance diagram (including reuse- recycle, if any) along with qualitative and quantitative analysis of each waste stream to be generated.

For water Balance diagram - Pls. refer figure 2.1, of chapter 2. For qualitative and quantitative analysis of each waste stream to be generated – Please Refer Table No. 2.9 – 2.12 of chapter 2

101

99 - 104

10. Plans for management and disposal of waste streams to be generated from spillage, leakages, vessel washing, used container washing etc. Measures proposed for preventing effluent discharge during unforeseen circumstances.

What so ever effluent generated that will be treated in ETP and finally evaporate into evaporator to achieve zero discharge.

11. Details of the ETP including size of each unit, retention time, other technical

For ETP details – Please Refer section 2.15 of Chapter

105


37



parameters etc. and its adequacy and efficacy report. Treatment of phenol in the effluent, if any. Action plan for ‘Zero’ discharge of effluent shall be included.

2 No use of phenol & phenol related compound in process and no chances to generate phenolic compound.

12. Explore the possibility of reuse/recycle and other cleaner production options for reduction of wastes and to conserve fresh water.

Our effluent qty. is very less i.e. 2.2 KLD and condensate after evaporation is reuse for greenbelt development and no other possibility to conserve water. Please Refer water balance diagram of fig 2.1 in chapter 2

101

13. Details of provisions to be made for evaporation of industrial effluent. Technical details of effluent evaporation system including evaporation capacity, steam required for evaporation, adequacy of the boilers to supply steam for evaporation in addition to the steam required for the process etc. Techno- economical viability of the evaporation system. Effective evaporation system shall be designed in such a way to strip or absorb the VOCs and effective stack height shall be provided to the evaporation system.

Please Refer section 2.15 of Chapter 2

106 - 107

14. Details of possibility of chemical seepage & consequent soil contamination & mitigation measure proposed for the same for the proposed project.

Proper handling of chemicals to avoid of seepage/spillages. We will evaporate entire qty. of generated effluent in close manner and no chances of any seepage and soil contamination.

15. One season Site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall should be incorporated.

Please Refer Section-3.6 of chapter 3.

152

16. Anticipated Environmental impacts due to Baseline study was 236 - 244


38



the proposed project/production may be evaluated for significance and based on corresponding likely impacts VECs (Valued Environmental Components) may be identified. Baseline studies may be conducted within the study area of 5 km for all the concerned/identified VECs and likely impacts will have to be assessed for their magnitude in order to identify mitigation measures.

conducted within the study area of 5 km from the proposed project site. For impact details, please refer section-4.7 to 4.14 of chapter 4.

17. One complete season base line ambient air quality data (except monsoon) to be given along with the dates of monitoring. The parameters to be covered shall be in accordance with the revised National Ambient Air Quality Standards as well as project specific parameters. Locations of the monitoring stations should be so decided so as to take into consideration the pre-dominant downwind direction, population zone and sensitive receptors. There should be at least one monitoring station in the upwind direction. There should be at least one monitoring station in the pre dominant downwind direction at a Location where maximum ground level concentration is likely to occur.

For monitoring station, please refer table No. 3.2 of chapter 3. AAQ data of 08 locations is given in table No 3.3 to 3.4 of chapter3.

142

143 - 146

18. Modeling indicating the likely impact on ambient air quality due to proposed activities. The details of model used and input parameters used for modeling should be provided. The air quality contours may be shown on location map clearly indicating the location of sensitive receptors, if any, and the habitation. The wind rose showing pre-dominant wind direction should also be indicated on the map. Impact due to vehicular movement shall also be included into the prediction using suitable model. Results of Air dispersion modeling should be superimposed on satellite image / geographical area map.

For Air Quality countor, Please Refer Figure 4.1, 4.2, 4.3 of chapter 4. For Windrose diagram, Please Refer Figure No.- 3.4 of Chapter 3.

237 – 239

154

19. Base line status of the noise Please Refer table No. 3.10 161 Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

39



Environmental, impact of noise on present Environmental due to the project and proposed measures for noise reduction including engineering controls.

For Noise Impact, Please Refer Section 4.9 of Chapter 4

241

20. Specific details of (i) Details of the utilities required (ii) Type and quantity of fuel to be used for each utility (iii) Flue gas emission rate from each utility (iv) Air Pollution Control Measures proposed to each of the utility along with its adequacy (v) List the sources of fugitive emission along with its quantification and proposed measures to control it.

For Details of the utilities required (ii) Type and quantity of fuel to be used for each utility (iii) Flue gas emission rate from each utility (iv) Air Pollution Control Measures proposed to each of the utility along with its adequacy (v) List the sources of fugitive emission along with its quantification and proposed measures to control it. Please Refer section 2.16 – 2.19 of chapter 2

108 - 111

21. Specific details of fugitive emission from the unit along with its quantification and proposed measures to control it along with measures proposed to monitor VOC within work area. Details of ventilation system proposed in the work area. Measures proposed to keep the work area environment as per the norms of GFR.

For fugitive emission details – Pl. Refer section 2.18 of chapter 2. For Measures proposed to keep the work area environment as per the norms of GFR – Pl. Refer section 5.2 and 5.3 of chapter 5.

110

249 - 250

22. Details of measures proposed for noise pollution abatement & its monitoring.

For noise pollution abatement. Pls. refer table section 2.21 of chapter 2. For noise level monitoring – Pl. Refer Table No. 3.10 of chapter 3

113

161

23. Details of management of the hazardous wastes to be generated from the project stating detail of storage area for each type of waste, its handling and its disposal. How the manual handling of the hazardous wastes will be minimized?

Pl. Refer section 2.20 of chapter 2

112

24. Methodology of de-contamination and disposal of discarded containers and its record keeping.

Drums will be washed by appropriate solvents which are generally used in process with same chemicals and washed solvent use for the next batch of respective product. Hence no


40



generation of waste from decontamination process. Log sheet will be regularly maintained for generation, decontamination & sell of containers.

25. Measures proposed to be taken for the work area ambient air quality monitoring as per Gujarat Factories Rules.

Pl. Refer sec 5.2 and 5.3 of chapter 5

249 - 250

26. A detailed EMP including the protection and mitigation measures for impact on human health and Environmental as well as detailed monitoring plan and Environmental management cell proposed for implementation and monitoring of EMP.

For Environmental Management Plan, Please Refer section -6.4 of chapter -6. For Environmental Monitoring Plan, Please Refer, Table 5.1 of chapter 5.

254

247

27. Detailed socio-economic development Measures including community welfare program most useful in the project area for the overall improvement of the environment.

Pls. refer sec. 6.14, of chapter - 6 for socio economic activities.

290

28. A detailed Green Belt Development Program including annual budget, types & number of trees to be planted, area under greenbelt development [with map]; along with commitment of the management to carry out the tree plantation activities outside the premises at appropriate places in the GIDC area and elsewhere.

For Details of greenbelt development – Please Refer section 2.29 of chapter 2

131

29. Details of hazardous characteristics and toxicity of raw materials and products to be handled and the control measures proposed to ensure safety and avoid the human health impacts. This shall include the details of Antidotes also.

For Details of hazardous characteristics and Toxicity of raw materials and products to be handled and the control measures proposed to ensure safety and avoid the human health impacts – please Refer section 2.2. – 2.23 of chapter 2. For Antidotes of chemicals – please Refer Table 2.21 of chapter 2.

114 – 125

127 30. Details of quantity of each hazardous

chemical to be stored, Material of Construction of major hazardous chemical

Please Refer sec 2.10 of chapter 2.

56


41



storage tanks, threshold storage quantity as per schedules of the Manufacture, Storage & Import of Hazardous Chemicals Rules of major hazardous chemicals. How the manual handling of the hazardous chemicals will be minimized?

For Hazardous chemicals – Please Refer table No. 2.20 of chapter 2.

114

31. Details of the separate isolated storage area for flammable chemicals. Details of flame proof electrical fittings, DCP extinguishers and other safety measures proposed.

Please refer section 2.23, 2.24, and 2.25 of chapter 2.

125 - 128

32. Specific safety details/provisions for Various hazardous chemicals and detailed fire control plan for flammable substances.

There is very limited inventory of Hazardous chemicals. Summary of fire fighting system is given in section 2.25 of chapter 2.

128

33. Details of possibilities of occupational Health hazards from the proposed manufacturing activities and proposed measures to prevent them.

Details of occupational health and safety including medical surveillance are covered under section 6.8 – 6.10 of chapter 6

268 - 282

34. Detailed risk assessment report including prediction of the worst-case scenario and maximum credible accident scenario along with damage distances and preparedness plan to combat such situation and risk mitigation measures. Vulnerable zone demarcation.

Please Refer Annexure -01 326 - 400

35. Submit checklist in the form of Do’s & Don’ts of preventive maintenance, strengthening of HSE, manufacturing utility staff for safety related measures.

Please Refer section – 6.13 of chapter 6.

288

36. Certificate of accreditation issued by the NABET, QCI to the environmental consultant should be incorporated in the EIA Report.

Please Refer Annexure B ---

37. An undertaking by the project proponent on the ownership of the EIA report as per the MoEF &CC OM dated 05/10/2011 and an undertaking by the consultant regarding the prescribed TORs have been complied with and the data submitted is factually correct as per the MoEF & CC OM dated 04-08-2009.

For Undertaking of Project proponent – please Refer Annexure – 06 For Undertaking of Consultant – please Refer Annexure – 07

410

411


42



1.11 Regulatory Frame work

The proposed project is yet at its technical investigation stage. Prior to its implementation, it will be necessary to acquire all the necessary clearance from the Government of India, as per the applicable national regulations. Key clearances include obtaining the No Objection Certificate from the Gujarat Pollution Control Board (GPCB) under The Water (Prevention and Control of Pollution) Act, 1974 and Rules, 1975; The Air (Prevention and Control of Pollution) Act, 1981 and Rules, 1982. In addition to that Manufacture, Storage and Import of Hazardous Chemicals (MSIHC) Rules, 1989 and amendments thereafter, Hazardous Waste (Management, Handling and Transboundary Movement) Rules, 2008 will also be applicable to the industry. The purpose of the study is to comply with legal requirements as per

Environmental Impact Assessment (EIA) Notification, 14th September 2006 (and

subsequent amendments) of Ministry of Environment and Forests (MoEF) Since

the proposed project M/s Atlas life sciences at C-1, 360-361,GIDC Estate,

Odhav, Ahmedabad will manufacture bulk drug products. The proposed project

falls under Category: 5(f) B. As per the Environmental Impact Assessment

notification, dated September 14, 2006 the project requires prior environmental

clearance from The State Level Environment Impact Assessment Authority,

Gujarat.

As per the requirements of the notification, an application in Form 1 was submitted to State level Appraisal Committee on 27-05-2016. The Terms of Reference (TOR) were discussed during meeting of State Level Environment Impact Assessment Authority, Gujarat held on 29-04-2017 and the ‘TORs’ were issued on 29-04-2017 for preparation of EIA/EMP. A copy of the TOR is included in chapter 1 of this EIA Report.

As per the requirements of the TOR and to estimate the environmental impacts

arising due to its proposed project, M/s. Atlas Life Sciences retain M/s. Bhagwati

Enviro Care Pvt. Ltd., Ahmedabad, to carry out Environmental Impact

Assessment study for various environmental components including air, noise,

water, land and biological components along with parameters of human interest

which may be affected and to prepare Environmental Management Plan (EMP)

for mitigating adverse impacts.

The environmental impact assessment report has been prepared for obtaining environmental clearance for the proposed activity for M/s. Atlas Life Sciences.


43



1.12 Photographs of the Plant site.


44




45



CHAPTER 2 PROJECT DESCRIPTION

2.1 PRELUDE

M/s. Atlas Life Sciences is a proposed unit located at Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad, Gujarat. In proposed unit they have decided to manufacture Pharmaceuticals bulk drugs @ 46.85 MT/Month. Considering scale of unit and its categorization, according to EIA notification dated 14th September 2006, by Ministry of Environment & Forest (MoEF), Government of India, their Proposed manufacturing activity is falls under Synthetic Organic Chemicals – Schedule 5(f)) & cat -B. For that unit needs Environmental clearance from State Level Environment Impact Assessment Authority, Gandhinagar, Gujarat. In order to assess the Environmental Impacts of the New proposed project, M/s Atlas Life Sciences entrusted Bhagwati Enviro Care Pvt Ltd, Ahmedabad (NABET Accredited) to undertake Draft Environmental Impact Assessment Study for various components of the Environment viz., Air, Water, Noise, Land and Socio-economics. This Report presents base line data collected for March-April-May-2017 for Air, Water, Noise, Land etc., for identification and assessment of the impacts.

2.2 LOCATION

The location of the project is as shown here in Table 2.1. TABLE 2.1

LOCATION OF THE PROJECT SITE Sr. No. Description Information

1 Latitude 23°01'15.40"N (23.020944) 2 Longitude 72°39'39.72"E (72.661028) 3 Plot.No. C-1, 360-361, 4 GIDC/Estate GIDC Estate, 5 Village Odhav, /Ahmedabad 5 Ta Ahmedabad 6 Dist Ahmedabad 7 State Gujarat




2.3 JUSTIFICATION OF PROJECT SITE The promoters are interested for setting up the project considering the following technical and economical features of the project:

• Increasing demand for the end products in the global as well as local market.

• Availability of the finance through internal and external sources.

• Use of environmental friendly technology for the manufacturing of bulk drugs.

• Availability of major raw material in the nearby vicinity

To meet the current market requirement M/s Atlas Life Sciences has intended to do proposed manufacturing activity at Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad. Specific site selection criteria of the unit have been given below.

• Plot size is suitable for proposed project. • Availability of the set up and the utility and support facilities within the

same premises. • The project site is well connected by road to National Highway No. NH 48,

which is about 1.5 km, E away from project site and NH 8 is 2.7 km W away from the project site.

• The proposed unit is located in Industrial Estate, including Availability of infrastructure facility like power, water supply, road drainage, manpower etc.

• There are no ecological sensitive areas located within 10 km radius of the project site.

• No any national park or wild life sanctuary located within 10 km radius of the project site.

• Availability of good communication and transport facilities.




2.4 PROMOTERS & THEIR BACKGROUND

2.5 INFRASTRUCTURE FACILITIES

Because of availability of space for project in the premises itself it becomes easy for the unit. The other supporting factor for justifying the location is mentioned as under:

• Due to Sufficient land area and residential area is away from the site and the

unit is in GIDC. • Availability of basic facilities like water, fuel, power, man power and raw

materials. • The proposed location is having connectivity with other parts of the country by

road and rail. • Availability of good communication and transportation facilities.

No national park, reserved forest or wild habitats as well as site of archeological significance or ecological importance fall within 10 km radius of the project site.

The details of resources are mentioned in Table No. 2.2:

Sr. No. Name Designation Postal Address

1 Mr. Jagdish K Sheth

Managing Director 2nd floor, Shiromani Complex, Satellite road, Ahmedabad-15 Email: [email protected]; contact @atlaslifesciences.com Cell: 9376761122

2 Mr. Keyur J Sheth Executive Director 2nd floor, Shiromani Complex, Satellite road, Ahmedabad-15 Email: [email protected]; contact @atlaslifesciences.com








TABLE NO. 2.2 DETAILS OF SOURCES

List of Plant Machineries for Proposed production Activity:

1. Reactor

2. Vessel

3. Boiler

4. TFH

5. DG set

6. RO System

Sr. no.

Project Requirements

Total Source/Remarks

1. Total Fresh Water 15 KL/Day GIDC Estate, Odhav

2. Power 65 KVA Torrent Power

25 KVA DG Set

3. Fuel Requirement

A Natural gas 3000 SCM/Day Adani Natural gas Supplier

B Diesel 10 L/Hr (DG set) Trader




2.6 LAND USE BREAKUP FOR TOTAL PLOT AREA

TABLE: 2.3 LAND USE BREAKUP FOR TOTAL PLOT AREA

Sr. No. Particulars Proposed

(Sq. m.) % of Land Use

1 Plant facilities 400 30.28 2 Storage (RM & Finished

Products) 150

11.35 3 Storage (Fuel & water) 70 5.29 4 Utilities 131 9.91 5 Internal Road 270 20.43 6 Green Belt 200 15.14 7 Office 50 3.80 8 Parking 50 3.80

Total 1321 100.00

2.7 PRODUCT DETAIL

List of products & capacity are given in the Table No. 2.4

TABLE NO 2.4 LIST OF PRODUCTS

Sr. No.

Name of Products CAS No. Qty. (MT/month)

1. Phenylephrine HCl 61-76-7 4.0

2. Pregabalin 148553-50-8 6.0

3. Levosulpiride 23672-07-3 1.0

4. Linezolid 165800-03-3 2.0

5. Olmesartan Medoxomil 144689-63-4 1.0

6. Gabapentin 60142-96-3 5.0

7. Levetirecetam 102767-28-2 2.0




8. Pantoprazole Sodium

Monohydride 138786-67-1 3.0

9. Sucralfate 54182-58-0 10.0

10. Montelukast sodium 151767-02-1 2.0

11. Telmisartan 144701-48-4 2.0

12. Amlodipine Besylate 88150-42-9 3.0

13. Silodosin 160970-54-7 0.1

14. Olenzapine 132539-06-1 1.0

15. Glimepride 93479-97-1 2.0

16. Chlorthalidone 77-36-1 2.0

17. Tapentadol HCl 175591-09-0. 0.5

18. Voricanazole 137234-62-9 0.25

Total 46.85




Chemical name of each products are given in the Table No. 2.5

TABLE NO. 2.5 CHEMICAL NAME OF PRODUCTS

Sr. No.

Name of Products Chemical / IUPAC Name

1. Phenylephrine HCl 3-[(1R)-1-hydroxy-2-(methylamine)ethyl] phenol; hydrochloride

2. Pregabalin (S)-3-(Aminomethyl)-5-methylhexanoic acid 3. Levosulpiride N-[[(2S)-1-ethylpyrrolidin-2-yl]methyl]-2-methoxy-5-

sulfamoylbenzamide 4. Linezolid N-((3-(3-fluoro-4-morpholinylphenyl)-2-oxo-5-

oxazolidinyl)methyl)acetamide 5. Olmesartan Medoxomil 5-Methyl-2-oxo-1,3-dioxolen-4-yl)methoxy-4-(1-

hydroxy-1-methylethyl)-2-propyl-1-(4-(2-(tetrazol-5-yl)phenyl)phenyl)methylimidazol-5-carboxylate

6. Gabapentin 1-(Aminomethyl) cyclohexane acetic acid 7. Levetirecetam alpha-ethyl-2-oxo-1-pyrrolidineacetamide 8. Pantoprazole Sodium

Monohydride 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-2,3-dihydro-, sodium salt, hydrate (1:1:1)

9. Sucralfate Aluminum Sucrose Sulfate 10. Montelukast sodium sodium 1-(((1-(3-(2-(7-chloro-2-

quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropylacetate

11. Telmisartan 4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H-benzimidazol)-1'-yl)methyl)-(1,1'-biphenyl)-2-carboxylic acid

12. Amlodipine Besylate Amlodipine, (S)-Isomer, Maleate (1:1) 13. Silodosin 1-(3-hydroxypropyl)-5-(2-(2-(2-(2,2,2-

trifluoroethoxy)phenoxy)ethylamino)propyl)indoline-7-carboxamide

14. Olenzapine 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno(2,3-b)(1,5)benzodiazepine

15. Glimepride 1-(4-(2-(3-ethyl-4-methyl-2-oxo-3-pyrrolinecarboxamido)ethyl)phenylsulfonyl)-3-(4-methylcyclohexyl)urea




16. Chlorthalidone Chlorphthalidolone 17. Tapentadol HCl 2-Chlor-5-(1-hydroxy-3-oxo-2,3-dihydro-1H-isoindol-1-

yl)benzolsulfonamid 18. Voricanazole (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-

yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol 2.8 PACKING AND FINAL APPLICATION OF PRODUCTS

TABLE NO .2.6

PACKING AND FINAL APPLICATION OF PRODUCTS

Sr. No.

Name of Product Type of Packing Storage facility Final application of

product 1. Phenylephrine HCl HDPE/Fibre Drum Room Temperature

In Pharmaceutical

industry

2. Pregabalin HDPE/Fibre Drum Room Temperature 3. Levosulpiride HDPE/Fibre Drum Room Temperature 4. Linezolid HDPE/Fibre Drum Room Temperature –

Powder 5. Olmesartan Medoxomil HDPE/Fibre Drum Below 25˚C Temperature

(20-25˚C), Protect from Moisture – Powder

6. Gabapentin HDPE/Fibre Drum Room Temperature

7. Levetirecetam HDPE/Fibre Drum Room Temperature


HDPE/Fibre Drum Room Temperature

9. Sucralfate HDPE Drum Room Temperature

10. Montelukast sodium HDPE Drum Room Temperature

11. Telmisartan HDPE Drum Room Temperature

12. Amlodipine Besylate HDPE Drum Room Temperature

13. Silodosin HDPE/Fibre Drum Room Temperature 14. Olenzapine HDPE/Fibre Drum 2-8˚C / 18 Months

25˚C / 6 Months 15. Glimepride HDPE/Fibre Drum Room Temperature 16 Chlorthalidone HDPE/Fibre Drum –20 17 Tapentadol HCl HDPE/Fibre Drum Room Temperature 18 Voricanazole HDPE/Fibre Drum 15-20˚C




2.9 RAW MATERIALS REQUIREMENT

List of Raw Materials, with consumption for manufacturing of Proposed Products, is given in Table No. 2.7

TABLE NO.2.7

DETAILS OF RAW MATERIALS

Sr. No Name of Raw Material Quantity (MT/Month) 1 L-Phenylephrine base 3.636 2 IPA 4.273 3 Methanol 5.516 4 IPA+HCl 0.327 5 Activated charcoal 0.752 6 (s)-(+)-3-aminomethyl-5-Methylhexanoic acid 6.316 7 N-{[(2S)-1-Ethylpyrrolidine-2-yl]-

methyl}-2- methoxy-5-sulfamoyl benzamide 1.053

8 n-Propanol 0.426 9 Linezolid crude 2.128 10 Acetone 1.878 11 Olmesartan Medoxomil crude 1.053 12 Gabapentin crude 5.376 13 Ethyl acetate 2.234 14 Levetirecetam crude 2.128 15 Pantoprazole Sodium crude 3.128 16 Tapentadol HCl crude 0.521 17 Voricanazole crude 0.272 18 Acetonitrile 0.032 19 Sucralfate crude 10.526 20 Montelukast crude 2.128 21 Toluene 0.16 22 N-Haptane 0.277 23 Telmisartan Crude 2.105 24 Acetic acid 0.526 25 Activated carbon 0.229 26 Amlodipine Besylate crude 3.191 27 Silodosin crude 0.105 28 Olenzapine Crude 1.064




29 MDC 0.266 30 Glimepride Crude 2.128 31 Chlorthalidone crude 2.083

Mode of Transportation: Road Source: Chemical Mfg. Units located in Kalol, Ahmedabad, Ankleshwar, Vapi, Vadodara etc, various Traders and Export from other Countries.




2.10 PHYSICAL FORM AND STORAGE OF RAW MATERIAL:

No. Name of Raw

Material CAS No. Physical

Form Container

Type MOC of

Container Storage capacity of each container

Maximum storage at a time (MT)

1. L-Phenylephrine base 61-76-7. Solid Fibre/HDPE Carboys

Fibre/HDPE 25.00 kg. 1.0 MT

2. Iso propyl Alcohol 67-63-0. Liquid MS Drums MS 200 L 5.0 MT 3. Methanol 67-56-1 Liquid MS Drums MS 200 L 5.0 MT 4. HCl 7647-01-0 Liquid HDPE Drum /

Carboys HDPE 200 L 0.5 MT

5. Activated charcoal 7440-44-0 Solid Bags --- 20.00 kg. 30.00 kg.

0.3 MT

6. (s)-(+)-3-aminomethyl-5-Methylhexanoic acid

128013-69-4 Solid Fibre/HDPE Carboys


7. N-{[(2S)-1-Ethylpyrrolidine-2-yl]- methyl}-2- methoxy-5-sulfamoyl benzamide

33045-52-2 Solid Fibre/HDPE Carboys


8. n-Propanol 102-60-3 Liquid MS Drums MS 200 L 1.0 MT 9. Linezolid crude 165800-03-3 Solid Fibre/HDPE

Carboys Fibre/HDPE 25.00 kg. 1.0 MT




No. Name of Raw Material

CAS No. Physical Form

Container Type

MOC of Container

Storage capacity of each container


10. Acetone 67-64-1 Liquid MS Drums MS 200 L 1.0 MT 11. Olmesartan

Medoxomil crude 144689-63-4 Solid HDPE/Fibre

Carboys HDPE/Fibre 25.00 kg. 0.50 MT

12. Gabapentin crude 60142-96-3 Solid HDPE/Fibre Carboys

HDPE/Fibre 25.00 kg. 2.0 MT

13. Ethyl acetate 141-78-6 Liquid MS Drums MS 200 L 1.0 MT 14. Levetirecetam crude 102767-28-2 Solid HDPE/Fibre


15. Pantoprazole Sodium crude

138786-67-1 Solid HDPE/Fibre Carboys


16. Tapentadol HCl crude 175591-09-0 Solid HDPE/Fibre Carboys


17. Voricanazole crude 2491-20-5 Solid HDPE/Fibre Carboys


18. Acetonitrile 75-05-8 Liquid MS Drums MS 200 L 1.0 MT 19. Sucralfate crude 54182-58-0 Solid HDPE/Fibre





No. Name of Raw Material

CAS No. Physical Form

Container Type

MOC of Container

Storage capacity of each container


20. Montelukast crude 151767-02-1 Solid HDPE/Fibre Carboys


21. Toluene 108-88-3 Liquid MS Drums MS 200 L 1.0 MT 22. N-Haptane 142-82-5 Liquid MS Drums MS 200 L 1.0 MT 23. Telmisartan Crude 144701-48-4 Solid HDPE/Fibre HDPE/Fibre 25.00 kg. 0.50 MT 24. Acetic acid 64-19-7 Liquid HDPE Carboys HDPE 30-35 kg. 0.50 MT 25. Amlodipine Besylate

crude 111470-99- Solid HDPE/Fibre


26. Silodosin crude 160970-54-7 Solid HDPE/Fibre Carboys


27. Olenzapine Crude 132539-06-1 Solid HDPE/Fibre Carboys


28. MDC 75-09-2 Liquid HDPE Drums HDPE 200 L 1.5 MT 29. Glimepride Crude 119018-29-0 Solid HDPE/Fibre


30. Chlorthalidone crude 77-36-1 Solid HDPE/Fibre Carboys





2.11 PHYSICAL AND CHEMICAL PROPERTIES OF THE HAZARDOUS RAW MATERIAL

Sr. No.

Full name Of Raw materials

Main properties (refer MSDS, Sch-9 of MSIHC Rules)

B.P. 0C

F.P. 0C

LEL UEL %

TLV ppm or mg/m3

LD50 mg/kg LC50 mg/l

Specific Gravity

(water=I) Gm/cc

Vapour Density (air=I)

Odor threshold

ppm or mg/m3

1 IPA 82.5 11.6 LEL: 2.0 UEL: 12.7

400 ppm

5045 mg/kg (Rat) 3600 mg/kg (Mouse) 0.785 2.07 22 ppm

2 Methanol 64.5 16.0 LEL: 6.0 UEL: 36.5

250 ppm

5628 mg/kg (Rat) 15800 mg/kg (Rabbit) 0.792 1.11 100 ppm

3 n-Propanol 97.22 27.2 LEL: 2.1 UEL: 13.5

250 ppm

1870 mg/kg (Rat) 6800 mg/kg (Mouse) 0.8053 2.07 5.3 ppm

4 Acetone 56.2 -9 LEL: 2.6 UEL: 12.8

750 ppm

5800 mg/kg (Rat) 3000 mg/kg (Mouse) 0.79 2 62 ppm

5 Ethyl acetate 77 7.2 LEL: 2.2 UEL: 9.0

400 ppm

5620 mg/kg (Rat) 4100 mg/kg (Mouse) 0.902 3.04 3.9 ppm

6 Acetonitrile 81.6 5.6 LEL: 4.4 UEL: 16.0 40 ppm 2460 mg/kg (Rat)

269 mg/kg (Mouse) 0.783 1.42 N.A.

7 Toluene 110.6 16 LEL: 1.1 UEL: 7.1

300 ppm

636 mg/kg (Rat) 14100 mg/kg (Rabbit) 0.8636 3.1 1.6 ppm

8 N-Haptane 98.4 -1.11 LEL: 1.05 UEL: 6.7

500 ppm 103 mg/l (rat, 4 h) 0.6838 3.5 150 ppm

9 Acetic acid 118.1 43 LEL: 4.0 UEL: 19.9 15 ppm 3310 mg/kg (Rat)

5620 mg/l (Mouse, 1 h) 1.049 2.07 0.48 ppm

10 MDC 39 N.A. LEL: 12.0 UEL: 19.0 50 ppm 1600 mg/kg (rat) 1.3266 2.93 214 ppm




2.12 MANUFACTURING PROCESS DETAILS, CHEMICAL REACTION AND MASS

BALANCE

1. Phenylephrine HCl Manufacturing Process

Take TPA in Reactor @ RT.

Charge L- Phenylephrine Base & Methanol @ RT.

Stir for 10 min.

Start addition of IPA + HCL in Reactor at 35-40°C

Adjust pH-0.5 to 1.0 with IPL + HCl.

Cross Check pH after 20 mins.

Heat the reaction mass up to 75-80°C & Check clarity of reaction mass @ 75-80°C.

IF rxn mass is clear solution then charge Activated charcoal + IPA slurry in reactor

@ 75-80°C.

Maintain the reaction mass 1.0 hr @ reflux temperature.

Filter the reaction mass and collect clear solution in Pharma reactor.

Distilled out IPA under Vacuum approx. half reaction mass volume.

After then, cool the reaction mass and chilled the reaction mass @5- 10°C.

Maintain the reaction mass for 1.0 hrs @5-10°C.

CF the reaction mass and wash with chill IPA & centrifuge it.

After centrifuge, packed the materials in dedicated HDPE drums.




Chemical reaction




Flow Diagram with Mass Balance




2. Pregabalin Manufacturing Process

Take IPA and D.M water in Reactor @ RT.

Charge (s0-(+)-3-aminomethyl-5-Methyl hexanoic acid @ RT.

Stir for 10 min.

Heat the reaction mass up to 75-80°C & Check clarity of reaction mass @ 75-80°C.

IF rxn mass is clear solution then charge Activated charcoal + IPA slurry in reactor

@ 75-80°C.

Maintain the reaction mass 1.0hrs @ reflux temperature.


After then, cool the reaction mass and chilled the reaction mass @8- 12°C.


CF the reaction mass and wash with chill IPA.

Unload the materials and dry it @ 70-75°C.

After drying packed the materials in dedicated HDPE drums.

Chemical Reaction




Flow diagram with Mass Balance




3. Levosulpiride Manufacturing Process

Take Methanol in Reactor @ RT.

Charge N-{[(2s)-1-Ethylpyrrolidine-2-yl]-Methyl}-2-methoxy-5-sulfamoyl benzamide)-

(Crude) @ RT.

Stir for 10 min.

Heat the reaction mass up to reflux temperature & Check clarity of reaction

mass @ reflux temperature.

If rxn mass is clear solution then charge Activated charcoal + slurry in

Reactor @ reflux temperature.



After then, cool the reaction mass and chilled the reaction mass @0-5°C.


CF the reaction mass and wash with chill Methanol & centrifuge it.


Chemical Reaction




4. Linezolid Manufacturing Process

Take Propanol in Reactor @ RT.

Charge Linezolid Crude @ RT.

Stir for 10 min.



IF rxn mass is clear solution then charge Activated charcoal + propanol slurry in

reactor @ reflux temperature.



Distilled out propanol under Vacuum aprrox. Half reaction mass volume.



CF the reaction mass and wash with chill propanol & centrifuge it.

After centrifuge, packed the materials in dedicated HDPE drums. Chemical Reaction




Flow diagram with Mass Balance:




5. Olmesartan Medoxomil Process Description

Take Acetone and water mixture in Reactor @ RT.

Charge Olmesartan Medoxomil Crude @ RT.

Stir for 10 min.



IF rxn mass is clear solution then charge Activated charcoal + Water slurry in




After then, Charge D.M. water Lot-1 within a period of 1.0 to 1.5 hrs

@40°C temp.

Cool the rxn mass 10°C and stirred for 3.0 hrs. Again charge D.M water lot-2@

10°C.

Cool the rxn mass 0°C and stirred for 3.0 hrs.

CF the reaction mass and wash with chill D.M water.

Unload the materials and dry it @ under vacuum below 50°C.

After drying packed the materials in dedicated HDPE drums. Chemical Reaction




6. Gabapentin Manufacturing Process:

Take Methanol + water in Reactor @ RT.

Charge Gabapentin Crude @ RT.

Stir for 10 min.



IF rxn mass is clear solution then charge Activated charcoal of Water slurry in


Maintain the reaction mass 30mins @ reflux temperature.


After then, Added IPA in rxn mass.


Maintain the reaction mass for 1.0 hrs @ 0-5°C.

After then, raise the temp of rxn mass up to 10-20°C.


CF the reaction mass and wash with chill IPA.

Unload the materials and dry it under vacuum @ 70-75°C.

After drying packed the materials in dedicated HDPE drums.

Chemical Reaction:




Flow diagram with Mass Balance:




7. Levetirecetam Manufacturing Process

Take Ethyl acetate + water in Reactor @ RT.

Charge Levetirecetam Crude @ RT.

Stir for 10 min.

Heat the reaction mass up to temp 50- 55°C & Check clarity of reaction mass @

50-55°C.

IF rxn mass is clear solution then charge Activated charcoal of water slurry in

reactor @ 50-55°C.



Distilled out ethyl acetate under Vacuum till reaction mass attained 4-5 volumes.

After then, cool the reaction mass and chilled the reaction mass @ 20- 25°C.


CF the reaction mass and wash with chill Ethyl acetate.






8. Pantoprazole Sodium Monohydride Manufacturing Process

Take Acetone + water in Reactor @ RT.

Charge Pantoprazole Sodium Crude @ RT.

Stir for 10 min.

Heat the reaction mass up to temp 50-55°C & Check clarity of reaction mass @

50-55°C.

IF rxn mass is clear solution then charge Activated charcoal of water slurry in

reactor @ 50-55°C.



Distilled out ethyl acetate under Vacuum till reaction mass attained 1 volume.

After then, cool the reaction mass and chilled the reaction mass @ 10- 20°C.


CF the reaction mass and wash with chill Acetone.






9. Sucralfate Manufacturing

process

Take Methanol in Reactor @ RT.

Charge Sucralfate Crude @ RT.

Raise the temperature @ 65°C.

Charge Activated Carbon @ 65°C.

Stir it for 30mins @ 65°C.


Cool the reaction mass @ RT.

Chill the Reaction @ 05°C.

Stir Reaction mass for 1.0 hrs.

Centrifuge the reaction mass and wash with chill Methanol & centrifuge it.


Chemical Reaction




10. Montelukast Sodium Manufacturing process

Take Toluene in Reactor @ RT.

Charge Montelukast sodium Crude @ RT.

Stir it for 15 mins.

Charge Activated Carbon @ RT

Stir it for 30 mins @ RT.


Charge N- Hepten in pharma reactor @ RT.

Chill the Reaction @ 15°C.

Stir it for 1.0 Hrs @ 15°C.

Centrifuge the reaction mass and wash with chill n-Heptane & centrifuge it.


Chemical Reaction




11. Telmisartan Manufacturing process

Take Methanol in Reactor @ RT

Charge Telmisartan crude @ RT

Stir it for 15 min @ RT

Charge Activated Carbon @ RT

Stir it for 30 min @ RT

Filter the Reaction mass and collect clear solution in pharma reactor.

Adjust pH 4.0 With Acetic acid at RT

Chill the Reaction @ 20oC to 25oC

Stir it for 1.0 Hrs@ 20oC to 25oC


After centrifuge, packed the material in dedicated HDPE drums.

Chemical Reaction




12. Amlodipine Besylate Manufacturing process


Charge Amlodipine Besylate crude @ RT

Raise the temperature up to 60oC

Charge Activated Carbon @60oC

Stir it for 30 min @ 60oC


Cool the Reaction mass at 30oC

Charge Ethyl acetate in pharma reactor @ RT

Chill the Reaction @ 15oC

Stir it for 1.0 hrs @ 15oC

Centrifuge the reaction mass & wash with chill ethyl acetate & centrifuge it.


Chemical Reaction




13. Silodosin Manufacturing process

Take Acetonitrile and Toluene in Reactor @ RT

Charge Silodosin crude @ RT


Stir it for 15 min.

Charge Activated Carbon @ 55oC




Stir it for 1.0 Hrs @ 10oC to 15oC

Centrifuge the reaction mass and wash with chill Toluene & centrifuge it.


Chemical Reaction




14. Olenzapine Manufacturing process

Take MDC in Reactor @ RT

Charge Olenzapine crude @ RT

Raise the temperature up to Reflux Temperature

Stir it for 15 min.

Charge Activated Carbon @ Reflux

Stir it for 30 min @ Reflux




Centrifuge the reaction mass and wash with chill MDC & centrifuge it.


Chemical Reaction




15. Glimepride Manufacturing process

Take Acetone in Reactor @ RT

Charge Glimepride crude @ RT


Stir it for 15 min.

Charge Activated Carbon @ Reflux

Stir it for 30 min @ Reflux



Stir it for 1.0 hrs. @ 0oC to 5oC

Centrifuge the reaction mass and wash with chill Acetone & centrifuge.

After centrifuge, drying packed the material in dedicated HDPE drums.

Chemical Reaction




16. Chlorthalidone Manufacturing process


Charge Chlorthalidone crude @ RT

Stir it for 15 min

Raise the temperature up to Reflux temperature

Charge Activated Carbon @ Reflux temperature

Stir it for 30 min @ Reflux temperature






Chemical Reaction




17. Tapentadol HCl Manufacturing process

Take Iso propyl alcohol in Reactor @ RT

Charge Tapentadol HCl crude @ RT


Charge DM water @82oC

Charge Activated Carbon @82oC



Cool the Reaction mass @ RT


Stir it for 1.0 Hrs

Centrifuge the reaction mass and wash with chill Iso propyl alcohol

Unload Material and dry it @ 50oC

After drying packed the material in dedicated HDPE drums.

Chemical Reaction




18. Voricanazole Manufacturing process

Take Acetonitrile in Reactor @ RT

Charge Voricanazole crude @ RT


Stir it for 15 min at Reflux temperature

Charge Activated Carbon @ Reflux temperature

Stir it for 30 min @ Reflux temperature



Stir it for 1.0 Hrs @ 15oC

Centrifuge the reaction mass & wash with chill Acetonitrile & centrifuge it.


Chemical Reaction




2.13 PLANT WATER REQUIREMENT & WASTEWATER

GENERATION

M/s Atlas Life Sciences is proposed unit and the source of water for proposed activity will be GIDC Water Supply. Water Balance Diagram is shown at Figure No. 2.1

TABLE NO. 2.8

DETAILS OF WATER CONSUMPTION & EFFLUENT GENERATION

Maximum Quantity of Water Consumption

(KL/Day)

Maximum Quantity of Waste Water generation

(KL/Day) Domestic 6.0 5.0 Gardening 2.0 Nil

Industrial DM Plant 1.0 1.0 Process 1.5 0.0 Cooling 3.0 1.0 Boiler 1.5 0.2 Total 15.0 7.2

*2.2 KL/D industrial wastewater will be sent to evaporator & condensate of evaporator around 2.0 KLD will be utilized for greenbelt development. Domestic effluent will be disposed through septic tank/soak pit system.




TABLE NO. 2.9 Product wise Water consumption and Effluent generation details: Process only

Sr. No. PRODUCT MT/MONTH

Batch Size in Kgs

Water consumption per batch in L

Water Consumption Waste water generation

KL/Month L/Day KL/Month L/Day

1. Phenylephrine HCL 4.0 110 0 0 0 0 0 2. Pregabalin 6.0 95 350 22.1 884 0 0 3. Levosulpiride 1.0 95 0 0 0 0 0 4. Linezolid 2.0 94 0 0 0 0 0 5. Olmesartan Medoxomil 1.0 95 1200 12.63 505 0 0 6. Gabapentin 5.0 93 55 2.956 118 0 0 7. Levetirecetam 2.0 94 40 0.851 34 0 0


3.0 95 0 0 0 0 0

9. Sucralfate 10.0 95 0 0 0 0 0 10. Montelukast sodium 2.0 94 0 0 0 0 0 11. Telmisartan 2.0 95 0 0 0 0 0 12. Amlodipine Besylate 3.0 94 0 0 0 0 0




13. Silodosin 0.1 95 0 0 0 0 0 14. Olenzapine 1.0 94 0 0 0 0 0 15. Glimepride 2.0 94 0 0 0 0 0 16. Chlorthalidone 2.0 96 0 0 0 0 0 17. Tapentadol HCl 0.5 96 35 0.182 8 0 0 18. Voricanazole 0.25 92 0 0 0 0 0

1549 0




Figure No. 2.1 WATER BALANCE DIAGRAM




WASTEWATER MANAGEMENT

• Domestic water consumption will be around 6 KLPD and sewage generated will be

disposed to soak pit via septic tank @ 5 KLPD.



2.14 CHARACTERISTICS OF EFFLUENT:

The characteristics of wastewater & final outlet would be as follows:

TABLE 2.10 CHARACTERISTICS OF INDUSTRIAL EFFLUENT

Sr. No Effluent

Parameters Results

ETP Inlet ETP Outlet (Before

Evaporation)

1. pH 7.5 7.0 – 7.5

2. S.S 30 20

3. TDS 4550 4500

4. COD <15 <15

5. Oil & Grease 5 3




TABLE 2.11

STREAMWISE AND COMBINED CHARACTERISTICS OF EFFLUENT

Sr. No. Parameters Unit DM Reject

Boiler Blow down

Cooling Blow down

Equalize

1. pH -- 7.7 6.5 7.8 7.5

2. SS mg/L 65 45 46 30

3. TDS mg/L 5230 4670 3850 4550

4. COD mg/L <15 <15 <15 <15

5. Oil & Grease mg/L 12 16 18 5




TABLE 2.12 PRODUCTWISE CHARACTERISTICS OF EFFLUENT

Sr. No.

PRODUCT MT/ MONTH

Water Consumption

KL/Day

Waste water generation

KL/Day

pH COD

1 Phenylephrine HCl 4.0 0 0 -- --- 2 Pregabalin 6.0 884 0 -- --- 3 Levosulpiride 1.0 0 0 -- --- 4 Linezolid 2.0 0 0 -- --- 5 Olmesartan

Medoxomil 1.0 505 0 -- ---

6 Gabapentin 5.0 118 0 -- --- 7 Levetirecetam 2.0 34 0 -- --- 8 Pantoprazole Sodium

Monohydride 3.0 0 0 -- ---

9 Sucralfate 10.0 0 0 -- --- 10 Montelukast sodium 2.0 0 0 -- --- 11 Telmisartan 2.0 0 0 -- --- 12 Amlodipine Besylate 3.0 0 0 -- --- 13 Silodosin 0.1 0 0 -- --- 14 Olenzapine 1.0 0 0 -- --- 15 Glimepride 2.0 0 0 -- --- 16 Chlorthalidone 2.0 0 0 -- --- 17 Tapentadol HCl 0.5 8 0 -- --- 18 Voricanazole 0.25 0 0 -- --- Total 1549




2.15 DETAILS OF EFFLUENT TREATMENT PLANT:

TABLE: 2.13 DETAILS OF PROPOSED EFFLUENT TREATMENT PLANT UNITS

Sr. No.

Name of Unit No. Capacity Size in m Retention Time (hr)

1 Equalization cum neutralization Tank

1 6.0 m3 1.5 x 1.5 x 2.0 65 Hr

2 Filter nutch 1 - 1.2 x 1.2 x 1.0 -- 3 Final treated

collection tank

1 6.0 m3 1.5 x 1.5 x 2.0

65 Hr

4 Sludge drying bed 1 1.44 m2 1.2 x 1.2 x 1.0 -- 5 Kettle type

Evaporator 1 250 Lit/Hr --- ---




Fig. 2.2: Effluent Treatment Plant Diagram

Details of Provisions to be made for evaporation of industrial effluent: • Technical details of effluent evaporation system including

evaporation capacity, steam required for evaporation

Capacity of kettle will be 2.0 KL and we will operate it once in a day. Total steam

requirement will be 1800 kg/day.

• Adequacy of the boilers to supply steam for evaporation in addition to the steam required for the process etc.

We will have boiler with steam generation capacity of 1.5 ton/hrs. and our total steam

requirement is only 1800 kg/day. We have calculated capacity of boiler to considering

steam requirement for evaporator. So same boiler will be used for evaporator.

• Techno-economical viability of the evaporation system

Collection Tank cum

neutralization tank 6.0 KL

Filter Nutch

Collection Tank

6.0 KL

Kettle type Evaporator Sludge Drying Bed

Solid Waste Storage Area




We will have only 2200 lit/day maximum effluent and in such small quantity, evaporation

is only a better option for us. Natural gas with 200 SCM/day is required to evaporate

our total industrial effluent which will be resulted to contribute Rs. 7000/- additional cost

for evaporate our wastewater and it is easily bear by unit to produce high profit

Pharma products.

• Effective evaporation system shall be designed in such a way to strip or absorb the VOCs and effective stack height shall be provided to the evaporation system Source of our effluent is utility & water treatment only and there shall be no organic load

including COD and VOCs so above facility is not required in our case and additional

precaution may not require in our case.




2.16 FLUE GAS EMISSION :

The details regarding flue gas emission are given at Table No. 2.14

TABLE NO.2.14

PROPOSED FLUE GAS STACKDETAILS

Sr. No.

Stack attached to

Capacity Fuel Consumpti

on

Stack Height

(m)

APCM Fuel used

1 Boiler 1.5 TPH

2750 SCM/Day

18

---

Natural Gas

2 Thermic fluid

Heater

1 Lacs kcal/hr

250

SCM/Day

---

3 D.G.Set 25 KVA 10 Lit./hr 6 --- HSD




TABLE 2.15

EMISSION RATE OF THE POLLUTANTS Sr. No.

Stack attached

to

Type of Fuel

Fuel Consump

tion

Dia. (m)

Height (m)

Exit Velocity (m/sec)

Exit Temp. (° C)

Emission Rates (gm/s) SPM(*) SO2

(**) NOX(***)

1 Boiler

1.5 TPH

Natural

gas

2750 SCM/Day

0.6 18 8 160 0.233 0.439 0.146

2 Thermic fluid

Heater 1 Lacs kcal/hr

Natural gas 250

SCM/Day

3 D.G.Set 25 KVA

Diesel 10 Lt/Hr 0.1 6 6.0 200 0.004 0.008 0.003

Note: (*) Actual stack emissions will be well below the permissible stack emissions limits, as the unit will utilize Wood as Fuel. To consider worst case scenario the emission rates are considered on maximum Stack Emission Limit.

(**) Based on maximum expected concentration of SPM-150 mg/Nm3 (**) Based on maximum expected concentration of NOx-50 PPM (***) As the unit will be using Natural Gas and Wood as a fuel, there will be negligible emissions of SO2.




2.17 PROCESS GAS EMISSION: Note: There will be no process gas emission from the manufacturing activity 2.18 FUEL REQUIREMENT

The details of fuels used for the project are given in Table No. 2.16 and Fuel characteristics are shown in Table No. 2.17.

TABLE 2.16

FUEL DETAILS

Sr.No Name of Fuel Consumption

1 Natural gas (Boiler & TFH) 3000 SCM/Day

2 Diesel (D G Set) 10 Lt/Hr

TABLE 2.17

FUEL CHARACTERISTICS

Characteristics Fuel Natural Gas Diesel

Gross Calorific Value (Kcal/Kg) 8600 9800




2.19 FUGITIVE EMISSION CONTROL:

Fugitive emission could occur from the storage yard of raw materials and finished products. The storage quantity is low since only 6 days inventory will be maintained at site and proper handling methods will be adopted. Emissions from transport of vehicles would occur to a certain extent. The emissions from traffic movements will be controlled by proper planning of the transport of raw materials and finished products to and fro from the factory premises. All the roads inside the plant will be concreted to reduce any dust emissions. Proper planning and maintenance will control the extent of fugitive emissions. During the production, the industry will carry out regular monitoring of fugitive emissions as per the factories Act. Measures taken for fugitive emission control:

• Proper storage of raw materials, products and fuels. • Ensuring closed feeding and sampling. • Establishing SOPs for start-up, shut down and maintenance operational

procedures. • Regular work place monitoring and ambient air quality monitoring as per

post project monitoring plan. • Pneumatically transfer of raw material in reactor. • PPE will be provided to the workers working in process area. • Greenbelt will be developed around the plant to arrest the fugitive

emission. • Paved road will make to reduce the fugitive emission. Water sprinkler will

be provided to reduce the




2.20 HAZARDOUS WASTE MANAGEMENT

The hazardous wastes generated by the industry & Method of Management and Handling is given In Table No. 2.18.

TABLE NO. 2.18

DETAILS OF HAZARDOUS WASTES

Sr. No.

Type of Waste

Category of Waste as per HWM

Rules 2008

Quantity in MT/Yr Disposal facility

1. ETP waste 34.3 0.3 Collection, Storage, Transportation & Disposal at TSDF site approved by GPCB.

2. Evaporation salt 34.3 3.0

Collection, Storage, Transportation & Disposal at TSDF site approved by GPCB.

3. Distillation residue 20.3 1.8


4. Spent carbon I-28.2 1.2


5. Discarded containers/

drums 33.3 2.4 Collection, Storage and sold to

approved recycler or traders.

6. Used oil 5.1 0.05 KL/Yr

Collection, Storage, Transportation & disposal by selling to Registered Recyclers.




2.21 NOISE POLLUTION

The main noise generating sources in the plant are operation of Boiler,

TFH, material handling, process plant, other machineries etc. All these

sources will generate continuous noise. However, the noise transmitted

outside the plant boundary will be low because most of the noise

generating equipments will be in closed structures provided with acoustic

enclosure.

The typical Noise levels of equipment. As indicated by the Equipment manufacturers are given in Table No. 2.19

TABLE NO. 2.19

TYPICAL NOISE LEVELS OF EQUIPMENT

Sr. No.

Name of Machinery/Unit Noise level in Db

1. Pumps 60-65 2. TFH 65-75 3. Compressors 65-70 4. D G Set 55-60

The following measures have been taken to reduce the noise levels to acceptable limits:

• Sound producing equipment are enclosed in the sound proofing enclosure to give residual sound pressure level of 85 dB(A) and

• Providing suitable ear protecting devices for working personnel.

• Greenbelt will be developed around the periphery of the plant.

• Ear muff, ear plug will be provided to all workers working in noisy area.

• Regular monitoring of noise level will be carried out and

corrective measures in concerned machinery will be adapted.

• Equipments will be statically and dynamically balanced.




2.22 LIST OF HAZARDOUS CHEMICALS

The Raw Materials, which are termed as Hazardous Chemicals as per the "Manufacturing, Storage and Import of Hazardous Chemicals Rules, 1989", are as listed in Table No. 2.20

Table No. 2.20 LIST OF HAZARDOUS CHEMICALS

Hazardous Chemicals

Reference The Manufacturer,

storage & Import of Hazardous chemical

Rules 1989

Threshold Quantity in

MT

Maximum quantity that can be stored at a time (MT)

IPA Sr. No. 334, Part II, Sch 1 of MSIHCR, 1989

--- 1.0

Methanol Sr. No. 377, Part II, Sch 1 of MSIHCR, 1989

--- 1.5

Acetone Sr. No. 4, Part II, Sch 1 of MSIHCR, 1989

--- 0.3

Ethyl acetate Sr. No. 247, Part II, Sch 1 of MSIHCR, 1989

--- 0.5

Acetonitrile Sr. No. 78, Part II, Sch 1 of MSIHCR, 1989

--- 0.16

Toluene Sr. No. 628, Part II, Sch 1 of MSIHCR, 1989

--- 0.175

Acetic acid Sr. No. 2, Part II, Sch 1 of MSIHCR, 1989

--- 0.1




DETAILS OF HAZARDOUS CHEMICALS

Name of Hazardous Chemicals

Toxicity (Oral LD50) mg/kg

Hazardous Characteristics

Isopropyl alcohol (IPA)

5045 mg/kg [Rat]

Flammability of the Product: Flammable. Auto-Ignition Temperature: 399°C (750.2°F) Flash Points: CLOSED CUP: 11.667°C (53°F) - 12.778 deg. C (55 deg. F) (TAG) Flammable Limits: LOWER: 2% UPPER: 12.7% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Flammable in presence of oxidizing materials. Nonflammable in presence of shocks. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Explosive in presence of open flames and sparks, of heat.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not Breathe gas/fumes/ vapor/spray. Avoid contact with eyes. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents, acids. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).




Methanol

5628 mg/kg [Rat].

Flammability of the Product: Flammable. Auto-Ignition Temperature: 464°C (867.2°F) Flash Points: CLOSED CUP: 12°C (53.6°F). OPEN CUP: 16°C (60.8°F). Flammable Limits: LOWER: 6% UPPER: 36.5% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Explosive in presence of open flames and sparks, of heat.

Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear Suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, metals, acids. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).




n-Propanol

1870 mg/kg [Rat.].

Flammability of the Product: Flammable. Auto-Ignition Temperature: 371°C (699.8°F) Flash Points: CLOSED CUP: 15°C (59°F). OPEN CUP: 27.2°C (81°F) (Cleveland). Flammable Limits: LOWER: 2.1% UPPER: 13.5% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat, of oxidizing materials. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapour/spray. In case of insufficient ventilation, wear suitable respiratory equipment If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes Keep away from incompatibles such as oxidizing agents, acids. Storage: Flammable materials should be stored in a separate safety storage cabinet or room. Keep away from heat. Keep away from sources of ignition. Keep container tightly closed. Keep in a cool, well-ventilated place. Ground all equipment containing material. A refrigerated room would be preferable for materials with a flash point lower than 37.8°C (100°F).




Acetone

Acute: 5800 mg/kg [Rat].

Flammability of the Product: Flammable. Auto-Ignition Temperature: 465°C (869°F) Flash Points: CLOSED CUP: -20°C (-4°F). OPEN CUP: -9°C (15.8°F) (Cleveland). Flammable Limits: LOWER: 2.6% UPPER: 12.8% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Slightly explosive in presence of open flames and sparks, of oxidizing materials, of acids.

Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducing agents, acids, alkalis. Storage: Store in a segregated and approved area (flammables area) . Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Keep away from direct sunlight and heat and avoid all possible sources of ignition (spark or flame).




Ethyl acetate


Flammability of the Product: Flammable. Auto-Ignition Temperature: 426.67°C (800°F) Flash Points: CLOSED CUP: -4.4°C (24.1°F). (TAG) OPEN CUP: 7.2°C (45°F) (Cleveland). Flammable Limits: LOWER: 2.2% UPPER: 9% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizing materials, of acids, of alkalis. Non-flammable in presence of shocks.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not Breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory Equipment. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents, acids, alkalis. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Moisture sensitive.




Acetonitrile

Acute: 2460 mg/kg

Flammability of the Product: Flammable. Auto-Ignition Temperature: 524°C (975.2°F) Flash Points: CLOSED CUP: 2°C (35.6°F). OPEN CUP: 5.6°C (42.1°F) (Cleveland). Flammable Limits: LOWER: 4.4% UPPER: 16% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat, of oxidizing materials. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available.

Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducing agents, acids, alkalis, moisture. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Do not store above 23°C (73.4°F).




Toluene

Acute: 636 mg/kg

Flammability of the Product: Flammable. Auto-Ignition Temperature: 480°C (896°F) Flash Points: CLOSED CUP: 4.4444°C (40°F). (Setaflash) OPEN CUP: 16°C (60.8°F). Flammable Limits: LOWER: 1.1% UPPER: 7.1% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).




N-Haptane

VAPOR (LC50): Acute: 103000 mg/m 4 hours [Rat].

Flammability of the Product: Flammable. Auto-Ignition Temperature: 203.89°C (399°F) - 223 C (433 F) Flash Points: CLOSED CUP: -4°C (24.8°F). (TAG) OPEN CUP: -1.1111°C (30°F). Flammable Limits: LOWER: 1.05% UPPER: 6.7% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available. Slightly explosive in presence of heat.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).




Acetic acid


Flammability of the Product: Flammable. Auto-Ignition Temperature: 463°C (865.4°F) Flash Points: CLOSED CUP: 39°C (102.2°F). OPEN CUP: 43°C (109.4°F). Flammable Limits: LOWER: 4% UPPER: 19.9% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizing materials, of metals.

Precautions: \Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Never add water to this product. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducing agents, metals, acids, alkalis. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).




Methylene chloride (MDC)


Flammability of the Product: May be combustible at high temperature. Auto-Ignition Temperature: 556°C (1032.8°F) Flash Points: Not available. Flammable Limits: LOWER: 12% UPPER: 19% Products of Combustion: These products are carbon oxides (CO, CO2), halogenated compounds.

Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe gas/ fumes/ vapor/spray. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area.




2.23 SAFETY & OCCUPATIONAL MEASURE FOR STORAGE & HANDLING

OF THE RAW MATERIAL & PRODUCT:

To prevent any spillage, accident and impacts of human health for safety measure will be taken while handling the raw material and products:

Occupational control measures for no health hazard to the worker and to keep the risk of accidents to a minimum from our manufacturing activities. Mitigatory measures: For the proposed project, company will make following arrangement within the factory premises for the different hazards:

Storage & Handling of Hazardous Chemicals: • Company will do planning to stock all the necessary material as

minimum as possible. • All containers with hazardous chemicals have labels

indicat ing the contents and warning of the hazard. • Necessary information on safe handling and f irst aid

measures and antidotes of major hazardous material wil l be available on the label.

• Workers dealing with hazardous chemicals wil l be trained on health r isks and safe handling.

• Exposure to hazardous chemicals will be minimized. • Liquid Hazardous chemicals will be transferred in closed

piping system. • Separate storage section wil l be provided for storage of

hazardous and non-hazardous raw materials.

Vessel and other Equipment related: • Checking of process vessels and equipment is carried out

regularly. • Records related to maintenance and its planning schedule

is maintained.




Fire related:

• Overhead water storage tank with adequate capacity is provided to ensure 24 hr. supply.

• Fire water tank with suff icient capacity of 10 KL (02 Nos.) wil l be provided with f ire pump (02 Nos.)

• Fire hydrant system wil l be provided. • Sprinkler system will be provided at raw material storage

area and tank farm area. • Fire extinguisher wil l be provided at production plant as per

the requirement. Contact numbers of nearest f ire agency will be provided.

• Nearest f ire station is Odhav GIDC Fire stat ion. Time required to reach the project site is 10 minutes.

• Unit wil l appoint qualif ied and trained f ire personnel having qualif icat ion l ike B.Sc or Diploma in Fire and Safety.

Electrical related:

• All electrical f it t ing and motors in the storage areas will be f lameproof.

• Checking of all earthings, wir ing & connection wil l be carried out regularly.

• Proper earthing wil l be provided at al l equipments and will be provided for additional equipment. Adequate Nos. of earth pits wil l be provided.

Safety related:

• Adequate types of personal protective equipment wil l be provided and also safety training wil l be provided to workers.

• Emergency showers and eye wash stations wil l be available at the worksite.

• Arrangement for 24 hr. medical facil it ies by contact with nearest health care centre/ hospital.

• Pre-employment medical check-up and annual medical check-up will be carried out and its records will be maintained properly.




TABLE 2.21

ANTIDOTES OF CHEMICALS

2.24 ACTION PLAN FOR TRANSPORTATION OF RAW MATERIALS AND

PRODUCTS INCLUDING HAZARDOUS CHEMICALS: Following safety precautions are suggested during transportation of hazardous chemicals in tankers / or other vehicles, while unloading, transportation and meeting the emergencies arising out of leakages and spillages of hazardous materials:

• Park the vehicle at designated place. • Stop the engine. • Checkup spark arrester. • Provide earthing to tanker securely. • Connect the piping properly • Before start unloading; check that, there should not be any leakage. • In case of leakage, immediately attend the leakages and rectify it. • After unloading is over, close the cover properly. • Vehicle to be started only after removal of all pipelines connected with tanker.

Sr. No. Name of Chemical Antidotes 1. IPA Novasine Eye Drops

2. Methanol Ethanol (30% solution through oral, 5% solution

through injection), epicake syrup, if Acidosis than Sodium bicarbonate, if effect of delirium than give 10mg diazepam through injection.

3. Ethyl acetate Novesine, Eye Drops 4. Toluene Diazem – 1 mg/kg. (Intravenous),Epenephia,

Efidrine

5. Acetic acid Milk of magnesia




2.25 DETAILS OF FIRE FIGHTING EQUIPMENTS:

The unit will provide fire extinguishers based on probability and type of fire hazards at strategic locations. The unit will install approximately 10 fire extinguishers (Dry powder type) to tackle the fire hazards of Class A, B & C at different levels of the plant. The unit has also decided to provide fire protection arrangements in the form of fixed water spray system (1 No.) and fire hydrant systems (1 Nos.) to tackle any fire emergency arising due to storage of chemicals.




2.26 COST OF THE PROJECT

The total project cost will be 3.5 Crores. Total capital and recurring cost towards Environmental protection Measures per annum will be 28.5 lacs & 21.95 lacs respectively.

TABLE - 2.22 Capital Cost & Recurring Cost of the Project

Sr. No

System Approximate recurring cost per annum

(in Lacs)

Approximate capital cost (Rs. In Lacs)

Basis for cost estimates

1 Air pollution control

3.0 12.0 The capital cost would include cost of providing adequate height of the stack, ladder and platform, and recurring cost would include cost of monitoring of air environment.

2 Water pollution control

13.20 10.0 Capital cost would include cost of ETP, Evaporation cost of effluent etc. In capital cost civil work, mechanical work, Electrical work and piping work is included. Recurring cost is for operational phase.

3 Noise pollution monitoring

0.25 0.0 DG sets will be provided with acoustic enclosures, the recurring cost would include cost of noise monitoring.

4 Solid and hazardous waste management

2.5 5.0 Capital cost would include cost of providing storage space for hazardous waste and membership of TSDF Fee. Recurring cost would include cost of land filling and transportation.

5 Environment monitoring and management

2.0 0.0 The recurring cost would be incurred on hiring of consultants and payment of various statutory fees to regulatory agencies.

6 Green belt 0.5 0.5 Development of Greenbelt including Gardening and Plantation.

7 Occupational health (OHC)

0.5 1.0 Occupational health check up of Employees and workers

Total 21.95 28.5




2.27 POWER REQUIREMENT

TABLE 2.23 POWER REQUIREMENT

Electricity DG Set

Required Proposed Connected Load hp Source 25 KVA 65 KVA Torrent Power

2.28 MAN POWER

The requirement of personnel for the Plant is met with keeping in view the following: • Technical support of Plant, including Process Control and

Instrumentation • Smooth and efficient operation of Plant • Effective co-ordination between the various Departments within the

Plant • Optimum organization with well-defined and judicious job distribution • Optimum utilization of different grades of workmen and supervisory

staff and Maximum capacity utilization of facilities. Total Manpower at Atlas Life Sciences will be summarized in Table No. 2.24

TABLE NO. 2.24

DETAILS OF MAN POWER

Total Workers in all Shifts

Male Female Total

Proposed 14 02 16




2.29 GREEN BELT DEVELOPMENT

The development of Green Belt is an important aspect for any plant because: • It acts as a 'Heat Sink' • It improves the Ambient Air Quality by controlling SPM in air • It helps in noise abatement for the surrounding area • It helps in settlement of new birds and insects within itself and • It increases the aesthetic value of Site.

Total plot area is 1321 Sq. meter. From that they had done planning for

gardening and plantation for 200 Sq. Meter. The unit proposes to

develop greenbelt in area of 200 m2 and it will be 15% of the total area,

because there is no availability of land and unit will compensate balance

greenbelt at common place of GIDC & road side.

The choice of trees species, suitable for plantation at the Industry Site, has been governed by the following guiding factors:

1. As per guidelines issued by Ministry of environment & Forests for

greenbelt development. 2. As per the study carried out by our FAE in Ecological & Biodiversity.

3. The tree must be tolerant to all the pollutants present in the area. 4. The tree should be able to grow and thrive on soil of the areas, be

evergreen, in habitat, having minimum of leaf fall. 5. The tree must be tall in peripheral curtain plantation and with large and

spreading canopy in the primary and secondary attenuation zones. 6. The tree should possess extensive foliar area to provide maximum

impinge surface for continued efficient adsorption and absorption of pollutants.

7. The tree should be fast growing and indigenous. 8. The tree should maintain ecological, land and hydrological balance of

the region.




The program will consist of the following elements: • Maintenance of greenbelt and vegetative zones within the plant where

possible. • Plantation of trees and vegetation around the plant. • Maintenance of greenbelt on the both sides of nearby roads. • To provide tree guards to the local villagers. • They will develop ~100 Trees in and around our premises. The tree species selected for the plantation will be pollutant tolerant, fast growing, wing firm, deep rooted, and ever green. The company will select pollutant tolerant plant species. They will also develop plantation as per the MoEF guidelines all along the periphery of plant so that these trees perform as natural barrier and bring down the fugitive emission and stop carryover of dust along with wind current.

The greenbelt developed by planting drought resistant trees suitable for local climate. Moreover, avenue trees will be planted all along the roads and local species are recommended to plant. The density of tree will be 1000 tree per acres i.e. 1 tree per 4 m2 to minimize the effect of air and noise pollution and to improve overall environment. These trees will be planted in open and close patches in multiple rows. Trees that are native of this area will be been chosen for plantation.

The plants are suitable for greenbelt development based on gaseous exchange capacity of foliage which is ascertained by the following characteristics:

- The plant should be fast growing. - It should have thick canopy cover.

- It should have large leaf area index.

- It should be indigenous.

- It should be efficient in absorbing pollutants without significant effects

on plant growth.




The objectives of the industrial greenbelt are to improve the micro-

environment and create environmental awareness among the local people.

Selection of tree species for industrial areas is influenced by the nature of

industry. The objective should be to ensure a green cover tolerating

pollutant gases and solid particulates present in the atmosphere. It is also

advisable to select suitable tree species and adopt simple techniques which

require minimum investment and care.

Budgetary Expenditure:-

Budgetary expenditure for development and establishment of greenbelts

are worked out as below:

TABLE 2.25 BUDGETARY EXPENDITURE FOR GBD

Wind breaker plant species will be (e.g. Polyanlthia, Eucalytus, Casuarina, etc.) planted around the periphery of near boundary walls. Grass mat along with combination flowering shrubs will be planned along the rest rooms. Potted plants and climbers will be used on the roof tops.

All the corners inside the rooms of administration building and along the stair case, potted shrubs will be put and change time to time for watering, pruning and fertilizing. Fast growing species with more calorific value is preferable. Necessary help will be taken from the local DFO in development of green belt.

Money plants like climbers will be used and make them to hang to avoid penetration dust inside the working areas. These climbers will be sprinkled regularly to remove adhered dust particles.

Sr. No.

Parameter Amount in Rs.

1 Site Development 35000.00

2 Plants/ Seeds 25000.00

3 Plant Care & Reg. 20000.00

TOTAL 80000.00




Based on the demand of nutrients by soil the fertilizer input shall be given. These trees will be planted in about different rows. The interspaces will be planted with grasses, bushes and hedges. Choosing native plant species which suits to local environmental conditions will be encouraging (percentage survival) and also for sustainable ecosystem development. Plants with flowering will give good aesthetic look. 1 meter width will be kept for tree plantation around the project boundaries. The plant species for green belt is given below in Table

Sr. No. Scientific Name Vernacular Name 1. Anthocephalus cadamba Kadam 2. Azadirachta indica Limdo 3. Cassia fistula Garmalo 4. Delonix regia Gulmohar 5. Derris indica Karanj 6. Ficus religiosa Peepal 7. Polyalthia longifolia Asopalav 8. Sizygium cuminii Jambu

Plantation Programme:- The plantation of trees in and around the company are meant mainly to reduce

air pollution caused by factory emissions, to absorb sound, to prevent soil

erosion and to maintain aesthetic value for healthy living. Details of year wise Tree

Plantation Programme

Year Area to be planted (Sq.m.)

No. of trees proposed to be

planted

Survival rate

1st 40 10 80% 2nd 40 10 80% 3rd 40 10 80% 4th 40 10 80% 5th 40 10 80%




Protection of plantation at site:-

• Protection from grazing will be done by erecting tree guards a

rounded planted sapling.

• Though the tree suggested for plantation will require very less

water, however during the first year watering will be done twice in a day.

There after watering will be done twice in a week.

• The manuring will be done when plantation take up. For this

propose cow dung will be dump in the pit. No other manuring will

require for proposed plantation. The cow dung is easily available in the

study area.

• Damaged planted will be replaced with new plants.




2.30 SCHEME FOR RAIN WATER HARVESTING

The source of water for the project is ground water. The unit has also proposed to design & implement rain water harvesting scheme within premises. The parameter considered for designing the Rain water harvesting is as follows:

• The average rainfall of the area considered for the design is 800 mm/year.

• The paved area available in front. • The amount of water collected from the run off. • The roof top area available. • The amount of water collected from the roof top. • Considering one hour of peak rainfall. • Total rain water to be collected.

Hence rain water harvesting pit will be made to collect the rain water from roof top and paved area based on the above data consideration. The Total land area is 1321Sq. m. The Average rain fall is 800 mm = 0.8 m Water recharge = Area x Avg. Rain fall x Efficiency = 1321 m2x 0.8 m x 0.7 = 739.76 m3




CHAPTER: 3 BASE LINE ENVIRONMENT QUALITY 3.1 INTRODUCTION

Preparation of this study needs a datum on which the evaluation can be done. It is necessary to collect data about different environmental attributes that are being affected by the development of the region which, in turn, defines an existing environmental quality of the region to serve as the datum.

Base line data requirement is also necessary to identify environmentally significant issues as well as to enumerate the critical environmental changes that are occurred due to the industrial development of the region.

Here an attempt has been made to collect the information about an existing environment on the below mentioned eight major environmental attributes:

I - Air Environment

II - Meteorology

III - Water Environment

IV - Hydro-geomorphology

V - Noise

VI - Land Environment

VII - Ecology

VIII - Socio-economic

3.2 STUDY AREA

The study area for Baseline Environmental Quality is the area with a radius of 5 Kms keeping project site as a centre. The same is shown in Figure No. 3.1 and the villages falls under the same is listed in Table No. 3.1.


137



Table No. 3.1 Name of Villages/ Area in Study Area.

Sr. No. Name of village/ Area

0 – 5 KM

1. Soni ni Chali 2. Odhav 3. Nikol 4. Kathwada 5. Odhav Chokdi 6. Vastral 7. CTM

5 – 10 KM 8. Gatrad 9. Vanch 10. Hathijan 11. Barkol Bujrang 12. Kujad 13. Kanbha 14. bhuvaladi 15. Zanu 16. Bilasya 17. Nana Chiloda 18. Ahmedabad City


138



Figure No. 3.1

Study Area Map of Base line Study


139



Figure No. 3.2 Study Area Map of Base line Study for 5 KM Radius and 10 KM Radius in Google Map.

Sr. No. Description Information 1 Latitude 23°01'15.40"N (23.020944) 2 Longitude 72°39'39.72"E (72.661028) 3 Plot.No. C-1, 360-361, 4 GIDC/Estate GIDC Estate, 5 Village Odhav, /Ahmedabad 5 Ta Ahmedabad 6 Dist Ahmedabad 7 State Gujarat


140



3.3 ENVIRONMENTAL STANDARDS OF THE REGION

• AMBIENT AIR QUALITY STANDARDS

National Ambient Air Quality Standards are reproduced in Annexure 2. The State has not promulgated separate Ambient Air Quality Standards.

• WATER QUALITY STANDARDS

Standards prescribed by BIS (IS 10500-91) and Indian Council of Medical Research (ICMR) for drinking water are given in Annexure 3.

• AMBIENT NOISE QUALITY STANDARDS

National Ambient Noise Quality Standards are presented in Annexure 4. The State has not promulgated separate Ambient Noise Quality Standards.

3.4 AIR ENVIRONMENT 3.4.1 AMBIENT AIR QUALITY (AAQ) IN THE STUDY AREA

The collection of base line information for Air Environment includes identification of specific air pollutants being released into the atmosphere having significant impact on neighborhood. The Ambient Air Quality status, with respect to the identified air pollutants, has been studied at eight major locations. This has been done through Air Quality surveillance program and based on TOR.

The back-ground air quality for PM10, PM2.5, Sulphur Dioxide (SO2), Oxides of Nitrogen (NOx), CO, HC including VOCs was monitored. The monitoring for these parameters has been done at sites located in different directions and situated within the suspected impact zone, in and around the proposed project site. We had considered minimum one monitoring station in the upwind direction and minimum one monitoring station in the pre dominant downwind direction at a location where maximum ground level concentration is likely to occur.

3.4.1.1 THE LOCATION OF AAQ STATIONS The locations of the AAQ stations are based on prevailing meteorology,

pollution source and available infrastructure facilities. One station has been particulary set-up in down wind direction.

Thus, monitoring has been done at eight sampling stations located in different directions and situated within the suspected impact zone in and around the existing project site.


141



The locations map of the AAQ monitoring station is shown in Figure No. 3.1 and tabulated in Table No. 3.2.

Table No.3.2 Locations of Ambient Air Quality Monitoring Stations

Sr. No. Locations Direction Distance in

KM

1 Project Site -- --

2 Soni ni Chali W 2.77

3 Odhav NE 1..26

4 Nikol N 2..63

5 Kathwada NE 4.36

6 Odhav Chokdi NE 126

7 Vastral S 3.08

8 CTM SW 4.22 3.4.1.2 BASE LINE DATA

At every sampling station, important parameters namely PM10, PM2.5, Sulphur Dioxide (SO2), Oxides of Nitrogen (NOx) including HC, CO and VOCs were monitored. The results are given in Table No.3.4.a to 3.4.c. The minimum, mximum, Average and 98 % of PM10, PM2.5, SO2 and NOx are as shown in Table No 3.3


142



Table No.3.3.

Ambient Air Quality Analysis Results (minimum, mximum, Average and 98 %)

For Indivisual Location

Sr. no. Sampling Location

PM10 PM2.5 SO2 NOX

01 Project Site

Min 72.95 31.30 15.65 22.73 Max. 93.81 45.41 25.94 49.51 Avg. 86.13 40.35 18.18 36.68 98 % 93.48 45.27 24.82 46.39

02 Soni ni Chali

Min 79.34 31.93 15.51 21.51 Max. 94.35 43.72 31.88 56.01 Avg. 85.60 40.06 18.88 38.76 98 % 93.27 43.57 26.20 54.87

03 Odhav

Min 75.41 31.16 15.65 23.13 Max. 90.90 43.93 38.26 47.48 Avg. 84.38 39.34 21.01 37.48 98 % 90.82 43.86 32.88 46.63

04 Nikol

Min 79.34 32.46 14.64 22.73 Max. 93.20 45.44 28.11 54.38 Avg. 86.10 40.03 19.68 38.27 98 % 92.71 44.91 26.49 52.39

05 Kathwada

Min 76.33 32.04 12.75 19.07 Max. 93.52 45.22 30.58 56.01 Avg. 85.84 39.79 19.68 38.27 98 % 93.11 44.91 29.46 52.03

06 Odhav Chokdi

Min 79.26 34.22 11.74 17.45 Max. 91.55 46.46 26.95 54.38 Avg. 85.75 40.77 19.01 37.37 98 % 91.14 46.01 25.64 48.13

07 Vastral

Min 78.72 33.25 9.42 17.05 Max. 95.31 45.60 24.35 49.11 Avg. 84.97 39.51 18.18 36.54 98 % 94.60 45.42 23.43 48.25

08 CTM

Min 77.43 33.44 16.09 24.35 Max. 92.86 45.01 26.95 46.27 Avg. 85.62 39.66 18.46 35.61 98 % 92.67 44.92 26.14 44.85


143



Figure No. 3.3

Sampling Locations for AAQ, Water Quality, Noise Level and Soil Analysis


144



Photograph of Ambient Air Quality

Nikol

Kathwada Gam


145



Table No.3.4.a

Ambient Air Quality Analysis Report for the Month of March to May 2017

No Location Date of

Sample

PM10 PM2.5 SOx NOx GPCB

limit 100 µg/m3

GPCB limit 60 µg/m3

GPCB limit 80 µg /m3


24 Hrs 24 Hrs 8 hrs 8 hrs 8 hrs 8 hrs 8 hrs 8 hrs 1 Project Site 05/03/2017 92.30 43.69 17.53 18.98 17.97 42.61 43.83 45.05 2 Soni ni Chali 05/03/2017 94.35 43.72 19.42 20.29 18.69 42.21 40.99 43.43 3 Odhav 06/03/2017 90.51 39.23 18.11 19.85 18.40 38.96 38.15 40.99 4 Nikol 06/03/2017 88.19 41.27 19.42 24.06 19.85 31.66 30.44 32.87 5 Kathwada 07/03/2017 93.52 45.22 18.40 19.85 18.11 42.21 43.43 45.05 6 Odhav Chokdi 07/03/2017 86.24 46.46 15.51 16.38 13.91 38.15 43.83 45.05 7 Vastral 08/03/2017 95.31 44.81 15.51 17.53 16.38 37.34 40.99 43.43 8 CTM 08/03/2017 92.86 44.63 16.95 21.74 18.84 32.06 30.03 35.71

No Location Date of

Sample


limit 100 µg/m3





No Location Date of

Sample


limit 100 µg/m3






146



No Location Date of

Sample


limit 100 µg/m3





No Location Date of

Sample


limit 100 µg/m3





No Location Date of

Sample


limit 100 µg/m3






147



No Location Date of

Sample


limit 100 µg/m3





No Location Date of

Sample


limit 100 µg/m3





No Location Date of

Sample


limit 100 µg/m3






148



No Location Date of

Sample


limit 100 µg/m3





No Location Date of

Sample


limit 100 µg/m3





No Location Date of

Sample


limit 100 µg/m3






149



Table No.3.4.d

VOC Analysis Report

Sr. No.

Location Date of Sampling

Benzene (µg/m3)

Toluene (µg/m3)

Xylene (µg/m3)

1

Project site

05/03/2017 0.95 2.73 1.02 2 12/03/2017 0.80 2.64 1.08 3 19/03/2017 0.84 2.78 1.05 4 26/03/2017 0.80 2.58 0.99 5 02/04/2017 0.75 2.61 0.96 6 09/04/2017 1.01 3.12 1.46 7 16/04/2017 1.01 2.87 1.26 8 23/04/2017 1.04 2.78 1.19 9 30/04/2017 0.98 2.73 1.17

10 07/05/2017 0.98 2.84 1.11 11 14/05/2017 0.99 2.81 1.26 12 21/05/2017 1.14 3.32 1.52

CO and HC Analysis Report

Sr. No.

Location Date of Sampling

CO (µg/m3) Limit: 4000

HC (µg/m3)

1

Project site

05/03/2017 393.90 8.16 2 12/03/2017 382.41 8.55 3 19/03/2017 462.96 5.82 4 26/03/2017 378.93 7.95 5 02/04/2017 364.20 5.25 6 09/04/2017 295.98 5.85 7 16/04/2017 395.25 4.95 8 23/04/2017 358.32 6.42 9 30/04/2017 440.46 7.41

10 07/05/2017 400.05 7.38 11 14/05/2017 299.19 6.72 12 21/05/2017 340.65 8.16


150



3.4.1.3 SAMPLE ANALYSIS

Monitoring and testing of ambient air quality were carried out for various parameters namely PM10,

PM2.5, SO2, NOx, by using Respirable Dust Sampler (RDS). Twenty four -hourly samples were collected for PM10 , PM2.5 and for SO2 & NOx 8 hourly samples were collected for the month of March – April – May - 2017. The sampling and testing of Ambient Air Quality Parameters were carried out as per relevant parts of IS: 5182. The brief details of testing procedures adopted are given in Table No.3.5.

Table No. 3.5 Details of Ambient Air Quality Monitoring & Analysis Procedures

Parameter Ambient Air Quality Monitoring & Analysis Procedure

PM10 Gravimatric Method, IS:5182, 11255 & Operational Manual of Instrument

PM2.5 Gravimatric Method & Operational Manual of Instrument

NOx Jacob & Hochheiser Method. Absorption in dilute NaOH and then estimating colorimetric with Sulphanilamide N(1-Nepthyl) Ethylene Diamine Dihydrochloride and Hydrogen Peroxide (IS : 5182 Part II : 1975)

SO2 Improved West & Gaeke Method. Absorption in Mercury Sodium Tetra Chloride followed by colorimetric estimation using P-Rosaniline Hydrochloride and Formaldehyde (IS : 5182 Part II : 1969)

VOC (Benzene, Toluene, Xylene,)

Instrumental manual method

CO and HC Instrumental manual method


151



3.5 METEOROLOGY

Meteorological conditions, of the site, regulates the transport and diffusion of air-pollutants released into the atmosphere. Ambient temperature, wind speed, wind direction and atmospheric stability are called primary or basic Meteorological Parameters because the dispersion and diffusion of pollutants depend mainly on these Parameters. Humidity, precipitation, pressure and visibility are secondary Meteorological Parameters as this control the dispersion of the pollutants indirectly by affecting primary Parameters.

3.6 Baseline Data

Meteorological data were obtained from our own meteorological station kept at Project site for the parameters namely ambient temperature, wind speed, wind direction, relative humidity for the period March, April and May 2017. The Wind Rose diagram for the month of March, April and May 2017. is shown in Figure No. 3.4.

3.6.1 Ambient Temperature

The monthly variations of monthly highest and monthly lowest temperatures recorded are as follows:

Location – Project site Temperature, oC March 2017 April 2017 May 2017

Maximum 41.0 44.0 48.10 Minimum 21.0 23.20 26.00

3.6.2 Wind Speed

Wind speed determines the rate of diffusion and travel time of air pollutants. The results of monitoring are as follows:

Location – Project Site Wind Velocity, Km/hr March 2017 April 2017 May 2017

Maximum 12.10 10.90 16.10 Minimum 0.0 0.0 0.0

3.6.3 Wind Direction

This is important in air pollution since it determines the direction of transport of air pollutants. The mean wind direction will be indicative of the direction of travel of the pollutants. The meteorological parameters namely: ambient temperature, wind speed, wind direction and stability class were obtained from our own meteorological station kept at the project site for the Period of March – April – May - 2017. As


152



specific mixing heights were not available, mixing height based on CPCB publication “Spatial Distribution of Hourly Mixing Depth over Indian Region”, PROBES/88/2002-03 has been used. The windrose diagram is shown in Figure No. 3.4


153



Figure No. 3.4

Windrose Diagram FOR THE MONTH OF March– April – May 2017


154



Table No.3.6

WINDROSE FREQUENCY DISTRIBUTION

Wind Direction Wind speed, m/sec 0.5 - 2.1 2.1 - 3.6 3.6 - 5.7 5.7 - 8.8 8.8 - 11.1 >= 11.1 Total

348.75 - 11.25 1.14014 0.09501 0.19002 0.09501 0 0 1.50659 11.25 - 33.75 1.04513 0 0.04751 0.04751 0 0 1.12994 33.75 - 56.25 0.57007 0.14252 0.23753 0.09501 0 0 1.03578 56.25 - 78.75 0.85511 0.14252 0 0 0 0 0.9887 78.75 - 101.25 0.52257 0.04751 0 0 0.04751 0.14252 0.7533 101.25 - 123.75 1.47268 0.66508 0.04751 0.04751 0.09501 0.09501 2.40113 123.75 - 146.25 3.70546 0.57007 0.19002 0.14252 0.04751 0 4.61394 146.25 - 168.75 0.99762 0.14252 0.09501 0 0 0 1.22411 168.75 - 191.25 0.14252 0.14252 0.09501 0.09501 0 0 0.47081 191.25 - 213.75 0.14252 0 0.04751 0.04751 0.04751 0 0.28249 213.75 - 236.25 0.23753 0 0 0.09501 0 0 0.32957 236.25 - 258.75 7.26841 0.33254 0.09501 0.19002 0.19002 0.04751 8.05085 258.75 - 281.25 17.6247 3.89549 0.38005 0.28504 0.28504 0.14252 22.4105 281.25 - 303.75 12.1615 2.80285 0.42755 0.28504 0.19002 0.04751 15.7721 303.75 - 326.25 3.04038 0.42755 0.38005 0.14252 0 0 3.9548 326.25 - 348.75 1.37767 0.28504 0.14252 0 0 0 1.78908 Sub-Total 51.8362 9.60452 2.35405 1.55367 0.89454 0.47081 66.7137 Clams 32.3917 Missing Incomplete 0.89454 Total 100 Frequency of Calm Winds: 32.39% Average Wind Speed: 1.22 m/s


155



Table No.3.7

WINDROSE FREQUENCY COUNT

Directions / Wind Classes (m/s) 0.5 - 2.1 2.1 - 3.6 3.6 - 5.7 5.7 - 8.8

8.8 - 11.1 >= 11.1 Total

1 348.75 - 11.25 24 2 4 2 0 0 32 2 11.25 - 33.75 22 0 1 1 0 0 24 3 33.75 - 56.25 12 3 5 2 0 0 22 4 56.25 - 78.75 18 3 0 0 0 0 21 5 78.75 - 101.25 11 1 0 0 1 3 16 6 101.25 - 123.75 31 14 1 1 2 2 51 7 123.75 - 146.25 78 12 4 3 1 0 98 8 146.25 - 168.75 21 3 2 0 0 0 26 9 168.75 - 191.25 3 3 2 2 0 0 10

10 191.25 - 213.75 3 0 1 1 1 0 6 11 213.75 - 236.25 5 0 0 2 0 0 7 12 236.25 - 258.75 153 7 2 4 4 1 171 13 258.75 - 281.25 371 82 8 6 6 3 476 14 281.25 - 303.75 256 59 9 6 4 1 335 15 303.75 - 326.25 64 9 8 3 0 0 84 16 326.25 - 348.75 29 6 3 0 0 0 38

Sub-Total 1101 204 50 33 19 10 1417

Calms

688

Missing/Incomplete

19

Total

2124


156



Fig. No .3.5

WIND CLASS FREQUANCY DISTRIBUTION


157



3.6.4 Relative Humidiy (RH)

Mean Monthly Relative Humidity for Meteorological station kept at project site of M/s. Atlas Life Sciences is given in Table No.3.8

Table No.3.8

Relative Humidity Month Relative Humidity ( % )

Minimum Maximum March 2017 3.0 68.60 April 2017 4.20 69.30 May 2017 4.50 78.50

3.6.5 Climate & Rain Fall

The study area has a tropical type of climate. There are three main seasons: summer, monsoon and winter. Aside from the monsoon season, the climate is dry. The weather is hot through the months of March to June – the average summer maximum temperature is 36°C and average minimum temperature is 23°C. From November to February, the average maximum temperature is 30°C, the average minimum is 15°C and the climate is extremely dry. Cold northerly winds are responsible for a mild chill in January. The southwest monsoon brings a humid climate from mid-June to mid-September. The average rainfall is about 800 mm. The highest temperature recorded is 47°C and the lowest is 5°C. During the south-west monsoon season the relative humidity is generally 60% and over. In the rest of the year, the air is comparatively dry. In summer season humidity is 25% while in monsoon generally the rainfall occurs whenever the relative humidity is more than 80%. The annual average rainfall is about 800-850 mm.

3.6.6 Topography

The topography of the project site and the study area of 5 km radial zone are almost plain. The average elevation of the study area is about 40 - 50 m above mean sea level. There are no hills or hillocks in the study area. The site area is plain with little undulating at few places. Agriculture and allied activities are most predominant in this area. Fallow land and barren lands were less observed near project site. There was no any Eco Fragile Zone or Natural Forest Observed near project site in study area.


158



3.6.7 Mixing Height

As specific mixing heights were not available, mixing height based on CPCB

publication “SPATIAL DISTRIBUTION OF HOURLY MIXING DEPTH OVER INDIAN REGION”, PROBES/88/2002-03 has been tabulated in Table No.3.9

Table No.3.9

Hourly Mixing Depth over Indian Region

Hour of the Day Mixing Height (mts.)

5 50 6 50 7 100 8 400 9 500

10 500 11 1000 12 1000 13 1000 14 1000 15 1000 16 1000 17 1000 18 500 19 500

3.7 ATMOSPHERIC STABILITY

The hourly occurrence of various stability classes at project site is determined by wind direction fluctuation method by employing on-line instrument.

The stability classification system based on wind direction fluctuation method is as follows. Relationship between σθ and stability class as suggested by Slade (1965) is given in Table:-

Stability Class σθ (degrees)

A > 22.5 B 22.4 - 17.5 C 17.4 - 12.5 D 12.4 - 7.5 E 7.4 - 3.5 F < 3.5


159



3.8 NOISE ENVIRONMENT

Noise, often defined as unwanted sound, interferes with speech communication, causes annoyance, distracts from work and disturbs sleep thus deteriorating quality of human environment. The noise is generated from multiple sources such as medium and heavy industries, urban activities in the commercial and human settlements, and vehicular traffic in the region.

The noise level in the study area has been measured through Leutron sound level meter, for a period of one day for 30 minutes interwal at each monitoring station. In the study area noise levels were monitored in eight locations at different locations for day and night time and are given Table No.3.10


160



Table No.3.10

Noise Levels in the Study Areas in the Month of March 2017

Noise Levels

Sampling Date 05/03/2017

Location Project Site (Atlas Life Sciences)

Monitoring Time

Result in dB (A) Monitoring

Time Result in dB (A)

Day Time Night Time

9.00 am 46 9.00 pm 48 9.30 am 50 9.30 pm 46

10.00 am 53 10.00 pm 50 10.30 am 52 10.30 pm 44 11.00 am 58 11.00 pm 44 11.30 am 53 11.30 pm 43 12.00 pm 51 12.00 pm 44 12.30 pm 46 1.00 pm 48 1.30 pm 46 2.00 pm 53 2.30 pm 50 3.00 pm 47 3.30 pm 44 4.00 pm 46 4.30 pm 44 5.00 pm 44 5.30 pm 52 6.00 pm 53 6.30 pm 59 7.00 pm 55 7.30 pm 52 8.00 pm 50 8.30 pm 48


161




Location Soni ni Chali

Monitoring Time



Day Time Night Time

9.00 am 46 9.00 pm 45 9.30 am 51 9.30 pm 47



162




Location Odhav

Monitoring Time



Day Time Night Time

9.00 am 50 9.00 pm 47 9.30 am 54 9.30 pm 45



163




Location Nikol

Monitoring Time



Day Time Night Time

9.00 am 45 9.00 pm 47 9.30 am 50 9.30 pm 44



164




Location Kathwada

Monitoring Time



Day Time Night Time

9.00 am 53 9.00 pm 50 9.30 am 56 9.30 pm 46



165




Location Odhav Chokdi

Monitoring Time



Day Time Night Time

9.00 am 46 9.00 pm 56 9.30 am 49 9.30 pm 54



166




Location Vastral

Monitoring Time



Day Time Night Time

9.00 am 44 9.00 pm 47 9.30 am 50 9.30 pm 44



167




Location CTM

Monitoring Time



Day Time Night Time

9.00 am 46 9.00 pm 50 9.30 am 44 9.30 pm 46



168



3.9 WATER ENVIRONMENT

Water is the most vital resource for all kinds of life. It should not only be available in sufficient quantity but should be of good quality as well. Defilement of water, as a result of human activities, industrial activities and consequent pollution of water, cause deterioration of the water environment.

3.9.1 BASELINE DATA COLLECTION GW & SW

Physico-chemical Parameters have been used for assessing the base line quality of ground water environment and identification of impacts due to the proposed project. The Samples, under all categories, were analysed for various Parameters specified by the Department of Environment. For the collection, preservation and analysis, APHA/IS methods were followed. The requisite Procedures, laid down in APHA/IS methods, were adopted for preserving the Samples with suitable preservative chemicals. The Samples were analysed within the time limits prescribed for each Parameter.

The monitoring has been done at eight sampling stations located in different

directions and situated within the suspected impact zone in and around the project site. The ground water quality is presented in Table No. 3.12 The ground water quality in is acceptable as per IS: 10500 for domestic water supply.

Table No. 3.11 Locations of Water Quality Monitoring Stations

Sr. No.

Type of sample Water sample location

1 Ground Water Project Site 2 Ground Water Soni ni Chali 3 Ground Water Odhav 4 Ground Water Nikol 5 Ground Water Kathwada 6 Ground Water Odhav Chokdi 7 Ground Water Vastral 8 Ground Water CTM


169



Photographs of water sampling

Odhav Lake sample

Nikol Gam Tape water


170



Table No.3.12

Water Quality Analysis for the month of March 2016.

RESULTS OF WATER QUALITY IN THE STUDY AREA

No Parameter Project site

Bore Water

Soni ni Chali

Tap water

Odhav Tap water

Nikol Tap water Unit Permissible

Limit

Sampling Date 05/03/17 05/03/17 05/03/17 05/03/17 1 pH 7.7 7.3 7.4 7.4 -- 6.5-8.5 2 Colour Colourless Colourless Colourless Colourless -- -- 3 Odour Odourless Odourless Odourless Odourless -- -- 4 Turbidity < 1 < 1 < 1 < 1 NTU 10

5 Total Dissolved Solids 950 330 360 320 mg/lit 2000

6 Total Hardness 256 88 98 88 mg/lit 600 7 Calcium 61.7 21.6 23.2 20.8 mg/lit -- 8 Magnesium 24.8 8.3 9.7 8.8 mg/lit -- 9 Sodium 260 89 98 87 mg/lit --

10 Potassium 18.4 6.4 7.0 6.2 mg/lit -- 11 Chloride 295 102 110.7 99.4 mg/lit 1000 12 Sulphate 49.1 17.0 18.6 16.5 mg/lit 400

13 Phenolic Compound < 0.002 < 0.002 < 0.002 < 0.002 mg/lit 0.002

14 Mineral Oil < 0.02 < 0.02 < 0.02 < 0.02 mg/lit 0.03 15 Suspended Solids < 0.5 < 0.5 < 0.5 < 0.5 mg/lit --

16 Chemical Oxygen Demand < 4 < 4 < 4 < 4 mg/lit --

17 Biological Oxygen demand < 2 < 2 < 2 < 2 mg/lit --

18 Ammonical Nitrogen < 1 < 1 < 1 < 1 mg/lit --

19 Alkalinity 310 110 110 100 mg/lit 600 20 Copper < 0.001 < 0.001 < 0.001 < 0.001 mg/lit 1.5 21 Nitrate 3.42 1.18 1.30 1.16 mg/lit 45 22 Phosphate < 0.1 < 0.1 < 0.1 < 0.1 mg/lit -- 23 Iron 0.18 0.05 0.07 0.05 mg/lit 1.0 24 Mercury < 0.001 < 0.001 < 0.001 < 0.001 mg/lit 0.001 25 Selenium < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.01 26 Cadmium < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.01 27 Arsenic < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.01 28 Lead < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.05 29 Chromium < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.05 30 MPN < 2 < 2 < 2 < 2 Nos 10/100ml


171



No Parameter Kathwada Bore water

Odhav Chokdi

Tap water

Vastral Tap water

CTM Tap water Unit Permissible

Limit

Sampling Date 05/03/17 05/03/17 05/03/17 05/03/17 1 pH 7.6 7.3 7.4 7.5 -- 6.5-8.5 2 Colour Colourless Colourless Colourless Colourless -- -- 3 Odour Odourless Odourless Odourless Odourless -- -- 4 Turbidity < 1 < 1 < 1 < 1 NTU 10

5 Total Dissolved Solids 1105 380 340 350 mg/lit 2000

6 Total Hardness 298 102 92 94 mg/lit 600 7 Calcium 71.3 24.8 21.6 22.4 mg/lit -- 8 Magnesium 29.2 9.74 9.25 9.25 mg/lit -- 9 Sodium 300 100 92 95 mg/lit --

10 Potassium 21.4 7.4 6.6 6.8 mg/lit -- 11 Chloride 341 119 105 108 mg/lit 1000 12 Sulphate 56.5 19.6 17.5 18.1 mg/lit 400

13 Phenolic Compound < 0.002 < 0.002 < 0.002 < 0.002 mg/lit 0.002

14 Mineral Oil < 0.02 < 0.02 < 0.02 < 0.02 mg/lit 0.03 15 Suspended Solids < 0.5 < 0.5 < 0.5 < 0.5 mg/lit --

16 Chemical Oxygen Demand < 4 < 4 < 4 < 4 mg/lit --

17 Biological Oxygen demand < 2 < 2 < 2 < 2 mg/lit --

18 Ammonical Nitrogen < 1 < 1 < 1 < 1 mg/lit --

19 Alkalinity 360 120 110 110 mg/lit 600 20 Copper < 0.001 < 0.001 < 0.001 < 0.001 mg/lit 1.5 21 Nitrate 3.98 1.38 1.22 1.26 mg/lit 45 22 Phosphate < 0.1 < 0.1 < 0.1 < 0.1 mg/lit -- 23 Iron 0.21 0.07 0.07 0.07 mg/lit 1.0 24 Mercury < 0.001 < 0.001 < 0.001 < 0.001 mg/lit 0.001 25 Selenium < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.01 26 Cadmium < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.01 27 Arsenic < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.01 28 Lead < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.05 29 Chromium < 0.005 < 0.005 < 0.005 < 0.005 mg/lit 0.05 30 MPN < 2 < 2 < 2 < 2 Nos 10/100ml


172



No Parameter Nikol gam Lake water

Odhav Lake

Ramol Lake Unit Permissible

Limit Sampling Date 05/03/17 05/03/17 05/03/17

1 pH 8.0 8.1 8.0 -- 6.5-8.5 2 Colour Colourless Colourless Colourless -- -- 3 Odour Odourless Odourless Odourless -- -- 4 Turbidity 12 11 10 NTU 10

5 Total Dissolved Solids 1580 1390 1510 mg/lit 2000

6 Total Hardness 428 378 408 mg/lit 600 7 Calcium 101.8 89.7 97.7 mg/lit -- 8 Magnesium 42.3 37.5 13.1 mg/lit -- 9 Sodium 430 380 410 mg/lit --

10 Potassium 30.6 26.9 29.2 mg/lit -- 11 Chloride 489 432 469 mg/lit 1000 12 Sulphate 81.7 71.4 77.7 mg/lit 400

13 Phenolic Compound < 0.002 < 0.002 < 0.002 mg/lit 0.002

14 Mineral Oil < 0.02 < 0.02 < 0.02 mg/lit 0.03 15 Suspended Solids < 0.5 18 < 0.5 mg/lit --

16 Chemical Oxygen Demand 139 180 130 mg/lit --

17 Biological Oxygen demand 45 51 39 mg/lit --

18 Ammonical Nitrogen < 1 < 1 < 1 mg/lit --

19 Alkalinity 510 450 490 mg/lit 600 20 Copper < 0.001 < 0.001 < 0.001 mg/lit 1.5 21 Nitrate 5.72 5.02 5.46 mg/lit 45 22 Phosphate < 0.1 < 0.1 < 0.1 mg/lit -- 23 Iron 0.31 0.27 0.29 mg/lit 1.0 24 Mercury < 0.001 < 0.001 < 0.001 mg/lit 0.001 25 Selenium < 0.005 < 0.005 < 0.005 mg/lit 0.01 26 Cadmium < 0.005 < 0.005 < 0.005 mg/lit 0.01 27 Arsenic < 0.005 < 0.005 < 0.005 mg/lit 0.01 28 Lead < 0.005 < 0.005 < 0.005 mg/lit 0.05 29 Chromium < 0.005 < 0.005 < 0.005 mg/lit 0.05 30 MPN 510 480 530 Nos 10/100ml


173



3.10 LAND ENVIRONMENT

3.10.1 GEOLOGY:

The geology of the area is underlain by recently placed alluvium, brown sand and millolite sand. As per the Geo-Environmental Regions of Gujarat, the study area falls in the Northern Alluvial Plains. The average elevation of the study area is about 70 m above mean sea level. There are no hills or hillocks in the study area. The entire area of the district is underlain by the basaltic lava flows of upper Cretaceous to lower Eocene age. The shallow alluvial formation of Recent age also occurs as narrow stretch along the major rivers flowing in the area. Geological Structure of Gujarat state and Figure no. 3.6 of Geology plan of Study Area. No other rock formations are exposed in the area.

Figure no. 3.6: Geological Structure of Gujarat State

Source: Water Resources Dept from http://guj-nwrws.gujarat.gov.in/


174



3.11 TYPE OF SOILS

Soil may be defined as a thin layer of earth’s crust that serves as a natural medium for the growth of vegetations. It is the unconsolidated mineral matter that has been subjected to and influenced by genetic and environmental factors. Soil serves as a reservoir of nutrients for plants and crops and also provides mechanical anchorage and favourable tilth. The study has alluvial loam soil locally known as Goradu or Bhatta. Goradu are nothing but alluvial soils of older origin while bhatta soils are of recent origin deposited chiefly along the banks of river. The soils of this group are very deep, well drained, fine soils on very gently sloping alluvial plain with moderate erosion associated with deep, modetely well-drained, calcareous, fine loamy soils with moderate erosion.

3.11.1 CHARACTERISTICS OF SOILS BASE LINE DATA

The soil samples were collected from different places in the study area. The soil samples are taken from eight villages.

At each sampling site, the samples were collected at random at a depth of 15 cms and mixed together to form a composite sample. Large stones, gravels and plant roots were removed from soil. The soil was then crushed and water suspension was prepared. The supernatant liquid was then subjected to Physico-Chemical analysis. Standard Procedures were followed for analysis. The results of soil analysis are tabulated in Table No. 3. 13


175



Table No.3.13

Analysis Results of Soil Samples

Sr. No. Parameter Unit 1 2 3 4

Location Project site Soni ni Chali Odhav Nikol

Sampling Date 05/03/17 05/03/17 05/03/17 05/03/17 1 pH 7.6 7.2 7.4 7.3 2 Total Hardness mg/kg 1360 1300 1320 1280 3 Calcium mg/kg 432.9 416.8 424.8 408.8 4 Magnesium mg/kg 68.2 63.3 63.3 63.3 5 Sodium mg/kg 314 300 307 297 6 Potassium mg/kg 47 44 46 44 7 Total Alkalinity mg/kg 1180 1120 1140 1120 8 Chloride mg/kg 596.4 568 582.2 568 9 Organic Carbon % 0.51 0.49 0.50 0.49

10 Organic Matter % 0.88 0.85 0.86 0.85 11 Available Nitrogen mg/kg 431.2 414.4 420 408.8 12 Available Phosphorus mg/kg 4.27 4.07 4.18 4.05 13 Boron mg/kg BDL BDL BDL BDL 14 Cadmium mg/kg BDL BDL BDL BDL 15 Chromium mg/kg BDL BDL BDL BDL 16 Cobalt mg/kg BDL BDL BDL BDL 17 Copper mg/kg BDL BDL BDL BDL 18 Nickel mg/kg BDL BDL BDL BDL 19 Zinc mg/kg BDL BDL BDL BDL 20 Lead mg/kg BDL BDL BDL BDL 21 Bulk Density Gm/cm3 1.18 1.12 1.15 1.11 22 Texture -- 23 Slit (%) % 25 19 20 21 24 Clay (%) % 4 11 15 12 25 Sand (%) % 71 70 65 67 26 Electrical Conductivity µmho/cm 706 674 690 669 27 Cation Exchange

Capacity mg/ 100

gm 81.8 76.1 82.6 82.6


176



Sr. No. Parameter Unit 5 6 7 8

Location Kathwada Odhav Chokdi Vastral CTM

Sampling Date 05/03/17 05/03/17 05/03/17 05/03/17 1 pH 7.2 7.5 7.5 7.9 2 Total Hardness mg/kg 1260 1420 1380 1460 3 Calcium mg/kg 408.8 448.9 440.9 464.9 4 Magnesium mg/kg 58.5 73.1 68.2 73.1 5 Sodium mg/kg 295 330 321 337 6 Potassium mg/kg 44 49 48 50 7 Total Alkalinity mg/kg 1100 1220 1200 1260 8 Chloride mg/kg 553.8 624.8 610.6 610.6 9 Organic Carbon % 0.48 0.54 0.52 0.55

10 Organic Matter % 0.82 0.93 0.89 0.95 11 Available Nitrogen mg/kg 408.8 453.6 442.4 464.8 12 Available Phosphorus mg/kg 4.02 4.5 4.36 4.58 13 Boron mg/kg BDL BDL BDL BDL 14 Cadmium mg/kg BDL BDL BDL BDL 15 Chromium mg/kg BDL BDL BDL BDL 16 Cobalt mg/kg BDL BDL BDL BDL 17 Copper mg/kg BDL BDL BDL BDL 18 Nickel mg/kg BDL BDL BDL BDL 19 Zinc mg/kg BDL BDL BDL BDL 20 Lead mg/kg BDL BDL BDL BDL 21 Bulk Density Gm/cm3 1.1 1.23 1.2 1.27 22 Texture -- 23 Slit (%) % 19 18 26 20 24 Clay (%) % 11 12 9 10 25 Sand (%) % 70 70 65 70 26 Electrical Conductivity µmho/cm 664 742 721 758 27 Cation Exchange

Capacity mg/ 100

gm 49.4 71.3 63.2 50.2


177



Photograph of soil sampling

Odhav Chokdi Soil

Kathwada Soil sample


178



3.12 LAND USE PATTERN

Remote Sensing is a process of identification and demarcation of various

earths’ objects from a distance without directly coming into contact with them.

Remote sensing is largely concerned with the measurement of

electromagnetic radiation from the sun, which is reflected, scattered, and

emitted by the objects on the surface of the earth. Different objects on the

surface of the earth reflect different amounts of the electromagnetic spectrum.

The potential of remote sensing in natural resources mapping basically

depends on spatial, radiometric and temporal resolution of the sensor. Thus

the satellite remote sensing with its capability of repetitive coverage, multi-

spectral imaging, synoptic view and low cost can play an important role in the

delineation of various landuse landcover classes.

Land cover is a fundamental parameter describing the Earth’s surface. This

parameter is a considerable variable that impacts on and links many parts of

the human and physical environments. Remote sensing technique has ability

to represent of land cover categories by means of classification process. With

the availability of multispectral remotely sensed data in digital form and the

developments in digital processing, remote sensing supplies a new

prospective for landuse/landcover analysis. Geographical Information Systems

have already been used for assessing environmental problems, since they

provides a flexible environment and a powerful tool for the manipulation and

analysis of spatial information for land cover feature identification and the

maps of all variables were combined to extract information to better

understand analyzing. Satellite remote sensing, in conjunction with geographic

information systems, has been widely applied and been recognized as a

powerful and effective tool in analyzing land cover/use categories This study

made use of remotely sensed data and GIS technologies; to evaluate

qualitatively and quantitatively outcome of part of land cover/use distribution.

Obtained results were compared, visualized and analyzed, in Geographic

Information System.


179



The Study Area up to 10 kms radius from the Proposed project Site.The

locations of these villages/ Areas are shown in Figure No. 3.1.

The important land uses, as classified by the Census Records, are the Forest,

Land irrigated by different water sources, un-irrigated areas, Cultivable waste

land and areas not available for cultivation.

Landuse and landcover distribution in the study area has been estimated using

the satellite imagery of generated from Landsat ETM+ scene of October 2006

(Refer: Figure 3.7). The landuse and landcover pattern of the study area (10

km radial zone) has been studied by the same. The land use distribution in the

study area (10 km radial zone) is presented in Table 3.14.

Table 3.14: Land Use Distribution in Study Area (10 km Radial Zone)

Area Calculation

Sr no Landuse/Landcover Class Area in Sq. Km Area in %

1 Habitation 101.08 32.176

2 Water Bodies 3.02 0.962

3 Land without scrub 14.32 4.558

4 Scrub 26.65 8.482

5 Open Vegetation 20.03 6.376

6 Industrial Area 28.54 9.084

7 River 4.66 1.483

8 Agricultural Land 115.86 36.880

Total: 314.16 100.000


180



Fig: 3.7

Land Use / land cover map of 10 km radius area around Project Site


181



3.13 HYDROGEOLOGY

Hydrology is the science that deals with the depletion and replenishment of water resources. It deals with surface as well as ground water. The water below the water table is known as ground water and water above the water table is known as soil moisture. The water table map and water quality map of study area is attached as a Figure No. 3.8 & 3.9

The geology of the area is underlain by recently placed alluvium, brown sand and millolite sand. As per the Geo-Environmental Regions of Gujarat, the study area falls in the Northern Alluvial Plains. The average elevation of the study area is about 70 m above mean sea level. There are no hills or hillocks in the study area. The entire area of the district is underlain by the basaltic lava flows of upper Cretaceous to lower Eocene age. The shallow alluvial formation of Recent age also occurs as narrow stretch along the major rivers flowing in the area. River Sabarmati is the principal river of the district. It originates from Dhebar Lake in Aravalli Range of Udaipur District, Rajasthan and finally debauches into Gulf of Khambat near Vataman village of Dholka taluka. Sabarmati forms the eastern boundary of the district flowing from NE to SW direction in Ahmedabad and Gandhinagar districts.


182



Figure No. 3.8

Hydro Chemistry Level of Ground water


183



Figure No. 3.9 Status of depth to water level in Gujarat


184



Figure No. 3.10

Ground water quality map of Gujarat


185



3.14 ECOLOGY

Collection of comprehensive baseline information on flora and fauna

is a prerequisite for assessment of impacts of any developmental

activities The biological environment is an important component of

the environment of any area. It covers flora & fauna in the region,

details of forests and wildlife sanctuaries in the region, with list of

endangered species. These components are addressed in details in

the following sections:

Flora and fauna are important components of the environment. They

are organized into natural communities with natural dependencies

among their members and show various responses and sensitivities

to anthropogenic activities. Flora and fauna describes information on

various species of trees, plants, shrubs, crops and natural

vegetation, animal, birds etc. and endangered species.

. Though, the need of collecting ecological data is many fold more. In

the context of present study, where the time was a serious constraint

for seasonal data collection on different ecological parameters, the

focus was, therefore, on to collect data on current status of plants

and animals as baseline information for future comparisons.

Following methodology was adopted in order to collect scientific

data.

We attempted to create baseline information through 1) review of

literature, 2) consultation and 2) first hand data collection through

field surveys.

Field Surveys

In order to get the first hand information on the project and

surrounding ecological status, field surveys were conducted. The

field surveys were conducted to assess baseline status of flora and

fauna between March – May 2017


186



Sampling Strategy

For assessment of flora and fauna, study team randomly sampled in

10.0 km radius of the project site. We collected the data on flora and

fauna in each sample plot of 10X10 mtr quadrate. Total 30

quadrates were laid in the study area in order to rapidly study the

fauna and flora of the region.

No national paik / Wildlife Sanctuary / Reserve Forest cover was

found in 10 Km radius of the project area. A detailed survey report

with the methodology and study is as given in the following section.

The surrounding area particularly in the 10.0 Km periphery of the

project unit area is dominated with irrigated agriculture farms, roads,

canal, and villages etc. The details of some major landuses are

described below.


187



TABLE NO. 3.15

List of Commonly Found Flora in the Study Area

No Botanical Name Local Name Family HERBS

1 Aloe vera Kunvar patha Lilaceae 2 Alysicarpus procumbens Samero Papilionaceae 3 Amaranthus gracilis Tandaljo Nyctaginaceae 4 Ammania Baccifera Lal agaio Lythraceae 5 Blumea mollis Chanchadmani Compositae 6 Boerhavia diffusa Satodi Nyctaginaceae 7 Brassica nigra Kali Rai Cruciferae 8 Cassia abrus Chimed Caesalpiniaceae 9 Cassia tora Puwad Caesalpiniaceae

10 Cleome viscosa Pili tilwan Capparaceae 11 Clitoria biflora Garni Papilionaceae 12 Cressa cretica Rudravanti Convolvulaceae 13 Desmodium dichotomum Shal parni Papilionaceae 14 Dipteracanthus prostratus Kalighavani Acanthaceae 15 Emilia sonchifolia Hirankhani Compositae 16 Evolvulus alsinoides Kalishankhavali Convolvulaceae 17 Glinus lotoides Mitho okharad Molluginaceae 18 Justicia simplex Kalikariatu Acanthaceae

SHRUBS 20 Agave americana Ketaki Agavaceae 21 Bougainvillea spectabilis Boganvel Nyctaginaceae 22 Calotropis procera Ankdo Asclepiadaceae 23 Capparis decidua Kerdo Capparaceae 24 Carica papaya Papaya Caricaceae 25 Cassia auriculata Awal Caesalpiniaceae 26 Cucumis callosus Kothimda Cucurbitaceae 27 Dioscorea hispida Bhoi kand Dioscoriaceae 28 Dolichos lablab Papadi Papilionaceae 29 Euphorbia nerifolia Thor Euphorbiaceae 30 Euphorbia nivulia Thor Euphorbiaceae 31 Hemidermus indicus Dudhvel Asclepiadaceae 32 Hibiscus rosa-sinensis Jasud Malvaceae 33 Lawsonia cuspidata Mendi Lythraceae 34 Momordica dioca Kankodi Cacurbitaceae 35 Nerium indicum Karen Apocynaceae 36 Zizyphus mauritiana Bordi Rhamnaceae 37 Zizyphus nummularia Chanibor Rhamnaceae


188



TREES 38 Acacia catechu Kher Fabiaceae 39 Acacia leucophloea Baval Fabiaceae 40 Acacia nilotica Desi Bawal Mimosaceae 41 Acacia senegal Kher Fabiaceae 42 Acacia tortilis Israili baval Fabiaceae 43 Azadirachta indica Limdo Meliaceae 44 Balanites aegyptica Ingoriya Balanitaceae 45 Butea monosperma Khakhro Fabiaceae 46 Cassia fistula Garmalo Fabiaceae 47 Eucalyptus globulus Nilgiri Myrtaceae 48 Ficus benghalensis Vad Moraceae 49 Ficus racemosa Umaro Moraceae 50 Ficus religiosa Piplo Moraceae 51 Mangifera indica Amba Ancardiaceae 52 Moringa concanensis Sargavo Moringaceae 53 Moringa oleifera Jungli Sargavo Moringaceae 54 Peltophorum pterocarpum Tamra parni Fabiaceae 55 Pithecollobium dulce Goras Amli Mimosaceae 56 Pongamia pinnata Karanj Papilionaceae 57 Prosopis cineraria Khijdo Mimosaceae 58 Prosopis juliflora Gando Bawal Mimosaceae 59 Tamarindus indica Khati Amli Caesalpiniaceae 60 Terminalia catappa Badam Combretaceae


189



TABLE NO. 3.16

Bird species reported during the study

No

Name of Species

Conservation Status as per IWPA-

1972 (Schedule I

to VI)

Conservation Status as per IUCN Common Name Scientific Name

1 Ashy Prinia Prinia socialis IV LC

2 Ashy-crowned Finch-lark Eremopterix grisea IV LC

3 Asian Koel Eudynamys scolopacea IV LC

4 Bank Myna Acridotheres ginginianus IV LC

5 Baya Weaver Ploceus philippinus IV LC

6 Bay-backed Shrike Lanius vittatus IV LC

7 Black drongo Dicrurus macrocercus IV LC

8 Black Ibis Pseudibis papillosa IV LC

9 Black Kite Milvus migrans IV LC

10 Black Redstart Phoenicurus ochruros IV LC

11 Black shoulder kite Elanus caeruleus IV LC

12 Black winged stilt Himantopus himantopus IV LC

13 Blue rock pigeon Columba livia IV LC

14 Bluethroat Luscinia svecica svecica IV LC

15 Brahminy Starling Sturnus pagodarum IV LC

16 Cattle egret Bulbulcus ibis IV LC

17 Comb Duck Sarkidiornis melanotos IV LC

18 Common babbler Turdoides caudatus IV LC

19 Common Crested Lark Galerida cristata IV LC

20 Common Iora Aegithina tiphia IV LC

21 Common Kingfisher Alcedo atthis IV LC

22 Common myna Acridotheres tristis IV LC

23 Common Swift Apus apus IV LC

24 Common tailor bird Orthotomus sutorius IV LC

25 Common Whitethroat Sylviacommunis IV LC

26 Common Woodshrike Tephrodornis pondicerianus IV LC

27 Coppersmith Barbet Megalaima haemacephala IV LC

28 Eurasian collared dove Streptopelia decaocto IV LC

29 Eurasian Stone-Curlew Burhinus oedicenemus IV LC

30 Franklin's Prinia Prinia hodgsonii IV LC

31 Greater Coucal Centropus sinensis IV LC


190



32 Greater Short-toed Lark Calandrella brachydactyla IV LC

33 Green bee eater Merops orientalis IV LC

34 Green Sandpiper Tringa ochropus IV LC

35 Grey francolin Francolinus pondicerianus IV LC

36 House crow Corvus splendens V LC

37 House sparrow Passer domesticus IV LC

38 Indian Baya Weaver Ploceus philippinus IV LC

39 Indian pond heron Ardeola grayii IV LC

40 Indian robin Saxicoloides fulicata IV LC

41 Indian Roller Coracias benghalensis IV LC

42 Indian silverbill Lonchura malabarica IV LC

43 Jungle babbler Turdoides striatus IV LC

44 Large Grey Babbler Turdoides malcolmi IV LC

45 Laughing dove Streptopelia senegalensis IV LC

46 Long tailed shrike Lanius schach IV LC

47 Oriental magpie robin Copsychus saularis IV LC

48 Purple sunbird Nectarinia asiatica IV LC

49 Red vented bulbul Pycnonotus cafer IV LC

50 Red wattled lapwing Vanellus indicus IV LC

51 Rose ringed parakeet Psittacula krameri IV LC

52 Rosy Starling Sturnus roseus IV LC

53 Rufous-tailed Shrike Lanius isabellinus IV LC

54 Rufus tailed lark Ammomanes phoenicurus IV LC

55 Sarus Crane Grus antegone IV VU 56 Shikra Accipiter badius IV LC

57 Southern Grey Shrike Lanius meridionalis IV LC

58 Spotted Owlet Athene brama IV LC

59 White throated kingfisher Halcyon smyrnensis IV LC

Vu=Vulnerable, LC=Least Concerned A


191



TABLE NO. 3.17

Mammals species reported during the study

No Name of Species Conservation

Status as per IWPA-1972 (Schedule I

to VI)

Conservation Status as per

IUCN Scientific Name Common Name

1 Canis aureus Indian Jackal II LC 2 Boselaphus tragocamelus Nilgai III LC 3 Lepus nigricollis Indian Hare IV LC 4 Sus scrofa Wild Pig III LC 5 Herpestes edwardsi Common mongoose II LC 6 Funambulus pennanti Palm squirrel IV LC 7 Rattus rattus House rat V LC 8 Cyanopterus sphynx Fruit Bat V LC 9 Semnopithecus hypoleucos Hanuman langur IV LC

LC= Least Concerned Forests & Wildlife There are 4 National Parks and 21 Wildlife Sanctuaries in Gujarat; however, none of them are falling in the study area. The Forest Vegetation Map of Gujarat is shown in Figure 3.11, and National Parks with Wildlife Sanctuaries Map of Gujarat is shown in Figure 3.12:


192



Figure 3.11, Forest Vegetation Map of Gujarat


193



Figure 3.12 - National Park and Sacturies of Gujarat

Protected Areas: There are no protected areas in the vicinity of the project area. There are also no monuments of historical and archaeological importance within the study area.


194



3.15 SOCIO-ECONOMIC ENVIRONMENT

M/s. Atlas Life Sciences is a proposed unit located at Plot No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad, Gujarat. In proposed unit they have decided to manufacture Pharmaceuticals bulk drugs @ 46.85 MT/Month. Any developmental activity exerts a direct impact on the socio-economic environment of the region. Usually, the beneficial impacts such as better job opportunities, improved education, communication, energy, housing, health, transportation facilities etc. outweighs the adverse impacts, if any. The study of socio-economic component of environment incorporates various facets, viz. demographic structure, availability of basic amenities such as housing, education, health and medical services, occupation, water supply, sanitation, communication and power supply, prevailing diseases in the region as well as features such as places of tourist attraction and monuments of archaeological importance. The study of these parameters helps in identifying predicting and evaluating the likely impacts due to project activity in the surrounding region. The present study on the socio-economic environment incorporates existing status of the socio-economic profile of the area covering 6 Villages and 4 town area in 10 km study area. 3 tehsil comes from Ahmedabad district namely Detroj Rampura, Daskori and Ahmedabad Baseline data such as demographic pattern, occupational status, educational, health and other amenities as existing in the study area have been studied.


195



Socio- economic Status The latest available data have been complied to generate the existing socio-economic scenario of the study area. Information on socio-economic profile was collected from the Primary Census Abstract CD 2011, including the population details of the region and DCHB 2011, having the details of basic amenities available in the region. The villages surveyed under Study Areas are shown in Table 1. The details of village and ward wise (rural and urban) demography and the occupational structure of the Study Areas are appended (Table 2) Literacy details in Table 3.The Socio-Economic status of the above eleven study areas is mentioned below:

Demographic Structure Demographic structure of the study area was demonstrated with the selected parameters such as households, population, sex ratio, scheduled caste, scheduled tribes, literacy, occupational pattern and employment drawn from Primary Census Abstract, CD 2011. The Summarized demographic structure of the study areas in comparison with District Gandhinagar and Mahesana graphical presentation on population distribution, literacy rate and occupational structure of the study areas in comparison with the District are given in Fig 1, Fig 2 and Fig 3 respectively. Population Total population of study area as per as per Census 2011 was 5627296. Total population of Study area is comprises 2964428 male and 2662868 female.

Population Density The population density of the 6 villages was 97 persons recorded per Sq.km area respectively

Sex Ratio Sex ratio (number of female per thousand male). Average sex ratio in the study area is 898 female to 1000 male.


196



Scheduled Castes & Scheduled Tribes Population The ratio of scheduled caste and scheduled tribe as compared to the total population of the study area are 599386(10.65%) and 67921(1.20%).

Literacy Average literacy rate of the study area is (78.39%) and illiteracy rate is (21.60%) (Fig.3.14). Total literates are 4411416 and illiterates are 1215880.Out of total literates male literates are 2422256 and female literates are 1989160.

Occupational Pattern Occupational Pattern of any region mainly depends upon its economically active group

i.e. the working population involved in productive work. There are different types of workers that

may be classified as -

Main Workers Main workers are those who have worked for a major part of the year (i.e. at least six

months or 183 days). Main activity of a person who was engaged in more than one activity was

reckoned in terms of time disposition.

Marginal workers

Marginal workers are those who have worked less than 6 months.

Non-Workers Non-Workers may be defined as those persons who have not worked at all during the entire year under the reference period. The proportion of non workers may show the unemployment level of the region. The details concerning the demographic structure of the study area was collected from Census record of Ahmedabad district from Gujarat state, 2011 census. The details about demographic structure are given in Table No. 3.18

The details concerning the demographic structure of the study area was collected from

Census record of Mehsana district from Gujarat state, 2011 census. The details about

demographic structure are given in Table No. 3.18


197



Table No. 3.18

Population Details

Sr. No Taluka Name Code Type No_HH TOT_P TOT_M TOT_F P_06 P_SC P_ST 0-5 km 1 Detroj-

Rampura Odhav 511455 Rural 158 555 285 270 42 78 0

5-10 km 2 Daskroi Gatrad 511649 Rural 1165 5560 2813 2747 819 110 9 3 Daskroi Vanch 511653 Rural 1386 6674 3438 3236 942 957 18 4 Daskroi Bakrol Bujrang 511648 Rural 668 3538 1838 1700 536 126 12 5 Daskroi Kujad (OG) Ward

No.-0062 Urban 1498 7535 3864 3671 1079 684 171

6 Daskroi Kanbha (OG) Ward No.-0061

802484 Urban 959 4498 2356 2142 529 280 39

7 Daskroi Bhuvaldi 511642 Rural 1478 7279 3745 3534 965 262 0 8 Daskroi Zanu 511637 Rural 831 4268 2201 2067 687 373 3 9 Daskroi Bilasiya (OG) Ward

No.-0060 802484 Urban 363 1861 966 895 238 48 10

10 Ahmadabad City

Ahmadabad City 000000 Urban 1181269 5585528 2942922 2642606 621829 596468 67659

Total 1189617 5626741 2964143 2662598 627624 599308 67921 Grand Total 1189775 5627296 2964428 2662868 627666 599386 67921

Source: Primary census abstract 2011, Ahmedabad district , state Gujarat

Note: No_ HH: No of households, TOT_P: Total Population, TOT_M: Total Male, TOT_F: Total Female, P_06: Population o-6 age, M_06: Male o-6 age F_06: Female 0-6 age, P_SC: population SC, M_SC: Male SC, F_SC: Female SC, P_ST: Population ST, M_ST: Male ST, F_ST: Female ST


198



Figure 3.13 Population Details

Figure 3.14 Literacy details


199



Table 3.19 Literacy details

Source: Primary census abstract 2011, Dist - Ahmedabad, state Gujarat

Sr. No Taluka Name P_LIT M_LIT F_LIT P_ILL M_ILL F_ILL 0-5 km 1 Detroj-

Rampura Odhav 384 228 156 171 57 114

5-10 km 2 Daskroi Gatrad 3889 2132 1757 1671 681 990 3 Daskroi Vanch 4549 2609 1940 2125 829 1296 4 Daskroi Bakrol Bujrang 2220 1297 923 1318 541 777 5 Daskroi Kujad (OG) Ward

No.-0062 5387 2987 2400 2148 877 1271


3358 1914 1444 1140 442 698

7 Daskroi Bhuvaldi 4923 2843 2080 2356 902 1454 8 Daskroi Zanu 2963 1610 1353 1305 591 714 9 Daskroi Bilasiya (OG)

Ward No.-0060 1332 787 545 529 179 350

10 Ahmadabad City

Ahmadabad City 4382411 2405849 1976562 1203117 537073 666044

Total 4411032 2422028 1989004 1215709 542115 673594 Grand Total 4411416 2422256 1989160 1215880 542172 673708


200



3.16 Economic Attributes Economic resource base of any region mainly depends upon its economically active group i.e. the working population involved in productive work. Work- Work may be defined as participation in any economically productive activity. Such participation may be physical or mental in nature. Work involves not actual work but also effective supervision and direction of work. It also includes unpaid work on farm or in family enterprise. The employment pattern of worker and Main worker of the study area is described below and presented in Table 3.20 as well as in Figure 3.15 Total workers in the study area are 1968449(34.98%) in which main workers are

1819249(32.32%)

Marginal workers are 149200(2.65%).

Total non workers are 3658847(65.01%)

Types of main workers Main other workers are 1759537 (96.71%).

Main cultivator’s workers are 11483(0.63%)

There are 12820(0.70%) and 35409(1.94%) workers as agriculture and house hold industry worker


201



Figure 3.15 Employment pattern


202



Table 3.20

Employment pattern and main worker employment pattern

Sr. No

Taluka Name TOT_WORK_P

MAINWORK_P

MARGWORK_P

NON_WORK_P

MAIN_CL_P

MAIN_AL_P

MAIN_HH_P

MAIN_OT_P

0-5 km 1 Detroj-

Rampura Odhav 206 200 6 349 87 44 1 68

5-10 km 2 Daskroi Gatrad 1658 1616 42 3902 460 644 8 504 3 Daskroi Vanch 2523 1813 710 4151 317 615 34 847 4 Daskroi Bakrol

Bujrang 1466 1187 279 2072 336 252 1 598

5 Daskroi Kujad (OG) Ward No.-0062

2441 1827 614 5094 383 350 10 1084


1625 1558 67 2873 103 408 7 1040

7 Daskroi Bhuvaldi 2530 2396 134 4749 310 619 53 1414 8 Daskroi Zanu 1327 611 716 2941 348 40 4 219 9 Daskroi Bilasiya

(OG) Ward No.-0060

623 591 32 1238 82 81 3 425

10 Ahmadabad City

Ahmadabad City

1954050 1807450 146600 3631478 9057 9767 35288 1753338

Total 1968243 1819049 149194 3658498 11396 12776 35408 1759469 Grand Total 1968449 1819249 149200 3658847 11483 12820 35409 1759537 Source: Primary census abstract 2011, District – Ahmedabad, state Gujarat


203



3.17 AVAILABILITY OF BASIC AMENITIES ACTIVITIES

Table 3.21

Availability of Basic Amenities Activities

Govt Primary School

Govt Secondary School Primary Health Sub Centre Maternity And Child Welfare Centre

Non Government Medical facilities Medicine Shop

6 2 5 5 4 Tap Water Untreated

Uncovered Well Tube Wells/Borehole River/Canal Tank/Pond/Lake

6 1 5 2 3 No Drainage Post Office Sub Post Office Telephone Public Call Office /Mobile

6 1 6 6 5 Public Bus Service Auto/Modified Autos Vans Tractors Foot path 6 6 2 5 6 Black Topped (pucca) Road

Gravel (kuchha) Roads Navigable Waterways

6 4 1 Power Supply For Domestic Use

Power Supply For Agriculture Use

Power Supply For Commercial Use

Power Supply For All Users

6 6 6 6


204



Source: District census hand book 2011, District – Ahmedabad, state Gujarat

Note:

PPPS: Private Pre - Primary School

TP:Telephone TW:Tap Water A/MA:Auto/Modified Autos

FP: Footpath

GPS: Govt Primary School

PCP:Public Call Office /Mobile SPO:Sub Post Office TX:Taxi CMB:Commercial Bank

PPS: Private Primary School

PO:Post Office TP:Telephone V:Vans COB:Cooperative Bank

GMS:Govt Middle School

HP: Hand Pump PCP:Public Call Office /Mobile T:Tractors ED:Power Supply For Domestic Use

PMS:Private Middle School

TW/BH:Tube Wells/Borehole PO:Post Office BTPR:Black Topped (pucca) Road

EAG:Power Supply For Agriculture Use

GSS:Govt Secondary School

S:Spring BS:Public Bus Service GKR:Gravel (kuchha) Roads

EC:Power Supply For Commercial Use

PSS:Private Secondary School

R/C:River/Canal PBS:Private Bus Service WBMR:Water Bounded Macadam

EA:Power Supply For All Users

GSS:Govt Senior Secondary School

T/P/L: Tank/Pond/Lake RS:Railway Station All Weather Road


205



Details of main commodities in the villages is given in Table 3.22

Table 3.22

Main commodities in the study area

Village Name

Gram Panchayat Name

Agricultural Commodities (First)

Agricultural Commodities (Second)

Agricultural Commodities (Third)

Odhav ODHAV WHEAT COTTON RICE Gatrad GATRAD WHEAT PADDY PEARLMILLET/BAJRA Vanch VANCH WHEAT PADDY PEARLMILLET/BAJRA Bakrol Bujrang

BAKROL BUJRANG WHEAT PADDY PEARLMILLET/BAJRA

Bhuvaldi BHUVALDI PADDY PEARLMILLET/BAJRA WHEAT Zanu ZANU PADDY WHEAT PEARLMILLET/BAJRA

Source: Village directory 2011, Distrci – Ahmedabad, state Gujarat


206



3.18 SOCIO - ECONOMIC SURVEY

Sampling Method A judgmental and purposive sampling method was used for choosing respondents

of various sections of the society i.e. Sarpanch, adult males and females, teachers, medical

practitioners, businesspersons, agriculture laborers, fishermen, unemployed group etc.

Judgmental and purposive sampling method includes the right cases from the total

population that helps to fulfill the purpose of research needs.

Data Collection Method Data collection is a term used to describe a process of preparing and

collecting data, for example, as part of a process improvement or similar project. The

purpose of data collection is to obtain information to keep on record, to make decisions

about important issues, to pass information on to others. Primarily, data are collected to

provide information regarding a specific topic. Data collection usually takes place early on in

an improvement project, and is often formalized through a data collection plan which often

contains the following activity.

• Pre collection activity — agree on goals, target data, definitions, methods

• Collection — data collection

• Present Findings — usually involves some form of sorting analysis and/or

presentation

Main types of data collection include census, sample survey, and administrative by-product

and each with their respective advantages and disadvantage.

Field Survey and Observations Field research involves the collection of primary data or information that is new.

This is collected through surveys and questionnaires that are made out specifically for a

purpose Observations can be conducted on nearly any subject matter and the kinds of

observations will do depend on survey question. Field Survey and Observations were made

at each sampling village and the quality of life of that region is studied.

Visits were made at hospitals, primary health centers and sub-centers to know the health

status of the region. Various governmental organizations such as statistical department,

department of census operations are visited to collect the population details of that region.


207

http://en.wikipedia.org/wiki/Data

http://en.wikipedia.org/wiki/Process_improvement

http://en.wikipedia.org/wiki/Data_collection_plan



Interview Method Interview is verbal questioning. Surveys are also conducted through interviews. Interviews

consist of asking questions, listening to individuals and recording their responses. At times,

you may find it more profitable to ask questions to a few individuals instead of carrying out a

large-scale questionnaire based survey. The interview can be done very informally, e.g. as

conversations with people met in the fields, co-operative stores or block offices. In these

settings, one question leads to the next based on. The responses given to the previous

one. At the other end of the scale, highly structured interviews often rely on questionnaires

or interview schedules with mostly closed-ended questions that allow the respondents only a

limited range of possible answers. Structured interview method is used to collect data

regarding the awareness and opinion from the sample selected of the various socio-

economic sections of the community. The questionnaire mainly highlights the parameters of

primary needs.

The interview method has the advantage that almost all perfect sample of the

general population can be reached and respond to the approach. Interview method helps to

collect more correct and accurate information as the interviewer is present during the field

survey.

Socio-economic survey was conducted in 8 villages within the study area located

in all directions with reference to the project site.

The respondents were asked for their awareness/opinion about the project and

their opinion about the impacts of the project, which is an important aspect of socio-

economic environment, viz. job opportunities, education, health care, transportation facility

and economic status.Villages surveyed are given in Table 3.23


208



Table 3.23

Name of Villages for survey in the Study Area

Sr. No. Locations Direction Distance in KM

1 Project Site --- ---

2 Odhav NE 1.26

3 Gatrad E 6.58

4 Vanch SSE 9.05

5 Bakrol Bujrang SE 8.99

6 Bhuvaldi E 6.05

7 Zanu E 8.37

The salient observations recorded during survey in the study area

According to survey done in the study area, survey observation as per below: Occupation: Study area is predominantly depending on agricultural activities.

House pattern: Most of the houses are in semi pakka form in the study area. Very

few houses are in kaccha form

Roads: Roads are well connected with district place. Internal roads of villages are

also satisfied

Agriculture: Farmers are depended on mainly monsoon for agricultural activity. Some

villages have canal water facility for agricultural purpose.

Communication: Communication facility is good with mobile network and

transportation facility

Power: All villages are well electrified and electricity is used for all purposes

Language: Official language and main language in study area is Gujaratias well as

Hindi is widely spoken by population.

Fuel: Main cooking fuel LPG is used by villagers for cooking purpose. Other sources

are wood chips and kerosene etc. Few population using LPG as a cooking fuel

Water: Main source of drinking water are tap, hand pump, tube well & well

Transportation: Mainly buses and private mini buses are available in the study area

for transportation purpose


209



Awareness and Opinion Awareness is the state or ability to perceive, to feel, or to be conscious of

events, objects or sensory patterns. In this level of consciousness, sense data can

be confirmed by an observer without necessarily implying understanding. In general,

an opinion is a subjective belief, and is the result of emotion or interpretation of facts.

An opinion may be supported by an argument, although people may draw opposing

opinions from the same set of facts. For assessing the awareness and opinion about

the project activity socio-economic survey was conducted in the sampling villages.

The salient observations drawn through survey are described below:

• Some of the respondents are aware about the project activity.

• Some of the respondents have very good opinion about the project and they opined

that due to project activity, quality of life of the villages will improve.

• Respondent have suggested minimizing the environmental pollution during and after

project activity

• Village leaders suggested that employment opportunity should given to local

population


210

http://en.wikipedia.org/wiki/Conscious

http://en.wikipedia.org/wiki/Object_(philosophy)

http://en.wikipedia.org/wiki/Pattern

http://en.wikipedia.org/wiki/Subjectivity

http://en.wikipedia.org/wiki/Emotion

http://en.wikipedia.org/wiki/Fact



.

CHAPTER 4 ENVIROMENTAL IMPACT ASSESSMENT

Environmental Impact Assessment (EIA) is an activity or an attempt to identify, predict, evaluate and communicate the likely environmental impacts of the proposed project on the surrounding environment. ENVIRONMENTAL IMPACT ASSESSMENT STUDY INCLUDES: • Identification of all the probable impacts (be it positive or negative) of the various

activities involved in the completion of the project. • Classification of the probable impacts i.e. positive or negative, reversible or

irreversible, short term or long term.

• Evaluation of the probable impacts i.e. qualitative and quantitative assessment of the likely impacts.

• Communication to the general public, interested parties, controlling authorities

(Government or Municipality) through a Public Hearing process, revealing all the probable impacts, which are likely to occur due to the proposed project, on the environment. It also includes the mitigation measures of those impacts, which are inevitable. This chapter presents the identification, prediction and evaluation of impacts with mitigation measures of the proposed project of M/s. Atlas Life Sciences affected in the baseline environmental status.

4.1 IMPACT IDENTIFICATION

Considering that identification of significant environmental impact is essential in the preparation of EIA report, an attempt has been made here through the use of “Activity Effect” Matrix.

4.1.1 IDENTIFICATION MATRIX

The impact identification matrix is shown in the Table No. 4.1. For simplicity the entire project has been divided into two phases:

1. Construction Phase

2. Operation Phase


211



.

Various activities belonging to each phase have been grouped separately and arranged in Columns. The environmental Factor or Parameter, which are anticipated to be impacted, has been arranged in Rows. A preliminary scrutiny has been done and the cells, which fall at the junction of the ‘Activity’ and ‘Factor’, that have possible interaction with each other, have been ‘marked’. The matrix thus establishes the possible ‘cause-effect’ relationship and identifies the environmental factors likely to be impacted and activities responsible for the same. The impact identified may be positive and negative, short term and long term, reversible and irreversible, minor and major. This determination will be done at prediction stage.

4.1.1.1 Construction Phase

Unit needs to do construction activity for installation of plant machineries. The various activities involved in construction phase of a proposed project are listed below:

• Construction / foundation. • Erection/Installations of equipment and machinery • Transportation • Material handling • Employment of labour • Green belt development

4.1.1.2 Operational Phase

The activities involved in the operation phase of the proposed project are listed below: • Raw material handling and Storage • Product Manufacturing • Utility Consumption • Product Handling & Storage • Effluent Generation • Gaseous Emissions • Hazardous Waste Generation • Employment • Green belt development


212



.

Table No. 4.1: Impact Identification Matrix

Activity

Env. Resource

Air Env. Water Env. Noise Env.

Land Env. Biological Env. Socio Economics Fuel & Energy

Air Quality

Water Availability

Water Quality

Land Use Pattern

Soil Forest Eco- Logy

Demo-graphic

Eco. Structure

Basic Amenities

Health

PLANT CONSTRUCTION PHASE Construction / Foundation √ √ Erection of equipment and machinery √ √ √ Transportation Material handling √ √ √ √ Employment of labour √ GBD √ √ √ √ √ √

PLANT OPERATIONAL PHASE Raw Mat. /Product Handling & Storage √ Manufacturing of Industrial Products √ √ √ √ √ √ √

√ √

Industrial Power Requirement √ √

Industrial Water Req. √ √

Industrial Air Emission √ √ √ √ √ √ √

Industrial Waste Water Generation √ √ √

√

Hazardous waste Generation √ √

√

Employment √ √ √ √

Green Belt Development √ √ √ √ Vehicular movement √ √ √ √ √ √


213



.

Table No. 4.2. : Impact Prediction Matrix Activity

Env. Resource

Air Env. Water Env. Noise Env.

Land Env. Biological Env. Socio Economics Fuel & Energy

Air Quality

Water Availability

Water Quality

Land Use Pattern

Soil Forest Eco- logy

Demo-graphic

Eco. Structure

Basic Amenities

Health

PLANT CONSTRUCTION PHASE Construction / Foundation

(-Ve), S.T. (-Ve), S.T.

Erection of equipment and machinery

(-Ve), S.T.

(-Ve), S.T. (-Ve), S.T.

Transportation Material handling

(-Ve), S.T.

(-Ve), S.T.

(-Ve), S.T. (-Ve), S.T.

Employment of labour (+Ve), S.T

GBD (+Ve), L.T.

(-Ve), S.T.

(-Ve), S.T.

(-Ve), S.T. (-Ve), S.T.

(-Ve), S.T.

PLANT OPERATIONAL PHASE Raw Mat. /Product Handling & Storage

(-Ve), L.T.

Manufacturing of Industrial Products

(-Ve), L.T.

(-Ve), L.T. (-Ve), L.T.

(-Ve), L.T.

(-Ve), L.T.

(-Ve), L.T. (-Ve), L.T.

(-Ve), L.T.

Industrial Power Requirement

(-Ve), L.T.

(-Ve), L.T.

Industrial Water Req. (-Ve), L.T. (-Ve), L.T.

Industrial Air Emission (-Ve), L.T.

(-Ve), L.T.

(-Ve), L.T.

(-Ve), L.T. (-Ve), L.T.

(-Ve), L.T.

Industrial Waste Water Generation

(-Ve), L.T.

(-Ve), L.T.

(-Ve), L.T. (-Ve), L.T.

(-Ve), L.T.

Hazardous waste Generation

(-Ve), L.T. (-Ve), L.T.

(-Ve), L.T.

Employment (+Ve), L.T.

(+Ve), L.T.

(+Ve), L.T.

(-Ve), L.T.

Green Belt Development (+Ve), L.T.

(+Ve), L.T.

(+Ve), L.T.

(+Ve), L.T.


214



.

Vehicular movement (-Ve), L.T.

(-Ve), L.T.

(-Ve), L.T.

(-Ve), L.T. (-Ve), L.T.

(-Ve), L.T.


215



.

This section is devoted to the prediction and assessment of impacts, which are the most important components of EIA. Such predictions are superimposed over the base-line status of the environmental quality to derive the ultimate environmental scenario.

4.2 IMPACT PREDICTION AND ASSESSMENT WITH MITIGATIVE MEASURES:

This section is devoted to the prediction and assessment of impacts, which are the most important components of EIA. Such predictions are superimposed over the base-line status of the environmental quality to derive the ultimate environmental scenario. Prediction involves determination of the nature and extent of the probable impacts due to the proposed project. Here it is determined, whether the likely environmental impacts are: 1. Positive or Negative 2. Long term or Short term Prediction of impacts during the construction and operational phase is as Shown in Table No 4.2. Based on Environmental Impact Analysis, the Environmental Impacts under this step are quantitatively and qualitatively assessed. Quantitative assessment with the help of a mathematical model has been done wherever possible. In other cases, the impact assessment has been qualitative which is based on available scientific knowledge and judgment. The mathematical model used for prediction in the present study includes “Industrial Source Complex Short Term Dispersion” model for ambient air quality. For other cases i.e. Water, Noise, Land/Soil, Ecology, Socioeconomic etc., the available scientific knowledge and judgments have been used.


216



.

4.3 AIR ENVIRONMENT 4.3.1 Construction Phase

The impacts during construction phase will be short-term impacts as they will be limited to the period of construction. Unit has to do Construction activity / foundation work for installation of proposed plant machineries. These activities may result in temporary increase in SPM levels, primarily, in the working environment. Following mitigative measures during construction phase have been planned

Impacts Mitigation Measures

Dust • Green belt development and water sprinkling will be carried out during the construction phase for suppression of dust.

Air Pollution • Vehicles and machinery will be regularly maintained

so that ambient air quality confirms to National Ambient Air Quality Standards.

Hence, the impacts on ambient air quality during construction phase will be marginal temporarily and reversible in nature (for short duration) and restricted to small plant area only.

4.3.2 Operation Phase

Generally, the operational activities are expected to have long-term negligible impacts on the air quality. The operational activity from proposed project is expected to have long term impact on the air quality. Major sources of air pollutants are proposed flue gas stacks.

Generally, the operational activities are expected to have long-term impacts on the air quality. Major source of air pollutant is flue gases generated from the Proposed Boiler, Thermic Fluid Heater. There will be no process gas emission from the proposed unit

All the suitable precautionary measures will be taken for the control of fugitive emissions.


217



.

Based on the above stated facts, predictions related to the Ground Level Concentrations (GLCs) have taken into account the flue gas emissions from the proposed common stack attached to Steam boiler and Thermic Fluid heater, and separate stack attached to DG set. The concentration of pollutants at the ground level has been computed using computer model to assess the impact of source emissions from the proposed stack which will be installed. Air quality impact assessment is an important study; Mathematical modeling is an established and accepted technique to predict the air quality.

In this study, impact on environment due to the proposed plant has been assessed with the help of Mathematical modeling following the Central Pollution Control Boards Guidelines. The mathematical model used for conducting the study is the latest version of Industrial Source Complex. Model developed by the Environment Protection Agency of United States (ISC-3, 1996), which is entirely in line with the requirements of Central Pollution Control Board, New Delhi. A mathematical model developed by the Environmental Protection Agency (EPA) is used for calculating GLCs. This is based, on the original Gaussian Plume Model equation but is defined in terms related to atmospheric phenomenon. The model used for assessment is an Industrial Source Complex Short Term (ISCST–3) Dispersion Model. The average and maximum Ground Level Concentrations (GLCs) have been determined for SPM, SO2 and NOx. The average 24hrs. concentrations have been determined in polar grid of 100 up to 3600 for a distance of 500m, 1000 m, 2000 m, 3000m, 5000m, 7000m, and 10000 m. has been calculated based on the micro-meteorological data collected from the meteorological station kept at the project site. The Dispersion modeling assumptions are considered as follows:

1. The receptor locations for 36 wind directions starting with 10 degrees

and incrementing with 10 degrees for radial distances viz. 50m, 100m, 200m, 300m, 500m, 1000m, 2000m, 3000m and 5000m has been taken for the Air Quality Modeling.

2. The impacts of the pollutants were identified up to 5000 meters. 3. The terrain of the study area was considered as FLAT. 4. Stability Class was evaluated based on Temperature Profile and Cloud

Cover. 5. The mathematical equations used for the dispersion modeling assumes

that the earth surface acts as a perfect reflector of plume and physic-chemical process, such as dry and wet deposition, and chemical transformation of pollutants are negligible.


218



.

6. The micro-meteorological data viz. Temperature, Wind Speed, Wind

Direction and Cloud Cover has been collected from the meteorological station kept at the project site.

4.4 MATHEMATICAL MODEL FOR POLLUTANTS

DISPERSION

In the present case ISC-3 (Industrial Source Complex) model has been used to assess the air impacts. This ISC model for stack uses the steady state Gaussian plume equation for a continuous elevated source. The features of this model are:

♦ Simulates dispersion from single/multi/area/line/volume sources.

♦ Allows calculations to be made at a user specified regular rectangular

grids.

♦ Provides estimates of concentrations for any averaging time period for the entire period of input meteorology.

♦ Allows calculations to be underwriters for source group as selected by the uses.

♦ Uses the Briggs dispersion curves as selected by the user, to derive the plume spread parameters.

♦ Adjust dispersion curves to account for user specified information on aerodynamic roughness.

♦ Adjust for wind speed variation with height, using user specified default urban/rural power. Co-efficient.

♦ Simulates dispersion from buoyant non buoyant Point sources, non buoyant area, non buoyant volume sources and non buoyant line sources.

♦ User Brigg’s plume rise algorithm to calculate plume height.

For a steady-state Gaussian plume, the hourly concentration at downwind distance x (meters) and crosswind distance y (meters) is given by:


219



.

QKVD X (x,y,z) = ------------------ exp [-0.5 (y/2 σy)2 ] ...................Equation 1.1 2 p u σyσz

Where: X = Concentration of pollutant at a point (x, y); (g/m3) Q = Source strength (Pollutant Release Rate); (g/s) u = Horizontal wind speed at the source level; (m/s) σy&σz = Vertical & Horizontal crosswind dispersion coefficients

respectively, which are a function of downwind distance 'x' and atmospheric stability; (m)

K = a scaling coefficient to convert calculated concentrations to desired units (default value of 1 x 106 for Q in g/sec and concentration in µg/m3)

V = Vertical Term, which includes the effects of source elevation, receptor elevation, plume rise, limited mixing in the vertical, and the gravitational settling and dry deposition of particulate (with diameter greater than 0.1 microns)

D = Decay Term

The ISC model uses either a Polar or a Cartesian receptor network. In this case Polar receptor network has been used.

4.4.1 VERTICAL TERM

The Vertical of the Gaussian plume. It includes the effects of source elevation, receptor elevation, plume rise, limited mixing in the vertical, and the gravitational settling and dry deposition of particulates. In addition to the plume height, receptor height and mixing height, the computation of the Vertical Term requires the vertical dispersion parameter (σz). The Vertical Term without Dry Deposition In general, the effects on ambient concentrations of gravitational settling and dry deposition can be neglected for gaseous pollutants and small particulates (less than about 0.1 microns in diameter). The Vertical Term without deposition effects is then given by:

V = exp[ -0.5((zr- he)/σz )2 ] + exp [-0.5((zr+ he)/σz )2 ] +

Σ∞i = 1 { exp[-0.5(H1 / σz )2 ] + exp[ -0.5(H2 / σz )2 ] +

exp[ -0.5(H3 / σz )2 ] + exp [-0.5(H4 / σz )2 ] }..................Equation 1-2


220



.

where: he = hs+ δh hs = stack height (mt) δh = Plume rise (mt) zr = receptor height above ground (flagpole) (mt) zi = mixing height (mt) H1 = zr - (2izi - he ) H2 = zr + (2izi - he ) H3 = zr - (2izi + he ) H4 = zr + (2izi + he )

The infinite series term in Equation 1- accounts for the effects of the restriction on vertical plume growth at the top of the mixing layer. The method of image sources is used to account for multiple reflections of the plume from the ground surface and at the top of the mixed layer. It should be noted that, if the effective stack height he, exceeds the mixing height, zi, the plume is assumed to fully penetrate the elevated inversion and the ground-level concentration is set equal to zero.

Equation 1-2 assumes that the mixing height in rural and urban areas is known for all stability categories. The meteorological preprocessor program uses mixing heights derived from twice-daily mixing heights calculated using the Holzworth procedures. The ISC models currently assume unlimited vertical mixing under stable conditions, and therefore delete the infinite series term in Equation 1-2 for the E and F stability categories. The Vertical Term defined by Equation1-2 changes the form of the vertical concentration distribution from Guassian to rectangular (i.e., a uniform concentration within the surface mixing layer) at long downwind distances. Consequently, in order to reduce computational time without a loss of accuracy, Equation 1-2 is changed to the form: V = √ 2πσz /zi ...................................................Equation 1- 3 at downwind distances where the σz/zi ratio is greater than or equal to 1.6. The meteorological preprocessor program, RAMMET, used by the ISC Short Term model uses an interpolation scheme to assign hourly rural and urban mixing heights on the basis of the early morning and afternoon mixing heights calculated using the Holzworth procedures. The interpolation procedures are functions of the stability category for the hour before sunrise. Because of the uncertainties about the applicability of Holzworth mixing heights during periods of E and F stability, the ISC models ignore the interpolated mixing heights for E and F stability, and treat such cases as having unlimited vertical mixing.


221



.

4.4.2 THE DECAY TERN (D)

The Decay Term in Equation 1-1 is a simple method of accounting for pollutant removal by physical or chemical processes. It is of the form: D = exp(-Ψ x/us) for Ψ> 0.........................................Equation 1-4 or = 1 for Ψ = 0 where: Ψ = the decay coefficient (sec-1) ( a value of zero means decay is not

considered) x = downwind distance (m) For example, if T1/2 is the pollutant half life in seconds, the user can obtain Ψ from the relationship: Ψ = 0.693/T1/2...............................................................................................Equation 1-5 The default value of Ψ is zero. That is, decay is not considered in the model calculations unless Ψ is specified. However, a decay half life of 4 hours ( Ψ = 0.0000481 sec-1) is automatically assigned for SO2 when modeled in the urban mode.

4.4.3 WIND SPEED AT STACK HEIGHT

The wind power law is used to adjust the observed wind speed, uref, from a reference measurement height, zref, to the stack or release height, hs. The stack height wind speed, us, is used in the Gaussian plume equation (Equation 1-1), and in the plume rise formulas. The power law equation is of the form:

us = uref (hs/zref)p ..................................................Equation 1-6

Stability Category

Rural Exponent Urban Exponent

A 0.07 0.15 B 0.07 0.15 C 0.1 0.20 D 0.15 0.25 E 0.35 0.30 F 0.55 0.30


222



.

4.4.4 EFFECTIVE STACK HEIGHT

The effective stack, height, he to be used in Gaussian equation is given. He = Hs + Hpr Where, Hpr. = Plume rise due to thermal and momentum factors. He = Effective stack height (m) Hs = Physical stack height (m) In the present case plums rise has been calculated by Brigg’s formula (1975). The details of this equation are given below.

Plume Rise Under Unstable And Neutral Conditions

(a) Buoyancy dominated

Hpr = 1.6 F 1/3 (X) 2/3 / U ....................................Equation 1-7

Where X ≤ 3.5 X* and X* = 14 F 5/8 if F< 55 m4/sec3

= 34 F 2/3 if F≥ 55 m4/sec3 ....................................Equation 1-8

In present computations X is taken equal to 3.5 X*. For this value of X maximum plume rise under unstable and neutral conditions is governed by the following simplified equations:

21.425 F 0.75

Hpr (max) = ; F < 55 m4/sec3 U 38.71 F 0.60 = ; F ≥ 55 m4/sec3 ............Equation 1-9

U

Here F = gVs (Ds/2)2 [(Ts - Ta)/Ts] ....................................Equation 1-10

Where,

g = 9.81 m/s2 Vs = Stack gas velocity (m/s) Ds = Stack Diameter at top (m) Ts = Stack gas temperature (deg.K) Ta = Ambient temperature (deg.K)


223



.

(b) Momentum Dominated Plume Rise Under Unstable And Neutral

Conditions:

Hpr (max) = 3 Ds (Vs/U); Vs/U > 4 ........................Equation 1-11

Determination of dominance of buoyancy or momentum under unstable and neutral conditions

First ∆T and (∆T)c are calculated by following equations :

∆T = Ts - Ta

0.0297 Ts Vs 1/3 (∆T)c = ; F < 55 m 4/S3...........Equation 1-12 DS 2/3 0.05757 TsVs1/3 = ; F ≥ 55 m4/s3...............Equation 1-13 DS 2/3

If Ts> Ta and ∆T > (∆c assumed plume rise is buoyancy dominated and if Ts< Ta or ∆T < (∆T)c plume rise is assumed momentum dominated.

Plume rise under stable weather conditions (a) Buoyancy dominated plume rise.

Hpr = 2.6 (F/US) 1/3 ...............................................Equation 1-14

Here

S = stability parameter

gδθ S = Ta δZ .....................................Equation 1-15

δθ Here = temperature gradient δZ

δθ = 0.02 for stability E δZ = 0.035 for stability F

U = wind velocity at stack level (m/s)


224



.

(b) Momentum dominated plume rise:

Vs2 Ds2 Ta-1/3-1/6 Hpr = 1.5 [-------------------------] S ...............Equation 1-16 4 T U

(c) Determination of dominance of momentum or buoyancy for plume rise under stable weather condition:

(∆T)c = 0.01958 Ta Vs S 1/2 ....................................Equation 1-17 Ts>Ta & (∆T) > (∆T)c plume rise is assumed buoyancy dominated ifTs< Ta or (∆T)< (∆T)c plume rise is assumed momentum dominated

Determination Of Plume Rise Under Calm Conditions (Wind Velocity At 10 M Less Than 2 Kmph)

In case of calm winds plume rise is calculated by equation (13) and following equation and the lower value of two is taken as final plume rise.

Hpr = 4 F 1/4 S -3/8 ............................................................Equation 1-18

4.4.5 DISPERSION CO-EFFICIENT

In the present computations the dispersion coefficients proposed by PASQUILL and GIFFORD and reported by TURNER for Rural area have been used. The dispersion coefficients are valid up to 10 Kms. distances from pollution source. The equations are as follows: PARAMETERS USED TO CALCULATE PASQULL-GIFFORD σy (m)

Pasquill Stability Category

σy = 465.11628 (x) tan (TH) TH = 0.017453293 (c-d ln (x))

A 24.1670 2.53340 B 18.3330 1.80960 C 12.5000 1.08570 D 8.3330 0.72382 E 6.2500 0.54287 F 4.1667 0.36191


225



.

PARAMETERS USED TO CALCULATE PASQULL-GIFFORD σz(m)

Pasquill Stability Category

σz = a(x) b ( x in km.)

A* X (km.) A b < 0.10 122.80 0.94470 0.10-0.15 158.080 1.05420 0.16-0.20 170.220 1.09320 0.21-0.25 179.520 1.12620 0.26-0.30 217.410 1.26440 0.31-0.40 258.890 1.40940

0.41-0.50 346.750 1.72830

0.51-3.11 453.850 2.11660

>3.11 ** **

B* <0.20 90.673 0.93198 0.21-0.40 98.483 >0.40 109.300

C* All 61.141 0.91465

D* <0.30 34.459 0.86974 0.31-1.00 32.093 0.81066 1.01-3.00 32.093 0.64403 3.01-10.00 33.504 0.60486 10.01-30.00 36.650 0.56589 >30.00 44.053 0.51179 E <0.10 24.260 0.83660 0.10-0.30 23.331 0.81956 0.31-1.00 21.628 0.75660 1.01-2.00 21.628 0.63077 2.01-4.00 22.534 0.57154 4.01-10.00 24.703 0.50527 10.01-20.00 26.970 0.46713 20.01-40.00 35.420 0.37615 >40.00 47.618 0.29592

F < 0.20 15.209 0.81558 0.21-0.70 14.457 0.78407 0.71-1.00 13.953 0.68465 1.01-2.00 13.953 0.63227 2.01-3.00 14.823 0.54503 3.01-7.00 16.187 0.46490


226



.

7.01-15.00 17.836 0.41507 15.01-30.00 22.651 0.32681 30.01-60.00 27.074 0.27436 >60.00 34.219 0.21716

Note: * If the calculated value of σz exceed 5000 m, σz is set to 5000

m. ** σz is equal to 5000 m.

4.4.6 ATMOSPHERIC STABILITY

The hourly occurrence of various stability classes at project site is determined by wind direction fluctuation method by employing on-line instrument.

The stability classification system based on wind direction fluctuation method is as follows.

Relationship between σθ and stability class as suggested by Slade (1965) is given in Table:-

Stability Class σθ (degrees) A > 22.5 B 22.4 - 17.5 C 17.4 - 12.5 D 12.4 - 7.5 E 7.4 - 3.5 F < 3.5

Data used for the evaluation of the Ground Level Concentration for the proposed project is given in the Table No. 4.3.


227



.

TABLE NO.4.3

BASIS OF EMISSION RATE CALCULATIONS Sr. No.

Stack attached

to

Type of Fuel

Fuel Consump

tion

Dia. (m)

Height (m)

Exit Velocity (m/sec)

Exit Temp. (° C)

Emission Rates (gm/s) SPM(*) SO2

(**) NOX(***)

Proposed 1 Steam

Boiler (1.5 MT/hr)

Natural Gas

2750 SCM /Day

0.6 18 8 160 0.233 0.439 0.146

2 Thermic Fluid Heater (1 Lacs kcal/hr)

Natural Gas

250 SCM /Day

3 DG SET -- -- 0.1 6 6.0 200 0.004 0.008 0.003

Note: (*) Actual stack emissions will be well below the permissible stack emissions limits, as the unit will utilize Lignite / white coal / Agro Brickets as Fuel. To consider worst case scenario the emission rates are considered on maximum Stack Emission Limit.

(**) Based on maximum expected concentration of SPM-150 mg/Nm3 (**) Based on maximum expected concentration of SOx-100 PPM (**) Based on maximum expected concentration of NOx-50 PPM


228



.

4.5 RESULTS OF THE ISCST-3 MODEL

The overlapped ISO plathes on Google Image of the same is shown as at Figure No. 4.1 to 4.3.

TABLE NO. 4.4 THE 1ST HIGHEST 24-HR AVERAGE

CONCENTRATION VALUES OF SPM IN MICROGRAMS/M3

Direction O

Distance (meters) 250 500 750 1000 2000

360 1.32595 0.75688 0.80456 0.63448 0.27550 10 1.46573 1.07812 1.22795 1.00337 0.47161 20 1.30313 0.90690 1.01230 0.81683 0.37674 30 0.97290 0.48140 0.44471 0.32692 0.12264 40 0.96154 0.44992 0.61439 0.51478 0.24334 50 0.98853 0.62036 0.85571 0.71560 0.33831 60 0.90572 0.64707 0.86005 0.71804 0.34158 70 0.76876 0.51536 0.64392 0.52508 0.25286 80 0.92682 0.44414 0.62859 0.54465 0.27622 90 1.34811 0.63122 0.97617 0.87587 0.46301

100 1.94885 0.64989 0.70249 0.62647 0.30540 110 2.42003 0.83609 0.43898 0.27247 0.12616 120 2.47353 0.92588 0.91181 0.76300 0.36862 130 2.36893 1.00381 1.03896 0.86621 0.41203 140 2.21202 1.05048 0.83189 0.70780 0.35334 150 1.64532 0.70936 0.51405 0.37357 0.15906 160 1.11999 0.43145 0.38222 0.29332 0.11926 170 0.84371 0.48478 0.52218 0.43024 0.20713 180 0.59970 0.26711 0.30156 0.24602 0.10922 190 0.52907 0.21608 0.18262 0.15535 0.07501 200 0.67323 0.29080 0.15134 0.09279 0.02803 210 0.44068 0.17772 0.08829 0.05231 0.01713 220 0.35449 0.11379 0.05667 0.03430 0.01713 230 0.73579 0.23469 0.11130 0.07736 0.06875 240 1.36214 0.52708 0.34444 0.29679 0.30075 250 2.06900 0.98948 0.78631 0.79158 0.89064 260 2.10923 1.11055 0.83203 0.72691 0.64057 270 1.99649 1.01748 0.65411 0.50525 0.38863 280 2.13426 1.09832 0.74188 0.58965 0.42975 290 1.89909 1.08810 0.82485 0.71333 0.48812 300 2.20450 0.93339 0.83734 0.76553 0.69308 310 2.29761 1.04511 0.55113 0.33694 0.19752 320 1.79131 0.80683 0.42232 0.25752 0.14481 330 0.89373 0.65825 0.57402 0.45212 0.20167 340 0.76144 0.45389 0.39017 0.30420 0.13162 350 0.96719 0.38880 0.32209 0.28042 0.15331


229



.

Direction O

Distance (meters) 3000 4000 5000 7500 10000

360 0.15250 0.09761 0.06825 0.03491 0.02150 10 0.27328 0.18066 0.12954 0.06941 0.04413 20 0.21710 0.14354 0.10327 0.05619 0.03642 30 0.06773 0.04667 0.03460 0.01976 0.01316 40 0.13973 0.09164 0.06531 0.03467 0.02192 50 0.19347 0.12616 0.08935 0.04667 0.02905 60 0.19774 0.13058 0.09361 0.05023 0.03197 70 0.14912 0.09948 0.07175 0.03875 0.02473 80 0.16475 0.11076 0.08033 0.04376 0.02804 90 0.28329 0.19466 0.14402 0.08204 0.05466

100 0.17416 0.11253 0.07884 0.04011 0.02446 110 0.07330 0.04889 0.03550 0.01975 0.01304 120 0.21645 0.14441 0.10435 0.05685 0.03664 130 0.23872 0.15743 0.11264 0.06020 0.03828 140 0.21055 0.14182 0.10328 0.05718 0.03737 150 0.09196 0.05963 0.04173 0.02091 0.01243 160 0.06416 0.04029 0.02781 0.01401 0.00856 170 0.12304 0.08309 0.06072 0.03382 0.02209 180 0.06384 0.04365 0.03214 0.01808 0.01189 190 0.04289 0.02775 0.01942 0.00973 0.00578 200 0.01399 0.00905 0.01327 0.02900 0.03465 210 0.01182 0.00905 0.00737 0.00513 0.00406 220 0.01182 0.00905 0.00737 0.00513 0.00406 230 0.04531 0.03045 0.02379 0.01496 0.01020 240 0.22234 0.16664 0.12911 0.07723 0.05826 250 0.66737 0.50170 0.39054 0.24425 0.21048 260 0.48624 0.36762 0.28555 0.16990 0.14902 270 0.28437 0.21364 0.16823 0.11854 0.13820 280 0.29496 0.21328 0.16152 0.15633 0.14608 290 0.38270 0.29357 0.23058 0.14137 0.10885 300 0.50795 0.38050 0.29534 0.20667 0.18967 310 0.14913 0.11178 0.08607 0.05030 0.05680 320 0.10367 0.08086 0.06634 0.04565 0.03453 330 0.11516 0.07568 0.05413 0.03075 0.02253 340 0.09033 0.07157 0.05892 0.04045 0.03425 350 0.09951 0.07197 0.05555 0.03686 0.02838


230



.

TABLE NO. 4.5

THE 1ST HIGHEST 24-HR AVERAGE CONCENTRATION VALUES OF SO2 IN MICROGRAMS/M3

Direction O

Distance (meters) 250 500 750 1000 2000

360 2.50020 1.43050 1.51818 1.19689 0.51956 10 2.76362 2.03699 2.31664 1.89243 0.88927 20 2.45723 1.71407 1.91009 1.54078 0.71042 30 1.84591 0.91074 0.83968 0.61702 0.23138 40 1.81669 0.85204 1.15978 0.97127 0.45892 50 1.86664 1.17416 1.61502 1.35002 0.63799 60 1.70944 1.22450 1.62319 1.35458 0.64414 70 1.45041 0.97557 1.21551 0.99072 0.47684 80 1.74875 0.84031 1.18609 1.02733 0.52087 90 2.54327 1.19472 1.84218 1.65217 0.87307

100 3.67600 1.22561 1.32615 1.18201 0.57599 110 4.56440 1.57676 0.82783 0.51412 0.23802 120 4.66544 1.74610 1.72059 1.43926 0.69508 130 4.47249 1.89498 1.96034 1.63386 0.77694 140 4.17475 1.98242 1.56909 1.33521 0.66631 150 3.10487 1.33918 0.96991 0.70470 0.30002 160 2.11564 0.81504 0.72124 0.55333 0.22493 170 1.59303 0.91561 0.98506 0.81142 0.39055 180 1.13023 0.50509 0.56913 0.46413 0.20601 190 0.99860 0.40763 0.34456 0.29301 0.14144 200 1.27046 0.54849 0.28544 0.17500 0.05286 210 0.83186 0.33528 0.16655 0.09867 0.03237 220 0.66989 0.21477 0.10697 0.06476 0.03237 230 1.39728 0.44600 0.21159 0.14733 0.13127 240 2.59740 1.00459 0.65947 0.56602 0.56870 250 3.96265 1.90858 1.50077 1.50624 1.68417 260 4.03810 2.11106 1.57800 1.38072 1.20981 270 3.79544 1.92445 1.23833 0.95561 0.73791 280 4.05816 2.08371 1.40562 1.11598 0.81139 290 3.61409 2.06088 1.55961 1.34749 0.92365 300 4.16412 1.78595 1.59868 1.45828 1.31264 310 4.34034 1.97660 1.04328 0.63824 0.37313 320 3.38399 1.52359 0.79750 0.48631 0.27396 330 1.68904 1.24379 1.08346 0.85312 0.38044 340 1.43867 0.85855 0.73682 0.57420 0.24833 350 1.82413 0.73414 0.60821 0.52927 0.28932


231



.

Direction O

Distance (meters) 3000 4000 5000 7500 10000

360 0.28759 0.18408 0.12871 0.06583 0.04055 10 0.51528 0.34064 0.24425 0.13087 0.08320 20 0.40938 0.27066 0.19472 0.10595 0.06866 30 0.12769 0.08799 0.06524 0.03726 0.02482 40 0.26349 0.17280 0.12316 0.06537 0.04134 50 0.36481 0.23788 0.16848 0.08800 0.05477 60 0.37285 0.24621 0.17650 0.09470 0.06028 70 0.28121 0.18761 0.13530 0.07308 0.04663 80 0.31067 0.20887 0.15148 0.08253 0.05288 90 0.53416 0.36703 0.27155 0.15469 0.10306

100 0.32846 0.21224 0.14870 0.07565 0.04613 110 0.13829 0.09223 0.06697 0.03726 0.02461 120 0.40811 0.27227 0.19675 0.10718 0.06908 130 0.45010 0.29683 0.21238 0.11351 0.07218 140 0.39701 0.26742 0.19474 0.10781 0.07046 150 0.17344 0.11247 0.07871 0.03944 0.02345 160 0.12102 0.07600 0.05246 0.02644 0.01616 170 0.23201 0.15669 0.11450 0.06377 0.04167 180 0.12036 0.08230 0.06060 0.03409 0.02241 190 0.08088 0.05233 0.03661 0.01836 0.01089 200 0.02638 0.01714 0.02540 0.05487 0.06543 210 0.02237 0.01714 0.01395 0.00972 0.00768 220 0.02237 0.01714 0.01395 0.00972 0.00768 230 0.08658 0.05821 0.04706 0.02956 0.02013 240 0.41987 0.31451 0.24363 0.14568 0.11011 250 1.26090 0.94756 0.73748 0.46109 0.39745 260 0.91767 0.69362 0.53869 0.32047 0.28155 270 0.53976 0.40534 0.31907 0.22829 0.26374 280 0.55663 0.40241 0.30472 0.29643 0.27633 290 0.72309 0.55437 0.43529 0.26678 0.20555 300 0.96079 0.71930 0.55811 0.39094 0.35838 310 0.28151 0.21095 0.16241 0.09490 0.10840 320 0.19614 0.15298 0.12551 0.08635 0.06532 330 0.21723 0.14275 0.10210 0.05811 0.04256 340 0.17198 0.13622 0.11207 0.07679 0.06495 350 0.18822 0.13684 0.10537 0.06970 0.05366


232



.

TABLE NO. 4.6 THE 1ST HIGHEST 24-HR AVERAGE

CONCENTRATION VALUES OF NOX IN MICROGRAMS/M3

Direction O

Distance (meters) 250 500 750 1000 2000

360 0.83292 0.47900 0.50659 0.39911 0.17314 10 0.92058 0.68161 0.77268 0.63081 0.29626 20 0.81865 0.57398 0.63729 0.51372 0.23671 30 0.62330 0.30562 0.28058 0.20599 0.07718 40 0.60787 0.28654 0.38733 0.32402 0.15294 50 0.62381 0.39440 0.53913 0.45025 0.21259 60 0.57068 0.41115 0.54184 0.45175 0.21463 70 0.48382 0.32779 0.40593 0.33052 0.15889 80 0.58342 0.28203 0.39575 0.34250 0.17355 90 0.84822 0.40130 0.61483 0.55089 0.29088

100 1.22557 0.40844 0.44293 0.39432 0.19199 110 1.52150 0.52546 0.27585 0.17171 0.07939 120 1.55528 0.58189 0.57415 0.47988 0.23157 130 1.49413 0.63291 0.65401 0.54470 0.25885 140 1.39357 0.66163 0.52309 0.44525 0.22202 150 1.03618 0.44732 0.32358 0.23500 0.10002 160 0.70760 0.27262 0.24067 0.18452 0.07497 170 0.53227 0.30615 0.32849 0.27043 0.13010 180 0.37612 0.16931 0.18998 0.15480 0.06867 190 0.33340 0.13594 0.11495 0.09768 0.04712 200 0.42400 0.18284 0.09514 0.05833 0.01762 210 0.27781 0.11182 0.05554 0.03290 0.01084 220 0.22424 0.07170 0.03572 0.02163 0.01084 230 0.47272 0.15112 0.07176 0.05014 0.04493 240 0.88650 0.34684 0.22701 0.19325 0.19063 250 1.36504 0.66717 0.51439 0.51178 0.56457 260 1.38988 0.71574 0.53239 0.46733 0.40448 270 1.28703 0.64543 0.41616 0.32050 0.24956 280 1.37671 0.70349 0.47320 0.37482 0.27108 290 1.22829 0.69328 0.52270 0.45070 0.31009 300 1.39262 0.61398 0.54708 0.49665 0.44152 310 1.45181 0.66286 0.35055 0.21476 0.12481 320 1.13197 0.50921 0.26655 0.16255 0.09193 330 0.56549 0.41628 0.36176 0.28465 0.12686 340 0.48142 0.28799 0.24629 0.19173 0.08284 350 0.60800 0.24533 0.20327 0.17670 0.09747


233



.

Direction O

Distance (meters) 3000 4000 5000 7500 10000

360 0.09583 0.06134 0.04289 0.02193 0.01351 10 0.17165 0.11348 0.08137 0.04359 0.02772 20 0.13639 0.09017 0.06487 0.03530 0.02287 30 0.04253 0.02930 0.02173 0.01241 0.00826 40 0.08779 0.05757 0.04103 0.02178 0.01377 50 0.12154 0.07925 0.05613 0.02931 0.01824 60 0.12421 0.08202 0.05879 0.03154 0.02008 70 0.09370 0.06251 0.04509 0.02436 0.01554 80 0.10351 0.06959 0.05047 0.02750 0.01762 90 0.17795 0.12227 0.09046 0.05153 0.03433

100 0.10947 0.07074 0.04957 0.02522 0.01538 110 0.04612 0.03076 0.02234 0.01243 0.00821 120 0.13594 0.09069 0.06553 0.03570 0.02301 130 0.14993 0.09887 0.07074 0.03781 0.02404 140 0.13226 0.08909 0.06487 0.03591 0.02347 150 0.05782 0.03750 0.02624 0.01315 0.00782 160 0.04035 0.02534 0.01750 0.00882 0.00540 170 0.07729 0.05220 0.03815 0.02125 0.01389 180 0.04009 0.02741 0.02018 0.01135 0.00746 190 0.02694 0.01743 0.01220 0.00611 0.00363 200 0.00879 0.00609 0.00875 0.01841 0.02187 210 0.00752 0.00576 0.00469 0.00327 0.00259 220 0.00752 0.00576 0.00469 0.00327 0.00259 230 0.02968 0.02121 0.01729 0.01084 0.00736 240 0.14033 0.10500 0.08129 0.04858 0.03686 250 0.42190 0.31682 0.24647 0.15400 0.13283 260 0.30632 0.23140 0.17965 0.10684 0.09422 270 0.18242 0.13687 0.10765 0.07954 0.09017 280 0.18577 0.13424 0.10202 0.09997 0.09271 290 0.24197 0.18528 0.14538 0.08903 0.06870 300 0.32228 0.24097 0.18683 0.13116 0.11994 310 0.09401 0.07041 0.05419 0.03166 0.03707 320 0.06583 0.05134 0.04212 0.02897 0.02191 330 0.07243 0.04759 0.03404 0.01945 0.01424 340 0.05850 0.04631 0.03804 0.02596 0.02192 350 0.06558 0.04793 0.03701 0.02336 0.01844


234



.

4.6 GROUND LEVEL CONCENTRATION

The result of the GLCs due to the flue gas stacks are given in the Table No. 4.7. When the above stated GLCs results are added in to the average ambient air parameters it gives overall AAQ of the surrounding study area. Air quality contours are shown in the Figure No. 4.1 to 4.3

TABLE NO.4.7

MAXIMUM COMPUTED GROUND LEVEL CONCENTRATION

Sr. No

Description Value Concn * ( µg/m3)

Co-ordinates X (m) Y (m)

A PM 1 1st Highest 24 hr. Result 2.47353 216.51 -125.00 B SO2 1 1st Highest 24 hr. Result 4.66544 216.51 -125.00 C NOx 1 1st Highest 24 hr. Result 1.55528 216.51 -125.00

Note :-(*) This predicted maximum Ground Level Concentration (GLC) is based on worst case scenario, considering maximum stack emission limit of SPM-150 mg/Nm3, SO2 100 PPM and NOx-50 PPM. As the actual emissions will be well below this predicted GLCs.


235



.

4.7 Assessment of Impact on Air Quality

Base line study reveals that the levels of various pollutants like PM, SO2 and NOx etc., in the ambient air of surrounding study area are well within the limits stipulated by National Ambient Air Quality (NAAQ) Standard for Residential, Rural and other areas. It can be seen from Table No. 4.7 that the maximum predicted 24 hours GLC(s) of all the pollutants i.e., PM, SO2 and NOx, and its incremental concentrations on baseline value is below the NAAQS. Thus, it can be concluded that, with proposed emissions from the Plant, the Ambient Air Quality within the industrial premises as well as in the surrounding study area will not exceed the NAAQ standards and hence there is no significant adverse impact on Ambient Air Quality.


236



.

Fig: 4.1: Isopleths of SPM


237



.

Fig. 4.2: Isopleths of SO2


238



.

Fig. 4.3: Isopleths of NOX


239



.


4.8.1 Construction Phase

Impact on water quality during construction phase / foundation work will be marginal and confined to use of water by workers only. The sewage generated will be disposed to Soak Pit and septic tank system & they will take all reasonable precautions for wastewater seepage. This will prevent soil contamination.


Water Consumption: o Total water consumption of proposed project will be 15 KL /Day.

o Domestic water consumption will be 6.0 KL/Day and sewage @ 5.0 KL/Day will be disposed to soak pit system.

o Water consumption for Gardening and Plantation will be 2 KL/Day.

o Industrial water consumption will be 7.0 KL/Day.

o Total Industrial Effluent generation will be 2.2 KL/Day.

o There will be no process effluent generation.

• Industrial Effluent will be treated in ETP, industrial wastewater will be sent

to evaporator & condensate of evaporator around 2.0 KLD will be utilized for greenbelt development. Thus, it can be concluded that negligible impact on surrounding water environment is caused. Further, it is emphasized that all precautionary measures have to be strictly adhered as mentioned in the Environmental Management Plan given in Chapter 6, to maintain ground water quality within norms in the future.


240



.

Impacts Mitigation Measures

Effluent Treatment

o Total water consumption of proposed project will be 15 KL /Day.

o Domestic water consumption will be 6.0 KL/Day and sewage @ 5.0 KL/Day will be disposed to soak pit system.

o Water consumption for Gardening and Plantation will be 2 KL/Day.

o Industrial water consumption will be 7.0 KL/Day.

o Total Industrial Effluent generation will be 2.2 KL/Day.

o There will be no process effluent generation.

Impact on ground water quality:

o Ground water was tested at eight different locations in the study area. The ground water norms were compared to IS: 10500 (1991) for evaluation.

o Unit will treat generated industrial effluent into proposed effluent treatment plant and finally it will be evaporated.

o So, due to proposed project there will be no any impact on ground water quality.

4.9 NOISE ENVIRONMENT 4.9.1 Construction Phase

There will be slightly increase in noise level during construction phase due to erection and installation of machinery. But it is restricted to construction phase only and it will occur during day time, when construction activities will be in progress.


241



.


As per observations, the Ambient Noise Level is within norms of Industrial Area. With the implementation of the mitigation measures proposed, the noise levels at plant boundaries will be well below the limits specified for industrial areas. The major sources contributing to Noise pollution during the plant operation will be Compressor, Boiler, Pumps, etc. The operation of the equipment will generate noise ranging between 70-80 dB (A). The occasional noise will be attenuated by the development of green belt in and around the industry, which will be taken up right from the construction phase. Also ear protecting devices will be provided for personnel working in high noise generating zone. Thus, there is practically no impact on surrounding environment.

4.10 LAND ENVIRONMENT


In Proposed unit needs to do Excavation for Proposed Effluent Treatment Plant. Unit will do construction activity for proposed foundation work. Hence there will be minor impact on the surrounding soil environment and there will be no change in Land Use Pattern.


Source emission, wastewater and hazardous waste generation from any project activity affects the soil environment. The impact due to air causes direct/indirect effect on soil. The emissions of SPM during operation will be effectively controlled. There will be practically no effect on the soil quality due to air emissions. Domestic effluent will be discharged to soak pit and septic tank system. Wastewater generated from the Industrial activity will be treated in Effluent Treatment Plant and finally it will be evaporated in evaporator system and ETP waste will be disposed to TSDF site. As per the Hazardous Waste (Management & Handling) Amendment Rules, 2003, all necessary control steps for each type of Hazardous Wastes generated will be taken for the proposed project. Hence, due to the proposed project the, land use pattern; land cover and topography of the area will be changed only for the project premises.


242



.

4.11 ECOLOGY


Any construction activity brings changes in some components of the local Terrestrial ecosystem. These adverse impacts are restricted to the project Construction site and to some extent it's immediate surroundings.


Impacts on terrestrial ecosystem can occur due to operation of the any industrial project mainly from air emissions, liquid effluents as well as hazardous wastes generation, which can interfere with the biotic and abiotic components of the ecosystem and may induce injurious effects when concentrations exceed permissible standards. The proposed project will be carried out on land within M/s. Atlas Life science without cutting of any trees. The proposed project does not alter the crop pattern and natural vegetation of the surrounding area. Due to the safe control technology of air pollutants, liquid effluents and hazardous wastes disposal, no impact on the surrounding ecology is anticipated. Development of greenbelt/green area will improve the ecological Environment of the surrounding areas.

4.12 SOCIO-ECONOMIC ENVIRONMENT

Like any other project, the proposed project is also expected to have certain positive and negative impacts on socio-economic environment.

4.128.1 Construction Phase Local people involved as contract laborers will have benefits of getting employment. Proposed project will generate temporary employment for personnel during operational phase.

4.12.2. Operation Phase

The proposed project will generate direct employment for persons. The indirect employment will be generated by way of transportation, shopkeepers and other casual employment. Implementation of this plant will also reduce production loss due to shortage of power. Thus, the proposed project will have significant positive impacts on the employment pattern of the study area.


243



.

4.13 HEALTH AND SAFETY 4.13.1 Construction Phase

Health problems are also likely to be experienced in the area as a result of Immigrant labour being careless about personal hygiene and also mosquito and fly-borne infections usually prevalent in the rural areas. Such Problems will be minimized by provision of adequate sanitary and health services.

4.13.2 Operational Phase

The impact on health and safety hazard is due to Fire. The company will provide sufficient fire fighting system. Therefore, no adverse impact is anticipated.

4.14 TRAFFIC STUDY & ITS IMPACT

Traffic study is important to calculate the existing and proposed load on the existing Road due to proposed Project. There is only one main junction nearby the Propsoed project i.e. M/S. Atlas Life Science. Traffic counts were collected at two Directions (1) From A to B – (Up) Project site to GIDC Odhav main Road and (2) From B to A – (Down) GIDC Odhav Main Road to project Site on 12/04/2017. Details regarding the traffic survey are: • Traffic counts were collected and recorded in 4 hours intervals. • Morning period (pick hours) survey was carried out from 8:00 to 12:00

hrs. • Evening period (pick hours) survey was carried out from 16:00 to 20:00

hrs. Traffic counts observed during the above survey are tabulated in Table 4.8


244



.

Table No.: 4.8

Traffic Study

Based on the above mentioned traffic study given in above Table, hourly vehicular traffic has been calculated. Considering worst case scenario, average number of vehicles observed during 4 hours has been taken as hourly counts. Passenger Car Unit (PCU) has been calculated by applying PCU factor. Proposed load of trucks due to the movement of raw materials, fuel and products has been calculated. Design capacities of both the routes have been taken from the Indian Road Code. Assessment of proposed traffic load is described in Table 4.9

Type of Vehicles

Direction -1 From A to B – (Up)

Project Site to Main Road of GIDC Odhav

Direction 2 From B to A – (Down) GIDC Odhav

Main Road to project Site

Timings of Survey(hrs) Timings of Survey(hrs) 12-04-2017 12-12-2017

8:00 to 12:00 hrs.

16:00 to 20:00 hrs.

8:00 to 12:00 hrs.

16:00 to 20:00 hrs.

Large Trailer 12 22 19 21 Heavy (Bus, Truck, etc)

12 14 21 24

Medium (Tractors, light commercial vehicles etc)

14 12 26 09

Light (Car, Jeep, Pickup Van etc.)

30 34 26 44

3 Wheeler (Rickshaw)

24 29 26 45

2 Wheeler (Scooter, motorcycle, cycle etc)

72 89 64 44


245



.

Table No.: 4.9 Assessment of Proposed Traffic Load

Type of Vehicles

Direction -1 From A to B – (Up)

Chhatral – Mehsana Highway

Direction 2 From B to A – (Down) Mehsana –

Chhatral Highway

PCU factor as per Indian Road Code Avg. vehicle

per Hr. (Worst case)

Equivalent PCU (Passenger Car Unit per Hr.)

Avg. vehicle per Hr. (Worst case)

Equivalent PCU (Passenger Car Unit per Hr.)

Large Trailer 17 76.5 20 90 4.5 Heavy (Bus, Truck, etc)

60 180 48 144 3

Medium (Tractors, light commercial vehicles etc)

39 58.5 32 48 1.5

Light (Car, Jeep, Pickup Van etc.)

44 44 66 66 1

3 Wheeler (Rickshaw)

27 27 39 39 1

2 Wheeler (Scooter, motorcycle, cycle etc)

120 60 104 52 0.5

Total PCU /Hr 446 439 Width of Road in m

4.0 4.0

Design PCU per Hr

1500 1500

Existing PCU per Hr.

446 439

Proposed Load Medium Vehicel / Day

10 10

Proposed PCU per day

15 15

Total PCU per Hr after the proposed Project

461 454

From the above table no. 4.9, it can be concluded that even for considering the worst case; there will be minor increase in vehicular load due to the proposed project. However, the total traffic load even after the proposed project will be very low compare to the design capacity of roads.


246



CHAPTER 5

ENVIRONMENTAL MONITORING PROGRAMME 5.1 MONITORING OF ENVIRONMENT Based on the findings of the Environmental Impact Assessment study, various mitigation measures have been proposed, which have been detailed out in Environmental Management Plan (EMP). In order to monitor the impacts and efficacy of these plans monitoring of various environmental attributes have been proposed during and after the completion of the management plans. A well defined environmental monitoring programme would be employed with trained and qualified staff of Environmental Management Cell of the proposed expansion project to monitor the environmental attributes of the area with respect to EMP as well as the guidelines of the GPCB/CPCB. Environmental monitoring schedule proposed to be adopted by the project. Authorities are as presented in Table 5.1:

Table 5.1: Environmental Monitoring Plan

S. No. Aspect Source of Impact

Monitoring Method and it’s Parameters


Monitoring Agency

1.0 Construction Phase (As the construction area is small so, steel structure will be used in the existing unit, hence the impact will be very less)

1.1 Local Manpower Absorption

Construction Work

Contractor’s report No. of people working in the project

Daily Contractor Atlas Life Sciences

1.2 Air Quality transportation of construction materials

Survey & observations; Levels of SPM, RSPM, SO2 and NOx

Weekly Atlas Life Sciences


1.3 Public Health Dust, Noise, Movement of labours

Regular medical checkup

Monthly Contractors Atlas Life Sciences

2.0 Operation Phase

2.1 Water Quality & Quantity

Surface & Ground water quality within the Project Area

Surveys, sample collection & field measurement;




247



2.2 Effluent

Quality Quality of Treated effluent Send to evaporator.

ETP sample collection & quality analysis

Daily (Internal); Monthly (Third Party)

Atlas Life Sciences


S. No. Aspect Source of

Impact

Monitoring Methods and Parameters


Monitoring Agency

2.3 Air Quality Emissions from utility .

Air quality monitoring at 2-3 location within (SO2, NOx, SPM, RSPM, CO, HC, VOC) as well as stack monitoring.

Ambient -Monthly (24 hourly); Stack – Monthly (third party)

Atlas Life Sciences


2.4 Noise Level Noise level compliance with respect to industrial standards

Ambient Equivalent Sound Pressure Levels (Leq) in day and Night time at 4 to 6 location.

Monthly (Third Party) and fortnightly (internal)

Atlas Life Sciences


2.5 Biological Environment

Horticulture/ Greenbelt Development

Survival rate of plants and shrubs



2.6 Solid Waste Management

Disposal of waste

Monitoring of waste collection, segregation and disposal



2.7 Hazardous Waste Management

Hazardous waste as required by hazardous waste authorization

Monitoring of hazardous waste collection, segreg ation, storage and disposal



Generation of used drums, bags and records of their dispatch to approved vendors.



Generation of waste oil and their treatment




248



5.2 Work zone Monitoring arrangement for Hazardous chemicals.

The following emergency equipment shall be present on site:

1. Fire Extinguishers. 2. Industrial First Aid Kit. 3. Portable Eye wash station, Capable of Supplying 15 minutes of water. 4. Emergency Shower. 5. Vehicle Suitable for emergency Transport. 6. Emergency Communication like Land Line Phones, Mobile Phones. Etc.

Requirements Plan for Compliance Gujarat Factories Rules want the occupier of the premises to carry out the required monitoring under Section 7A (2) e and Rule – 12B in Form 37 prescribed therein.

As seen from the foregone discussions it is clear that the airborne contaminants and their concentrations including the composition is likely to vary a lot. Hence, portable sampling equipment capable to sample different contaminants shall have to be procured.

Records for Location of operation, contaminant, sampling instrument, concentration of air borne contamination, method of analysis followed, and the number of workers exposed to the process are supposed to be maintained by the occupier.

The Drager make or similar equipment is best fitted for the purpose and will be arranged for with necessary absorbing media tubes for expected contaminants.


249



5.3 CHEMICALS WHICH ARE EXPOSED TO WORKERS DIRECTLY OR INDIRECTLY 1. Exposure of workers with major chemicals IPA, Methanol, n-Propanol, Acetone, Ethyl Acetate will be the main hazardous chemicals

used in the process. Proper care will be taken during handling of such chemicals as per MSDS

guidelines.

2. List of chemicals, their threshold limit and measures IPA, Methanol, n-Propanol, Acetone, Ethyl Acetate will be the main hazardous chemicals

used in the process, where workers are directly or indirectly exposed in work area. Details

of hazardous chemicals characteristics are summarized in Risk Assessment report. Unit will

handle above chemicals with proper handling process suggested in MSDS.

3. Details of pre-placement and periodical medical monitoring of workers Pre-employment Medical Examinations There are two main purposes of pre-employment medical examinations: • To provide base-line health data against which subsequent changes after

employment can be evaluated This i s impo r tan t f o r a s se s sme n t o f t he effectiveness o f p reven t i ve measures at work. For example, where the hearing threshold of a worker, which is normal before employment in a noisy occupation, is found to have increased after employment, this possibly indicates noise-induced hearing loss and a review of the hearing protection measures would be required. On the other hand, if the pre-employment hearing threshold of the workers has not been assessed, it would be difficult to ascertain whether the worker’s high hearing threshold after employment is due to excessive noise exposure at work or to his own hearing problem before employment. Pre-employment health data is also important in substantiating or negating employees’

compensation claims since it provides evidence of the health status of claimants

before employment.

• To ensure medical fitness for work Pre-employment medical examinations identify those persons who are medically unfit

for employment in particular occupations. Persons with certain underlying medical


250



conditions are particularly vulnerable to the effects of certain health hazards and

are not suitable for employment in particular occupations. Persons with certain

underlying medical conditions are particularly vulnerable to the effects of certain health

hazards and are not suitable for employment in work with such exposures. For

example, workers with thalassemia (a genetic disease of the blood) should not be

engaged in work involving lead exposure which may aggravate the anaemia.

Workers may fail to meet the specific health requirements for particular job so that

they cannot undertake the jobs safely without risks to themselves or others.

• Periodic Medical Examinations Periodic medical examinations aim to detect susceptible workers for whom corrective

actions are required before they develop overt occupational diseases. The

frequency of periodic medical examinations depends on the nature of the

occupational hazards. For most hazardous exposures, however, these examinations

are conducted annually.

• Requirements of Medical Examination: The requirements of medical examinations depend on the nature of the hazardous exposures of workers. In general, the doctor will take a detailed occupational and medical history, conduct a physical examination and prescribe a range of ancillary laboratory and/or radiological investigations such as urine test, blood test, X-ray, lung function test and audiometric test. • Liver Function Test (LFT) Clinical examination and Pre-placement medical examination carried out in every 12

months. Liver function tests including serum bilirubin, alkaline phosphatase

estimations every 12 months are required.


251



CHAPTER 6

ENVIRONMENTAL MANAGEMENT PLAN

6.1 INTRODUCTION

Any industrial development is associated with certain positive impacts as well as some negative impacts on the environment. However, the negative or adverse impacts cannot possibly rule out scientific development. At the same time, adverse impacts cannot be neglected.

An Environmental Management Plan has been formulated for mitigation of the adverse impacts and is based on the present environmental conditions and the environmental impact appraisal. This plan helps in formulating, implementing and in monitoring the environmental parameters during and after commissioning of the project.

The Environmental Management Plan describes, in brief, the management's plan for proper and adequate implementation of treatment and control system for air and liquid pollutants and for maintaining the environment. It also includes development of green belts around the Plant, proper safety of the workers, noise control, fire protection systems and measures. This chapter provides mitigation and control measures to satisfy or eliminate environmental impacts, which are likely to be caused by the proposed project. An Environmental Management Plan (EMP) has been developed to mitigate the potential adverse impacts and to strengthen the beneficial environmental impacts as well as to create positive environmental footprints during the construction and operation phases. The institutional capacity of Atlas Life Science as the owner & facility developer and the reporting requirement to fully implement the mitigation measures have also been described in this chapter. In addition to that during the operation phase, the company will have an additional responsibility to comply with the statutory requirements as per the guidelines of Central/ State Government.

6.2 The EMP

The Environmental Management Plan (EMP) consists of a set of mitigation, monitoring and institutional measures to be taken during the design, construction and operation (post construction) stages of the project. The plan also includes the actions needed for implementation of these measures. Overall objective of EMP:

• Prevention: Measures aimed at impeding the occurrence of negative

environmental impacts and/or preventing such an occurrence having harmful environmental impacts.

252




• Preservation: Preventing any future actions that might adversely affect an environmental resource or attribute.

• Minimization: Limiting or reducing the degree, extent, magnitude, or duration of adverse impacts.

The major components of the Environmental Management Plan are:

• Mitigation of potentially adverse impacts. • Monitoring during project implementation and operation. • Implementation schedule and environmental cost estimates. • Integration of EMP with project planning, design, construction and operation. The EMP has been designed keeping in view the regulatory and other requirements to ensure the following:

• Minimum disturbance to the native flora and fauna. • Compliance with the air, water, soil and noise quality norms. • Conservation of water to the extent possible. • Encourage the socio-economic development.

6.3 OBJECTIVES OF EMP

The main objectives in formulating this environmental management plan are:

To treat all the pollutants viz., liquid and gaseous which contribute to the degradation of the environment, with appropriate technology.

To comply with all regulations stipulated by the Central / State Pollution Control Boards related to air emissions and liquid effluents discharges as per air and water pollution control laws

To handle hazardous wastes as per the Hazardous Waste (Management and Handling Rules, 1989 of the Environment (Protection) Act, 1986

To encourage support and conduct developmental work for the purpose of achieving environmental standards and to improve the methods of environmental management.

To promote further afforestation in the surrounding areas of the Plant To create good working conditions (devoid of air and noise pollution) for

employees To reduce fire and accident hazards. Perspective budgeting and allocation of funds for environment management

expenditure. Dissemination of technological solutions on Commercial basis to interested parties

and Continuous Development and search for innovative technologies for a cleaner and better environment.




6.4 BRIEF ENVIRONMENTAL MANAGEMENT PLAN

6.4.1 CONSTRUCTION PHASE :

Adequate and effective environment protection measures will be planned and designed to minimize the impacts due to activities related to preconstruction (preparatory phase) of the project, machinery installation and commissioning stages and end with the induction of manpower and start up. The impacts during the construction phase on the environment will basically be very insignificant as the project construction area is very small. Only foundation for RCC structure will be made. Ready mix Concrete will be used and therefore no possibility of fugitive emission due to material handling. In view of the above, the following measures are recommended to reduce the impact during this period:

• Due provision of necessary infrastructural services like water and power supply etc.,

for the construction area. • All possible care will be taken to reduce the noise level due to construction activity. As

planned, no such noise generating machineries will be used. Also, noise prone activities shall be restricted to the extent possible during night particularly during the period 10 PM to 6 AM in order to have minimum environmental impact.



Construction Phase: Erection of Plant Machineries

• Air • Noise • Socio Economic

• Well maintained vehicles will be used.

• Metalled Road for Vehicle Movement

• Well maintained equipment will be utilized to prevent noise generation.

• Local labour will be hired for the work so that housing arrangement will be avoided.





6.4.2 OPERATIONAL PHASE:

As discussed in the Chapter 2 showing pollution controls arrangement, M/s. Atlas Life Science have planned all the necessary steps to control Water Pollution, Air Pollution, as well as Hazardous Waste Pollution and Noise Pollution. The detailed mitigation measures planned during operation phase of the project are as follows:



Manufacturing of Products

• Air • Land • Water • Noise

• Ensure proper handling of all chemical by introducing spill control procedures.

• Ensure usages of PPE’s by workers.

• Strictly following the appropriate spill control procedures.

• The charging of the hazardous chemical will be done through very carefully.

• MSDS of Raw material & products will be displayed at storage & handling area.

• Water usage will be strictly by putting water meter plant wise.

• Monitored data will be analyzed and reviewed time to time.

• Contaminated solid waste will be sent to approve TSDF Facilities.

• Storage area will be designed in line with the factory Act requirement.





Environmental Management Plan: Operation Phase:


Mitigation Measures Remarks

Operation of Thermic Fluid Heater and Boiler

• Air • Noise • Water

• Ensure proper preventive maintenance of fuel firing system and optimization of air fuel ratio.

• Ensure proper maintenance of machinery to reduce noise level

• After clean up of spillage ensure that disposed it properly.

• Provision of Adequate Stack Height.

• Ensure usage of Personal Protective Equipments.


Operation of Cooling Tower

• Air • Water • Noise

• Ensure proper maintenance of machinery to reduce noise level.

• Blow down is being sent in ETP provided within premises.




Environmental Management Plan: Operation Phase

Storage, Handling & Transportation of Raw materials and Products

• Air • Water • Land

• Chemical to be stored in accordance with the rules and regulations of the Safety Department.

• Separate storage area for solid/liquid raw materials.

• Install proper facilities to prevent rain/storm water contamination during the storage of solid raw materials.

• Ensure disposal of used drums, bags as per the rules/regulations.


Transportation of all the raw materials, Finished products & Hazardous wastes.

Air Water Land

• Work will be given to Trained/Approved Transports for the transportation of the raw materials/products.

• TERMCARD will be followed.

• Ensure availability of MSDS of all the raw materials and finished products to the Off-site Emergency team.

Development and maintenance of green belt

• Air. • Land

Ensure development and maintenance of proper green belt as proposed.

Direct / Indirect Employment

• Socio Economic issue

Continue policy of local employment according to the skill and availability of the manpower




6.5 ENVIRONMENTAL MANAGEMENT CELL

Apart from having an EMP, it is also necessary to have a permanent organizational set up charged with the task of ensuring its effective implementation. M/s. Atlas Life Sciences has created a department for management and implementation of the environmental control measures. Organization chart of M/s. atlas Life sciences, including Environmental Management Cell for the proposed is shown in the Figure No. 6.1.

FIGURE NO. 6.1

ORGANIZATION CHART

Director

Manager Overall responsibility for production & environmental management and

decision making for all environmental issues

Supervisor (Production) Overall in charge of operation of production & environmental management

facilities. Ensuring legal compliance by properly undertaking activities as laid down by

various regulatory agencies from time to time and interacting with the same.

Asst. Supervisor (Environment) Secondary responsibility for environmental management and decision

making for all environmental issues and EMS operation. To carry out periodical medical check-up and maintain health register of

workers. To carry out regular maintenance of EMS and carry out EMS operations as

per standard procedure and requirements. To submit daily reports to the Manager for environment, pollution and safety

related activities. To look after proper control of pollution control system.

Chemist




Basically, supervisor will undertakes to monitor the environmental pollution levels by measuring stack emissions, ambient air quality, noise level etc. either departmentally or by appointing external agencies wherever necessary. Constant monitoring of environmental parameters will be exercised to find out any deterioration in environmental quality. In case the monitored results of environmental pollution are found to exceed the allowable values, the General Manager Pollution monitoring will suggest remedial action and get these suggestions implemented through the concerned plant authorities. The actual operation and maintenance of pollution control equipment of each unit will be under the respective Engineers.

6.6 OCCUPATIONAL HEALTH AND SAFETY

Health hazards associated with occupation are called occupational hazard.

Following check-ups shall be carried out regularly to avoid occupational

hazards:

• Inspection and maintenance of pollution control systems regularly.

• All safety measures such as safety appliances, training, safety awards, posters,

slogans related to safety.

• The workers exposed to noisy sources will be provided with ear muffs/plugs.

• Adequate facilities for drinking water and toilets insufficient numbers will be provided

to the employees.

• Fire proof aprons and necessary personnel protective appliances and equipment will

be provided to the concerned personnel.

• Pre-medical check-up of the employees at the time of employment in unit.

• Provision of periodic medical check-up for all the employees.

• To provide necessary first aid facilities, the first aid training shall also be given to the

employees.

• The first aid training shall also be given to the employees. Monitoring of

occupational hazards like noise, ventilation shall be carried out at frequent intervals.

• Appointing the medical officer for the regular medical examination and treatment of

the employee.

259




The following precautions shall be taken to avoid foreseeable accident like spillage, fire and

explosion hazards and to minimize the effect of any such accident and to combat the

emergency at site level in case of emergency.

• Various emergency spots in plant area will be identified and kept in sharp and alert

watch.

• Protective equipments will be regularly checked and will be kept easily accessible and

easily workable during emergency.

• Safety installations like available quantity of running water will be regularly watched.

• Fire bucket and hose reels will be provided to withstand the fire or explosion conditions.

• Various types of fire extinguishers such as (Foam type, water CO2 type, CO2 type) will

be providing inside the factory premises.

6.7 POSSIBILITY OF OCCUPATIONAL HEALTH HAZARDS AND ITS PREVENTIVE MEASURES To prevent any spillage, accident and impacts of human health for safety measure will be taken while handling the raw material and products:

Occupational control measures for health hazard to the worker and to keep the risk of accidents to a minimum from our manufacturing activities. Occupational hazards can be divided into two categories: safety hazards that

cause accidents that physically injure workers, and health hazards which result

in the development of disease. Hazards can be rated according to the severity of the

harm they cause - a significant hazard being one with the potential to cause a critical

injury or death.

Following are major health hazards involve in proposed activities mainly:




Chemical agents: There are possibility to generate vapors of solvents and dust.

We will take care to reduce it at optimum minimum level and advices to workers

to use PPE who work in such identify area.

Noise: Noise is considered as any unwanted sound that may adversely affect

the health and well-being of individuals or populations. Aspects of noise hazards

include total energy of the sound, frequency distribution, duration of exposure

and impulsive noise. Noise might result in acute effects like communication

problems, decreased concentration, and sleepiness and as a consequence

interference with job performance. Exposure to high levels of noise (usually above

85 dB(A)) over a significant period of time may cause both temporary and chronic

hearing loss. Permanent hearing loss is the most common occupational disease in

compensation claims.

Occupational surveillance involves active programmes to anticipate, observe,

measure, evaluate and control exposures to potential health hazards in the

workplace. Depending upon the occupational environment and problem, two

surveillance methods can be employed: Medical and Environmental.

Medical surveillance is used to detect the presence or absence of adverse health effects for an individual from occupational exposure to

contaminants, by performing medical examinations and appropriate tests. Medical

surveillance is performed because diseases can be caused or exacerbated by

exposure to hazardous substances.

Environmental surveillance is used to document potential exposure to

contaminants for a group of employees, by measuring the concentration of

contaminants in the air, in bulk samples of materials, and on surfaces. Medical

surveillance is performed because diseases can be caused or exacerbated by




exposure to hazardous substances. So periodic medical check-up will be carried

out.

Mitigatory measures:

For the proposed project, company will make following arrangement within the factory premises for the different hazards: • Enclosures or special ventilator control of processes;

• Good general ventilation - particularly important if the solvent is used in a

confined space;

• Personal protection - Protective clothing should be worn, including gloves.

Suitable respiratory protection is necessary like Panorama gas mask with

cartridge suitable for the chemicals we will be handling, breathing air

apparatus and air hood with instrument air connection.

• Keep Emergency alarm systems in confined area.

• Emergency preparedness plan.




Storage & Handling of Hazardous Chemicals:

• Company will do planning to stock all the necessary material as minimum as possible.

• All containers with hazardous chemicals have labels indicating the contents and warning of the hazard.

• Necessary information on safe handling and first aid measures and antidotes of major hazardous material will be available on the label.

• Workers dealing with hazardous chemicals will be trained on health risks and safe handling.

• Exposure to hazardous chemicals will be minimized. • Liquid Hazardous chemicals will be transferred in closed piping system. • Separate storage section will be provided for storage of hazardous and non-

hazardous raw materials.

Vessel and other Equipment related: • Checking of process vessels and equipment is carried out regularly. • Records related to maintenance and its planning schedule is maintained.

Fire related • Overhead water storage tank with adequate capacity is provided to ensure 24

hr. supply. • Fire water tank with sufficient capacity of 10 KL (02 Nos.) is provided with fire

pump (02 Nos.) • Fire hydrant piping is provided. • Sprinkler system will be provided over hazardous area. • Fire extinguisher is provided for proposed production capacity. Contact numbers

of nearest fire agency is provided.

Electrical related • All electrical fitting and motors in the storage areas are flame proof. • Checking of all earthings, wiring & connection are carried out regularly. • Proper earthing is provided at all equipments and will be provided for additional

equipment. • Adequate Nos. of earth pits is provided.

Safety related

• Adequate types of personal protective equipment will be provided and also safety training will be provided to workers.

• Emergency showers and eye wash stations is available at the worksite. Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

263



• Arrangement for 24 hr. medical facilities by contact with nearest health care centre/ hospital.

• Pre-employment medical check-up and annual medical checkup is carried out and its records is maintained properly.

DETAILS OF OCCUPATIONAL HEALTH PROGRAMME:

o Worker can be directly or indirectly exposed by chemical like, Sulphuric Acid, Hydro Chloric, Acid Formaldehyde etc during process or material handling.

COMAPANY HAVE TAKEN FOLLOWING ACTION TO KEEP CHEMICALS WITHIN PEL/ TLV:

• Process should be carried out in isolated area or closed system.

• Dilution ventilation/local exhaust ventilation system should be provided.

• Chemical handled by competent person.

• MSDS of hazardous substance must be maintained by company.

• Quantity of substance should kept to absolute minimize.

• Flame proof electric fitting should be provided.

• Safety devices like temp. Control and pressure control must be provided to

vessel.

• Labeling and sign board should be provided.

• Fire fighting, sprinkling system and emergency exit should be provided.

• PPE must be used during handling of chemicals.


264



EVALUATION OF EXPOSURE OF CHEMICAL DURING REPLACEMENT AND PERIODICAL MEDICAL MONITORING.

• Emergency /exposure examination and test should be carried out. Examination is based on irritation, sensitization of skin, respiratory system, eye, shortness of breath

• Test must be carried out as per handling of chemicals as per OSHA guideline.

• Check the previous medical opinion of worker/employee as well as history.


265



TREATMENT OF WORKERS AFFECTED BY ACCIDENTAL SPILLAGE OF CHEMICALS: Hazards with Acute Exposure

• Contact with skin may cause severe burns or systemic poisoning. • Systemic effects may occur from any route of exposure, especially after skin

absorption.

Hazards with Chronic Exposure • Repeated or prolonged exposure may harm the respiratory system. Can irritate and

inflame the airways. • Hazardous material affects the central nervous system, liver, and kidneys.

Special Safety Precautions • Prevent contact with skin by wearing neoprene gloves, lab coat, and resistant apron. • Wear safety glasses or a face shield if splashing may occur. • Store in a cool, dry, well-ventilated area, away from heated surfaces or ignition

sources. • Skin contact requires immediate washing of the affected area with soap and water. • Remove contaminated clothing and launder before wearing again.

Procedure for treating workmen after skin contact • Skin contact requires immediate flushing of the contaminated area with soap and water

at a sink or emergency shower for a good fifteen minutes. Remove contaminated clothing. In case of eye contact, promptly flush the eyes with copious amounts of water for 15 minutes (lifting upper and lower lids occasionally) and obtain medical attention. If methanol is ingested, obtain medical attention immediately. If large amounts of methanol are inhaled, move the person to fresh air and seek medical attention at once. It is recommended to provide the safety shower and eyewash station in plant.


266



Possibility of chemical spillage/leakages and its control measures Despite the best efforts for safe practice for handling of chemicals in chemical plants, there are chances of accidents due to release of chemicals. For this reason, it is essential that all plant personnel have adequate PPE to spill response. The following procedures should be used as a guide to help an effective spill control in the plant. These procedures tell you how to prepare step-by-step instructions for spill cleanup. They also outline when and who to call for assistance.

Check the possibility of fire or explosion;

Estimate release of a type and quantity of a chemical that poses an Immediate risk to health;

Evacuate the area of spillage;

If possibility of fire or explosion, call fire brigade and ready fire extinguishers for

primary control of fire.If the accident involves personal injury or chemical

contamination, follow the above steps as appropriate and locate nearest emergency

eyewash or safety shower. Remove any contaminated clothing from the victim and

flush all areas of the body contacted by chemicals with copious amounts of water for

15 minutes. Administer first aid as appropriate and seek medical attention.

Decontaminate the spillage area by appropriate procedure like, Acid spillage,

decontaminate by alkali materials, if solvent release, control it by add sand/soil to

control major contamination.

After control of spillage, all contaminate; if water generation, take it into

ETP for further treatment and disposal. If soil/sand, collect all soil/sand for final

disposal as advice by Environmental expert.

Ventilation system Ventilation is most important for the control of airborne hazards in the process

area. It involves the removal (from the workplace) of air that contains a hazardous

contaminant and its replacement with uncontaminated outside air. There are two

types of ventilation system: natural ventilation and mechanical ventilation.

Unit will focus in work zone area to maintain work air quality by natural ventilation

system provided by design of open structure operation plants. Wind Turbine

ventilation system will be is provided on roof top of warehouse, shed etc. & window

ventilation is provided to utilities area, offices, etc. Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

267



6.8 DETAILS OF OCCUPATIONAL HEALTH SURVEILANCE PROGRAMME: Aim:

• Workplace injuries, illness can be prevented and hazard should be identified.

• Evaluations of accident analysis due to unsafe act and condition as well as identified the health and safety problems in workplace.

• Effective Preventive measures strategies can be prepared.

• New technologies, educational activities, public awareness and regulatory and

policy changes can be achieved.

The overall mission of the Occupational Health Surveillance Program is to promote the health, safety and quality of life of working people will be achieved: Unit will employ well qualified and experienced production manager, who will look

out safety part. Part time or panel Factory Medical Officer will be appointed for

regular health check-up of employees. Record has been maintained. Regular

training to plant personnel in safety fire fighting and first aid will be provided. Being a

SSI unit, arrangement of own ambulance van is very difficult & facility of

ambulance van is round the clock available at Odhav Fire station, Ahmedabad. it will

maintain a healthy work environment. This will be accomplished through the

identification, evaluation and control of workplace environmental factors which may

cause sickness, impaired health or significant discomfort and inefficiency among

workers. Environmental factors such as noise, physical hazards toxicity/chemical

hazard and ergonomic hazards will be monitored on a periodic basis to assist in

maintaining a healthy work environment. Hearing protection aid will be provided

to workers who work in the high noise areas, during construction of the proposed

facilities and also to those who will continue through the life of the facility.


268



Surveillance program can be improved by following action.

• Pre-placement examination and periodic examination must be carried out at

Work place. • Maintain the work profile and medical history of employee/workers.

• Pulmonary function test must be carried out in case handling of hazardous

chemicals.

• Written medical opinion must be maintained by industry.

• Examination must be certify by qualified medical practitioners

Exposure of workers with major chemicals IPA, Methanol, n-Propanol, Acetone, Ethyl Acetate will be the main hazardous

chemicals used in the process. Proper care will be taken during handling of such

chemicals as per MSDS guidelines.

List of chemicals, their threshold limit and measures IPA, Methanol, n-Propanol, Acetone, Ethyl Acetate will be the main hazardous

chemicals used in the process, where workers are directly or indirectly exposed in

work area. Details of hazardous chemicals characteristics are summarized in Risk

Assessment report. Unit will handle above chemicals with proper handling process

suggested in MSDS.


269



6.9 HAZARDOUS IDENTIFICATION AND PREVENTIVE MEASURES Raw Material Storage hazardous and controls:

Name of Hazardous Chemicals

Toxicity (Oral LD50)

mg/kg Hazardous Characteristics

Isopropyl alcohol (IPA)

5045 mg/kg [Rat]

Flammability of the Product: Flammable. Auto-Ignition Temperature: 399°C (750.2°F) Flash Points: CLOSED CUP: 11.667°C (53°F) - 12.778 deg. C (55 deg. F) (TAG) Flammable Limits: LOWER: 2% UPPER: 12.7% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Flammable in presence of oxidizing materials. Nonflammable in presence of shocks. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Explosive in presence of open flames and sparks, of heat.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Avoid contact with eyes. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents, acids. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).


270



Methanol

5628 mg/kg [Rat].

Flammability of the Product: Flammable. Auto-Ignition Temperature: 464°C (867.2°F) Flash Points: CLOSED CUP: 12°C (53.6°F). OPEN CUP: 16°C (60.8°F). Flammable Limits: LOWER: 6% UPPER: 36.5% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Explosive in presence of open flames and sparks, of heat.

Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, metals, acids. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).


271



n-Propanol

1870 mg/kg [Rat.].

Flammability of the Product: Flammable. Auto-Ignition Temperature: 371°C (699.8°F) Flash Points: CLOSED CUP: 15°C (59°F). OPEN CUP: 27.2°C (81°F) (Cleveland). Flammable Limits: LOWER: 2.1% UPPER: 13.5% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat, of oxidizing materials. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapour/spray. In case of insufficient ventilation, wear suitable respiratory equipment If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes Keep away from incompatibles such as oxidizing agents, acids. Storage: Flammable materials should be stored in a separate safety storage cabinet or room. Keep away from heat. Keep away from sources of ignition. Keep container tightly closed. Keep in a cool, well-ventilated place. Ground all equipment containing material. A refrigerated room would be preferable for materials with a flash point lower than 37.8°C (100°F).


272



Acetone


Flammability of the Product: Flammable. Auto-Ignition Temperature: 465°C (869°F) Flash Points: CLOSED CUP: -20°C (-4°F). OPEN CUP: -9°C (15.8°F) (Cleveland). Flammable Limits: LOWER: 2.6% UPPER: 12.8% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Slightly explosive in presence of open flames and sparks, of oxidizing materials, of acids.

Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducing agents, acids, alkalis. Storage: Store in a segregated and approved area (flammables area) . Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Keep away from direct sunlight and heat and avoid all possible sources of ignition (spark or flame).


273



Ethyl acetate


Flammability of the Product: Flammable. Auto-Ignition Temperature: 426.67°C (800°F) Flash Points: CLOSED CUP: -4.4°C (24.1°F). (TAG) OPEN CUP: 7.2°C (45°F) (Cleveland). Flammable Limits: LOWER: 2.2% UPPER: 9% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizing materials, of acids, of alkalis. Non-flammable in presence of shocks.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents, acids, alkalis. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Moisture sensitive.


274



Acetonitrile

Acute: 2460 mg/kg

Flammability of the Product: Flammable. Auto-Ignition Temperature: 524°C (975.2°F) Flash Points: CLOSED CUP: 2°C (35.6°F). OPEN CUP: 5.6°C (42.1°F) (Cleveland). Flammable Limits: LOWER: 4.4% UPPER: 16% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat, of oxidizing materials. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available.

Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducing agents, acids, alkalis, moisture. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Do not store above 23°C (73.4°F).


275



Toluene

Acute: 636 mg/kg

Flammability of the Product: Flammable. Auto-Ignition Temperature: 480°C (896°F) Flash Points: CLOSED CUP: 4.4444°C (40°F). (Setaflash) OPEN CUP: 16°C (60.8°F). Flammable Limits: LOWER: 1.1% UPPER: 7.1% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).


276



N-Haptane

VAPOR (LC50): Acute: 103000 mg/m 4 hours [Rat].

Flammability of the Product: Flammable. Auto-Ignition Temperature: 203.89°C (399°F) - 223 C (433 F) Flash Points: CLOSED CUP: -4°C (24.8°F). (TAG) OPEN CUP: -1.1111°C (30°F). Flammable Limits: LOWER: 1.05% UPPER: 6.7% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available. Slightly explosive in presence of heat.

Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).


277



Acetic acid


Flammability of the Product: Flammable. Auto-Ignition Temperature: 463°C (865.4°F) Flash Points: CLOSED CUP: 39°C (102.2°F). OPEN CUP: 43°C (109.4°F). Flammable Limits: LOWER: 4% UPPER: 19.9% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizing materials, of metals.

Precautions: \Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Never add water to this product. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducing agents, metals, acids, alkalis. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame).


278



Methylene chloride (MDC)


Flammability of the Product: May be combustible at high temperature. Auto-Ignition Temperature: 556°C (1032.8°F) Flash Points: Not available. Flammable Limits: LOWER: 12% UPPER: 19% Products of Combustion: These products are carbon oxides (CO, CO2), halogenated compounds.

Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe gas/ fumes/ vapor/spray. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area.


279



General Hazards & controls:

Type of Emergency

Identification of

area Possible Causes Possible Result Preventive/control Measures

Fire Drum Storage area

• Fire due to Drum leakages.

• Damage of drum Pump discharge nozzle failure

• Major fire in the drum storage area, it may spread all over the company and surrounding area

• May cause fatalities

• Licensed and isolated Drum Storage Area.

• Flame proof fittings. • Earthling while unloading. • Spark arrestor at main gate. • Provision of dyke. • Earthling of tanks and

pumps • Get approval from an

explosive department for plan approval, equipment layout & emergency control measures.

• No electrical junction box close to storage materials.

• Hot work permit system followed for hot working in the ware house.


280



Type of Emergency

Identification of area

Possible Causes

Possible Result

Preventive/control Measures

Explosion

All material handling areas

• Vapor explosion due to contact of spark to accumulated flammable vapor in confined area

• Improper discharge of static charge

• Use of non FLP equipment for solvent Handling

• Metal to metal impact

• Electrical short circuit

• Open flame

• Flameproof electric installation areas & spark less tools

• Isolated storage use of Flammable material drums

• Hot work permit for hot working in the plant

• Earthling for human static charge

• Good ventilated area for Flammable material storage

Material handling In Plant

Flammable, eye irritating & body accident

Fire and health hazards

• Trained employee • Required PPE and Fire • Protective Provided

equipment • Good engineering practice • Separate storage are with

dyke valve system provided


281



6.10 Occupational Health and First aid measures Unit is using numbers of chemicals, which if handled in safe ways with all precautions (as

detailed in respective MSDS) will not cause harm to employees. However, in rare case of

exposures, immediate action is to be taken to save life and reduce the extent of damage.

Unit has first aid facilities and calling base ambulance facilities as and when required.

Industry will appoint part time doctor for periodically health check-up. Instructions for

immediate actions to exposures to some of the chemicals will be given to employees.

Mitigation Measures: Entire materials will be transfer either pneumatically or closed

manner and charging the raw materials in reactor with deep charges so that chances of un-

reacted materials are minimized.

Engineering controls: Engineering controls are the preferred method of controlling

exposure to workplace hazards. They can be placed in three categories:

• Substitution includes the use of a less hazardous material, a change in the

process equipment used, or a change in the process itself. Care must be taken to

ensure that the substitution actually does result in less hazardous conditions.

• Isolation is a method of limiting exposure to those employees who are working

directly with the hazard, often by enclosing them within a containment structure.

While isolation will reduce the risk to those outside the isolated area, it should be

accompanied by appropriate controls to ensure that those within are not faced with

an increased exposure to the hazard.

Ventilation is most important for the control of airborne hazards. It involves the removal (from

the workplace) of air that contains a hazardous contaminant and its replacement with

uncontaminated outside air. There are two types: local exhaust and general dilution. A

properly designed local exhaust system can capture a contaminant where it is generated

and remove it before it is dispersed into the work environment. Unit has focus on above three

areas to maintain work air quality in work zone area.


282



Occupational Health and First aid measures Unit will be used numbers of chemicals, which if handled in safe ways with all precautions

(as detailed in respective MSDS) will not harm to employees. However, in rare case of

exposures, immediate action is to be taken to save life and reduce the extent of damage.

Unit will provide first aid facilities. Industry will appoint part time doctor for periodically

health check-up of workers. Instructions for immediate actions to exposures to some of the

chemicals will be given to employees.

Hazard Communication and Industrial Safety

A hazardous chemical directory is being developed to maintain information on the hazards

associated with each chemical used. Copies of Material Safety Data Sheets for all

hazardous materials at the proposed facility will be kept at the unit and will be available

for employee review. Specific programs and procedures for the control of health hazards

associated with potentially harmful materials such as solvents will be followed. Material

handling areas should be clearly defined.

• The workers should be made aware about the hazards associated with

manual material handling. • A written process safety information document should be compiled for general

use.

• The document compilation should include an assessment of the hazards

presented including (i) Physical data (ii) Thermal data (iii) process and

Mechanical design.

• Personnel engaged in handling of hazard activities should be trained to respond

in an unlikely event of emergencies.

• The plant should check and ensure that all instruments provided in the plant are

in good condition and documented.

The hazard communication program will serve as the basis for selection of personal

protective equipment such as gloves, goggles, face shields, etc. A select group of

employees at the proposed facilities will receive first aid training to provide an immediate

response and medical care for injuries. Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

283



6.11 EXPENDITURE ON ENVIRONMENTAL MATTERS

The Table No. 6.3 table gives the expenditure to be incurred by M/s. Atlas Life Sciences On environmental matters.

Table No.6.1

Expenditure on Environmental Matters

Sr. No

System Approximate recurring cost per annum

(in Lacs)

Approximate capital cost (Rs. In Lacs)

Basis for cost estimates

1 Air pollution control

3.0 12.0 The capital cost would include cost of providing adequate height of the stack, ladder and platform, and recurring cost would include cost of monitoring of air environment.

2 Water pollution control

13.20 10.0 Capital cost would include cost of ETP, Evaporation cost of effluent etc. In capital cost civil work, mechanical work, Electrical work and piping work is included. Recurring cost is for operational phase.

3 Noise pollution monitoring

0.25 0.0 DG sets will be provided with acoustic enclosures, the recurring cost would include cost of noise monitoring.

4 Solid and hazardous waste management

2.5 5.0 Capital cost would include cost of providing storage space for hazardous waste and membership of TSDF Fee. Recurring cost would include cost of land filling and transportation.

5 Environment monitoring and management

2.0 0.0 The recurring cost would be incurred on hiring of consultants and payment of various statutory fees to regulatory agencies.

6 Green belt 0.5 0.5 Development of Greenbelt including Gardening and Plantation.

7 Occupational health (OHC)

0.5 1.0 Occupational health check up of Employees and workers

Total 21.95 28.5


284



6.12 CONCEPT OF WASTE MINIMIZATION, RECYCLE / REUSE / RECOVER TECHNIQUES, ENERGY CONSERVATION AND NATURAL RESOURCES CONSERVATION.

WASTE MINIMIZATION, RECYCLE / REUSE / RECOVER TECHNIQUES: The unit shall also implement the concept of waste minimization circle including:

Good House Keeping: Proper housekeeping practices make the system easier and less costly.

Rain water harvesting system shall be adopted to reduce the fresh water requirement.

Cleaner production technology shall be adopted for the resource conservation and pollution control.

Unit shall to do moping in their unit instead of washing of water. Unit should try to minimize the excess raw material in batch, so it will reduces the

unreacted raw material in effluent generation. Ultimately, it will reduce the concentration of effluent.

We shall provide fix pipeline in their unit to minimize the leakages. ENERGY CONSERVATION: Energy Conservation and Energy Efficiency are separate, but related concepts. Energy conservation is achieved when growth of energy consumption is reduced, measured in physical terms. Energy Conservation can, therefore, be the result of several processes or developments, such as productivity increase or technological progress. On the other hand Energy efficiency is achieved when energy intensity in a specific product, process or area of production or consumption is reduced without affecting output, consumption or comfort levels. Promotion of energy efficiency will contribute to energy conservation and is therefore an integral part of energy conservation promotional policies. Energy efficiency is often viewed as a resource option like coal, oil or natural gas. It provides additional economic value by preserving the resource base and reducing pollution. For example, replacing traditional light bulbs with Compact Fluorescent Lamps (CFLs) means you will use only 1/4th of the energy to light a room. Pollution levels also reduce by the same amount nature sets some basic limits on how efficiently energy can be used, but in most cases our products and manufacturing processes are still a long way from operating at this theoretical limit. Very simply, energy efficiency means using less energy to perform the same function. Inadequate control of steam supply wastes energy. So, we will investigate the

possibility of installing automatic controls. Monitoring drying operations enables energy consumption to be assessed and

possibly reduced. Monitor parameters by us


285



Heat losses from dryers by radiation and convection will be minimized. And we will

improve the insulation of dryers to save energy costs.

Routine cleaning and maintenance programme for the combustion system will improve efficiency and reduce energy costs.

Investigate the possibility of changing any upstream processes in order to decrease

the water content before drying operations. Relatively minor modifications of upstream operating procedures may significantly reduce energy costs.

We will check, if it is possible to use heat recovered from the dryer exhausts in the drying process.

Waste Heat Recovery System Understanding the process is essential for development of Waste Heat Recovery system. This can be accomplished by reviewing the process flow sheets, layout diagrams, piping isometrics, electrical and instrumentation cable ducting etc. Detail review of these documents will help us in identifying: a) Sources and uses of waste heat b) Upset conditions occurring in the plant due to heat recovery c) Availability of space d) Any other constraint, such as dew point occurring in an equipments etc. After identifying source of waste heat and the possible use of it, our next step is to select suitable heat recovery system and equipments to recover and utilize the same. Economic Evaluation of Waste Heat Recovery System It is necessary to evaluate the selected waste heat recovery system for our unit on the basis of financial analysis such as investment, depreciation, payback period, rate of return etc. In addition the advice of experienced consultants and suppliers must be obtained for rational decision. Natural Resources Conservation: Renewable energy is energy obtained from sources that are essentially inexhaustible. Examples of renewable resources include wind power, solar power, geothermal energy, tidal power and hydroelectric power. The most important feature of renewable energy is that it can be harnessed without the release of harmful pollutants. Non-renewable energy is the conventional fossil fuels such as coal, oil and gas, which are likely to deplete with time. Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

286



Measures for Conservation of Energy Unit shall adopt various measures for energy conservation:

• Energy efficient machineries will be used during operation phase.

• Company shall try to utilize renewable sources of energy

for conservation of non-renewable sources of energy.

• Enough care will be taken to prevent/minimize energy losses at each stage.

• External lights will be controlled through timers for auto on/off function

based on timings.

• The cable size will be selected so as to minimize the power losses.

• Efficient lamps and ballasts.

• Replacement of conventional lighting fixture by more energy efficient fittings.


287



6.13 CHECKLIST IN THE FORM OF DO’S AND DON’T. The checklist in the form of Do’s and don’t of preventive maintenance, strengthening of HSE, manufacturing utility staff for safety related measures are as follows. DO’S

1) Check the raw material availability as per the job on hand required for all stages.

2) Check the vessels expected to be used in the process for good physical condition.

3) Check the availability of utilities required till the end of the batch / job.

4) Check for proper manpower available till the entire operation in over.

5) All equipments including the stand-by should be in operable condition.

6) Verify the test certificates of materials being taken for process.

7) Prepare time schedule of material flow on basis of the process.

8) Monitor the temperature and pressure wherever possible during the process.

9) Use pumps for transferring the liquids to the reactor tank.

10) Familiarize the worker about what is the job on hand.

11) Ensure the worker / operator is having sufficient knowledge of the materials

handled.

12) Ensure proper display of visual instructions for characteristics of the chemicals.

13) Ensure proper training of personnel.

14) Ensure sufficient numbers of safety devices are available.

15) In view of the chemicals handled, whether required or not, please ensure availability

of SCBA apparatus near every use and storage area of chemical.

16) Ensure the workers wear proper PPE of adequate grade.

17) Demarcation of the chemical storage area for chemical in test.

18) Ensure removal of used containers from workspaces.

19) Prepare and follow the safe work instruction.

20) Record every incident that led to an accident irrespective of the seriousness of the

accident and analyze the same to improvise the system continuously.

21) Always check the fire water tank to be filled up to the brim to ensure availability of

fire water in sufficient quantity at all times. The design of other water to be used

shall be from the overflow of the fire water tank to ensure this system.

22) Never work bare foot or without safety shoes.


288



23) Never use mobile phones in work zones.

24) In case of any confusion try to acquire correct information before any action.

25) Use only proper grade PPEs and use them properly.

26) Before disconnecting any electrical installation, neutralize the static charge in a safe

manner.

27) Open or use containers only on written instruction.

28) Verify the label with the instruction before use.

29) Maintain your attendance at the time-office.

30) Participate wholeheartedly in all safety related exercises an keep yourself updated.

Don’ts: 1) Don’t use the raw material without checking as per the job on hand required for

all stages.

2) Don’t use the vessels expected to be used in the process without checking.

3) Don’t fail to check the availability of utilities required till the end of the batch / job

4) Don’t work without enough and proper man power.

5) Don’t use the equipments which are not in operable condition.

6) Don’t use the materials for process without verify the test certificates.

7) Don’t use the material without Prepare time schedule of material flow on basis of

the process.

8) Don’t perform without Monitoring the temperature and pressure during process.

9) Don’t handle chemicals with open hands where manual handling is a must.

10) Don’t keep the workers under wraps about what is the job on hand.

11) Don’t let the worker / operator do the work having lack of sufficient knowledge of

the materials handled.

12) Don’t use the chemical with unknown characteristics or having unreadable label.

13) Don’t let the personnel do the work without giving proper training.

14) Don’t work without sufficient numbers of safety devices.

15) In view of the chemicals handled, whether required or not, don’t work without

ensuring availability of SCBA apparatus near every use and storage area of

chemical.

16) Don’t let the workers do work without wearing proper PPE of adequate grade.

17) Don’t use material that is under testing for production.

18) Don’t store used containers at workspaces. Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

289



19) Don’t breach the safe work instruction.

20) Don’t try to conceal information regarding missed accidents or small injuries.

Remember every and any mishap can be fatal if not for your self for others.

21) After any shutdown never start operation without having ensured the fire water

tank filled up.

22) Don’t work bare foot or without safety shoes.

23) Don’t use mobile phones in work zones.

24) Never undertake any operation without work permit.

25) Do not use PPEs which are not relevant to the operational aspect that has been

identified.

26) Never remove any electrical equipment without neutralization of static charge

after written permission only.

27) Don’t open or use containers on which instruction are not written.

28) Don’t work without Verifying the label with the instruction before use.

29) Don’t enter the workplace without registering your attendance.

30) Don’t ever even thinking of evading safety instructions.

6.14 SOCIO ECONOMIC DEVELOPMENT ACTIVITY:

Socio-economic development activities refers to voluntary actions undertaken

by company/organization to either improve the living conditions (economically,

socially, and environmentally) of local communities or to reduce the negative

effects of the project.

Various Programs/Projects related to Social & Economic development of

surrounded area has been planned.


290



Following activity will be under taken as a part of CSR under different

heads:

Education

• Awarding meritorious school students in SSC & HSC • Providing utensils to schools and Aanganwadi for Mid Day meal preparation. • Science Lab – Equipment and books in libraries for schools. • Supports for sport and culture competitions in schools.

Health and family welfare

• Malaria eradication camps (collection of blood sample & detection of

virus & free medicine distribution, Blood donation camp)

• General Health Camp for men, women & kids

• Support for Pulse Polio Immunization camp

• Contribution towards primary Health Services depending on local needs.

Preservation of the Environment and to Sustainable Development

• Water harvesting systems in nearby villages.

• Landscaping and greenbelt development in and around of the project site.

• Provide sanitation facilities to villagers.

Unit has committed to spend about Rs. 1,25,000/- towards various rural up-

liftman and community development programs.


291



6.15 ENVIRONMENTAL POLICY:

1. We strive to completely understand the environmental impact of business activities at our factory, set forth goals and objectives regarding elements of activities that negatively impact the environment, and regularly revise our outlook in order to continually improve the environment. Areas in which we are directing particularly focused efforts are as follows.

A. Seeking a reduction in environmental burden, we continually work towards improvements in output levels, minimize waste material production, and implement a natural resource and energy conserving philosophy.

B. As a chemical factory, we handle a variety of chemical substances. However, we work towards prevention of environmental pollution by implementing appropriate management procedures with respect to environmental pollutants.

C. As a factory that handles hazardous materials, we work to actualize safe operations by reducing accidents and trouble through absolute and constant awareness towards preventing explosions and fires.

2. While adhering to environmental laws, regulations, and agreements, we will work towards preventing environmental pollution.

3. We educate all our employees about environmental conservation and are working to heighten awareness and understanding of our environmental policy. At the same time, we perform environmental conservation activities from a wide range of viewpoints with a focus on the local community and global environment.

The industry's management will actively initiate, develop and support the environmental policy, which is relevant to its activities, products and services and their environmental effects. Broadly this covers the following:

• Be consistent with the occupational health and safety policy and other industrial policies (such as quality policy);

• Indicate which of the industrial activities are covered by the environmental management system;

The corporate policy for Environmental Management is to create sound and eco-friendly environment for sustainable development at all production projects, plan new projects with environment -friendly considerations, plan regulative, ameliorative and mitigative measures to protect environment and fully merge into the overall corporate policy for achieving the targeted business goals of the Corporation.


292



Objectives: The environmental policy is framed specifically to fulfill the following objectives: • Create a work environment which enhances/motivates production and productivity. • Create a residing environment for the enjoyment and peace of employee. • Encourage safe and scientific operations and other well-established engineering

practices. Promoting awareness amongst the employees and the neighborhood population for adopting environmentally friendly acceptable procedures and restricting environmental degradation and pollution to the barest minimum 6.16 INFRASTRUCTURE FACILITIES TO THE LABOURS DURING

CONSTRCITON PHASE: During the construction period, there will be increase in floating population. The project will provide temporary employment of skilled and highly skilled manpower. Most of the people will be employees of contractors/sub-contractors. Additional strain on civic amenities like road, transport, communication, drinking water, sanitation and other facilities will take place, to meet the work force requirement. During the construction phase there will be increased demand of services, as most of the employees deployed during the construction period will be from local area. These include hotels, lodges, public transport (including taxis), etc. There will also be ample opportunities for providing these services. In addition to the opportunity of getting employment as construction laborers, the local population would also have employment opportunities in related service activities like petty commercial establishments, small contracts/sub-contracts and supply of construction materials for buildings and ancillary infrastructures etc. Consequently, this may lead to economic upliftment of the area. The movement of work force to and from the place of work and the movement of vehicles carrying equipment and construction material is expected to increase the stress on the local transport and road network. However, considering the number of people deployed, the impact on road/traffic is marginal and temporary. Consumer Prices: Usually the local population will be affected by inflationary trend sometime later, when prices of local services and produce, egg, fish, vegetables, milk, etc. start rising. This will happen only when a sizeable staff of the project and other associate companies settle permanently in the area. However any such rise in consumer prices is anticipated because the influx of population due to the project activities is minimal. Transport and Civil Construction: The transport companies would benefit from the construction of the plant. Services: The services like retail shops, banks, and automobile workshops; health care, etc. will expand in and near the plant. Prepared By M/s. Bhagwati Enviro Care Pvt Ltd.

293



Employment: Large-scale influx of material and money tend to increase the employment opportunities. Transport: Transport services on the connecting road will improve further. Traffic: The plant construction phase will also see a moderate increase in traffic. Development of Slums: The contractors have to necessarily provide basic amenities like water supply, sanitation, electricity etc. at the labor camp to maintain hygienic condition and aesthetics.


294



CHAPTER-7 ADDITIONAL STUDIES

7.1 PUBLIC CONSULTATION As per the EIA notification 2006 and its subsequent amendments, “Public Consultation” refers to the process by which the concerns of local affected persons and others who have plausible stake in the environmental impacts of the project or activity are ascertained with a view to taking into account all the material concerns in the project or activity design as appropriate. All Category ‘A’ and Category B1 projects or activities shall undertake Public Consultation, except the following:-

(a) Modernization of irrigation projects (item 1(c) (ii) of the Schedule). (b) All projects or activities located within industrial estates or parks (item 7(c) of the

Schedule) approved by the concerned authorities, and which are not disallowed in such approvals.

(c) Expansion of Roads and Highways (item 7 (f) of the Schedule), which do not

involve any further acquisition of land. (d) All Building /Construction projects/Area Development projects and Townships

(item 8). (e) All Category ‘B2’ projects and activities. (f) All projects or activities concerning national defense and security or involving other

strategic considerations as determined by the Central Government. M/s. Atlas Life Science is located in notified GIDC Estate. Unit is a small scale, water consumption is less than 25 KLPD, Fuel Consumption less than 25 MTPM, and unit is not falls under MAH category. So, as per EIA notification, Proposed Project is fall under category B and activity 5 (f). So, as per notification, Public Consultation is required for proposed project.


295



7.2 RISK ASSESSMENT

Risk assessment may be broadly categorized as under: Design and Pre-modification review: Improper layout like location of plant in downwind side of tank farm, fire station near process area, process area very close to public road and wrong material of selection can cause severe damages to the work and outside environment. Chemical Risk Assessment: It is being assessed for chemicals from the point of view of compatibility, storage, fire protection, toxicity, hazard index rating, fire and explosion hazards. Process Safety Management: Before effecting major process changes, lack of Management of Change procedure (MOC) like reliability assessment of process equipment, incorporating safety tips and interlocks, scrubbing system, etc. Electrical Safety: Ignorance of hazardous area classification, protection against static electricity, improper maintenance of specialized equipment like flameproof etc. Safety Audits: Lack of Periodical assessment of safety procedures and practices, performance of safety systems and implementation of the same along with follow up measures. Emergency Planning: Lack of comprehensive risk analysis indicating the impact of consequences and specific written down and practiced emergency procedures along with suitable facilities had increased the severity of the emergency situations.


296



Training: Lack of safety induction and periodical refresher training for the regular employees and contract workmen. Risk Management & Insurance Planning: Lack of identification and analysis of all risks and insurance planning so that interruption risks and public liability risks could also be managed effectively.

To assess fire risk assessment in the industrial unit following steps shall be considered and measures shall be taken.

FIRE RISK ASSESSMENT

o Identification & assessment of fire risks during operations in receipt, storage, transfer and handling of chemicals (raw materials and finished products).

o Identification & control of ignition sources in areas where flammable chemicals will be stored/handled/transferred.

o Review of chemical compatibility in storage areas and to suggest appropriate fire loss control measures.

o Review of fire detection measures adopted in the plant & to suggest suitable improvement measures.

o Review of the various active (fire hydrant, sprinkler, portable fire extinguishers) and passive fire protection requirements for chemical storage and handling areas and to suggest improvements as necessary.

o Review of contractor safety awareness (chemical spill, fire fighting, emergency communication, knowledge of plant hazards & safety regulations) and to recommend suitable improvement measures to enhance contractor safety.

o Review of safety awareness and safety training requirements (training identification and efficacy) of plant employees with respect to hazards present in the plant.


297



RISK ANALYSIS & EMERGENCY PLAN

o Identification of scenarios of potential disasters/emergencies leading to loss of life, property damage etc. and qualitative assessment of their likelihood.

o Recommendations for risk control measures wherever applicable.

o Preparation of onsite emergency preparedness plan.

RISK MANAGEMENT & INSURANCE PLANNING

• Identification of all major internal and external pure risks including the natural risks and analysis of the impact of above risks.

• Scrutiny of all existing major insurance policies in respect of:

1. Rationalization of basic rate of premium and widening of covers.

2. Applicability/eligibility of discounts in premium.

3. Application of suitable clauses, warranties and conditions.

• Identification of possible areas for refund of premium and suggestions regarding procedure for the same.

• Selection of insurance coverage on the basis of risk analysis.

• Evaluation of business interruption exposure due to identified risks.

• Providing guidelines on documentation requirements, procedures for claims under various policies, evaluation of insurers.

• Risk Assessment including prediction of the worst case scenario and maximum credible accident scenario should be carried out. The worst case scenario has been taken into account the maximum inventory of storage at site at any point in time. The risk contours should be plotted on the map clearly showing which of the facilities and surrounding units would be affected in case of an accident taking place.

• The Risk Assessment report is enclosed herewith. Please Refer Enclosure : 01


298



7.3 ONSITE & OFFSITE DISASTER PREPARDNESS &

EMERGENCY MANAGEMENT PLAN OF THE INDUSTRY Risk leads to disasters & disasters have great impact on the profitability, stability & reputation of an industry. Disaster occurs when a hazard or a threat rises in vulnerable condition and the trend reflects an increase in both. To uphold righteous image of an organization, Disaster Management is of prime importance. For tackling the major consequences inside the port and in the vicinity of port DMP has to be formulated and this planned emergency document is called ‘DISASTER MANAGEMENT PLAN’. Indian industry of late has begun to be aware of the necessity to apply more systematic approaches to safety particularly in plant design. Primarily, safety in the design of plant extends to the application of various codes of practice or design codes, which are based on the wide experience and knowledge of professional experts and specialists in the industry. Such application is backed by the experience of local plant managers and engineers who have been involved in similar plants and who have direct experience in their operation over a number of years. The main objective of evolving this emergency and disaster control plan is to create a procedure and infrastructure based on combined resources of the factory and the outside services with a view to minimize emergencies and disaster. This may arise as a result of usage, handling and storage of certain toxic, corrosive, inflammable and explosive materials used in the manufacturing process and any other emergencies which may directly or indirectly affect the employees, property and local community. Objectives are further classified as under:

• Rescue operation and treatment of persons affected by the emergency.

• Safeguard of other persons not affected by the emergency.

• Keep the damage to property and environment at a minimum level.

• Initially contain the impact of incident and ultimately bring the incident under control.

• Provide authentic information to outsiders and media.

• Rehabilitation of affected person.

• Preservation of relevant records.

• Inquiry into the cause of emergency situations and then analysis to prevent recurrence.


299



PURPOSE OF PLAN:

• To save lives and injuries,

• To prevent or reduce property losses,

• For protection of environment,

• For protection of installation & restoration of production,

• To provide help for quick continuation of normal situation or operation.

More specifically the elements that will form the backbone of the emergency preparedness organization are: o Availability organization and utilization of resources for facility emergencies. o Accident evaluation procedures. o The command, coordination and responsible organization structure. o Notification and communication mechanism. o Training exercises and plans maintenance. Emergencies and disasters can happen at any moment - and, they usually occur without warning. When an emergency strikes, immediate safety and prompt recovery are depends on the existing levels of preparedness among workers and management. Emergency incidents that may occur, including • Earthquakes • Fires or Explosions • Hazardous Materials Releases • Extended Power or Utility Outages • Floods • Mass Casualty Events As discussed in earlier chapters, emergencies are classified as minor or major, according to their severity and potential impact. The Disaster management of any firm mainly covers steps like PREPAREDNESS, RESPONSE and RECOVERY PREPAREDNESS is a first step to assemble appropriate human and physical resources before any emergency occurs, So the industry shall have a designated an “Emergency Coordinator” with the management experience and financial authority to deal with the Disaster plan. The person shall arrange related staff safety education and training; Purchase department emergency supplies and equipment and give quick response on occurrence of any emergency- disaster.


300



The company will have the following essentials in an accessible location:

• First aid supplies, with instructions

• Flashlights/batteries, approved power strips and extension cords, emergency power supply

• Portable AM/FM radios/batteries

• Laboratory spill kits

• Portable emergency water supply

• Eyeglasses, medications and personnel protective measures

• Personal’s emergency contact numbers. The company will be in direct contact with the offsite Disaster plan of District Disaster Management authority. The important telephone numbers including Protective Services i.e Fire station, Hospital, Police department, factory inspector etc. shall be made readily available and in updated forms. A brief onsite emergency plan shall be readily available to all.

FIRE PREVENTION The fire accident may take place because of the electrical spark or static electricity. All the precautionary measures will be taken by the industry to prevent fire in any part of the plant as per the followings: • The company will identify the sources of accidents.

• Adequate fire extinguishers is provided and additional will be provided as per

requirement.

• Mechanical rooms or utility rooms will not be used for storage.

• All the chemicals will be stored with recommendation storage and handling practice.

• Storage and process area will be posted with “No Smoking” signs.

• All the Personnel Protective equipment will be easily available to all the workers.

• The company will provide firewater reservoir, fixed water monitors/foam monitor,

foam trolley, sand bucket, eye wash shower, flame arrester and fire extinguisher to prevent from any causalities.


301



LABORATORY SAFETY & PREPAREDNESS The company will maintain clean work environment; post laboratory safety work rules, train all personnel; carry out inventory and label chemicals; not purchasing excess quantities of chemicals; segregates incompatible chemicals; keeps flammables in flammable storage cabinets with copies of Material Safety Data Sheets; installs seismic restraints on chemical storage tanks and reactors and disposed off chemical waste properly. In case of occurrence of disaster, the company gives training to all workers and personnel to react as under: MINOR release in the laboratory • Follow laboratory eyewash, rinse or shower procedures • Flush affected area continuously for 15 minutes • Vacate persons in immediate area if necessary • Clean spill • Wear protective equipment • Use appropriate kit to contain, neutralize and absorb • Collect, containerize, and label waste MAJOR release in the industry and vicinity area • Report factory name, location, phone number, the material spilled, possible injuries

to concerned department for emergency help and measures. • Assist injured persons. • Isolate contaminated persons and area. • Avoid contamination or chemical exposure further. • Close doors or control access to spill site MATERIAL SAFETY DATA SHEETS As part of quality for Hazard Communication Standard, all company is required to have Material Safety Data Sheets (MSDS) available to all employees working with hazardous chemicals. The concept is “that employees have both a need and a right to know the hazards and identities of the chemicals they are exposed to when working. They also need to know what protective measures are available to prevent adverse effects from occurring.” Information that can be found in a MSDS includes: • The identity of the chemical substance • Physical and chemical characteristics • Physical and health hazards • Primary routes of entry


302



• Permissible Exposure Limits (PELs) • Carcinogenic status • Precautions for safe handling and use (including personal protective equipment) • Spill response • Emergency and first aid procedures • Date of the MSDS • Although not required, it is highly recommended for the company to maintain a file of

MSDS sheets for all of the chemicals used in lab/work area. A central file is maintained at the office.

ON SITE EMERGENCY PLAN Emergency Response Room (Safety officer room) The place identified as Emergency Response Center will be considered as the Security Gate Office. The location of the Emergency Response Center may change in future as per convenience. The facilities available at the Emergency Response Center shall include:

1. Internal Telephone 2. External Telephone 3. Manual Fire/Emergency Siren 4. Siren Actuation Switch 5. Important Address and Telephone Numbers 6. Emergency Vehicles 7. Confined Space Entry Procedure 8. List of Antidote/actions to be taken in case of hazardous chemical/materials. 9. Material Safety Data Sheets of chemicals 10. A copy of On-Site Disaster Management Plan

All communications after General Shift working hours and on Sundays/ Holidays are to be routed through the Security Gate Office. General Rules:

1. Follow sense of discipline and do not pain. 2. Do not rush and endanger your personnel safety 3. Use personnel protective equipment according to the situation 4. Do not block any passages, which may hinder the movement of emergency

vehicles. 5. In case you have to shut down your plant operation, do it in an orderly manner as

per standard operating procedures. 6. In situation when you have to leave your work and evacuate to identify places out

of operating areas, do it in an orderly manner. 7. Follow instructions of the Safety officer. 8. Understand the Disaster Management Plan well and take interest in practice mock

drill.


303



An emergency in the premises has the potential to cause serious injury or loss of lives or extensive damage to the property and/or environment and serious disruption both inside and outside the plant. In such cases sometimes outside agencies are required to call for help in handling the situation. The causative factors like plant/equipment failure, human error, earth quake, sabotage etc. will normally manifest in various forms viz. Fire, Explosion, Toxic release, structure collapse etc. This OEP lays down the code of conduct of all personnel in the Plants and the procedures to be adopted by them in the event of an "Emergency". These procedures have been prepared taking into account the minimum strength of manpower available at all times in the premises. The individuals under the direction of the respective Team Leaders shall carry out the responsibilities assigned. The emergency procedures outlined are suitable for round the clock coverage including holidays. These emergency procedures shall be followed as outlined in the OEP during general shifts as well. OBJECTIVES: The overall objectives of OEP are:

• To control the situation and if possible eliminate as quickly as possible. • To avoid confusion/panic and to attend the emergency with clear-cut line of action. • To minimize the loss of property to the plant as well as to our neighbourhood. • To safe guard the non-affected areas. • To alert the neighbourhood. • To arrange head-count and rescue operations. • Treatment of the injured. • To safeguard others by timely evacuation. • To prevent any cascade of emergencies.

EMERGENCY: An emergency is the situation, which has potential to cause a large-scale damage or destruction to life or property or Environment or combination of these within or outside the factory. Therefore it is essential to have a laid down procedure to meet emergency systematically. In any industry, emergency can arise at any moment and this depends on the type of: • Structure • Raw materials • Machines • Nearby Industries • Location of the Industry etc.


304



NATURE OF EMERGENCY: The "Emergency" specified in this plan will refer to occurrence of one or more of the following natural/manmade events. • Earthquakes • Fires or Explosions • Hazardous Materials Releases • Extended Power or Utility Outages • Floods • Mass Casualty Events MEDICAL HELP: First Aid Boxes have been provided at various strategic locations. Requisite number employees are trained about First Aid, Liaison with nearest hospitals. COMMUNICATION SYSTEM:

• Alarm Rising for Emergency by blowing the sirens installed • The siren will be used for raising the emergency alarm and also for all clear

signals. • Emergency Siren: The wailing alarm will be sounded intermittently at fixed interval

of 30 seconds for a period of two minutes in case of emergency, such alarm will signify the employees that an emergency has occurred and that the emergency services should be put into operation.

• Incident Controller after assessing the situation will declare that emergency is over. Till the Incident Controller issues the declaration, all the leaders will adhere to the task and be present at the prescribed location.

• All clear signal will be sounded through continuous siren for 1 minute. Even after the emergency is over a skeleton staff of the Rescue/Evacuation Team will be available at the site of emergency for at least 30 minutes to ensure that the situation is absolutely free from danger.

• After the emergency is over, all the team leaders should meet at the Emergency Control Center and each team leader should submit a report to the Incident Controller about team performance and other details observed.

• In addition to the above systems, Internal telephones, P.A.System, Mobile telephones, Computer System etc. will be used for communication.

• If situation is beyond the control, the external agencies will be informed accordingly and asked for the help. Direct telephone, cell phone or messengers / runners may achieve this.

ASSEMBLY POINT: In case of emergency some locations are considered as Assembly Points. Depending on the wind direction and location of emergency, Assembly Point will be declared. The employees should run across the wind direction and not against the wind direction.


305



Depending upon the location of the emergency the Incident Controller will fix the Assembly Point and Officer will announce the location of the Assembly Point. Employee’s attendance, visitors and contractors workmen register will be made available at the Assembly Point for head count. Emergency control centre: Factory Manager Office will be declared as an Emergency control centre. Emergency control centre is facilities with:

I. Address and Telephone numbers of the Factory Inspectorate, Gujarat Pollution Control Board, Police, Fire Brigade, Hospitals and OEP Team Members

II. Plant layout-indicating storage of hazardous materials, layout of fire Hydrants/extinguishers, entrances/exits, roads etc.

III. Portable P.A. System, Manual Siren, flood lights, Torches, Pickaxe, Saw, Nylon Ropes.

IV. Fire Blankets / Fire Proximity Suit, Breathing Apparatus, First Aid Box etc. V. List of employees with address, telephone number, blood group etc.

VI. Material Safety Data Sheets of all chemicals handled. WIND SOCKS: Wind direction will be determined with the help of installed windsocks. MOCK DRILL: Mock drills are carried out regularly to familiarize the staff with their roles, fire protection equipment/system installed in the plant and use of personnel protective equipment. Senior officials monitor this and shortcomings are thoroughly studied and necessary corrective measures are taken. PROCEDURES FOR MOCK DRILLS

A. Inform all the employees about mock drills and the signal to be given. B. Fix the date and location of the emergency for mock drills. C. Mock drills will be monitored by observers. D. Raise the siren for emergency.

PROCEDURE ON NOTICING AN EMERGENCY

1. If anybody notices any situation, which may lead to a disaster, should be immediately inform the Shift In-charge / site controller / Incident Controller / Fire & Safety Supervisor / Security.

2. Take charge of the situation as Incident Controller. 3. Rush to the site of emergency to get the correct picture and then to Emergency

Control Center for speedy control over the situation by making an arrangement for raising the alarm.

4. On arrival of Team members, he shall assign duties as required and activate the On-Site Emergency Plan.


306



5. Ensure safety of the plant and the personnel in the plant. He will make an

assessment of the emergency and decide on external assistance. 6. Communicate and Coordinate among the Incidents Controller/ Site Controller/

Factory manager/ fire safety supervisor etc. and will be the final authority on all matters related with management of emergency such as:

Fire fighting. Welfare and rescue operations. Arrange for Civil/Mechanical/Electrical work during emergency. Transport.

INCIDENT CONTROLLER / SITE CONTROLLER: Rush immediately to the scene of the fire/emergency, select and set out appropriate fire/emergency equipment. He will take the below mentioned actions at the earliest opportunity, if the fire/emergency is not controlled. He will Call the security personnel from their residences for additional manpower if

required. Regulate entry and exit of personal required for controlling the fire/emergency. Restrict exit of personal required for controlling the fire/emergency. Arrange for Personnel Protective Equipment required for the emergency. Call, the local Fire Brigade, Police in case of necessity in consultation with the

Incident controller. Arrange transport facilities for removal of causalities to dispensary / hospital. Take responsibility of law and order. Keep detailed records of the incident and progress of operations to fight the

emergency. FACTORY MANAGER: He will rush to the Emergency Control Centre and collect the information from the Incident Controller. Further he will,

• Announce the location of the Assembly Point after getting information from Incident Controller / site controller.

• Take the list of persons to be communicated internally and externally. • Maintain liaison with the press, government agencies i.e. Police, Fire Brigade etc.

and the neighbourhood regarding the emergency under instructions from Incident Controller.

• Courteously Receive officers from the State Government or neighbours to the Administration Block only and inform to Incident Controller that they can be taken care off.

• Take all the steps required for the welfare such as providing tea, snacks, emergency temporary Medical Center in consultation with the incident controller/site controller.

• Disclose all the necessary information in the plant and media so as to avoid rumours and Confusion.

• Also be responsible for the head counts at the Assembly Points.


307



FIRE & SAFETY SUPERVISOR/ SHIFT INCHARGE & SECURITY:

o Proceed to the scene; establish contact with firemen and incident controller to supplement efforts in fire fighting.

o Assist in searching casualties and help to remove them to the medical centre. o Organize outside assistance in fire fighting and rescue operations if required. o Mobilize personal protective equipment and safety appliances and assist personnel

handling emergency in using them. o Keep and check on any new development of unsafe situation and report the same

to Site Main Controller. o Collect and preserve evidence to facilitate future inquiries.

o Effectively cordon off the emergency area and will prevent unauthorized people

entering the scene. o Permit the Fire tenders or Ambulance requisitioned by Incident Controller to the

plant. o Ensure that vehicles and trolleys are sent out of the plant premises. o Ensure that all the employees are conducted out of plant and assembled at

Assembly Point. o Control Traffic Movement. o Remove tankers, tanker drivers outside. o Entry of unauthorized public to be prevented. o Arrange for vehicles for shifting casualties and essential workers to safe assembly

points. ENGINEERING/ OPERATION & MAINTENANCE:

o Ensure the safety of the remaining part of the plant. o Take necessary steps for plant shutdown in consultation with the site controller. o Ensure that an Operator is immediately available at the Water Pump House for fire

fighting. o Mobilize with necessary tools and tackles to handle any repair work on an

emergency basis. OFFSITE EMERGENCY PREPAREDNESS PLAN The task of preparing the Offsite Emergency Plan lies with the District Collector; however the offsite plan will be prepared with the help of the local district authorities. The proposed plan will be based on the following guidelines. Introduction

o Offsite emergency plan would follow the onsite emergency plan. When the consequences of an emergency situation go beyond the plant boundaries, it becomes an offsite emergency.

o Offsite emergency is essentially the responsibility of the public administration. However, the plant management will provide the public administration with the technical information relating to the nature, quantum and probable consequences on the neighbouring population.


308



o The offsite plan in detail will be based on those events, which are most likely to

occur, but other less likely events, which have severe consequence, will also be considered. Incidents which have very severe consequences yet have a small probability of occurrence would also be considered during the preparation of the plan.

o However, the key feature of a good offsite emergency plan is flexibility in its

application to emergencies other than those specifically included in the formation of the plan.

o The roles of the various parties who will be involved in the implementation of an

offsite plan are described below. Depending on local arrangements, the responsibility for the offsite plan would either rest with the plant management or with the local authority.

o Either way, the plan would identify an emergency coordinating officer, who would

take the overall command of the offsite activities. As with the onsite plan, an emergency control centre would be setup within which the emergency coordinating officer can operate.

o An early decision will be required in many cases on the advice to be given to

people living o "Within range" of the accident - in particular whether they should be evacuated or

told to go indoors. In the latter case, the decision can regularly be reviewed in the event of an escalation of the incident.

o Consideration of evacuation may include the following factors: In the case of a

major fire. Only houses close to the fire are likely to need evacuation, although a severe smoke hazard may require this to be reviewed periodically; and if a fire is escalating and in turn threatening a store of hazardous material, it might be necessary to evacuate people nearby, but only if there is time; if insufficient time exists, people should be advised to stay indoors and shield them from the fire.

o This later case particularly applies if the installation at risk could produce a fireball

with very severe thermal radiation effects. Aspects Proposed to be considered in the Offsite Emergency Plan The main aspects, which should be included in the emergency plan, are: Organization Detail of command structure, warning systems, and implementation procedures, emergency control centres. Names and appointments of incident controller, site main controller, their deputies and other key personnel.


309



Communications Identification of personnel involved, communication centre, call signs, network, list of telephone numbers. Specialized Knowledge Details of specialist bodies, firms and people upon whom it may be necessary to call e.g. those with specialized fuel knowledge, laboratories Voluntary Organizations Details of organizers, telephone numbers, resources etc Fuel Information Details of the hazardous substances stored and a summary of the risk associated with them. Meteorological Information Arrangements for obtaining details of weather forecasts and weather conditions prevailing at that time Humanitarian Arrangements Transport, evacuation centres, emergency feeding, treatment of injured, first aid, ambulances and temporary mortuaries. Responsibility of the Emergency Co-ordinating Officer The various emergency services would be co-ordinated by an Emergency Coordinating Officer (ECO), who will be designated by the district collector. The ECO would liaison closely with the site main controller. Again depending on local arrangements, for very severe incidents with major or prolonged offsite consequences, the external control would be passed to a senior local authority administrator or even an administrator appointed by the central or state government. The ECO will be equipped with address and phone numbers of important agencies. Responsibility of Police Formal duties of the police during an emergency include protecting life and property and Controlling traffic movements. Their functions should include controlling bystanders, evacuating the public, identifying the dead and dealing with casualties, and informing relatives of death or injury.


310



Responsibility of the Local Authority

The duty to prepare the offsite plan lies with the local authorities. The emergency planning Officer (EPO) appointed should carry out his duty in preparing for a whole range of different emergencies within the local authority area. The EPO should liaison with the plant, to obtain the information to provide the basis for the plan. This liaison should ensure that the plan is continually kept up to date. It will be the responsibility of the EPO to ensure that all those organizations which will be involved offsite in handling the emergency, know of their role and are able to accept it by having for example, sufficient staff and appropriate equipment to cover their particular responsibilities. Rehearsals for offsite plans should be organized by the EPO. Responsibility of Fire Authorities The control of a fire should be normally the responsibility of the senior fire brigade officer who would take over the handling of the fire from the site incident controller on arrival at the site. The senior fire brigade officer should also have a similar responsibility for other events, such as explosions. Fire authorities in the region should be appraised about the location of all stores of flammable materials, water and foam supply points, and fire fighting equipment. They should be involved in onsite emergency rehearsals both as participants and, on occasion, as observers of exercises involving only site personnel. Responsibility of Health Authorities Health authorities, including doctors, surgeons, hospitals, ambulances and so on, should have a vital part to play following a major accident, and they should form an integral part of the emergency plan. For major fires, injuries should be the result of the effects of thermal radiation to a varying degree, and the knowledge and experience to handle this in all but extreme cases may be generally available in most hospitals. Major off site incidents are likely to require medical equipment and facilities additional to Those available locally, and a medical "mutual aid” scheme should exist to enable the Assistance of neighbouring authorities to be obtained in the event of an emergency. Responsibility of Government Safety Authority This will be the factory inspectorate available in the region. Inspectors are likely to satisfy themselves that the organization responsible for producing the offsite plan has made adequate arrangements for handling emergencies of all types including major emergencies. They may wish to see well documented procedures and evidence of exercise undertaken to test the plan. In the event of an accident, local arrangements regarding the role of the factory inspector will apply. These may vary from keeping a watch, to a close involvement in advising on operations.


311



7.4 SOCIAL IMPACT ASSESSMENT

Operational phase of the expansion in existing unit cover the entire life span of the project. The proposed expansion project will generate direct employment for local persons. The indirect employment will also be generated by way of transportation, shopkeepers and other casual employment for many people. Local people will be given training and preference for almost all the jobs in the plant, direct as well as indirect. Economic status of the local people will be improved due to the increased business opportunities, thereby, making a positive impact. Educational, medical and housing facilities in the study area will considerably improve. Thus, the proposed expansion project will have long term-irreversible positive impact on the employment pattern of the study area.


312

Draft Environmental Impact Assessment of

Proposed Manufacturing unit by M/s. Atlas Life Sciences At No.C-1, 360-361, GIDC Estate, Odhav, Ahmedabad

Dist: Ahmedabad, Gujarat.

CHAPTER - 8 PROJECT BENIFITS Due to the proposed project, 10 nos. of local peoples and outside peoples will get employment during the construction phase and l 16 peoples will be employed during the operation phase. Local people will be given preference for almost all the jobs in the Plant, direct as well as indirect. Economic status of the local people will be improved due to the increased business opportunities, thereby, making a positive impact. Educational, medical and housing facilities in the study area will considerably improve. Therefore, social infrastructure of the study area will be improved. The company will also do following developmental activities in the area: The proposed Project does not involve any displacement of villages; however it will lead to development of the region and increase in infrastructure facility. During the operation phases of the project a work force will be needed which will include both skilled and unskilled people. Due to the proposed project direct employment for local employees will be generated. Existing ancillary as well as auxiliary industries would be benefited by way of getting additional work. In addition to direct employment, indirect employment will generate ancillary business to some extent for the local population. Due to the proposed Project, facilities are likely to grow with the development. There is a positive effect due to improved communication and health services, which have lead to economic prosperity, better educational opportunities and access to better health and family welfare facilities. There will be beneficial effect on human settlement due to employment opportunities from the industry. Local quality of life will be improved. This factor combined with all other mitigation measures like proper treatment and disposal of wastewater, hazardous waste and gaseous emission has minimized the adverse impact on ecology and had a beneficial impact on human settlement and employment opportunities. There has been a beneficial impact on the local socio-economic environment. The increasing industrial activity will boost the commercial and economical status of the locality up to some extent.


313




CHAPTER 9 SUMMARY OF ENV. IMPACTS & CONCLUSION The environmental impacts of projects or actions generally encompass a broad range of impact from Air and Noise pollution to affect on employment and neighborhood as well as on social structure. All of these impacts vary in magnitude as well as in their beneficial or adverse classification. As a result, a natural question arises as to what is the “collective” or “overall” environmental impact of the project or action taken. Is the project beneficial or is it adverse? To answer such a question requires a comparison of these impacts and to some extent subjective evaluation of those impacts which are more important than others. Environment Impact Assessment as detailed in previous chapter can now be concise to impact statement given below.

9.1 AIR ENVIRONMENT

Meteorological data collected during the study period confirms that climatic Status of the study area is consistent with the regional meteorology. Average concentration of ambient air quality parameters such as PM10, PM 2.5, SO2 and NOx in the surrounding study area are well within the permissible limits as prescribed in the National Ambient Air Quality (NAAQ) Standards for respective residential rural areas and industrial areas. Evaluated GLCs due to the proposed air pollution load in existing AAQ. When added to the monitored existing ambient air quality, provides the expected ambient air quality when the proposed fuel qty will be added in propsoed utility and the same indicates that expected AAQ are well within the permissible limit of National Ambient Air Quality Standards for residential rural areas as well as industrial areas. It is concluded from the above that there will be a minor impact on the AAQ of the surrounding environment due to operation of the proposed project.


M/s. Atlas life Sciences is a proposed unit and the source of water for proposed activity will be by GIDC Estate. The quality of the water was tested at eight locations in the study area. The ground water norms were compared to IS: 10500 (1991) for evaluation. The Industry generates industrial effluent apart from washing, Cooling Tower blow down, Boiler Blow down, Dm rejected and domestic effluent.


314




Wastewater Generation & Disposal:

• Domestic water consumption will be around 6 KLPD and sewage generated will be disposed to soak pit via septic tank @ 5 KLPD.



Thus, it can be concluded that negligible impact on surrounding water environment is caused. Further, it is emphasized that all precautionary measures have to be strictly adhered as mentioned in the Environmental Management Plan given in Chapter 6, to maintain ground water quality within norms in the future.

9.3 NOISE ENVIRONMENT

Base line data indicates that noise levels in the study area are not on higher sides. Noise level in and around plant site were measured. Measured noise levels within premises indicate that overall noise levels are within the Damage Risk Criteria. The company will provide ear-protecting devices/ earplugs for working personnel exposed to high noise level. It can be concluded that there will be no impact on the noise level of the surrounding environment.

9.4 HAZARDOUS WASTES

As per the Hazardous Waste (Management & Handling) Amendment Rules, 2003, all necessary control steps for each type of Hazardous Wastes generated from the proposed project will be taken. Therefore, no impact of hazardous wastes generation on surrounding soil environment is anticipated.

9.5 ECOLOGY

The proposed project will be carried out on land within their premises without cutting of any trees. Also, the project site is located in non-agricultural land devoid of any permanent eco-system. So it does not alter the crop pattern and natural vegetation of the surrounding area. Due to the safe control technology of air pollutants, liquid effluents and solid/hazardous wastes disposal, no impact on the surrounding ecology is anticipated.


315




9.6 SOCIO - ECONOMIC ENVIRONMENT

The proposed project will generate direct employment for employment persons. The indirect employment will be generated by way of transportation, shopkeepers and other casual employment. Implementation of this plant will also reduce production loss due to shortage of power. Thus, the proposed project will have significant positive impacts on the employment pattern of the study area.

9.7 CONCLUSION

As such the Environmental Impact Statement recommends the implementation of the proposed project with the proposed environmental protection measures.


316




CHAPTER 10 ENVIRONMENTAL CONSULTANTS PROFILE

We are one of the leading Environmental Consultant based at Ahmedabad, Gujarat. India. The group of companies have successfully completed more than 1200 projects in the field of pollution control i.e. Design, Installation and commissioning of wastewater treatment plants and air pollution control equipments, during last 20 years. We are also dealing in the projects of waste minimization and cleaner production technology. We are having a strong team of Technocrats and Scientists. We have well equipped analytical laboratory facility including facilities to analyze physical, chemical and biological parameters as per the requirements of the State Pollution Control Board and our clients. Our team of technocrats and scientists are well experienced to deal with the Design, Installation and Commissioning of wastewater treatment plants and air pollution control equipments and also well conversant to the projects of Waste Minimization and Cleaner Production Technology. We, BHAGWATI ENVIRO CARE PVT. LTD, are a registered with Gujarat Pollution Control Board, Gandhinagar as an ENVIRONMENTAL CONSULTANT. We are also registered with Himachal Pradesh Pollution Control Board, Simala as an ENVIRONMENTAL CONSULTANT.

10.1. INTRODUCTION

THE COMPANY BHAGWATI ENVIRO CARE PVT. LTD.

Corporate Office: - 28,29,30, Parmeshwar Estate II, Opp. AMCO Bank, Phase I, G.I.D.C. Estate, Vatva, Ahmedabad - 382445, Gujarat, India. Mobile No.: +91 98240 51541 Telephone No. : +91 79 40083051,40083052, 25834567, Fax No : +91 79 40083053 URL : www.bhagwatienviro.com Email : [email protected] [email protected]


317





a) Field Studies and Surveys Assessment of Pollution Load. Guidance to get water consent, Air consent and Solid Waste Authorization. O & M contracts for ETP, STP and CETP. Collection of Samples at site for the characterization of waste.

b) Project Execution Execution of construction work of ETP as per design. Manufacturing of mechanical equipments like Agitators, Aerators, Clarifiers, etc. Manufacturing of filtration equipments like Carbon Filter, Sand Filter, Dual Media Filter etc. Manufacturing of other equipments like Oil Skimmer, dosing tanks etc. Design and Fabrication of Air Pollution Control Equipments like HDPE & FRP Packed column, Water / Alkali scrubber, Dust Collectors, Cyclone Separators, Multi cyclone etc. Erection and commissioning of all the above-mentioned equipments/system.

c) Commissioning Services

Commissioning of Primary /Secondary/Tertiary Effluent Treatment Plants and Sewage Treatment Plant.

d) Up Gradation / Modification of existing Effluent Treatment Plant

After careful study of the existing effluent treatment plant if required we suggest suitable addition/up gradation/modification in existing Effluent Treatment Plant so as to meet with the standards as specified by the state pollution control board as per the mode of disposal.

e) Consultation work with State Pollution Control Board

Preparation of application form to get NOC for Establishment and NOC

for Operation of the state pollution control board for Air Consent, Water Consent and Solid waste authorization with all the required technical details And documents.

Providing technical guidance to the clients to do the technical correspondence and also consulting work with state pollution control board.

10.2. EXPERTISE IN


318




a) Analysis of water and waste water Analysis of various parameters like pH, Hardness, Sulphate, Chloride,

COD, BOD, TDS, TSS, O&G, Ammonical Nitrogen and other specific parameters as per the requirement of clients.

b) Analysis of Air Emissions

c) Analytical and Laboratory services

Specialized in measurement of flow. Collection of sample to check the concentration of pollutants like SPM

and other gaseous pollutants like SO2, NOx, HCl, Cl2, Co, H2S, Hydrocarbons, NH3, from the process and flue gas stacks.

Ambient Air quality monitoring to determine the concentration of RSPM, SPM and other gaseous pollutants like SO2, NOx, HCl, Cl2, Co, H2S, in the Environment.

d) Analysis of Solid / Hazardous waste

Analysis of various parameters and other specific parameters as per

the requirement of clients.

e) Noise Monitoring We are having a Digital Noise Meter to measure the noise level at a

particular location to check the intensity of noise in db.

Physico – Chemical Treatment

Biological Treatment

Tertiary / Advanced Treatment

10.3 LABORATORY FACILITY

10.4. TREATABILITY STUDIES


319




SR. NO. NAME

QULIFICATION EXPERIENCE DESIGNATION

1. Mr. Shailesh Patel M.Sc. Chemistry 20 years Managing Director

2. Mr. Amar Mehta Management 15 years Director

3. Dr. Upendra Patel Ph.D in Environment Engg.

18 Years Technical Director

4. Dr. Bharat D Jethava Ph. D in Forest Ecology & Env.

16 years Empanelled FAEs

5. Mr. Jayendrasinh Parmar B.E. Chemical & Chartered Engineer

15 years Chemical Engineer & Chartered Engineer

6. Mr. Maheshbhai Oza M.Sc. Chemistry 20 years H.O.D. Lab

7. Mr. Rajesh Chauhan M.Sc. Chemistry 20 years Lab Incharge

8. Mr. Nilesh V. Patel B.Sc. Chemistry 16 years Chief Environment Chemist

9. Mr. Gopalbhai M Kathiria M.Sc. Chemistry Dip.In Environment

20 Years Env. Chemist

10. Mr. Prashnnjeet Solanki B.E. Chemical 2 Years Chemical Engineer

11. Miss. Taral Dhanani MSc. Env.Science 3 Years Env. Chemist

12. Mr. Rohan Goswami B.E Environment 5 Years Environmental Engg.

13. Mr. Vijay Gondaliya B.E Environment 3 Years Environmental Engg.

14. Miss Mansi Patel B.Sc. Chemistry 3 Year Lab Chemist

15. Mr. Vamanray Mehta Dip. Mech & Electrical

35 Years Mechanical / Electrical Engg.

16. Mr. Himanshu Patel Structure Engineer 8 Years Civil Engineer

17. Mr. Vijay Rajput B.Com. 20 Years Site Supervisor 18. Mr. Bhaumik Patel B.Com 3 Year Site Supervisor 19. Mr. Paresh Patel Metric 2 Year Assistant for laboratory 20. Mr. Dipak Patel Metric 3 Year Assistant for laboratory 21. Mr. Rashmikant Khamar M.Com LLB 20 Years HRD Manager 22. Mr. Ishwarbhai Prajapati B.Com. 20 Years Sr. Accountant

23. Mr. Chetan Chauhan B.Com 1 year Accountant

24. Mr. Ramesh Goswami B.Com 4 Year Clerical Work

10.5 OUR TEAM OF HIGHLY QUALIFIED TECHNOCRAT & SCIENTISTS


320




Sr. No. Name of the Client Address 01. Tata Motors Ltd (Nano Project) Sanand, Gujarat. 02. Sheela Woodbridge Pvt Ltd. Sanand, Gujarat 03. ONGC, Ankleshwar & Mehsana Asset Ankleshwar & Mehsana 04. Camphor & Allied products Limited Nandesari, Baroda 05. Common Effluent treatment plant (CETP) GIDC, Kalol, N.G. 06. Common Effluent treatment plant (CETP) GIDC, Odhav. 07. Panoli Enviro technology Limited Panoli 08. Sterling Auxiliaries Pvt ltd. Dahej

09. Paras Pharmaceutical Limited Kalol (Gujarat) & Baddi 10. Timber Association Gandhidham Gandhidham, Kutch 11. Ashapura Group of Industries Gandhidham , Kutch 12. Banas Oil Processing Plant Palanpur 13. Matangi Industries GIDC, Vatva, Ahmedabad 14. Alembic Glass Limited Vadodara 15. Banaskantha Dist. Co -Op. Milk Producers Union Ltd. Banaskantha 16. Schutz Carbon Electrodes Pvt. Ltd. Kalol, Dist: Mehasana 17. Galaxy Group of Industries (Reputed Construction

Company) Ahmedabad

18. Halewood Laboratory (Unit of Rasna) Vatva GIDC, A’bad 19. Maheshwari Paper Mills Limited Palanpur 20. Kemrij Paper industries Palanpur 21. Amee Castor & Derivatives Pvt. Ltd. Palanpur 22. Star Clay Tech Pvt. Ltd. Mandvi, Kutch 23. Daywell Pharmaceuticals Pvt. Ltd. Chhatral, Dist: Mehasana 24. Mahalaxmi Industries Chhatral, Dist: Mehasana 25. SBF Pharma Pvt. Ltd., Santej, Dist: Mehasana 26. Charbhuja Metals Pvt. Ltd. Chhatral, Dist: Mehasana 27. Cupro Recycling Pvt Ltd. (EOU) Sachin GIDC, Surat 28. Manglam Alloys Limited Chhatral 29. Unision Metal Limited Ahmedabad 30. Duggad Aluminum Pvt. Ltd. Talod, Dist: Sabarkantha 31. S. Kumar Aluminium Industries Talod, Dist: Sabarkantha 32. Jeshree Metals Industries Talod, Dist: Sabarkantha 33. Rajkumar Metals Industries Talod, Dist: Sabarkantha 34. Maheshwari Steel Rolling Mills Vijapur 35. Gujarat Krushi Rasayan Ltd. Naroda GIDC, A’ bad 36. Maheshwari Paper Ltd. Palanpur, Gujarat 37. Samir Synthetics Ltd. Odhav, GIDC, A’ bad 38. Neptune Textile Mills Ltd. Odhav, GIDC, A’ bad 39. Dharmentdra Textile Ltd. Narol, A’bad 40. Murlidhar Textile Industries Narol, A’bad 41. View Laboratory Vatva GIDC, A’ bad 42. Suchem Laboratory Vatva GIDC, A’ bad 43. Apex Dyestuff Industries Vatva GIDC, A’bad 44. Denim Industries Vatva GIDC, A’bad 45. Varahi Industries Vatva GIDC, A’bad

10.6 LIST OF VALUABLE CLIENTS IN GUJARAT


321




46. Nilkanth Organics Ltd. Ankleshwer, Dist: Bharuch 47. Surya Organics Pvt. Ltd. Ankleshwer, Dist: Bharuch 48. Avni Dye Chem Industries Vatva GIDC, A’bad 49. BLG Electronics Ltd. Gandhinagar 50. Raja Industries Limited Kadi, Dist: Mehsana 51. Atlas Pharma Chem Pvt. Ltd. GIDC, Vatva, A’Bad 52. Nikishu Fab. Pvt Ltd. Ahmedabad 53. Maheshwari Global Ind. Palanpur 54. Vaishnodevi Refoils & Solvex Ltd. GIDC, Chandisar, Palanpur 55 Shakti Refoils Pvt. Ltd/. Himmatnagar 56. Pooja Protein Limited Nandasan, Dist: Mehsana 54. Changodar Metal P. Ltd Changodar 55. Harambha Steel P. Ltd Visnagar 56. Nahar Granites P. Ltd Kalol 57. PTC India P. Ltd Chhatral 58. Cupro Recycling P. Ltd Surat 59. Hindustan Impex Jamnagar 60. Sabar Dairy Himmatnagar, Gujarat 61. Banas Dairy Palanpur 62. Madhur Dairy Gandhinagar 63. Dudhsagar dairy Mehsana 64. Kapoor Dairy Visnagar 65. Sanjay Milk Products Gozaria

* We are dealing with more than 1000 Companies in the field of Environment in Gujarat state.


322




Sr. No.

Name of The Client Address Services Provided

1. Paras Pharmaceuticals Ltd. (Mfg. of Moov, Borosoft, Itch Guard and Pharma Product)

Vill: - Sandholi, Teh: - Nalagar

Design, Construction, erection& commissioning of ETP, Preparation of Application for approval of NOC to Established & NOC to Operation.

2. Cachet Pharmaceuticals Ltd. Vill: - Thana Baddi Nalagarh

Road,

Design, erection & commissioning of ETP, Internal pipeline of HDPE

3. Zeiss Pharmaceuticals Ltd. 72,Jharmajri, Baddi Design, Construction, erection& commissioning of ETP, Internal pipeline of HDPE

4. H.R.Personal Care Pvt.Ltd (A company of Olima Cosmetics)

Vill: - Malpur, Teh: - Nalagar

Design, erection & commissioning of ETP, Internal pipeline of HDPE

5. Asian Aerosol India Ltd. (Mfg.of Premium Room Freshener, Deodorant)

Vill: - Kisanpura, Teh: - Nalagarh

Design, & commissioning of ETP, Preparation of Application for approval of NOC to Established & NOC to Operation.

6. Acme Remedies (Mfg of Sugar Free medicines)

HPSIDC, Baddi Design of ETP & Carbon filter as a part of ETP

7. Acme Formulation Pvt. Ltd(Pharma Formulation) Nalagarh

Design of ETP erection & commissioning

8. S.K. Industries. (A Mahak Group Company)

P.No.10, Sector-II, Parwanoo

Design of ETP with internal pipeline of HDPE & Instillation of Evaporator.

9. Shri Nivas Laboratory

Sai Road, Baddi Design of ETP, erection & commissioning of ETP, Mech. Equipment, Internal pipeline of HDPE

10. GMH Laboratory Baddi-Nalagarh Road, Nalagarh.

Design of ETP, erection & commissioning of ETP, Mech. Equipment, Internal pipeline of HDPE

11 Cosmos Pharmacals Baddi. Design of Modular ETP, erection & commissioning of ETP, Mech. Equipment, Internal pipeline of HDPE

12 Rachet Pharmaceuticals Ltd Baddi-Nalagarh Road, Nalagarh.

Design of ETP, erection & commissioning of ETP, Mech. Equipment, Internal pipeline of HDPE

10.7 LIST OF VALUABLE CLIENTS IN HIMACHALPRADESH


323




SR.NO. NAME OF INDUSTRY LOCATION CAPACITY IN MT/M 1. Ashapura Volclay Limited

(Ashapura group) Gandhidham 3850

2. Gujarat Ambuja Export Ltd. Himmatnagar 6106 3. Matangi Industries Dahej 3000 4. Ishan Dyes & Chemicals Ltd. Vatva, Ahmedabad 5. Aries Colour Chem Pvt. Ltd Dahej 1950 6. Neel Pigment Pvt.Ltd. Ankleshwar 350 7. Karnavati Chemicals Ankleshwar 350 8. Dhruv Intermediates Pvt.Ltd. Jaghdia 50 9. Samip Chemicals Ankleshwar 50 10. Arunachal Chemicals Sachin, Surat 150 11. Gopinath Chem Tech Pvt.Ltd. Chhatral 600 12. Bhagwati Organics Pvt.Ltd. Vatva, Ahmedabad 45 13. Printex Industries Vatva, Ahmedabad 45 14. Vidhi Industries Vatva, Ahmedabad 40 15. Vibfast Pigments Pvt.Ltd. Vatva, Ahmedabad 45 16. Bhagwati Dyes & Chemicals Vatva, Ahmedabad 30 17. Bhavin Industries Vatva, Ahmedabad 45 18. S.M.Dye Chem Vatva, Ahmedabad 25 19. Tulsi Intermediates Pvt.Ltd. Khambhat 30 20. S, V. Dye Chem Pvt.Ltd. Khambhat 30 21. Patel Industries Vatva, Ahmedabad 500 22. Yashka Polymers Pvt.Ltd. Moraiya, Ahmedabad 600 23. Vardhman Chemicals Vatva, Ahmedabad 500 24. Shri Hari dyes & Chemicals Vatva, Ahmedabad 50 25. Mahak Dye Chem Industries Vatva, Ahmedabad 50 26. Arihant Chemical Pvt.Ltd. Vatva, Ahmedabad 25 27. Bansari Industries Vatva, Ahmedabad 50 28. Gayatri Dye Stuff Vatva, Ahmedabad 50 29. Arbuda Industries Vatva, Ahmedabad 50 30. Nepa Overseas Vatva, Ahmedabad 50 31. Appex Dyestuff Vatva, Ahmedabad 60 32. Aadi Cement Idar 1.0 Lakh TPA 33. Lion Cement Ranasan 18,000 TPA 34. Kangaroo Industry (Unit - 1) Ankleshwar 60 35. Kangaroo Industry (Unit - 2) Ankleshwar 60 36. Chhatariya Dyestuff Pvt.Ltd. Mahuva 30 37. Manish Chemical Vatva 500 38. Ishan Dyes & Chemicals Ltd. Vatva 250 39. Ushanti Colorchem Pvt.Ltd Vatva 100 40. Sulpho Chem Ind. Vatva, Ahmedabad 50 41. Appex Engg. & Consultants

(Construction Company) Ahmedabad More than 20000

M2 Built up Area 42. Galaxy Group of Industries

(Construction Company) Ahmedabad More than 20000

M2 Built up Area 43. Cedar Décor Pvt. Ltd (Resin

Plant) Kadi Road, Kadi 800

44. A. k. Formaline Pvt. Ltd. Gandhidham 1000 45. Vallora Plyboard Gandhidham 500 46. Super crop Safe Ltd. – Bilodra, Dist - Mehsana 500 47. Kundan Pesticides Pvt Ltd. Ahmedabad 700

10.8 EC APPLICATION APPLIED BY M/S. BHAGWATI ENVIROCARE PVT.LTD. AFTER EFFECTIVE NOTIFICATION DATED 14/09/2006


324




** Many Project under process

SR.NO. NAME OF INDUSTRY LOCATION

01 M/s .Torrent Research Center Limited Bhat, Gandhinagar

02 M/s. Gujarat Spices & oilseeds Growers Co

– Op. Union Ltd (Vimal Oil)

Gandhidham, Dist – Kutch.

03 M/s. Dharmendra Textile Processors Narol, Ahmedabad

04 M/s. Madhur Dairy Gandhinagar

05 M/s. Laakoonaa Reactions Vatva, Ahmedabad.

06 M/s. Dye-Fab Textiles Vatva, Ahmedabad.

07 M/s. Atul Corporation Pvt. Ltd. Bavla, Dist – Ahmedabad.

08 M/s. Unison Metals Ltd. Vatva, Ahmedabad.

09 M/s. Ishan Dyes & Chemicals Ltd Vatva, Ahmedabad

10 M/s. Manglam Alloys Ltd. Chhatral, Dist: Gandhinagar.

11 M/s. Gopinath Chem Tech Ltd. Kundal, Ta. Kadi, Dist: Mehsana

12 M/s. Vasudev Dye Chem Kalol, Dist - Gandhinagar.

13 M/s. Larson Color Chem Modasa, Dist – Sabarkantha.

14 M/s. Murlidhar Textile Narol, Ahmedabad

15 M/s. Blue Star Industries GIDC, Kalol

16 M/s. Shakti Intermediate Pvt. Ltd. Sanand

17 M/s. Ashapura Volclay Ltd. Gandhidham

18 M/s. Ikon Orgo Chem Kadi

19 ONGC, Ankleshwar Asset 29 Unit, Ankleshwar

20 ONGC, Mehsana Asset 7 Unit, Ankleshwar

21 Camphor & Allied products Limited Nandesari

22 M/s. Aries Color chem Pvt. Ltd. Dahej

10.9 SCHEDULE - II ENVIRONMENTAL AUDIT CARRIED OUT BY M/S. BHAGWATI ENVIROCARE PVT.LTD.


325

Annexure: 02

National Ambient Air Quality Standards

Annexure 2 of M/s. Atlas Life Sciences 402

Annexure: 02

National Ambient Air Quality Standards


Annexure: 03

Drinking Water Quality Standards DRINKING WATER QUALITY STANDARDS AS PER IS NO. 10500 (1991)

Substance or characteristics Permissible Limit Colour Hazen units 25 Odour Unobjectionable Taste Agreeable Turbidity NTU, Maximum 10 PH 6.5-8.5 Total Hardness (as CaCO3) mg/l 600 Iron (as Fe) mg/l 1 Chlorides (as Cl) mg/l 1000 Residual Free Chlorine, mg/l 0.2 Dissolved Solids, mg/l 2000 Calcium (as Ca) mg/l 200 Magnesium (as Mg), mg/l 100 Copper (as Cu), mg/l 1.5 Manganese (as Mn), mg/l 0.3 Sulphate (as SO4), mg/l 400 Nitrate (as NO2 mg/l) 100 Fluoride (as F), mg/l 1.5 Phenolic Compound, mg/l 0.002 Mercury, mg/l 0.001 Cadmium, mg/l 0.01 Selenium, mg/l 0.01 Arsenic, mg/l 0.05 Cyanide, mg/l 0.05 Lead, mg/l 0.05 Zinc, mg/l 5 Anionic detergent, mg/l 0.2 Chromium (as Cr+6), mg/l 0.05 Polynuclear Aromatic Hydrocarbons, mg/l -- Mineral Oil, mg/l 0.03 Pesticides, mg/l 0.001 Radioactive materials 1 Alpha emitters Bq/l 2. Beta emitters Bq/l

0.1 1

Alkalinity, mg/l 600 Aluminum, mg/l 0.2 Boron , , mg/l 5


Annexure: 04

National Ambient Noise Quality standards

NATIONAL AMBIENT NOISE QUALITY STANDARDS (CENTRAL POLLUTION CONTROL BOARD, INDIA)

Area code Category of areas Leq in db(A) Day time Night Time

A Industrial Area 75 70 B Commercial Area 65 55 C Residential Area 55 45 D Silence zone 50 40

Note:

1) Daytime is reckoned in between 6 am and 10 pm

2) Night time is reckoned in between 10 pm and 6 am

3) Silence zone is defined as areas upto 100 meters around such premises

as hospitals, educational institutes and courts. The silence zones are to

be declared by the competent authority.

4) Mixed categories of areas should be declared as one of the four

above mentioned categories by the competent authority and the

corresponding standards shall apply.


Annexure: 05

Land Supporting Document


Annexure: 05



Annexure: 06

Undertaking of Atlas Life Sciences


Annexure: 07

Undertaking of BECPL

Annexure 07 of Atlas Life Sciences 411

p. 1

1 2 0

He a lt h

Fire

Re a c t iv it y

Pe rs o n a lPro t e c t io n

2

1

0

E

Material Safety Data SheetPhenylephrine hydrochloride MSDS

Section 1: Chemical Product and Company Identification

Product Name: Phenylephrine hydrochloride

Catalog Codes: SLP4207

CAS#: 61-76-7

RTECS: DO7525000

TSCA: TSCA 8(b) inventory: Phenylephrine hydrochloride

CI#: Not available.

Synonym: (R)-3-Hydroxy-alpha-[(methylamino)methyl]benzenemethanol hydrochloride

Chemical Name: Phenylephrine Hydrochloride

Chemical Formula: C9-H13-N-O2.HCl orHOC6H4CH(OH)CH2NHCH3.HC1

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Phenylephrine hydrochloride 61-76-7 100

Toxicological Data on Ingredients: Phenylephrine hydrochloride: ORAL (LD50): Acute: 350 mg/kg [Rat]. 120 mg/kg [Mouse].

Section 3: Hazards Identification

Potential Acute Health Effects: Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Classified 4 (No evidence.) by NTP. MUTAGENIC EFFECTS: Mutagenic for mammalian somaticcells. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female[POSSIBLE]. Repeated or prolonged exposure is not known to aggravate medical condition.

Section 4: First Aid Measures

Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Cold water may be used. Get medical attention.

412

http://www.sciencelab.com/

p. 2

Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Cold water may be used.Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medicalattention.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medicalattention.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention.

Serious Inhalation: Not available.

Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar,tie, belt or waistband.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: May be combustible at high temperature.

Auto-Ignition Temperature: Not available.

Flash Points: Not available.

Flammable Limits: Not available.

Products of Combustion: These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...).

Fire Hazards in Presence of Various Substances:Slightly flammable to flammable in presence of heat. Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available.

Fire Fighting Media and Instructions:SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray, fog or foam. Do not use water jet.

Special Remarks on Fire Hazards: Not available.

Special Remarks on Explosion Hazards: Not available.

Section 6: Accidental Release Measures

Small Spill:Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water onthe contaminated surface and dispose of according to local and regional authority requirements.

Large Spill:Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on thecontaminated surface and allow to evacuate through the sanitary system.

Section 7: Handling and Storage

Precautions:

413

p. 3

Keep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporatethe residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. Wear suitableprotective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical adviceimmediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such asoxidizing agents, acids.

Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area. Do not store above 25°C (77°F).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommendedexposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminantsbelow the exposure limit.

Personal Protection:Splash goggles. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits: Not available.

Section 9: Physical and Chemical Properties

Physical state and appearance: Solid. (Powdered solid.)

Odor: Odorless.

Taste: Bitter.

Molecular Weight: 203.67 g/mole

Color: White.

pH (1% soln/water): Not available.

Boiling Point: Not available.

Melting Point: 143°C (289.4°F)

Critical Temperature: Not available.

Specific Gravity: Not available.

Vapor Pressure: Not applicable.

Vapor Density: Not available.

Volatility: Not available.

Odor Threshold: Not available.

Water/Oil Dist. Coeff.: Not available.

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water.

Solubility: Easily soluble in cold water, hot water.

Section 10: Stability and Reactivity Data

414

p. 4

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Excess heat, incompatible materials.

Incompatibility with various substances: Reactive with oxidizing agents, acids.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity: Also incompatible with acid chloride, and acid anhydrides.

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Inhalation. Ingestion.

Toxicity to Animals: Acute oral toxicity (LD50): 120 mg/kg [Mouse].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: Classified 4 (No evidence.) by NTP. MUTAGENIC EFFECTS: Mutagenic for mammalian somaticcells. DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female [POSSIBLE].

Other Toxic Effects on Humans: Hazardous in case of skin contact (irritant), of ingestion, of inhalation.

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans:May affect genetic material. May cause adverse reproductive effects (maternal effects(parturition) and fetotoxicity) based onanimal data. No human data found.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin and Eyes: May cause eye and skin irritaiton. May cause dilation of the pupils (mydriasis)Inhalation: May cause respiratory tract irritation. Ingestion: Harmful if swallowed. May cause gastrointestinal tract irritationwith nausea, vomiting and diarrhea. It may also affect the endocrine system, cardiovascular system(rapid, irregular poundingheart beat), respiration (dyspnea), and the brain. May affect behavior/central nervous system and cause convulsions,muscle weakness, somnolence, dizziness, nervousness, trembling, headache, increased sweating. Moderately toxic in highconcentrations.

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

415

p. 5

DOT Classification: Not a DOT controlled material (United States).

Identification: Not applicable.

Special Provisions for Transport: Not applicable.

Section 15: Other Regulatory Information

Federal and State Regulations: TSCA 8(b) inventory: Phenylephrine hydrochloride

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada): Not controlled under WHMIS (Canada).

DSCL (EEC):R22- Harmful if swallowed. R36/38- Irritating to eyes and skin. R40- Possible risks of irreversible effects. R62- Possiblerisk of impaired fertility. S2- Keep out of the reach of children. S36/37- Wear suitable protective clothing and gloves. S46- Ifswallowed, seek medical advice immediately and show this container or label.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 1

Reactivity: 0

Personal Protection: E

National Fire Protection Association (U.S.A.):

Health: 2

Flammability: 1

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Splash goggles.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/10/2005 11:21 AM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

416

Click http://www.guidechem.com/cas-148/148553-50-8.html for suppliers of this product

Pregabalin (cas 148553-50-8) MSDS

1.1.1

IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKINGProduct identifiersProduct name

Product NumberBrandCAS-No.

:

:::

pregabalinPZ0010Anonymous148553-50-8

1.2 Relevant identified uses of the substance or mixture and uses advised againstIdentified uses : Laboratory chemicals, Manufacture of substances

2.2.1

2.2

HAZARDS IDENTIFICATIONClassification of the substance or mixtureClassification according to Regulation (EC) No 1272/2008 [EU-GHS/CLP]Serious eye damage (Category 1)Reproductive toxicity (Category 2)

Classification according to EU Directives 67/548/EEC or 1999/45/ECHarmful: danger of serious damage to health by prolonged exposure if swallowed. Possible risk of harm tothe unborn child.

Label elementsLabelling according Regulation (EC) No 1272/2008 [CLP]Pictogram

Signal word

Hazard statement(s)H318H361

Precautionary statement(s)P280P305 + P351 + P338

Supplemental Hazard

Danger

Causes serious eye damage.Suspected of damaging fertility or the unborn child.

Wear protective gloves/ eye protection/ face protection.IF IN EYES: Rinse cautiously with water for several minutes. Removecontact lenses, if present and easy to do. Continue rinsing.

none

Statements

According to European Directive 67/548/EEC as amended.Hazard symbol(s)

R-phrase(s)R48/22

R63

S-phrase(s)S22S36/37

Harmful: danger of serious damage to health by prolonged exposure ifswallowed.Possible risk of harm to the unborn child.

Do not breathe dust.Wear suitable protective clothing and gloves.

2.3

3.3.1

Other hazards - none

COMPOSITION/INFORMATION ON INGREDIENTSSubstancesSynonyms

FormulaMolecular Weight

:

::

LyricaS)-3-(Aminomethyl)-5-methylhexanoic acidCI-1008PD-144723

C8H17NO2159,23 g/mol

417

http://www.guidechem.com

http://www.guidechem.com/cas-148/148553-50-8.html

Component

PregabalinConcentration

CAS-No. 148553-50-8 -

4.4.1

4.2

4.3

5.5.1

FIRST AID MEASURESDescription of first aid measuresGeneral adviceConsult a physician. Show this safety data sheet to the doctor in attendance.

If inhaledIf breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.

In case of skin contactWash off with soap and plenty of water. Consult a physician.

In case of eye contactRinse thoroughly with plenty of water for at least 15 minutes and consult a physician.

If swallowedNever give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.

Most important symptoms and effects, both acute and delayedTo the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughlyinvestigated.

Indication of any immediate medical attention and special treatment neededno data available

FIRE-FIGHTING MEASURESExtinguishing mediaSuitable extinguishing mediaUse water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

5.2

5.3

5.4

6.6.1

6.2

6.3

6.4

7.7.1

7.2

7.3

8.8.1

8.2

Special hazards arising from the substance or mixtureCarbon oxides, nitrogen oxides (NOx)

Advice for firefightersWear self contained breathing apparatus for fire fighting if necessary.

Further informationno data available

ACCIDENTAL RELEASE MEASURESPersonal precautions, protective equipment and emergency proceduresUse personal protective equipment. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensureadequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust.

Environmental precautionsPrevent further leakage or spillage if safe to do so. Do not let product enter drains.

Methods and materials for containment and cleaning upPick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closedcontainers for disposal.

Reference to other sectionsFor disposal see section 13.

HANDLING AND STORAGEPrecautions for safe handlingAvoid contact with skin and eyes. Avoid formation of dust and aerosols.Provide appropriate exhaust ventilation at places where dust is formed.Normal measures for preventive fireprotection.

Conditions for safe storage, including any incompatibilitiesStore in cool place. Keep container tightly closed in a dry and well-ventilated place.

Specific end usesno data available

EXPOSURE CONTROLS/PERSONAL PROTECTIONControl parametersComponents with workplace control parametersExposure controlsAppropriate engineering controls

418

Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and atthe end of workday.

Personal protective equipmentEye/face protectionFace shield and safety glasses Use equipment for eye protection tested and approved underappropriate government standards such as NIOSH (US) or EN 166(EU).

Skin protectionHandle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique(without touching glove's outer surface) to avoid skin contact with this product. Dispose ofcontaminated gloves after use in accordance with applicable laws and good laboratory practices.Wash and dry hands.

The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and thestandard EN 374 derived from it.

Body ProtectionComplete suit protecting against chemicals, The type of protective equipment must be selectedaccording to the concentration and amount of the dangerous substance at the specific workplace.

Respiratory protectionWhere risk assessment shows air-purifying respirators are appropriate use a full-face particlerespirator type N100 (US) or type P3 (EN 143) respirator cartridges as a backup to engineeringcontrols. If the respirator is the sole means of protection, use a full-face supplied air respirator. Userespirators and components tested and approved under appropriate government standards such asNIOSH (US) or CEN (EU).

9.9.1

PHYSICAL AND CHEMICAL PROPERTIESInformation on basic physical and chemical propertiesa)

b)c)

d)

e)

f)

g)

h)

Appearance

OdourOdour Threshold

pH

Melting point/freezingpoint

Initial boiling point andboiling range

Flash point

Evaporation rate

Form: solidColour: off-white, white

no data availableno data available

6,22 - 6,88

190 °C

no data available

no data available

no data availablei) Flammability (solid, gas) no data available

j)

k)

l)

Upper/lowerflammability orexplosive limits

Vapour pressure

Vapour density

no data available

no data available

no data available

m) Relative density no data availablen)

o)

p)

q)

r)

s)t)

Water solubility

Partition coefficient: n-octanol/water

Autoignitiontemperature

Decompositiontemperature

Viscosity

Explosive propertiesOxidizing properties

no data available

log Pow: -1,35

no data available

no data available

no data available

no data availableno data available

9.2

10.10.1

10.2

Other safety informationno data available

STABILITY AND REACTIVITYReactivityno data available

Chemical stability419

10.3no data available

Possibility of hazardous reactionsno data available

10.4

10.5

10.6

11.11.1

Conditions to avoidno data available

Incompatible materialsno data available

Hazardous decomposition productsOther decomposition products - no data available

TOXICOLOGICAL INFORMATIONInformation on toxicological effectsAcute toxicityTDLo Oral - rat - 63 mg/kgRemarks: Behavioral:Analgesia.

TDLo Oral - rat - 3 mg/kg

TDLo Oral - rat - 10 mg/kgRemarks: Behavioral:Altered sleep time (including change in righting reflex).

LD50 Oral - mouse - > 5.050 mg/kg

TDLo Intraperitoneal - rat - 100 mg/kgRemarks: Behavioral:Analgesia.

TDLo Subcutaneous - rat - 60 mg/kg

Remarks: Behavioral:Analgesia.

Skin corrosion/irritationSerious eye damage/eye irritationSevere eye irritation

Respiratory or skin sensitizationGerm cell mutagenicityno data available

CarcinogenicityIARC: No component of this product present at levels greater than or equal to 0.1% is identified as

probable, possible or confirmed human carcinogen by IARC.

Reproductive toxicitySuspected human reproductive toxicant

Reproductive toxicity - rat - Oral

Specific target organ toxicity - single exposureno data available

Specific target organ toxicity - repeated exposureno data available

Aspiration hazardno data available

Potential health effectsInhalationIngestionSkinEyes

May be harmful if inhaled. May cause respiratory tract irritation.May be harmful if swallowed.May be harmful if absorbed through skin. May cause skin irritation.Causes eye burns.

Signs and Symptoms of ExposureTo the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughlyinvestigated.

Additional InformationRTECS: Not available

12.12.1

ECOLOGICAL INFORMATIONToxicityToxicity to fish

Toxicity to daphnia and

LC50 - Oncorhynchus mykiss (rainbow trout) - > 1.000 mg/l - 96 h

EC50 - Daphnia magna (Water flea) - > 1.000 mg/l - 48 h

420

other aquaticinvertebrates.

Toxicity to algae EbC50 - Scenedesmus quadricauda (Green algae) - > 300 mg/l - 72 h

ErC50 - Scenedesmus quadricauda (Green algae) - > 300 mg/l - 72 h

12.2

12.3

12.4

12.5

12.6

13.13.1

14.14.1

Persistence and degradabilityno data available

Bioaccumulative potentialno data available

Mobility in soilno data available

Results of PBT and vPvB assessmentno data available

Other adverse effectsno data available

DISPOSAL CONSIDERATIONSWaste treatment methodsProductOffer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed professionalwaste disposal service to dispose of this material. Dissolve or mix the material with a combustible solventand burn in a chemical incinerator equipped with an afterburner and scrubber.

Contaminated packagingDispose of as unused product.

TRANSPORT INFORMATIONUN number

14.2

14.3

14.4

14.5

14.6

15.

ADR/RID: -

UN proper shipping nameADR/RID: Not dangerous goodsIMDG: Not dangerous goodsIATA: Not dangerous goods

Transport hazard class(es)ADR/RID: -

Packaging groupADR/RID: -

Environmental hazardsADR/RID: no

Special precautions for userno data available

REGULATORY INFORMATION

IMDG: -

IMDG: -

IMDG: -

IMDG Marine pollutant: no

IATA: -

IATA: -

IATA: -

IATA: no

This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.

15.1

15.2

16.

Safety, health and environmental regulations/legislation specific for the substance or mixtureno data available

Chemical Safety Assessmentno data available

OTHER INFORMATIONFurther informationThe above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information this document is based on the resent state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. guidechem shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale.

421

SIGMA-ALDRICH MATERIAL SAFETY DATA SHEET Date Printed: 02/26/2008 Date Updated: 01/29/2006 Version 1.4 Section 1 - Product and Company Information Product Name (S)-(-)-SULPIRIDE Product Number S7771 Brand SIGMA Company Sigma-Aldrich Canada, Ltd Address 2149 Winston Park Drive Oakville ON L6H 6J8 CA Technical Phone: 9058299500 Fax: 9058299292 Emergency Phone: 800-424-9300 Section 2 - Composition/Information on Ingredient Substance Name CAS # SARA 313 (S)-(-)-SULPIRIDE 23672-07-3 No Formula C15H23N3O4S Synonyms Benzamide, 5-(aminosulfonyl)-N-((1-ethyl-2-pyrrolidinyl)methy l)-2-methoxy-, (S)- (9CI) * Benzamide, N-((1-ethyl-2-pyrrolidinyl)methyl)-2-methoxy-5-sul famoyl-, S-(-)- * S-(-)-N-(1-Ethyl-2-pyrrolidinomethyl)-2-methoxy-5- sulfamoylebenzamide * (S)-(-)-N-((1-Ethyl-2-pyrrolidinyl)methyl)-5-sulfa moyl-o-anisamide * Levopraid * Levosulpiride * RV-12309 * S-(-)-Sulpiride RTECS Number: BZ3400100 Section 3 - Hazards Identification EMERGENCY OVERVIEW Target organ(s): Central nervous system. HMIS RATING HEALTH: 1* FLAMMABILITY: 0 REACTIVITY: 0 NFPA RATING HEALTH: 0 FLAMMABILITY: 0 REACTIVITY: 0 *additional chronic hazards present. For additional information on toxicity, please refer to Section 11. Section 4 - First Aid Measures ORAL EXPOSURE

422

If swallowed, wash out mouth with water provided person is conscious. Call a physician. INHALATION EXPOSURE If inhaled, remove to fresh air. If breathing becomes difficult, call a physician. DERMAL EXPOSURE In case of contact, immediately wash skin with soap and copious amounts of water. EYE EXPOSURE In case of contact with eyes, flush with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating the eyelids with fingers. Call a physician. Section 5 - Fire Fighting Measures FLASH POINT N/A AUTOIGNITION TEMP N/A FLAMMABILITY N/A EXTINGUISHING MEDIA Suitable: Water spray. Carbon dioxide, dry chemical powder, or appropriate foam. FIREFIGHTING Protective Equipment: Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Specific Hazard(s): Emits toxic fumes under fire conditions. Section 6 - Accidental Release Measures PROCEDURE(S) OF PERSONAL PRECAUTION(S) Exercise appropriate precautions to minimize direct contact with skin or eyes and prevent inhalation of dust. METHODS FOR CLEANING UP Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete. Section 7 - Handling and Storage HANDLING User Exposure: Avoid inhalation. Avoid contact with eyes, skin, and clothing. Avoid prolonged or repeated exposure. STORAGE Suitable: Keep tightly closed. Store at 2-8˚C Section 8 - Exposure Controls / PPE ENGINEERING CONTROLS Safety shower and eye bath. Mechanical exhaust required. SIGMA - S7771 www.sigma-aldrich.com Page 2423

PERSONAL PROTECTIVE EQUIPMENT Respiratory: Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Respiratory protection is not required. Where protection from nuisance levels of dusts are desired, use type N95 (US) or type P1 (EN 143) dust masks. Hand: Protective gloves. Eye: Chemical safety goggles. GENERAL HYGIENE MEASURES Wash thoroughly after handling. Section 9 - Physical/Chemical Properties Appearance Physical State: Solid Property Value At Temperature or Pressure Molecular Weight 341.43 AMU pH N/A BP/BP Range N/A MP/MP Range 183.0 - 186.0 ˚C Freezing Point N/A Vapor Pressure N/A Vapor Density N/A Saturated Vapor Conc. N/A SG/Density N/A Bulk Density N/A Odor Threshold N/A Volatile% N/A VOC Content N/A Water Content N/A Solvent Content N/A Evaporation Rate N/A Viscosity N/A Surface Tension N/A Partition Coefficient N/A Decomposition Temp. N/A Flash Point N/A Explosion Limits N/A Flammability N/A Autoignition Temp N/A Refractive Index N/A Optical Rotation N/A Miscellaneous Data N/A Solubility N/A N/A = not available Section 10 - Stability and Reactivity STABILITY Stable: Stable. Materials to Avoid: Strong oxidizing agents. HAZARDOUS DECOMPOSITION PRODUCTS Hazardous Decomposition Products: Carbon monoxide, Carbon dioxide, Nitrogen oxides, Sulfur oxides. HAZARDOUS POLYMERIZATION Hazardous Polymerization: Will not occur SIGMA - S7771 www.sigma-aldrich.com Page 3424

Section 11 - Toxicological Information ROUTE OF EXPOSURE Skin Contact: May cause skin irritation. Skin Absorption: May be harmful if absorbed through the skin. Eye Contact: May cause eye irritation. Inhalation: May be harmful if inhaled. Material may be irritating to mucous membranes and upper respiratory tract. Ingestion: May be harmful if swallowed. TARGET ORGAN(S) OR SYSTEM(S) Central nervous system. SIGNS AND SYMPTOMS OF EXPOSURE To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated. Tachycardia, arrhythmias, hypertension, fatigue, agitation, sleep disorders, overstimulation, amenorrhoea, galactorrhoea, gynaecomastia, extrapyramidal dysfunction, impotence, skin rash, and photosensitization. Exposure can cause: TOXICITY DATA Oral Rat 2600 mg/kg LD50 Intraperitoneal Rat 270 MG/KG LD50 Intravenous Rat 53 MG/KG LD50 Oral Mouse 2450 mg/kg LD50 Intraperitoneal Mouse 170 MG/KG LD50 Oral Rabbit > 1500 mg/kg LD50 Intravenous Rabbit 42 MG/KG LD50 Section 12 - Ecological Information No data available. SIGMA - S7771 www.sigma-aldrich.com Page 4425

Section 13 - Disposal Considerations APPROPRIATE METHOD OF DISPOSAL OF SUBSTANCE OR PREPARATION Incinerate in a furnace providing environmental regulations permit. Observe all federal, state, and local environmental regulations. Section 14 - Transport Information DOT Proper Shipping Name: None Non-Hazardous for Transport: This substance is considered to be non-hazardous for transport. IATA Non-Hazardous for Air Transport: Non-hazardous for air transport. Section 15 - Regulatory Information US CLASSIFICATION AND LABEL TEXT US Statements: Target organ(s): Central nervous system. UNITED STATES REGULATORY INFORMATION SARA LISTED: No CANADA REGULATORY INFORMATION WHMIS Classification: This product has been classified in accordance with the hazard criteria of the CPR, and the MSDS contains all the information required by the CPR. DSL: No NDSL: No Section 16 - Other Information DISCLAIMER For R&D use only. Not for drug, household or other uses. WARRANTY The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Sigma-Aldrich Inc., shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale. Copyright 2008 Sigma-Aldrich Co. License granted to make unlimited paper copies for internal use only. SIGMA - S7771 www.sigma-aldrich.com Page 5

426

09/06/2017Revision:

Page: 1 of 5

LinezolidSAFETY DATA SHEET

04/15/2014Supersedes Revision:

according to Regulation (EC) No. 1907/2006 as amended by (EC) No. 1272/2008

150121.1 Product Code:

Section 1. Identification of the Substance/Mixture and of the Company/Undertaking

Linezolid Product Name:

Cayman Chemical CompanyCompany Name:1180 E. Ellsworth Rd.Ann Arbor, MI 48108

CHEMTREC Within USA and Canada:Emergency Contact: +1 (800)424-9300CHEMTREC Outside USA and Canada: +1 (703)527-3887

Cayman Chemical CompanyInformation: +1 (734)971-3335

For research use only, not for human or veterinary use.Relevant identified uses:

www.caymanchem.comWeb site address:

N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-acetamide; PNU100766; Zyvox®;

Synonyms:

1.3 Details of the Supplier of the Safety Data Sheet:

1.2 Relevant identified uses of the substance or mixture and uses advised against:

1.4 Emergency telephone number:

Section 2. Hazards Identification

Specific Target Organ Toxicity (repeated exposure), Category 12.1 Classification of the Substance or Mixture:

H372: Causes damage to organs through prolonged or repeated exposure.GHS Hazard Phrases:

2.2 Label Elements:

DangerGHS Signal Word:

P260: Do not breathe {dust/fume/gas/mist/vapours/spray}.P264: Wash {hands} thoroughly after handling.

GHS Precaution Phrases:

P314: Get medical attention/advice if you feel unwell.GHS Response Phrases:

Please refer to Section 7 for Storage and Section 13 for Disposal information.GHS Storage and Disposal Phrases:

2.3 Causes damage to organs through prolonged or repeated exposure.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause eye, skin, or respiratory system irritation.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.

Adverse Human HealthEffects and Symptoms:

Multi-region format

427

09/06/2017Revision:

Page: 2 of 5



CAS # /RTECS #

Hazardous Components (Chemical Name)/REACH Registration No.

Section 3. Composition/Information on IngredientsConcentration EC No./

EC Index No.GHS Classification

165800-03-3AC2720000

Acetamide,N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-

100.0 % 605-416-1 NA

STOT (RE) 1: H372

Section 4. First Aid MeasuresDescription of First AidMeasures:

Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes. Have eyes examinedand tested by medical personnel.

In Case of Eye Contact:

Immediately wash skin with soap and plenty of water for at least 15 minutes. Remove contaminatedclothing. Get medical attention if symptoms occur. Wash clothing before reuse.

In Case of Skin Contact:

Wash out mouth with water provided person is conscious. Never give anything by mouth to anunconscious person. Get medical attention. Do NOT induce vomiting unless directed to do so bymedical personnel.

In Case of Ingestion:

Remove to fresh air. If not breathing, give artificial respiration or give oxygen by trained personnel.Get immediate medical attention.

In Case of Inhalation:

4.1

5.1

5.2

Section 5. Fire Fighting Measures

Flash Pt: No data.

As in any fire, wear self-contained breathing apparatus pressure-demand (NIOSH approved orequivalent), and full protective gear to prevent contact with skin and eyes.

Fire Fighting Instructions:

Autoignition Pt: No data.

Explosive Limits: LEL: No data. UEL: No data.

Use alcohol-resistant foam, carbon dioxide, water, or dry chemical spray.Use water spray to cool fire-exposed containers.

Suitable ExtinguishingMedia:

A solid water stream may be inefficient.Unsuitable ExtinguishingMedia:

No data available.Flammable Properties andHazards:

5.3

No data available.

6.3

6.1

6.2

Section 6. Accidental Release Measures

Contain spill and collect, as appropriate.Transfer to a chemical waste container for disposal in accordance with local regulations.

Methods and Material ForContainment and CleaningUp:

Avoid raising and breathing dust, and provide adequate ventilation.As conditions warrant, wear a NIOSH approved self-contained breathing apparatus, or respirator,and appropriate personal protection (rubber boots, safety goggles, and heavy rubber gloves).

Protective Precautions,Protective Equipment andEmergency Procedures:

Take steps to avoid release into the environment, if safe to do so.EnvironmentalPrecautions:

Multi-region format

428

09/06/2017Revision:

Page: 3 of 5



7.1

7.2

Section 7. Handling and StorageAvoid breathing dust/fume/gas/mist/vapours/spray.Avoid prolonged or repeated exposure.

Precautions To Be Takenin Handling:

Keep container tightly closed.Store in accordance with information listed on the product insert.

Precautions To Be Takenin Storing:

Section 8. Exposure Controls/Personal Protection8.1 Exposure Parameters:

8.2.1

NIOSH approved respirator, as conditions warrant.Respiratory Equipment(Specify Type):

Safety glassesEye Protection:Compatible chemical-resistant glovesProtective Gloves:Lab coatOther Protective Clothing:

Use process enclosures, local exhaust ventilation, or other engineering controls to control airbornelevels below recommended exposure limits.

Engineering Controls(Ventilation etc.):

Do not take internally.Facilities storing or utilizing this material should be equipped with an eyewash and a safety shower.Wash thoroughly after handling.

Work/Hygienic/Maintenance Practices:

No data available.

8.2 Exposure Controls:

8.2.2 Personal protection equipment:

Section 9. Physical and Chemical Properties

Physical States: [ ] Gas [ ] Liquid [ X ] Solid

Melting Point: No data.

Boiling Point: No data.

Flash Pt: No data.


Vapor Pressure (vs. Air or mmHg):

No data.

Vapor Density (vs. Air = 1): No data.

Evaporation Rate: No data.

pH: No data.

A crystalline solidAppearance and Odor:

9.1 Information on Basic Physical and Chemical Properties

Flammability (solid, gas): No data available.

Specific Gravity (Water = 1): No data.

Solubility in Water: No data.

~0.1 mg/ml in PBS (pH 7.2); ~1 mg/ml in EtOH; ~20 mg/ml in DMSO; ~30 mg/ml in DMF;Solubility Notes:Octanol/Water PartitionCoefficient:

No data.

Multi-region format

429

09/06/2017Revision:

Page: 4 of 5



Decomposition Temperature: No data.Autoignition Pt: No data.

Viscosity: No data.

Percent Volatile: No data.

9.2 Other Information

Molecular Formula & Weight: C16H20FN3O4 337.4

10.4

10.5

10.6

10.110.210.3

Section 10. Stability and Reactivity

No data available.Conditions To Avoid:

Unstable [ ] Stable [ X ]Stability:

strong oxidizing agentsIncompatibility - MaterialsTo Avoid:

carbon dioxidecarbon monoxidehydrogen fluoridenitrogen oxides

HazardousDecomposition orByproducts:

Will occur [ ] Will not occur [ X ]Polymerization:

Stable if stored in accordance with information listed on the product insert.Stability Note(s):

No data available.Reactivity:

11.1

CAS # Hazardous Components (Chemical Name) NTP

Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Information on

Toxicological Effects:

IARC ACGIH OSHA

165800-03-3 Acetamide,N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-

n.a. n.a. n.a. n.a.

12.1

12.2

12.3

12.4

12.5

Avoid release into the environment.Runoff from fire control or dilution water may cause pollution.

Toxicity:

Section 12. Ecological Information

No data available.Persistence andDegradability:

No data available.BioaccumulativePotential:

No data available.Mobility in Soil:

No data available.Results of PBT and vPvBassessment:

12.6 No data available.Other adverse effects:

Multi-region format

430

09/06/2017Revision:

Page: 5 of 5



13.1 Dispose in accordance with local, state, and federal regulations.Waste Disposal Method:

Section 13. Disposal Considerations

Section 14. Transport Information

Not dangerous goods.DOT Proper Shipping Name:DOT Hazard Class:UN/NA Number:

14.1 LAND TRANSPORT (US DOT):

Not dangerous goods.ADR/RID Shipping Name:

14.1 LAND TRANSPORT (European ADR/RID):

UN Number:Hazard Class:

Not dangerous goods.ICAO/IATA Shipping Name:

14.3 AIR TRANSPORT (ICAO/IATA):

Transport in accordance with local, state, and federal regulations.Additional TransportInformation:

CAS # Hazardous Components (Chemical Name)

Section 15. Regulatory Information

S. 302 (EHS) S. 304 RQ S. 313 (TRI)

EPA SARA (Superfund Amendments and Reauthorization Act of 1986) Lists

165800-03-3 Acetamide,N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-

No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 165800-03-3 Acetamide,

N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-

CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CAPROP.65: No

This SDS was prepared in accordance with 29 CFR 1910.1200 and Regulation (EC)No.1272/2008.

Regulatory InformationStatement:

Section 16. Other Information

No data available.Additional Information AboutThis Product:

DISCLAIMER: This information is believed to be accurate and represents the best informationcurrently available to us. However, we make no warranty of merchantability or any other warranty,express or implied, with respect to such information, and we assume no liability resulting from itsuse. Users should make their own investigations to determine the suitability of the information fortheir particular purposes.

Company Policy or Disclaimer:

09/06/2017Revision Date:

Multi-region format

431

10/03/2014Revision:

Page: 1 of 6

Olmesartan MedoxomilSAFETY DATA SHEET




Olmesartan Medoxomil Product Name:






4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-(5-methyl-2-oxo-1,3-dioxol-4-(5-methyl-2-oxo-1,3-dioxol-4-(5-methyl-2-oxo-1,3-dioxol-4-(5-methyl-2-oxo-1,3-dioxol-4-y)methyl ester; Benicar; CS 866; Olmetec;

Synonyms:





Acute Toxicity: Inhalation, Category 4Acute Toxicity: Oral, Category 4Acute Toxicity: Skin, Category 4

2.1 Classification of the Substance or Mixture:2.1.1 Classification according to Regulation (EC) No 1272/2008 [CLP]:

2.1.2 Classification according to Directive 1999/45/EC:Xn: HarmfulRisk Phrases: R20/21/22For full text of R- phrases: see SECTION 15.

H332: Harmful if inhaled.H302: Harmful if swallowed.H312: Harmful in contact with skin.

GHS Hazard Phrases:

2.2 Label Elements:2.2.1 Labeling according to Regulation (EC) No 1272/2008 [CLP]:

WarningGHS Signal Word:

Multi-region format

432

10/03/2014Revision:

Page: 2 of 6


P261: Avoid breathing {dust/fume/gas/mist/vapours/spray}.P264: Wash {hands} thoroughly after handling.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.P362+364: Take off contaminated clothing and wash it before reuse.


P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.P312: Call a {POISON CENTER/doctor/...} if you feel unwell.P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.P330: Rinse mouth.P302+352: IF ON SKIN: Wash with plenty of soap and water.P321: Specific treatment {see ... on this label}.

GHS Response Phrases:


Xn

2.2.2 Labeling according to Directive 1999/45/EC:

2.3 Harmful if inhaled.Harmful if swallowed.Harmful in contact with skin.Material may be irritating to the mucous membranes and upper respiratory tract.May cause eye, skin, or respiratory system irritation.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #



EC Index No.Risk Phrases/GHS Classification

144689-63-4NA

Olmesartan 100.0 % 604-433-1 NA

Xn; R20/21/22Acute Tox.(O) 4: H302Acute Tox.(D) 4: H312Acute Tox.(I) 4: H332

Multi-region format

433

10/03/2014Revision:

Page: 3 of 6


Section 4. First Aid MeasuresNo data available.Description of First Aid

Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

6.3

6.1

6.2







7.1

7.2





Section 8. Exposure Controls/Personal Protection

Britain EH40 France VLCAS # Partial Chemical Name Europe

8.1 Exposure Parameters:

No data. No data. 144689-63-4 Olmesartan No data.

Multi-region format

434

10/03/2014Revision:

Page: 4 of 6


OSHA TWA ACGIH TWACAS # Partial Chemical Name Other Limits


8.2.1







No data available.







Flash Pt: No data.



No data.







~0.5 mg/ml in 1:1 EtOH:PBS (pH 7.2); ~0.2 mg/ml in EtOH; ~20 mg/ml in DMSO; ~30mg/ml in DMF;

Solubility Notes:




Molecular Formula & Weight: C29H30N6O6 558.6

10.4

10.5

10.6

10.110.210.3





carbon dioxidecarbon monoxidenitrogen oxides

HazardousDecomposition Or




Multi-region format

435

10/03/2014Revision:

Page: 5 of 6


Byproducts:

11.1

Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Olmesartan Medoxomil - Toxicity Data: Oral TDLO (rat): 12 mg/kg/14D (intermittent); Oral TDLO(woman): 4 mg/kg/10D (intermittent);

Information onToxicological Effects:

Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Olmesartan Medoxomil RTECS Number: NI4014200

Chronic ToxicologicalEffects:

NTP? No IARC Monographs? No OSHA Regulated? NoCarcinogenicity:

12.1

12.2

12.3

12.4

12.5


Toxicity:



















S. 302 (EHS) S. 304 RQ S. 313 (TRI)


144689-63-4 Olmesartan No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 144689-63-4 Olmesartan CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No

Multi-region format

436

10/03/2014Revision:

Page: 6 of 6


XnEuropean Community Risk and Safety Phrases:

European Community Hazard Symbol codes:

Harmful by inhalation, in contact with skin and if swallowed.R20/21/22Avoid contact with skin and eyes.S24/25Wear suitable protective clothing, gloves and eye/face protection.S36/37/39

This SDS was prepared in accordance with Regulation (EC) No.1272/2008 and European Directive67/548/EEC as amended.







Multi-region format

437

p. 1

1 1 0

He a lt h

Fire

Re a c t iv it y


1

1

0

E

Material Safety Data SheetGabapentin MSDS


Product Name: Gabapentin

Catalog Codes: SLA3310

CAS#: 60142-96-3

RTECS: GU6496000

TSCA: TSCA 8(b) inventory: No products were found.

CI#: Not available.

Synonym: 1-(Aminomethyl)cyclohexaneacetic Acid;Neurontin

Chemical Name: Gabapentin

Chemical Formula: C9-H17-N-O2









Composition:


Gabapentin 60142-96-3 100

Toxicological Data on Ingredients: Gabapentin: ORAL (LD50): Acute: >8000 mg/kg [Rat]. >8053 mg/kg [Mouse].


Potential Acute Health Effects: Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, ofinhalation.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: ClassifiedPOSSIBLE for human. DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female [POSSIBLE]. Thesubstance may be toxic to central nervous system (CNS), pancreas. Repeated or prolonged exposure to the substance canproduce target organs damage.


Eye Contact:

438


p. 2

Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Get medical attention if irritation occurs.

Skin Contact: Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.

Serious Skin Contact: Not available.



Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear.







Products of Combustion: These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...).

Fire Hazards in Presence of Various Substances:Slightly flammable to flammable in presence of heat. Non-flammable in presence of shocks.









Precautions:Keep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporatethe residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. Wear suitableprotective clothing. If ingested, seek medical advice immediately and show the container or the label. Keep away fromincompatibles such as oxidizing agents.

439

p. 3

Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area. Do not store above 24°C (75.2°F).



Personal Protection: Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent.Gloves.




Physical state and appearance: Solid.

Odor: Not available.

Taste: Not available.

Molecular Weight: Not available.

Color: Not available.



Melting Point: Not available.









Dispersion Properties: Not available.

Solubility: Not available.




Conditions of Instability: Excess heat, incompatible materials

440

p. 4

Incompatibility with various substances: Reactive with oxidizing agents.

Corrosivity: Not available.

Special Remarks on Reactivity: Not available.





Toxicity to Animals: Acute oral toxicity (LD50): >8000 mg/kg [Rat].

Chronic Effects on Humans:TERATOGENIC EFFECTS: Classified POSSIBLE for human. DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female [POSSIBLE]. May cause damage to the following organs: central nervous system (CNS), pancreas.

Other Toxic Effects on Humans: Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.


Special Remarks on Chronic Effects on Humans: May cause adverse reproductive effects and birth defects based onanimal data

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Causes skin irritation. Eyes: Dust can cause eye irritation. Inhalation: Can causerespiratory tract and mucous membrane irritation. Ingestion: May cause digestive tract irritation with nausea. May also affectbehavior/Central Nervous system (CNS). Symptoms may include headache, dizziness, and CNS depression.





Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.









441

p. 5

Federal and State Regulations: No products were found.

Other Regulations: EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances.



DSCL (EEC):R40- Possible risks of irreversible effects. R62- Possible risk of impaired fertility. R63- Possible risk of harm to the unbornchild. S2- Keep out of the reach of children. S36/37- Wear suitable protective clothing and gloves.

HMIS (U.S.A.):

Health Hazard: 1

Fire Hazard: 1

Reactivity: 0



Health: 1

Flammability: 1

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Safety glasses.




Created: 10/09/2005 03:42 PM

Last Updated: 05/21/2013 12:00 PM


442

07/16/2014Revision:

Page: 1 of 6

LevetiracetamSAFETY DATA SHEET




Levetiracetam Product Name:






(.alpha.S)-ethyl-2-oxo-1-pyrrolidineacetamide; UCB-L 059; Keppra®; Synonyms:





Acute Toxicity: Oral, Category 4Serious Eye Damage/Eye Irritation, Category 2


2.1.2 Classification according to Directive 1999/45/EC:Xn: HarmfulRisk Phrases: R22, R36For full text of R- phrases: see SECTION 15.

H302: Harmful if swallowed.H319: Causes serious eye irritation.

GHS Hazard Phrases:



P264: Wash {hands} thoroughly after handling.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.


P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.P330: Rinse mouth.P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P337+313: If eye irritation persists, get medical advice/attention.



Multi-region format

443

07/16/2014Revision:

Page: 2 of 6


Xn


2.3 Causes serious eye irritation.Harmful if swallowed.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation or skin absorption.May cause skin or respiratory system irritation.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




102767-28-2NA

1-Pyrrolidineacetamide, .alpha.-ethyl-2-oxo-,(.alpha.S)-

100.0 % 600-348-9 NA

Xn; R22-36Acute Tox.(O) 4: H302Eye Damage 2: H319


Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

Multi-region format

444

07/16/2014Revision:

Page: 3 of 6


6.3

6.1

6.2







7.1

7.2








No data. No data. 102767-28-2 1-Pyrrolidineacetamide,.alpha.-ethyl-2-oxo-, (.alpha.S)-

No data.



No data.

8.2.1







No data available.



Multi-region format

445

07/16/2014Revision:

Page: 4 of 6






Flash Pt: No data.



No data.







~10 mg/ml in PBS (pH 7.2); ~16.7 mg/ml in EtOH; ~20 mg/ml in DMSO; ~20 mg/ml in DMF;Solubility Notes:Autoignition Pt: No data.




10.4

10.5

10.6

10.110.210.3




oxidizing agentsIncompatibility - MaterialsTo Avoid:


HazardousDecomposition OrByproducts:




11.1

Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Levetiracetam - Toxicity Data: Oral TDLO (woman): 10 mg/kg; Intravenous LD50 (rat): 1038 mg/kg;Intravenous LD50 (mouse): 1081 mg/kg; Intraperitoneal TDLO (rat): 17 mg/kg; IntraperitonealTDLO (mouse): 17 mg/kg;


Levetiracetam - Investigated as a reproductive effector.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Levetiracetam RTECS Number: UX9656166



Multi-region format

446

07/16/2014Revision:

Page: 5 of 6


12.1

12.2

12.3

12.4

12.5


Toxicity:



















S. 302 (EHS) S. 304 RQ S. 313 (TRI)


102767-28-2 1-Pyrrolidineacetamide, .alpha.-ethyl-2-oxo-,(.alpha.S)-

No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 102767-28-2 1-Pyrrolidineacetamide, .alpha.-ethyl-2-oxo-,

(.alpha.S)-CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CAPROP.65: No



Harmful if swallowed.R22Irritating to eyes.R36Avoid contact with skin and eyes.S24/25Wear suitable protective clothing, gloves and eye/face protection.S36/37/39

Multi-region format

447

07/16/2014Revision:

Page: 6 of 6









Multi-region format

448

Material Safety Data Sheet

Pantoprazole Sodium

sc-204831

Hazard Alert CodeKey: EXTREME HIGH MODERATE LOW

Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAMEPantoprazole Sodium

STATEMENT OF HAZARDOUS NATURECONSIDERED A HAZARDOUS SUBSTANCE ACCORDING TO OSHA 29 CFR 1910.1200.

NFPA

SUPPLIERCompany: Santa Cruz Biotechnology, Inc.Address:2145 Delaware AveSanta Cruz, CA 95060Telephone: 800.457.3801 or 831.457.3800Emergency Tel: CHEMWATCH: From within the US andCanada: 877-715-9305Emergency Tel: From outside the US and Canada: +800 24362255 (1-800-CHEMCALL) or call +613 9573 3112

PRODUCT USEAntiulcerative in the treatment of pathological hypersecretion (e.g. Zollinger-Ellison syndrome). A substituted benzimidazolewhich does not exhibit anticholinergic or H2 histamine antagonist properties but suppresses gastric acid secretion by specificinhibition of the H+/K+ ATPase enzyme system at the secretary surface of the gastric parietal cell. Because this enzymesystem is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterised as a gastric-pump inhibitor

SYNONYMSC16-H14-F2-N3-O4-S.Na, "1H-benzimidazole, 5-(difluoromethoxy)-2-[((3, 4-dimethoxy-2-pyridinyl)-", "methyl)sulfinyl]-,sodium", "1H-benzimidazole, 5-(difluoromethoxy)-2-[((3, 4-dimethoxy-2-pyridinyl)-", "methyl)sulfinyl]-, sodium", "5-(difluoromethoxy)-2-[((3, 4-dimethoxy-2-pyridnyl)methyl)sulfinyl)-1H-", "benzimidazole monosodium salt", "5-(difluoromethoxy)-2-[((3, 4-dimethoxy-2-pyridnyl)methyl)sulfinyl)-1H-", "benzimidazole monosodium salt", "pentaprazole sodium", "pantoprazolesodium sesquihydrate [CAS RN: 164579-32-2]", "pantoprazole sodium sesquihydrate [CAS RN: 164579-32-2]", SKF-96022,BY-1023, "gastrointestinal agent/ gastric proton-pump inhibitor", anti-ulcerative

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEWRISKHarmful if swallowed.May cause long-term adverse effects in the aquatic environment.

FLAMMABILITY1HEALTH HAZARD1 INSTABILITY0

449

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS SWALLOWED■ Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram maybe fatal or may produce serious damage to the health of the individual.■ Gastric proton pump inhibitors (GPPIs) are generally well tolerated, and the incidence of short-term adverse effects isrelatively uncommon. The range and occurrence of adverse effects are similar for all of the proton pump inhibitors, though theyhave been reported more frequently with omeprazole. This may be due to its longer availability and hence clinical experience.Common adverse effects include: headache, nausea, diarrhea, abdominal pain, fatigue, dizziness.Infrequent adverse effects include: rash, itch, flatulence, constipation. Decreased vitamin B12 absorption may occur with long-term use. Rarely GPPIs cause"‘idiosyncratic" reactions such as erythema multiforme, pancreatitis, Stevens Johnson syndromeand acute interstitial nephritis.It has been observed that gastric acid suppression, using H2-receptor antagonists and proton pump inhibitors, is associatedwith an increased risk of community-acquired pneumonia. It is suspected that acid suppression results in insufficient eliminationof pathogenic organisms. It has therefore been suggested that patients at higher risk of pneumonia should only be prescribedproton pump inhibitors at lower doses and only when necessary.GPPIs have also been shown to raise risk of Clostridium difficile infection.EYE■ Although the material is not thought to be an irritant, direct contact with the eye may cause transient discomfortcharacterized by tearing or conjunctival redness (as with windburn). Slight abrasive damage may also result. The material mayproduce foreign body irritation in certain individuals.SKIN■ Skin contact is not thought to produce harmful health effects (as classified using animal models). Systemic harm, however,has been identified following exposure of animals by at least one other route and the material may still produce health damagefollowing entry through wounds, lesions or abrasions. Good hygiene practice requires that exposure be kept to a minimum andthat suitable gloves be used in an occupational setting.■ Open cuts, abraded or irritated skin should not be exposed to this material.■ Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmfuleffects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected.INHALED■ The material is not thought to produce either adverse health effects or irritation of the respiratory tract following inhalation (asclassified using animal models). Nevertheless, adverse effects have been produced following exposure of animals by at leastone other route and good hygiene practice requires that exposure be kept to a minimum and that suitable control measures beused in an occupational setting.■ Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, mayincur further disability if excessive concentrations of particulate are inhaled.

CHRONIC HEALTH EFFECTS■ Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involvingorgans or biochemical systems.There has been some concern that this material can cause cancer or mutations but there is not enough data to make anassessment.There is limited evidence that, skin contact with this product is more likely to cause a sensitization reaction in some personscompared to the general population.Long term exposure to high dust concentrations may cause changes in lung function i.e. pneumoconiosis; caused by particlesless than 0.5 micron penetrating and remaining in the lung. Prime symptom is breathlessness; lung shadows show on X-ray.In a study of 135,000 people 50 or older, those taking high doses of GPPIs for longer than one year have been found to be2.6 times more likely to break a hip. Those taking smaller doses for 1 to 4 years were 1.2 to 1.6 times more likely to break ahip. The risk of a fracture increased with the length of time taking GPPIs. Theories as to the cause of the increase are thepossibility that the reduction of stomach acid reduces the amount of calcium dissolved in the stomach or that GPPIs mayinterfere with the breakdown and rebuilding of bone by interfering with the acid production of osteoclasts. Also, the reduction ofvitamin B12 (by raising homocysteine) may increase bone fragility, an effect that may be offset by the consumption, or by theco-packaging, of about 100 mcg of B12 with the GPPI.The use of gastric proton pump inhibitors (antiulceratives) has been associated with the induction of carcinoid-like tumours ofthe gastric mucosa. This is thought to be associated with a complete block of gastric acid secretion leading tohypergastrinaemia and hyperplasia of enterochromaffin-like cells. As a result, the therapeutic use of these inhibitors isgenerally restricted.A number of benzimidazoles have been shown to also inhibit mammalian tubulin polymerisation and to be aneugenic in vivo.Aneugens affect cell division and the mitotic spindle apparatus resulting in loss or gain of whole chromosomes, therebyinducing an "aneuploidy". Mitotic aneuploidy is a characteristic of many types of tumorigenesis (in cancer). Severalbenzimidazoles have been shown to be genotoxic. Genotoxicity may arise as aneugens may also be clastogens, or mayproduce clastogenic metabolites. Clastogens increase the rate of genetic mutation by interfering with the function of nucleicacids. A clastogen is a specific mutagen that causes breaks in chromosomes.In rat studies, pantoprazole produced a carcinoid-like tumour of the gastric mucosa when given in high doses over a longperiod of time.

Section 3 - COMPOSITION / INFORMATION ON INGREDIENTS

HAZARD RATINGS Min Max

Flammability: 1

Toxicity: 2

Body Contact: 0

Reactivity: 1

Chronic: 2

Min/Nil=0Low=1Moderate=2High=3Extreme=4

450

NAME CAS RN %

pantoprazole sodium 138786-67-1 >98

Section 4 - FIRST AID MEASURES

SWALLOWED■

IF SWALLOWED, REFER FOR MEDICAL ATTENTION, WHERE POSSIBLE, WITHOUT DELAY.Where Medical attention is not immediately available or where the patient is more than 15 minutes from a hospital or unlessinstructed otherwise:For advice, contact a Poisons Information Center or a doctor.Urgent hospital treatment is likely to be needed.If conscious, give water to drink.INDUCE vomiting with fingers down the back of the throat, ONLY IF CONSCIOUS. Lean patient forward or place on leftside (head-down position, if possible) to maintain open airway and prevent aspiration.

NOTE: Wear a protective glove when inducing vomiting by mechanical means.In the mean time, qualified first-aid personnel should treat the patient following observation and employing supportivemeasures as indicated by the patient's condition.If the services of a medical officer or medical doctor are readily available, the patient should be placed in his/her care and acopy of the MSDS should be provided. Further action will be the responsibility of the medical specialist.If medical attention is not available on the worksite or surroundings send the patient to a hospital together with a copy ofthe MSDS.

EYE■ If this product comes in contact with the eyes:

Wash out immediately with fresh running water.Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionallylifting the upper and lower lids.If pain persists or recurs seek medical attention.Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.

SKIN■ If skin contact occurs:

Immediately remove all contaminated clothing, including footwearFlush skin and hair with running water (and soap if available).Seek medical attention in event of irritation.

INHALED■

If dust is inhaled, remove from contaminated area.Encourage patient to blow nose to ensure clear passage of breathing.If irritation or discomfort persists seek medical attention.

NOTES TO PHYSICIAN■ for poisons (where specific treatment regime is absent):--------------------------------------------------------------BASIC TREATMENT--------------------------------------------------------------

Establish a patent airway with suction where necessary.Watch for signs of respiratory insufficiency and assist ventilation as necessary.Administer oxygen by non-rebreather mask at 10 to 15 l/min.Monitor and treat, where necessary, for pulmonary edema .Monitor and treat, where necessary, for shock.Anticipate seizures .DO NOT use emetics. Where ingestion is suspected rinse mouth and give up to 200 ml water (5 ml/kg recommended) fordilution where patient is able to swallow, has a strong gag reflex and does not drool.

--------------------------------------------------------------ADVANCED TREATMENT--------------------------------------------------------------

Consider orotracheal or nasotracheal intubation for airway control in unconscious patient or where respiratory arrest hasoccurred.Positive-pressure ventilation using a bag-valve mask might be of use.Monitor and treat, where necessary, for arrhythmias.Start an IV D5W TKO. If signs of hypovolemia are present use lactated Ringers solution. Fluid overload might createcomplications.Drug therapy should be considered for pulmonary edema.Hypotension with signs of hypovolemia requires the cautious administration of fluids. Fluid overload might createcomplications.Treat seizures with diazepam.Proparacaine hydrochloride should be used to assist eye irrigation.

BRONSTEIN, A.C. and CURRANCE, P.L.EMERGENCY CARE FOR HAZARDOUS MATERIALS EXPOSURE: 2nd Ed. 1994.Treat symptomatically.No antidote is known. Pantoprazole is extensively protein-bound and is therefore not readily dialysable.

Section 5 - FIRE FIGHTING MEASURES

Vapour Pressure (mmHG): Negligible

Upper Explosive Limit (%): Not available.

451

Upper Explosive Limit (%): Not available.

Specific Gravity (water=1): Not available

Lower Explosive Limit (%): Not available

EXTINGUISHING MEDIA■

Water spray or fog.Foam.Dry chemical powder.BCF (where regulations permit).Carbon dioxide.

FIRE FIGHTING■

Alert Emergency Responders and tell them location and nature of hazard.Wear breathing apparatus plus protective gloves.Prevent, by any means available, spillage from entering drains or water course.Use water delivered as a fine spray to control fire and cool adjacent area.DO NOT approach containers suspected to be hot.Cool fire exposed containers with water spray from a protected location.If safe to do so, remove containers from path of fire.Equipment should be thoroughly decontaminated after use.

GENERAL FIRE HAZARDS/HAZARDOUS COMBUSTIBLE PRODUCTS■

Combustible solid which burns but propagates flame with difficulty.Avoid generating dust, particularly clouds of dust in a confined or unventilated space as dusts may form an explosivemixture with air, and any source of ignition, i.e. flame or spark, will cause fire or explosion. Dust clouds generated by thefine grinding of the solid are a particular hazard; accumulations of fine dust may burn rapidly and fiercely if ignited.Dry dust can be charged electrostatically by turbulence, pneumatic transport, pouring, in exhaust ducts and duringtransport.Build-up of electrostatic charge may be prevented by bonding and grounding.Powder handling equipment such as dust collectors, dryers and mills may require additional protection measures such asexplosion venting.

Combustion products include: carbon monoxide (CO), carbon dioxide (CO2), nitrogen oxides (NOx), sulfur oxides (SOx), otherpyrolysis products typical of burning organic material.May emit poisonous fumes.May emit corrosive fumes.FIRE INCOMPATIBILITY■ Avoid contamination with oxidizing agents i.e. nitrates, oxidizing acids,chlorine bleaches, pool chlorine etc. as ignition mayresult.

PERSONAL PROTECTIONGlasses:Chemical goggles.Gloves:Respirator:Particulate

Section 6 - ACCIDENTAL RELEASE MEASURES

MINOR SPILLS■

Clean up waste regularly and abnormal spills immediately.Avoid breathing dust and contact with skin and eyes.Wear protective clothing, gloves, safety glasses and dust respirator.Use dry clean up procedures and avoid generating dust.Vacuum up or sweep up. NOTE: Vacuum cleaner must be fitted with an exhaust micro filter (HEPA type) (considerexplosion-proof machines designed to be grounded during storage and use).Dampen with water to prevent dusting before sweeping.Place in suitable containers for disposal.

MAJOR SPILLS■ Moderate hazard.

CAUTION: Advise personnel in area.Alert Emergency Responders and tell them location and nature of hazard.Control personal contact by wearing protective clothing.Prevent, by any means available, spillage from entering drains or water courses.Recover product wherever possible.IF DRY: Use dry clean up procedures and avoid generating dust. Collect residues and place in sealed plastic bags or othercontainers for disposal. IF WET: Vacuum/shovel up and place in labelled containers for disposal.ALWAYS: Wash area down with large amounts of water and prevent runoff into drains.If contamination of drains or waterways occurs, advise emergency services.

ACUTE EXPOSURE GUIDELINE LEVELS (AEGL) (in ppm)AEGL 1: The airborne concentration of a substance above which it is predictedthat the general population, including susceptible individuals, couldexperience notable discomfort, irritation, or certain asymptomatic nonsensoryeffects. However, the effects are not disabling and are transient andreversible upon cessation of exposure.AEGL 2: The airborne concentration of a substance above which it is predictedthat the general population, including susceptible individuals, could

452

experience irreversible or other serious, long-lasting adverse health effectsor an impaired ability to escape.AEGL 3: The airborne concentration of a substance above which it is predictedthat the general population, including susceptible individuals, couldexperience life-threatening health effects or death.

Section 7 - HANDLING AND STORAGE

PROCEDURE FOR HANDLING■

Avoid all personal contact, including inhalation.Wear protective clothing when risk of exposure occurs.Use in a well-ventilated area.Prevent concentration in hollows and sumps.DO NOT enter confined spaces until atmosphere has been checked.DO NOT allow material to contact humans, exposed food or food utensils.Avoid contact with incompatible materials.When handling, DO NOT eat, drink or smoke.Keep containers securely sealed when not in use.Avoid physical damage to containers.Always wash hands with soap and water after handling.Work clothes should be laundered separately.Launder contaminated clothing before re-use.Use good occupational work practice.Observe manufacturer's storing and handling recommendations.Atmosphere should be regularly checked against established exposure standards to ensure safe working conditions aremaintained.

Empty containers may contain residual dust which has the potential to accumulate following settling. Such dusts may explodein the presence of an appropriate ignition source.

Do NOT cut, drill, grind or weld such containersIn addition ensure such activity is not performed near full, partially empty or empty containers without appropriateworkplace safety authorisation or permit.

RECOMMENDED STORAGE METHODS■ Glass container.

Polyethylene or polypropylene container.Check all containers are clearly labelled and free from leaks.

STORAGE REQUIREMENTS■

Store in original containers.Keep containers securely sealed.Store in a cool, dry, well-ventilated area.Store away from incompatible materials and foodstuff containers.Protect containers against physical damage and check regularly for leaks.Observe manufacturer's storing and handling recommendations.

SAFE STORAGE WITH OTHER CLASSIFIED CHEMICALS

+ X + X X +

X: Must not be stored togetherO: May be stored together with specific preventions+: May be stored together

Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION

EXPOSURE CONTROLS

The following materials had no OELs on our records• pantoprazole sodium: CAS:138786-67-1 CAS:142678-34-0 CAS:226904-33-2 CAS:164579-32-2

MATERIAL DATAPANTOPRAZOLE SODIUM:■ It is the goal of the ACGIH (and other Agencies) to recommend TLVs (or their equivalent) for all substances for which thereis evidence of health effects at airborne concentrations encountered in the workplace.At this time no TLV has been established, even though this material may produce adverse health effects (as evidenced inanimal experiments or clinical experience). Airborne concentrations must be maintained as low as is practically possible andoccupational exposure must be kept to a minimum.NOTE: The ACGIH occupational exposure standard for Particles Not Otherwise Specified (P.N.O.S) does NOT apply.Airborne particulate or vapor must be kept to levels as low as is practicably achievable given access to modern engineeringcontrols and monitoring hardware. Biologically active compounds may produce idiosyncratic effects which are entirelyunpredictable on the basis of literature searches and prior clinical experience (both recent and past).

453

CEL TWA: 0.5 mg/m3* *[AstraZeneca for omaprazole]

PERSONAL PROTECTION

Consult your EHS staff for recommendationsEYE■ When handling very small quantities of the material eye protection may not be required.For laboratory, larger scale or bulk handling or where regular exposure in an occupational setting occurs:

Chemical gogglesFace shield. Full face shield may be required for supplementary but never for primary protection of eyesContact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. A written policydocument, describing the wearing of lens or restrictions on use, should be created for each workplace or task. This shouldinclude a review of lens absorption and adsorption for the class of chemicals in use and an account of injury experience.Medical and first-aid personnel should be trained in their removal and suitable equipment should be readily available. In theevent of chemical exposure, begin eye irrigation immediately and remove contact lens as soon as practicable. Lens shouldbe removed at the first signs of eye redness or irritation - lens should be removed in a clean environment only afterworkers have washed hands thoroughly. [CDC NIOSH Current Intelligence Bulletin 59]

HANDS/FEET■ NOTE: The material may produce skin sensitization in predisposed individuals. Care must be taken, when removing glovesand other protective equipment, to avoid all possible skin contact.Suitability and durability of glove type is dependent on usage. Important factors in the selection of gloves include: such as:

frequency and duration of contact,chemical resistance of glove material,glove thickness anddexterity

Select gloves tested to a relevant standard (e.g. Europe EN 374, US F739).When prolonged or frequently repeated contact may occur, a glove with a protection class of 5 or higher (breakthrough timegreater than 240 minutes according to EN 374) is recommended.When only brief contact is expected, a glove with a protection class of 3 or higher (breakthrough time greater than 60minutes according to EN 374) is recommended.Contaminated gloves should be replaced.

Gloves must only be worn on clean hands. After using gloves, hands should be washed and dried thoroughly. Application of anon-perfumed moisturiser is recommended.

Rubber gloves (nitrile or low-protein, powder-free latex). Employees allergic to latex gloves should use nitrile gloves inpreference.Double gloving should be considered.PVC gloves.Protective shoe covers.Head covering.

Experience indicates that the following polymers are suitable as glove materials for protection against undissolved, dry solids,where abrasive particles are not present.

polychloroprenenitrile rubberbutyl rubberfluorocaoutchoucpolyvinyl chloride

Gloves should be examined for wear and/ or degradation constantly.OTHER■

For quantities up to 500 grams a laboratory coat may be suitable.For quantities up to 1 kilogram a disposable laboratory coat or coverall of low permeability is recommended. Coverallsshould be buttoned at collar and cuffs.For quantities over 1 kilogram and manufacturing operations, wear disposable coverall of low permeability and disposableshoe covers.For manufacturing operations, air-supplied full body suits may be required for the provision of advanced respiratoryprotection.Eye wash unit.Ensure there is ready access to an emergency shower.For Emergencies: Vinyl suit

■Respirators may be necessary when engineering and administrative controls do not adequately prevent exposures.The decision to use respiratory protection should be based on professional judgment that takes into account toxicityinformation, exposure measurement data, and frequency and likelihood of the worker's exposure - ensure users are notsubject to high thermal loads which may result in heat stress or distress due to personal protective equipment (powered,positive flow, full face apparatus may be an option).Published occupational exposure limits, where they exist, will assist in determining the adequacy of the selected respiratory. These may be government mandated or vendor recommended.Certified respirators will be useful for protecting workers from inhalation of particulates when properly selected and fit testedas part of a complete respiratory protection program.Use approved positive flow mask if significant quantities of dust becomes airborne.Try to avoid creating dust conditions.

RESPIRATOR

454

■Protection Factor Half-Face Respirator Full-Face Respirator Powered Air Respirator10 x PEL P1 - PAPR-P1

Air-line* - -50 x PEL Air-line** P2 PAPR-P2100 x PEL - P3 -

Air-line* -100+ x PEL - Air-line** PAPR-P3* - Negative pressure demand ** - Continuous flowExplanation of Respirator Codes:Class 1 low to medium absorption capacity filters.Class 2 medium absorption capacity filters.Class 3 high absorption capacity filters.PAPR Powered Air Purifying Respirator (positive pressure) cartridge.Type A for use against certain organic gases and vapors.Type AX for use against low boiling point organic compounds (less than 65ºC).Type B for use against certain inorganic gases and other acid gases and vapors.Type E for use against sulfur dioxide and other acid gases and vapors.Type K for use against ammonia and organic ammonia derivativesClass P1 intended for use against mechanically generated particulates of sizes most commonly encountered in industry, e.g.asbestos, silica.Class P2 intended for use against both mechanically and thermally generated particulates, e.g. metal fume.Class P3 intended for use against all particulates containing highly toxic materials, e.g. beryllium.The local concentration of material, quantity and conditions of use determine the type of personal protective equipmentrequired. Use appropriate NIOSH-certified respirator based on informed professional judgement. In conditions where no reasonableestimate of exposure can be made, assume the exposure is in a concentration IDLH and use NIOSH-certified full facepressure demand SCBA with a minimum service life of 30 minutes, or a combination full facepiece pressure demand SAR withauxiliary self-contained air supply. Respirators provided only for escape from IDLH atmospheres shall be NIOSH-certified forescape from the atmosphere in which they will be used.

ENGINEERING CONTROLS■ Enclosed local exhaust ventilation is required at points of dust, fume or vapor generation.HEPA terminated local exhaust ventilation should be considered at point of generation of dust, fumes or vapors.Barrier protection or laminar flow cabinets should be considered for laboratory scale handling.The need for respiratory protection should also be assessed where incidental or accidental exposure is anticipated: Dependenton levels of contamination, PAPR, full face air purifying devices with P2 or P3 filters or air supplied respirators should beevaluated.Fume-hoods and other open-face containment devices are acceptable when face velocities of at least 1 m/s (200 feet/minute)are achieved. Partitions, barriers, and other partial containment technologies are required to prevent migration of the material touncontrolled areas. For non-routine emergencies maximum local and general exhaust are necessary. Air contaminantsgenerated in the workplace possess varying "escape" velocities which, in turn, determine the "capture velocities" of freshcirculating air required to effectively remove the contaminant.Type of Contaminant: Air Speed:

solvent, vapors, etc. evaporating from tank (in still air) 0.25-0.5 m/s (50-100 f/min.)

aerosols, fumes from pouring operations, intermittentcontainer filling, low speed conveyer transfers (released atlow velocity into zone of active generation)

0.5-1 m/s (100-200 f/min.)

direct spray, drum filling, conveyer loading, crusher dusts, gasdischarge (active generation into zone of rapid air motion) 1-2.5 m/s (200-500 f/min.)

Within each range the appropriate value depends on:Lower end of the range Upper end of the range

1: Room air currents minimal or favourable to capture 1: Disturbing room air currents

2: Contaminants of low toxicity or of nuisance value only. 2: Contaminants of high toxicity

3: Intermittent, low production. 3: High production, heavy use

4: Large hood or large air mass in motion 4: Small hood-local control onlySimple theory shows that air velocity falls rapidly with distance away from the opening of a simple extraction pipe. Velocitygenerally decreases with the square of distance from the extraction point (in simple cases). Therefore the air speed at theextraction point should be adjusted, accordingly, after reference to distance from the contaminating source. The air velocity atthe extraction fan, for example, should be a minimum of 1-2.5 m/s (200-500 f/min.) for extraction of gases discharged 2 metersdistant from the extraction point. Other mechanical considerations, producing performance deficits within the extractionapparatus, make it essential that theoretical air velocities are multiplied by factors of 10 or more when extraction systems areinstalled or used.

Section 9 - PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL PROPERTIES

Solid.Mixes with water.State Divided solid Molecular Weight 405.38

Melting Range (°F) 278.6.5- 293.5 Viscosity Not Applicable

Boiling Range (°F) Not available Solubility in water (g/L) Miscible

Flash Point (°F) Not available pH (1% solution) 9.9-10.9 (2%)

Decomposition Temp (°F) >266 pH (as supplied) Not applicable

455

Autoignition Temp (°F) Not available Vapour Pressure (mmHG) Negligible

Upper Explosive Limit (%) Not available. Specific Gravity (water=1) Not available

Lower Explosive Limit (%) Not available Relative Vapor Density (air=1) >1

Volatile Component (%vol) Negligible Evaporation Rate Not applicable

APPEARANCEWhite to off-white crystalline powder; mixes with water. A weak base, rapidly degraded in acid media.

Section 10 - CHEMICAL STABILITY

CONDITIONS CONTRIBUTING TO INSTABILITY■

Presence of incompatible materials.Product is considered stable.Hazardous polymerization will not occur.

STORAGE INCOMPATIBILITY■ Avoid reaction with oxidizing agents.

For incompatible materials - refer to Section 7 - Handling and Storage.

Section 11 - TOXICOLOGICAL INFORMATION

pantoprazole sodium

TOXICITY AND IRRITATION■ unless otherwise specified data extracted from RTECS - Register of Toxic Effects of Chemical Substances.TOXICITY IRRITATION

Oral (rat) LD50: 747 mg/kg Nil Reported

Intravenous (rat) LD50: 256 mg/kg

Oral (mouse) LD50: >1000 mg/kg

Intravenous (mouse) LD50: 395 mg/kg

Section 12 - ECOLOGICAL INFORMATION

Refer to data for ingredients, which follows:PANTOPRAZOLE SODIUM:■ May cause long-term adverse effects in the aquatic environment.■ Do NOT allow product to come in contact with surface waters or to intertidal areas below the mean high water mark. Do notcontaminate water when cleaning equipment or disposing of equipment wash-waters.Wastes resulting from use of the product must be disposed of on site or at approved waste sites.■ DO NOT discharge into sewer or waterways.

Section 13 - DISPOSAL CONSIDERATIONS

Disposal InstructionsAll waste must be handled in accordance with local, state and federal regulations.¦ Puncture containers to prevent re-use and bury at an authorized landfill.Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to lawsoperating in their area. In some areas, certain wastes must be tracked.A Hierarchy of Controls seems to be common - the user should investigate:

ReductionReuseRecyclingDisposal (if all else fails)

This material may be recycled if unused, or if it has not been contaminated so as to make it unsuitable for its intended use.Shelf life considerations should also be applied in making decisions of this type. Note that properties of a material may changein use, and recycling or reuse may not always be appropriate.DO NOT allow wash water from cleaning equipment to enter drains. Collect all wash water for treatment before disposal.

Recycle wherever possible.Consult manufacturer for recycling options or consult Waste Management Authority for disposal if no suitable treatment ordisposal facility can be identified.Dispose of by: Burial in a licensed land-fill or Incineration in a licensed apparatus (after admixture with suitable combustiblematerial)Decontaminate empty containers. Observe all label safeguards until containers are cleaned and destroyed.

Section 14 - TRANSPORTATION INFORMATION

NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS: DOT, IATA, IMDG

456

Section 15 - REGULATORY INFORMATION

No data for pantoprazole sodium (CAS: , 138786-67-1, 142678-34-0, 226904-33-2, 164579-32-2)

Section 16 - OTHER INFORMATION

LIMITED EVIDENCE■ Cumulative effects may result following exposure*.■ Limited evidence of a carcinogenic effect*.■ Possible skin sensitizer*.* (limited evidence).

Ingredients with multiple CAS NosIngredient Name CASpantoprazole sodium 138786-67-1, 142678-34-0, 226904-33-2, 164579-32-2

Reasonable care has been taken in the preparation of this information, but the author makes no warrantyof merchantability or any other warranty, expressed or implied, with respect to this information. The authormakes no representations and assumes no liability for any direct, incidental or consequential damagesresulting from its use. For additional technical information please call our toxicology department on +800CHEMCALL.

■ Classification of the mixture and its individual components has drawn on official and authoritative sources as well asindependent review by the Chemwatch Classification committee using available literature references.A list of reference resources used to assist the committee may be found at:www.chemwatch.net/references.

■ The (M)SDS is a Hazard Communication tool and should be used to assist in the Risk Assessment. Many factors determinewhether the reported Hazards are Risks in the workplace or other settings. Risks may be determined by reference toExposures Scenarios. Scale of use, frequency of use and current or available engineering controls must be considered.

This document is copyright. Apart from any fair dealing for the purposes of private study, research, reviewor criticism, as permitted under the Copyright Act, no part may be reproduced by any process withoutwritten permission from CHEMWATCH. TEL (+61 3) 9572 4700.

Issue Date: Oct-12-2009

Print Date:Apr-21-2010

457

p. 1

1 1 0

He a lt h

Fire

Re a c t iv it y


1

1

0

E

Material Safety Data SheetSucralfate MSDS


Product Name: Sucralfate

Catalog Codes: SLS3421, SLS1204

CAS#: 54182-58-0

RTECS: BD0900000


CI#: Not available.

Synonym: Ulcerlmin; Carafate; Sucrose Octasulfate-Aluminum Complex; Beta-D-Fructofuranosyl-alpha-D-glucopryanoside octakis aluminum

Chemical Name: Aluminum, hexadeca -mu-hydrosytetracosahydroxy(mu(sup 8)-(1,2,4,6-tetra-O-sulfo-beta-D-fructofuranosyl-alpha-D-glucopyranoside tetrakis(hydrogen sulfato)(8-)))hexadeca-

Chemical Formula: C12H54Al16O75S8









Composition:


Sucralfate 54182-58-0 100

Toxicological Data on Ingredients: Not applicable.



Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Not available. Repeated or prolonged exposure is not known to aggravate medical condition.


458


p. 2

Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Get medical attention if irritation occurs.












Products of Combustion: These products are carbon oxides (CO, CO2), sulfur oxides (SO2, SO3...). Some metallic oxides.

Fire Hazards in Presence of Various Substances: Slightly flammable to flammable in presence of heat.



Special Remarks on Fire Hazards: As with most organic solids, fire is possible at elevated temperatures

Special Remarks on Explosion Hazards:Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust explosionhazard.





Precautions:

459

p. 3

Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe dust. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatiblessuch as oxidizing agents.

Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area.







Physical state and appearance: Solid. (Amorphous solid powder or lumps.)

Odor: Odorless.



Color: White.

pH (1% soln/water): Not applicable.












Solubility:Insoluble in cold water. Practically insoluble in ethanol, chloroform. Soluble in dilute hydrochloric acid and sodium hydroxidesolution.


460

p. 4











Toxicity to Animals: Acute oral toxicity (LD50): >8000 mg/kg [Mouse].

Chronic Effects on Humans: Not available.



Special Remarks on Chronic Effects on Humans: Not available.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: May cause skin irritation. Eyes: May cause eye irritation. Inhalation: May causerespiratory tract irritation. Ingestion: Low Hazard. It is not readily absorbed into the body. May cause abdominal pain/stomachcramps, indigestion, gas (flatulence), constipation. Other less common or rare symptoms may include diarrhea, headache,drowsiness, vertigo, dizziness or lightheadness, dry mouth, nausea, skin rash, hives or itiching, back pain, Medical ConditionsAggravated by Exposure: Gastrointestinal tract obstruction disease. Sucralfate may bind with other foods and drugs and causeobstruction of the gastrointestinal tract; Kidney failure or decreased kidney function. Use may leaed to a toxic increase ofaluminum blood levels; Use of the following drugs: Ciprofloxacin, Digoxin, Norfloxacin, Ofloxacin, Phenytoin, TheophypllineKetoconazole, Thyroxine, Warfarin, Lansoprazole, Amitriptyline. Sucralfate may prevent these medicines from workingproperly.










461

p. 5









DSCL (EEC):This product is not classified according to the EU regulations. Not applicable.

HMIS (U.S.A.):

Health Hazard: 1

Fire Hazard: 1

Reactivity: 0



Health: 1

Flammability: 1

Reactivity: 0

Specific hazard:





Created: 10/09/2005 06:40 PM

Last Updated: 05/21/2013 12:00 PM


462

06/29/2015Revision:

Page: 1 of 5

Montelukast (sodium salt)SAFETY DATA SHEET





Montelukast (sodium salt) Product Name:






1-[[[(1R)-1-[3-(1E)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]-methyl]-cyclopropaneacetic acid, monosodium salt; Singulair®;

Synonyms:





Serious Eye Damage/Eye Irritation, Category 12.1 Classification of the Substance or Mixture:

H318: Causes serious eye damage.GHS Hazard Phrases:

2.2 Label Elements:


P280: Wear {protective gloves/protective clothing/eye protection/face protection}.GHS Precaution Phrases:

P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P310: Immediately call a {POISON CENTER/doctor/...}.



2.3 Causes serious eye damage.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause skin or respiratory system irritation.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


Multi-region format

463

06/29/2015Revision:

Page: 2 of 5



CAS # /RTECS #




151767-02-1GZ0698000

Montelukast sodium 100.0 % 604-813-7 NA

Eye Damage 1: H318










4.1

5.1

5.2


Flash Pt: No data.









5.3

No data available.

6.3

6.1

6.2







Multi-region format

464

06/29/2015Revision:

Page: 3 of 5



7.1

7.2








No data. No data. 151767-02-1 Montelukast sodium No data.



8.2.1







No data available.







Flash Pt: No data.



No data.








~0.15 mg/ml in 1:9 EtOH:PBS (pH 7.2); ~30 mg/ml in EtOH, DMSO, & DMF;Solubility Notes:

Multi-region format

465

06/29/2015Revision:

Page: 4 of 5






Molecular Formula & Weight: C35H35ClNO3S · Na 608.2

10.4

10.5

10.6

10.110.210.3




No data available.Incompatibility - MaterialsTo Avoid:

No data available.HazardousDecomposition orByproducts:




11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Montelukast (sodium salt) - Toxicity Data: Intraperitoneal TDLO (mouse): 1 mg/kg;


Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Montelukast (sodium salt) RTECS Number: GZ0698000


IARC ACGIH OSHA

151767-02-1 Montelukast sodium n.a. n.a. n.a. n.a.

12.1

12.2

12.3

12.4

12.5


Toxicity:









Multi-region format

466

06/29/2015Revision:

Page: 5 of 5














S. 302 (EHS) S. 304 RQ S. 313 (TRI)


151767-02-1 Montelukast sodium No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 151767-02-1 Montelukast sodium CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No








Multi-region format

467

02/06/2015Revision:

Page: 1 of 6

TelmisartanSAFETY DATA SHEET




Telmisartan Product Name:






4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylicacid; BIBR 277; Micardis; Pritor;

Synonyms:





Toxic To Reproduction, Category 2Aquatic Toxicity (Chronic), Category 2


H361: Suspected of damaging fertility or the unborn child.H411: Toxic to aquatic life with long lasting effects.

GHS Hazard Phrases:



P201: Obtain special instructions before use.P202: Do not handle until all safety precautions have been read and understood.P281: Use personal protective equipment as required.P273: Avoid release to the environment.


P308+313: IF exposed or concerned: Get medical attention/advice.P391: Collect spillage.



Multi-region format

468

02/06/2015Revision:

Page: 2 of 6


2.3 Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause eye, skin, or respiratory system irritation.Suspected of damaging fertility or the unborn child.Toxic to aquatic life with long lasting effects.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




144701-48-4DV2037500

Telmisartan 100.0 % NA NA

Toxic Repro. 2: H361Aquatic (C) 2: H411


Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

Multi-region format

469

02/06/2015Revision:

Page: 3 of 6


6.3

6.1

6.2







7.1

7.2








No data. No data. 144701-48-4 Telmisartan No data.



8.2.1







No data available.



Multi-region format

470

02/06/2015Revision:

Page: 4 of 6






Flash Pt: No data.



No data.







~0.5 mg/ml in 1:1 DMF:PBS (pH 7.2); ~1 mg/ml in DMSO; ~1.6 mg/ml in DMF;Solubility Notes:





10.4

10.5

10.6

10.110.210.3




acidsoxidizing agents

Incompatibility - MaterialsTo Avoid:






11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Telmisartan - Toxicity Data: Oral TDLO (man): 32 mg/kg; Intraperitoneal TDLO (mouse): 3 mg/kg;Oral TDLO (rat): 2 mg/kg;


Telmisartan - Investigated as a mutagen.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Telmisartan RTECS Number: DV2037500


IARC ACGIH OSHA

144701-48-4 Telmisartan n.a. n.a. n.a. n.a.

Multi-region format

471

02/06/2015Revision:

Page: 5 of 6


12.1

12.2

12.3

12.4

12.5


Toxicity:



















S. 302 (EHS) S. 304 RQ S. 313 (TRI)


144701-48-4 Telmisartan No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 144701-48-4 Telmisartan CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No





DISCLAIMER: This information is believed to be accurate and represents the best informationcurrently available to us. However, we make no warranty of merchantability or any other warranty,express or implied, with respect to such information, and we assume no liability resulting from its



Multi-region format

472

02/06/2015Revision:

Page: 6 of 6


use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes.

Multi-region format

473

MSDS : 024/00 Effective Date : 03/07/2007 Page 1 of 5

1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY

2. COMPOSITION / INFORMATION ON INGREDIENTS

3. HAZARDOUS IDENTIFICATION

MATERIAL SAFETY DATA SHEET

Material Amlodipine Besylate Tablets 2.5 mg, 5 mg and 10 mg Manufacturer Lupin Limited Mumbai 400 098 INDIA Distributor Lupin Pharmaceuticals, Inc. Harborplace Tower, 21st Floor 111, South Calvert Street Baltimore, MD 21202 United States Tel. 001-410-576-2000 Fax 001-410-576-2221 Ingredients CAS Quantity Amlodipine Besylate equivalent to Amlodipine 88150-42-9 2.5 mg/tablet; 5 mg/tablet; 10 mg/tablet Non-hazardous ingredients -------------- q.s. Fire and Explosion Assume that this product is capable of sustaining combustion. Health Exposure might occur via skin; eyes; ingestion; inhalation. May cause sensitisation by inhalation or skin contact.

Harmful if swallowed. Antihypertensive drug: Has blood pressure lowering properties.

Environment No information is available about the potential of this product to

produce adverse environmental effects.

474


4. FIRST AID MEASURES

Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the exposed subject is unconscious or semi-conscious. Wash out the mouth with water. Obtain medical attention.

Inhalation Move individual to fresh air. Obtain medical attention if breathing difficulty occurs. If not breathing, provide artificial respiration assistance.

Skin Contact Remove contaminated clothing and flush exposed area with large amounts of water. Wash all exposed areas of skin with plenty of soap and water. Obtain medical attention if skin reaction occurs.

Eye Contact Flush eyes with plenty of water. Get medical attention. NOTES TO HEALTH PROFESSIONALS

Medical Treatment Treat according to locally accepted protocols. For additional guidance, refer to the current prescribing information or to the local poison control information center. Protect the patient’s airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, etc. Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Intravenous calcium gluconate may help to reverse the effects of calcium entry blockade. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

Antidotes No specific antidote exists.

475


5. FIRE-FIGHTING MEASURES

6. ACCIDENTAL RELEASE MEASURES

7. HANDLING AND STORAGE

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Fire and Explosion Hazards Assume that this product is capable of sustaining combustion. Extinguishing Media Water spray, carbon dioxide, dry chemical powder or appropriate

foam. Special Firefighting Procedures For single units (packages): No special requirements needed. For larger amounts (multiple packages/pallets) of product: Since

toxic, corrosive or flammable vapors might be evolved from fires involving this product and associated packaging, self contained breathing apparatus and full protective equipment are recommended for firefighters.

Hazardous Combustion Products Hazardous combustion or decomposition products are expected

when the product is exposed to fire. Personal Precautions Wear protective clothing and equipment consistent with the degree

of hazard. Environmental Precautions For large spills, take precautions to prevent entry into waterways,

sewers, or surface drainage systems. Clean-up Methods Collect and place it in a suitable, properly labeled container for

recovery or disposal. Handling No special control measures required for the normal handling of

this product. Normal room ventilation is expected to be adequate for routine handling of this product.

Storage Store at 20°-25°C (68°-77°F) [See USP Controlled Room

Temperature]. Protect from light. Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after handling.

476


11. TOXICOLOGICAL INFORMATION

9. PHYSICAL & CHEMICAL PROPERTIES

10. STABILITY AND REACTIVITY

Physical Form 2.5 mg : White to off-white, diamond shaped tablets 5 mg : White to off-white, elongated octagonal tablets 10 mg : White to off-white, round tablets Stable under recommended storage conditions.

Oral Toxicity: Not expected to be toxic following ingestion of recommended maximum daily dose.

Inhalation Toxicity: Can produce respiratory irritation. Adverse effects might occur following inhalation.

Skin Effects: Irritation might occur following direct contact.

Eye Effects: Irritation might occur following direct contact with eyes.

Gastrointestinal Reactions: Anorexia, constipation, dyspepsia, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia

Subchronic effects: Subchronic toxicity of amlodipine besylate was evaluated in rats at oral doses up to 30 mg/kg/day for three months. Drug- related changes included increased heart and gland weight and were reversed one month after cessation of the treatment. These changes are considered to be the effect of the desired effects of the drug, however, they are considered potential hazards in the workplace.

Genetic Toxicity: Not expected to be genotoxic based on animal studies.

Carcinogenicity: Not expected to be carcinogenic based on animal studies.

Reproductive Effects: Not expected to produce adverse effects on fertility or development based on animal studies. No adequate and well-controlled studies in pregnant women. No studies during labor and delivery. Should be used during pregnancy only if clearly needed.

Pharmacological Effects: This material is a calcium channel blocker. It is antianginal and antihypertensive.

477


12. ECOLOGICAL INFORMATION

13. DISPOSAL CONSIDERATION

14. TRANSPORT INFORMATION

15. REGULATORY INFORMATION

16. OTHER INFORMATION

No relevant studies identified. Incinerate in an approved facility. Follow all federal state and local environmental regulations. The Material Safety Data Sheet (MSDS) should accompany all shipments for reference in the event of spillage or accidental release. Transportation and shipping of this product is not restricted. It has no known, significant hazards requiring special packaging or labeling for air, maritime, or ground transport purposes. No information found. The above information is believed to be correct but does not purport to be all-inclusive and shall be used only as a guide. Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine the applicability of this information and the suitability of the material or product for any particular purpose. Lupin shall not be held liable for any damage resulting from handling or from contact with the above product. Lupin reserves the right to revise this MSDS.

478

11/26/2014Revision:

Page: 1 of 6

SilodosinSAFETY DATA SHEET




Silodosin Product Name:






2,3-dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carboxamide; KMD-3213;

Synonyms:





Skin Corrosion/Irritation, Category 2Serious Eye Damage/Eye Irritation, Category 2Target Organ Systemic Toxicity (single exposure), Category 3


2.1.2 Classification according to Directive 1999/45/EC:Xi: IrritantRisk Phrases: R36/37/38For full text of R- phrases: see SECTION 15.

H315: Causes skin irritation.H319: Causes serious eye irritation.H335: May cause respiratory irritation.

GHS Hazard Phrases:



Multi-region format

479

11/26/2014Revision:

Page: 2 of 6


P264: Wash {hands} thoroughly after handling.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.P362+364: Take off contaminated clothing and wash it before reuse.P261: Avoid breathing {dust/fume/gas/mist/vapours/spray}.


P302+352: IF ON SKIN: Wash with plenty of soap and water.P332+313: If skin irritation occurs, get medical advice/attention.P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P337+313: If eye irritation persists, get medical advice/attention.P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.P312: Call a {POISON CENTER/doctor/...} if you feel unwell.



Xi


2.3 Causes skin irritation.Causes serious eye irritation.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause respiratory irritation.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




160970-54-7NA

2,3-dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carboxamide

100.0 % NA NA

Xi; R36/37/38Skin Corr. 2: H315Eye Damage 2: H319TOST (SE) 3: H335 H336

Multi-region format

480

11/26/2014Revision:

Page: 3 of 6



Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

6.3

6.1

6.2







7.1

7.2








No data. No data. 160970-54-7 2,3-dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carbox

No data.

Multi-region format

481

11/26/2014Revision:

Page: 4 of 6


amide


No data. No data. 160970-54-7 2,3-dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carboxamide

No data.

8.2.1







No data available.







Flash Pt: No data.



No data.











Molecular Formula & Weight: C25H32F3N3O4 495.5

Multi-region format

482

11/26/2014Revision:

Page: 5 of 6


10.4

10.5

10.6

10.110.210.3










11.1

Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Information on

Toxicological Effects:NTP? No IARC Monographs? No OSHA Regulated? NoCarcinogenicity:

12.1

12.2

12.3

12.4

12.5


Toxicity:

















Multi-region format

483

11/26/2014Revision:

Page: 6 of 6




S. 302 (EHS) S. 304 RQ S. 313 (TRI)


160970-54-7 2,3-dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carboxamide

No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 160970-54-7 2,3-dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2

,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carboxamide

CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CAPROP.65: No

XiEuropean Community Risk and Safety Phrases:


Irritating to eyes, respiratory system and skin.R36/37/38Avoid contact with skin and eyes.S24/25Wear suitable protective clothing, gloves and eye/face protection.S36/37/39

This SDS was prepared in accordance with 29 CFR 1910.1200, Regulation (EC) No.1272/2008,and European Directive 67/548/EEC as amended.







Multi-region format

484

03/05/2015Revision:

Page: 1 of 6

OlanzapineSAFETY DATA SHEET




Olanzapine Product Name:






2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine; Zyprexa®; Synonyms:





Skin Corrosion/Irritation, Category 2Serious Eye Damage/Eye Irritation, Category 2Aquatic Toxicity (Chronic), Category 4


H315: Causes skin irritation.H319: Causes serious eye irritation.H413: May cause long lasting harmful effects to aquatic life.

GHS Hazard Phrases:



P264: Wash {hands} thoroughly after handling.P273: Avoid release to the environment.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.


P302+352: IF ON SKIN: Wash with plenty of soap and water.P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P332+313: If skin irritation occurs, get medical advice/attention.P337+313: If eye irritation persists, get medical advice/attention.P362: Take off contaminated clothing and wash before re-use.


GHS Storage and Disposal Phrases:

Multi-region format

485

03/05/2015Revision:

Page: 2 of 6


Please refer to Section 7 for Storage and Section 13 for Disposal information.

2.3 Causes serious eye irritation.Causes skin irritation.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause respiratory system irritation.May cause long lasting harmful effects to aquatic life.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




132539-06-1XJ9007750

10H-Thieno[2,3-b][1,5]benzodiazepine,2-methyl-4-(4-methyl-1-piperazinyl)-

100.0 % 603-618-4 NA

Skin Corr. 2: H315Eye Damage 2: H319Aquatic (C) 4: H413


Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

Multi-region format

486

03/05/2015Revision:

Page: 3 of 6


6.3

6.1

6.2







7.1

7.2








No data. No data. 132539-06-1 10H-Thieno[2,3-b][1,5]benzodiazepine,2-methyl-4-(4-methyl-1-piperazinyl)-

No data.



No data.

8.2.1







No data available.



Multi-region format

487

03/05/2015Revision:

Page: 4 of 6






Flash Pt: No data.



No data.







~0.5 mg/ml in a 1:1 solution of DMSO:PBS (pH 7.2); ~1 mg/ml in EtOH; ~16 mg/ml inDMSO; ~20 mg/ml in DMF;

Solubility Notes:




Molecular Formula & Weight: C17H20N4S 312.4

10.4

10.5

10.6

10.110.210.3





carbon dioxidecarbon monoxidenitrogen oxidessulfur oxides





Multi-region format

488

03/05/2015Revision:

Page: 5 of 6


11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Olanzapine - Toxicity Data: Oral LDLO (man): 7067 ug/kg; Oral TDLO (woman): 400 ug/kg;Subcutaneous TDLO (rat): 625 ug/kg; Intraperitoneal TDLO rat 5 mg/kg;


Olanzapine - Investigated as a drug.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Olanzapine RTECS Number: XJ9007750


IARC ACGIH OSHA

132539-06-1 10H-Thieno[2,3-b][1,5]benzodiazepine,2-methyl-4-(4-methyl-1-piperazinyl)-

n.a. n.a. n.a. n.a.

12.1

12.2

12.3

12.4

12.5


Toxicity:


















Multi-region format

489

03/05/2015Revision:

Page: 6 of 6




S. 302 (EHS) S. 304 RQ S. 313 (TRI)



No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 132539-06-1 10H-Thieno[2,3-b][1,5]benzodiazepine,

2-methyl-4-(4-methyl-1-piperazinyl)-CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CAPROP.65: No








Multi-region format

490

11/25/2014Revision:

Page: 1 of 6

GlimepirideSAFETY DATA SHEET




Glimepiride Product Name:






3-ethyl-2,5-dihydro-4-methyl-N-[2-[4-[[[[(trans-4-methylcyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-2-oxo-1H-pyrrole-1-carboxamide; Amaryl; Glista OD;

Synonyms:





Serious Eye Damage/Eye Irritation, Category 2A


2.1.2 Classification according to Directive 1999/45/EC:Xi: IrritantRisk Phrases: R36For full text of R- phrases: see SECTION 15.

H319: Causes serious eye irritation.GHS Hazard Phrases:





P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P337+313: If eye irritation persists, get medical advice/attention.



Multi-region format

491

11/25/2014Revision:

Page: 2 of 6


Xi


2.3 Causes serious eye irritation.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause skin or respiratory system irritation.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




93479-97-1UX9363950

Glimepiride 100.0 % NA NA

Xi; R36Eye Damage 2A: H319


Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

Multi-region format

492

11/25/2014Revision:

Page: 3 of 6


6.3

6.1

6.2







7.1

7.2








No data. No data. 93479-97-1 Glimepiride No data.


No data. No data. 93479-97-1 Glimepiride No data.

8.2.1







No data available.



Multi-region format

493

11/25/2014Revision:

Page: 4 of 6






Flash Pt: No data.



No data.







~0.5 mg/ml in 1:1 DMF:PBS (pH 7.2); ~3 mg/ml in DMSO; ~10 mg/ml in DMF;Solubility Notes:




Molecular Formula & Weight: C24H34N4O5S 490.6

10.4

10.5

10.6

10.110.210.3










Multi-region format

494

11/25/2014Revision:

Page: 5 of 6


11.1

Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Glimepiride - Toxicity Data: Oral TDLO (man): 28 µg/kg/2D (intermittent); Oral LD (rat): >10 g/kg;


Glimepiride - Investigated as a reproductive effector.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Glimepiride RTECS Number: UX9363950



12.1

12.2

12.3

12.4

12.5


Toxicity:



















S. 302 (EHS) S. 304 RQ S. 313 (TRI)


93479-97-1 Glimepiride No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 93479-97-1 Glimepiride CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No

Multi-region format

495

11/25/2014Revision:

Page: 6 of 6


XiEuropean Community Risk and Safety Phrases:


Irritating to eyes.R36Avoid contact with skin and eyes.S24/25In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.S26Wear suitable protective clothing, gloves and eye/face protection.S36/37/39

This SDS was prepared in accordance with 29 CFR 1910.1200, Regulation (EC) No.1272/2008,and European Directive 67/548/EEC as amended.





N.A.=Not available, N.P.=Not applicable, N.D.=Not determined, N.E.=Not established, N.R.=Notrequired



Multi-region format

496

03/01/2015Revision:

Page: 1 of 6

ChlorthalidoneSAFETY DATA SHEET




Chlorthalidone Product Name:






2-chloro-5-(2,3-dihydro-1-hydroxy-3-oxo-1H-isoindol-1-yl)-benzenesulfonamide; Hygroton; NSC69200; Oradil; Thalitone®;

Synonyms:





Skin Corrosion/Irritation, Category 2Serious Eye Damage/Eye Irritation, Category 2Toxic To Reproduction, Category 1BTarget Organ Systemic Toxicity (single exposure), Category 3


H315: Causes skin irritation.H319: Causes serious eye irritation.H360: May damage fertility or the unborn child.H335: May cause respiratory irritation.

GHS Hazard Phrases:



P264: Wash {hands} thoroughly after handling.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.P362+364: Take off contaminated clothing and wash it before reuse.P201: Obtain special instructions before use.P202: Do not handle until all safety precautions have been read and understood.P281: Use personal protective equipment as required.P261: Avoid breathing {dust/fume/gas/mist/vapours/spray}.



Multi-region format

497

03/01/2015Revision:

Page: 2 of 6


P302+352: IF ON SKIN: Wash with plenty of soap and water.P332+313: If skin irritation occurs, get medical advice/attention.P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P337+313: If eye irritation persists, get medical advice/attention.P308+313: IF exposed or concerned: Get medical attention/advice.P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.P312: Call a {POISON CENTER/doctor/...} if you feel unwell.


2.3 Causes serious eye irritation.Causes skin irritation.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause respiratory system irritation.May damage fertility or the unborn child.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




77-36-1DB1556000

Chlortalidone 100.0 % 201-022-5 NA

Skin Corr. 2: H315Eye Damage 2: H319TOST (SE) 3: H335 H336Toxic Repro. 1B: H360


Measures:









4.1

Multi-region format

498

03/01/2015Revision:

Page: 3 of 6


5.1

5.2


Flash Pt: No data.









5.3

6.3

6.1

6.2







7.1

7.2








No data. No data. 77-36-1 Chlortalidone No data.


No data. No data. 77-36-1 Chlortalidone No data.

8.2.1





Do not take internally.Facilities storing or utilizing this material should be equipped with an eyewash and a safety shower.




Multi-region format

499

03/01/2015Revision:

Page: 4 of 6


Wash thoroughly after handling.

No data available.





Flash Pt: No data.



No data.







~0.5 mg/ml in a 1:1 solution of DMSO:PBS (pH 7.2); ~10 mg/ml in EtOH; ~30 mg/ml inDMSO & DMF;

Solubility Notes:




Molecular Formula & Weight: C14H11ClN2O4S 338.8

10.4

10.5

10.6

10.110.210.3





No data available.HazardousDecomposition OrByproducts:




Multi-region format

500

03/01/2015Revision:

Page: 5 of 6


11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Chlorthalidone - Toxicity Data: Oral LD50 (rat): >5 gm/kg; Subcutaneous LD50 (rat): >5 gm/kg;Oral LD50 (mouse): >5 gm/kg; SubcutaneousLD50 (mouse): >5 gm/kg; Oral TDLO (man): 5714ug/kg/4D (intermittent); Oral Human - woman 12 mg/kg/6D (intermittent);


Chlorthalidone - Investigated as a reproductive effector.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Chlorthalidone RTECS Number: DB1556000


IARC ACGIH OSHA

77-36-1 Chlortalidone n.a. n.a. n.a. n.a.

12.1

12.2

12.3

12.4

12.5


Toxicity:

















Multi-region format

501

03/01/2015Revision:

Page: 6 of 6




S. 302 (EHS) S. 304 RQ S. 313 (TRI)


77-36-1 Chlortalidone No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 77-36-1 Chlortalidone CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No








Multi-region format

502

01/25/2016Revision:

Page: 1 of 5

Tapentadol (hydrochloride) RMSAFETY DATA SHEET




Tapentadol (hydrochloride) RM Product Name:






3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol, monohydrochloride; Nucynta;Palexia;

Synonyms:





Toxic To Reproduction, Category 22.1 Classification of the Substance or Mixture:

H361: Suspected of damaging fertility or the unborn child.GHS Hazard Phrases:

2.2 Label Elements:


P201: Obtain special instructions before use.P202: Do not handle until all safety precautions have been read and understood.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.


P308+313: IF exposed or concerned: Get medical attention/advice.GHS Response Phrases:


2.3 Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause eye, skin, or respiratory system irritation.Suspected of damaging fertility or the unborn child.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


Multi-region format

503

01/25/2016Revision:

Page: 2 of 5


CAS # /RTECS #




175591-09-0SL1550000

Tapentadol (hydrochloride) RM 100.0 % NA NA

Toxic Repro. 2: H361










4.1

5.1

5.2


Flash Pt: No data.









5.3

No data available.

6.3

6.1

6.2







Multi-region format

504

01/25/2016Revision:

Page: 3 of 5


7.1

7.2








No data. No data. 175591-09-0 Tapentadol (hydrochloride) RM No data.



8.2.1







No data available.







Flash Pt: No data.



No data.



A neat solidAppearance and Odor:






Multi-region format

505

01/25/2016Revision:

Page: 4 of 5




Molecular Formula & Weight: C14H23NO • HCl 257.8

10.4

10.5

10.6

10.110.210.3









11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Tapentadol (hydrochloride) - Toxicity Data: Intraperitoneal TDLO (rat): 10 mg/kg;


Tapentadol (hydrochloride) - Investigated as a drug.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Tapentadol (hydrochloride) RTECS Number: SL1550000


IARC ACGIH OSHA

175591-09-0 Tapentadol (hydrochloride) RM n.a. n.a. n.a. n.a.

12.1

12.2

12.3

12.4

12.5


Toxicity:









Multi-region format

506

01/25/2016Revision:

Page: 5 of 5













S. 302 (EHS) S. 304 RQ S. 313 (TRI)


175591-09-0 Tapentadol (hydrochloride) RM No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 175591-09-0 Tapentadol (hydrochloride) RM CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No








Multi-region format

507

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGProduct Identifier

Material Name: Voriconazole for IV infusion

Trade Name: Vfend: SPIONIC; VIMERO; Voriconazole pfizerChemical Family: Mixture

Relevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use: Pharmaceutical product used as antifungal agent

Details of the Supplier of the Safety Data Sheet

2. HAZARDS IDENTIFICATION

Classification of the Substance or MixtureGHS - Classification

Skin Sensitization: Category 1Reproductive Toxicity: Category 1BCarcinogenicity: Category 2Specific target organ systemic toxicity (repeated exposure): Category 2

US OSHA Specific - ClassificationPhysical Hazard: Combustible Dust

EU Classification:EU Indication of danger: Toxic to Reproduction: Category 2

Carcinogenic: Category 3Irritant

EU Risk Phrases:R40 - Limited evidence of a carcinogenic effect.R43 - May cause sensitization by skin contact.R61 - May cause harm to the unborn child.

Label ElementsSignal Word: Danger

_______________________________________________________________________________________________________556

Contact E-Mail: [email protected]

SAFETY DATA SHEET

Page 1 of 9

Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-800-879-3477

Pfizer LtdRamsgate RoadSandwich, KentCT13 9NJUnited Kingdom+00 44 (0)1304 616161

Revision date: 04-Apr-2015

Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300

Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887

Version: 3.0

508

SAFETY DATA SHEET

_______________________________________________________________________________________________________

2. HAZARDS IDENTIFICATIONHazard Statements: H317 - May cause an allergic skin reaction

H351 - Suspected of causing cancerH360D - May damage the unborn childH373 - May cause damage to organs through prolonged or repeated exposureMay form combustible dust concentrations in air

Precautionary Statements: P202 - Do not handle until all safety precautions have been read and understoodP260 - Do not breathe dust/fume/gas/mist/vapors/sprayP272 - Contaminated work clothing should not be allowed out of the workplaceP280 - Wear protective gloves/protective clothing/eye protection/face protectionP308 + P313 - IF exposed or concerned: Get medical attention/adviceP302+ P352 - IF ON SKIN: Wash with plenty of soap and waterP333 + P313 - If skin irritation or rash occurs: Get medical advice/attentionP363 - Wash contaminated clothing before reuseP405 - Store locked upP501 - Dispose of contents/container in accordance with all local and national regulations

Other Hazards No data availableAustralian Hazard Classification(NOHSC):

Hazardous Substance. Non-Dangerous Goods.

Note: This document has been prepared in accordance with standards for workplace safety, whichrequire the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warnings included may not apply in all cases.Your needs may vary depending upon the potential for exposure in your workplace.


HazardousIngredient CAS Number EU

EINECS/ELINCSList

EU Classification GHSClassification

%

Voriconazole 137234-62-9 Not Listed Carc. Cat.3;R40Repr. Cat.2;R61

Xn;R22Xn;R48/22

Acute Tox.3 (H301)Carc. 2 (H351)

Repr. 1B (H360D)STOT RE 2 (H373)

Aquatic Acute 3(H402)

5-7

Sulfobutylether b-cyclodextrin sodium(SBECD)

7585-39-9 231-493-2 Xi;43 Skin Sens. 1(H317)

*

Additional Information: * ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety.In accordance with 29 CFR 1910.1200, the exact percentage composition of this mixture hasbeen withheld as a trade secret.

_______________________________________________________________________________________________________556

Revision date: 04-Apr-2015Material Name: Voriconazole for IV infusion

Version: 3.0Page 2 of 9

509

SAFETY DATA SHEET

_______________________________________________________________________________________________________

For the full text of the R phrases and CLP/GHS abbreviations mentioned in this Section, see Section 16


Description of First Aid MeasuresEye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention

immediately.

Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical attention.

Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention immediately.

Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.

Most Important Symptoms and Effects, Both Acute and DelayedSymptoms and Effects ofExposure:

For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological Information.

Medical ConditionsAggravated by Exposure:

None known

Indication of the Immediate Medical Attention and Special Treatment NeededNotes to Physician: None

5. FIRE FIGHTING MEASURES

Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.

Special Hazards Arising from the Substance or MixtureHazardous CombustionProducts:

Carbon monoxide, carbon dioxide, nitrogen oxides and fluorine-containing compounds

Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.

Advice for Fire-FightersDuring all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.


Personal Precautions, Protective Equipment and Emergency ProceduresPersonnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.

Environmental PrecautionsPlace waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.

Methods and Material for Containment and Cleaning UpMeasures for Cleaning /Collecting:

Contain the source of spill if it is safe to do so. Collect spilled material by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area thoroughly.

Additional Consideration forLarge Spills:

Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained personnel.

_______________________________________________________________________________________________________556



510

SAFETY DATA SHEET

_______________________________________________________________________________________________________


Precautions for Safe HandlingAvoid generating airborne dust. Avoid breathing dust. Avoid contact with eyes, skin and clothing. When handling, useappropriate personal protective equipment (see Section 8). Wash thoroughly after handling. Releases to the environment shouldbe avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphereshould be controlled with dust collectors, HEPA filtration systems or other equivalent controls.

Conditions for Safe Storage, Including any IncompatibilitiesStorage Conditions: Store as directed by product packaging.

Specific end use(s): Pharmaceutical drug product

8. EXPOSURE CONTROLS / PERSONAL PROTECTIONControl Parameters

Analytical Method: Analytical method available for Voriconazole and Sulfobutylether b-cyclodextrin sodium.Contact Pfizer Inc for further information.

Exposure ControlsEngineering Controls: Engineering controls should be used as the primary means to control exposures. General

room ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this section.

Personal ProtectiveEquipment:

Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).

Hands: Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing operations.

Eyes: Wear safety glasses or goggles if eye contact is possible.Skin: Impervious protective clothing is recommended if skin contact with drug product is possible and

for bulk processing operations.Respiratory protection: If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate

respirator with a protection factor sufficient to control exposures to below the OEL.

9. PHYSICAL AND CHEMICAL PROPERTIES

Solvent Solubility: No data availableWater Solubility: No data availablepH: 5.7-7.3 (reconstituted)Melting/Freezing Point (°C): No data availableBoiling Point (°C): No data available.Partition Coefficient: (Method, pH, Endpoint, Value)

_______________________________________________________________________________________________________556

Mixture Molecular Weight: Mixture

Pfizer OEL TWA-8 Hr: 100µg/m3

Sulfobutylether b-cyclodextrin sodium (SBECD)


Pfizer OEL TWA-8 Hr: 3000µg/m3

Physical State: Lyophilized powder Color: White

Version: 3.0


Odor:

No data available

No data available.

Voriconazole

Odor Threshold: No data available.

Page 4 of 9

Molecular Formula:

511

SAFETY DATA SHEET

_______________________________________________________________________________________________________


Decomposition Temperature (°C): No data available.

Evaporation Rate (Gram/s): No data availableVapor Pressure (kPa): No data availableVapor Density (g/ml): No data availableRelative Density: No data availableViscosity: No data available

Flammablity:Autoignition Temperature (Solid) (°C): No data availableFlammability (Solids): No data availableFlash Point (Liquid) (°C): No data availableUpper Explosive Limits (Liquid) (% by Vol.): No data availableLower Explosive Limits (Liquid) (% by Vol.): No data available

Polymerization: Will not occur


Reactivity: No data availableChemical Stability: Stable under normal conditions of use.Possibility of Hazardous Reactions

Oxidizing Properties: No data availableConditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions.Incompatible Materials: As a precautionary measure, keep away from strong oxidizersHazardous DecompositionProducts:

No data available


Information on Toxicological EffectsGeneral Information: The information included in this section describes the potential hazards of the individual

ingredients.Short Term: May produce slight eye irritation., May be harmful if swallowed. (based on components) .

Accidental ingestion may cause effects similar to those seen in clinical use.Long Term: Adverse reproductive effects seen in repeat-dose animal studies are consistent with the

pharmacologic action of this drug and are expected to be relevant to humans. Animal studiesindicate that this material may cause adverse effects on the liver, the developing fetus.

Known Clinical Effects: The most common adverse effects reported with clinical use of voriconazole include visualdisturbances, elevations of liver function tests and skin rash. Voriconazole has beenassociated with photosensitivity skin reactions especially during long term therapy.

Acute Toxicity: (Species, Route, End Point, Dose)

_______________________________________________________________________________________________________556


Voriconazole

Version: 3.0

Rat/Mouse Oral LD50 < 300 mg/kg

Page 5 of 9

Voriconazole

Rat/Mouse Oral LDmin. > 100mg/kgRat IV LD50 > 100mg/kg


Rat Dermal LD50 > 2000mg/kg

Measured 7 Log P 1.75

Rat Oral LD50 > 2000 mg/kg


Rat/Mouse IV LD50 > 2000mg/kg

512

SAFETY DATA SHEET

_______________________________________________________________________________________________________

11. TOXICOLOGICAL INFORMATIONAcute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable

at the highest dose used in the test.

Irritation / Sensitization: (Study Type, Species, Severity)

Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)

Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))

Genetic Toxicity: (Study Type, Cell Type/Organism, Result)

_______________________________________________________________________________________________________556

Page 6 of 9

Skin Irritation Rabbit Non-irritating


Sulfobutylether b-cyclodextrin sodium (SBECD)Fertility and Embryonic Development Rat Intravenous1500 mg/kg/day NOAEL No effects at maximum dose

6 Month(s) Rat Intravenous 600 mg/kg/day NOAEL Kidney, Liver

Embryo / Fetal Development Rabbit Intravenous 1500 mg/kg/day NOAEL Not Teratogenic

Skin Sensitization - GPMT Guinea Pig Positive

Prenatal & Postnatal Development Rat Intravenous 600 mg/kg/day NOAEL Maternal Toxicity

1 Month(s) Rat Intravenous 160 mg/kg/day NOAEL Kidney


Voriconazole


Reproductive & Fertility Rat Oral3 mg/kg/day NOAEL Fetotoxicity

6 Month(s) Dog Intravenous 600 mg/kg/day NOAEL Kidney

Embryo / Fetal Development Rat Oral 10 mg/kg/day LOAEL Teratogenic

Voriconazole

1 Month(s) Dog Intravenous 120 mg/kg/day NOAEL Kidney



Bacterial Mutagenicity (Ames) Salmonella , E. coli Negative

Voriconazole

In Vitro Chromosome Aberration Human Lymphocytes Negative


Mammalian Cell Mutagenicity Chinese Hamster Ovary (CHO) cells HGPRT Negative

1 Month(s) Rat Oral30 mg/kg/day NOAEL Liver

In Vivo Micronucleus Mouse Bone Marrow Negative

Version: 3.0

Voriconazole

6 Month(s) Rat Oral 3 mg/kg/day NOAEL Liver, Kidney

Bacterial Mutagenicity (Ames) Bacteria Negative

Skin Sensitization - GPMT Guinea Pig Negative

In Vitro Human Lymphocytes Equivocal

12 Month(s) Dog Oral 8 mg/kg/day NOAEL Liver

In Vivo Micronucleus Mouse Negative

Eye Irritation Rabbit Non-irritating

6 Month(s) Rat Intravenous 10 mg/kg/day NOAEL Liver

Eye Irritation Rabbit Minimal


513

SAFETY DATA SHEET

_______________________________________________________________________________________________________


Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))

Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.


Environmental Overview: In the environment, the active ingredient in this formulation is expected to remain in water ormigrate through the soil to groundwater and degrade slowly . Harmful effects to aquaticorganisms could occur.

Toxicity:

Aquatic Toxicity: (Species, Method, End Point, Duration, Result)

Aquatic Toxicity Comments: A greater than symbol (>) indicates that aquatic toxicity was not observed at the maximumdose tested.

Bacterial Inhibition: (Inoculum, Method, End Point, Result)

Chronic Aquatic Toxicity: (Species, Method, Duration, Endpoint, Result, Adverse Endpoint)

Persistence and Degradability:Biodegradation: (Method, Inoculum, Biodeg Study, Result, Endpoint, Duration, Classification)

Bio-accumulative Potential:

_______________________________________________________________________________________________________556

Activated sludge OECD EC50 > 810 mg/L

Green algae OECD IC50 72 Hours > 100 mg/L

Page 7 of 9

Polytox MIC > 100 mg/L

Voriconazole

Voriconazole

Voriconazole

Daphnia magna (Water Flea) OECD 21 Day(s) NOEC > 1 mg/L

Mysidopsis bahia (Mysid Shrimp) NPDES LC50 48 Hours 62 mg/L

Pimephales promelas (Fathead Minnow) OECD 32 Day(s) NOEC 1.2 mg/L


Chironomus riparius (Sediment-Dwelling Midges) OECD 28 Day(s) NOEC 100 mg/L

Red Algae IC50 73 mg/L

2 Year(s) Rat Oral 18 mg/kg/day NOEL Benign tumors, Liver

Skeletonema costatum (Marine Diatom) NPDES IC-50 48 Hours 74.7 mg/L


Green Algae OECD EbC50/72hr (OECD) EC50 72 Hours > 97 mg/L

Voriconazole


OECD Activated sludge Ultimate (CO2 Evolution) -0.24% After 28 Day(s) Not Ready

Oncorhynchus mykiss (Rainbow Trout) OECD LC50 96 Hours 110 mg/L

Oncorhynchus mykiss (Rainbow Trout) OECD LC50 96 Hours > 220 mg/L

2 Year(s) Mouse Oral 30 mg/kg/day NOAEL Malignant tumors, Liver

Daphnia magna (Water Flea) OECD EC-50 48 Hours > 96 mg/L

Voriconazole

Version: 3.0

514

SAFETY DATA SHEET

_______________________________________________________________________________________________________

Partition Coefficient: (Method, pH, Endpoint, Value)

Mobility in Soil: No data available

13. DISPOSAL CONSIDERATIONS

Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the material, review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and wastewater.

14. TRANSPORT INFORMATIONThe following refers to all modes of transportation unless specified below.

Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.


Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture

Canada - WHMIS: ClassificationsWHMIS hazard class:Class D, Division 2, Subdivision A

_______________________________________________________________________________________________________556

CERCLA/SARA 313 Emission reporting Not ListedCalifornia Proposition 65 Not Listed


Standard for the Uniform Schedulingfor Drugs and Poisons:

Schedule 4


EU EINECS/ELINCS List Not Listed


Voriconazole

Voriconazole

515

SAFETY DATA SHEET

_______________________________________________________________________________________________________



Text of R phrases and GHS Classification abbreviations mentioned in Section 3

Acute toxicity, oral-Cat.3; H301 - Toxic if swallowedCarcinogenicity-Cat.2; H351 - Suspected of causing cancerReproductive toxicity-Cat.1B; H360D - May damage the unborn childSpecific target organ toxicity, repeated exposure-Cat.2; H373 - May cause damage to organs through prolonged or repeated exposureSensitization, skin-Cat.1; H317 - May cause an allergic skin reactionHazardous to the aquatic environment, acute toxicity-Cat.3; H402 - Harmful to aquatic life

Carcinogenic: Category 3Toxic to Reproduction: Category 2Xn - HarmfulXi - Irritant

R22 - Harmful if swallowed.R40 - Limited evidence of a carcinogenic effectR61 - May cause harm to the unborn child.R43 - May cause sensitization by skin contact.R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed.

Data Sources: Pfizer proprietary drug development information.

Reasons for Revision: Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information onIngredients. Updated Section 7 - Handling and Storage. Updated Section 11 - ToxicologyInformation. Updated Section 12 - Ecological Information. Updated Section 1 - Identification ofthe Substance/Preparation and the Company/Undertaking. Updated Section 16 - OtherInformation.


Prepared by:Product Stewardship Hazard Communication

Pfizer Global Environment, Health, and Safety Operations

Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, itis without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no knowninformation at this time.

End of Safety Data Sheet

_______________________________________________________________________________________________________556


EU EINECS/ELINCS List 231-493-2

CERCLA/SARA 313 Emission reporting Not Listed


California Proposition 65 Not Listed


Inventory - United States TSCA - Sect. 8(b) Present


Australia (AICS): Present

516

SAFETY DATA SHEETRevision Date 25-May-2017 Revision Number 2

1. IdentificationProduct Name L(-)-Phenylephrine hydrochloride

Cat No. : AC207240000; AC207240100; AC207240250; AC207241000

Synonyms 3-Hydroxy-$1-(methylaminomethyl)benzyl alcohol

Recommended Use Laboratory chemicals.Uses advised against Not for food, drug, pesticide or biocidal product use

Details of the supplier of the safety data sheet

Emergency Telephone NumberFor information US call: 001-800-ACROS-01 / Europe call: +32 14 57 52 11Emergency Number US:001-201-796-7100 / Europe: +32 14 57 52 99CHEMTREC Tel. No.US:001-800-424-9300 / Europe:001-703-527-3887

2. Hazard(s) identificationClassification This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Label Elements

Signal WordWarning

Hazard StatementsHarmful if swallowedCauses skin irritationCauses serious eye irritationMay cause respiratory irritation

CompanyFisher ScientificOne Reagent LaneFair Lawn, NJ 07410Tel: (201) 796-7100

Acros OrganicsOne Reagent LaneFair Lawn, NJ 07410

Acute oral toxicity Category 4Skin Corrosion/irritation Category 2Serious Eye Damage/Eye Irritation Category 2Specific target organ toxicity (single exposure) Category 3Target Organs - Respiratory system.

______________________________________________________________________________________________

Page 1 / 7

517

______________________________________________________________________________________________L(-)-Phenylephrine hydrochloride Revision Date 25-May-2017

Precautionary StatementsPreventionWash face, hands and any exposed skin thoroughly after handlingDo not eat, drink or smoke when using this productWear protective gloves/protective clothing/eye protection/face protectionAvoid breathing dust/fume/gas/mist/vapors/sprayUse only outdoors or in a well-ventilated areaInhalationIF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathingCall a POISON CENTER or doctor/physician if you feel unwellSkinIF ON SKIN: Wash with plenty of soap and waterIf skin irritation occurs: Get medical advice/attentionTake off contaminated clothing and wash before reuseEyesIF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsingIf eye irritation persists: Get medical advice/attentionIngestionIF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwellRinse mouthStorageStore in a well-ventilated place. Keep container tightly closedStore locked upDisposalDispose of contents/container to an approved waste disposal plantHazards not otherwise classified (HNOC) None identified

3. Composition / information on ingredients

Component CAS-No Weight %Phenylephrine hydrochloride 61-76-7 99

4. First-aid measures

Eye Contact Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes.Obtain medical attention.

Skin Contact Wash off immediately with soap and plenty of water while removing all contaminatedclothes and shoes. Obtain medical attention.

Inhalation Remove from exposure, lie down. Move to fresh air. If breathing is difficult, give oxygen. Ifnot breathing, give artificial respiration. Obtain medical attention.

Ingestion Clean mouth with water. Get medical attention.

Most important symptoms/effects No information available.Notes to Physician Treat symptomatically

______________________________________________________________________________________________

Page 2 / 7

518


5. Fire-fighting measuresSuitable Extinguishing Media Water spray. Carbon dioxide (CO 2). Dry chemical. Chemical foam.

Unsuitable Extinguishing Media No information available

Flash Point No information availableMethod - No information available

Autoignition Temperature No information availableExplosion Limits

Upper No data availableLower No data availableSensitivity to Mechanical Impact No information availableSensitivity to Static Discharge No information available

Specific Hazards Arising from the ChemicalKeep product and empty container away from heat and sources of ignition.

Hazardous Combustion ProductsHydrogen chloride gas Nitrogen oxides (NOx) Carbon monoxide (CO) Carbon dioxide (CO2)Protective Equipment and Precautions for FirefightersAs in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and fullprotective gear.

NFPA

6. Accidental release measuresPersonal Precautions Ensure adequate ventilation. Use personal protective equipment.Environmental Precautions See Section 12 for additional ecological information.

Methods for Containment and CleanUp

Sweep up or vacuum up spillage and collect in suitable container for disposal. Do not letthis chemical enter the environment.

7. Handling and storageHandling Avoid contact with skin and eyes. Do not breathe dust. Do not breathe vapors or spray mist.

Do not ingest.

Storage Keep in a dry, cool and well-ventilated place. Keep container tightly closed.

8. Exposure controls / personal protectionExposure Guidelines This product does not contain any hazardous materials with occupational exposure

limitsestablished by the region specific regulatory bodies.

Health2

Flammability0

Instability0

Physical hazardsN/A

Engineering Measures Ensure adequate ventilation, especially in confined areas. Ensure that eyewash stationsand safety showers are close to the workstation location.

Personal Protective Equipment

Eye/face Protection Wear appropriate protective eyeglasses or chemical safety goggles as described byOSHA's eye and face protection regulations in 29 CFR 1910.133 or European StandardEN166.

Skin and body protection

______________________________________________________________________________________________

Page 3 / 7

Wear appropriate protective gloves and clothing to prevent skin exposure.

519


9. Physical and chemical propertiesPhysical State Powder SolidAppearance WhiteOdor No information availableOdor Threshold No information availablepH No information availableMelting Point/Range 140 - 145 °C / 284 - 293 °FBoiling Point/Range No information availableFlash Point No information availableEvaporation Rate No information availableFlammability (solid,gas) No information availableFlammability or explosive limits

Upper No data availableLower No data available

Vapor Pressure No information availableVapor Density No information availableSpecific Gravity No information availableSolubility No information availablePartition coefficient; n-octanol/water No data availableAutoignition Temperature No information availableDecomposition Temperature No information availableViscosity No information availableMolecular Formula C9 H13 N O2 . H ClMolecular Weight 203.67

10. Stability and reactivity

Reactive Hazard None known, based on information available

Stability Stable under normal conditions.

Conditions to Avoid Incompatible products.

Incompatible Materials Strong oxidizing agents

Hazardous Decomposition Products Hydrogen chloride gas, Nitrogen oxides (NOx), Carbon monoxide (CO), Carbon dioxide(CO2)

Hazardous Polymerization Hazardous polymerization does not occur.

Hazardous Reactions None under normal processing.

11. Toxicological informationAcute Toxicity

Product Information No acute toxicity information is available for this productComponent Information

Component LD50 Oral LD50 Dermal LC50 InhalationPhenylephrine hydrochloride LD50 = 350 mg/kg ( Rat ) Not listed Not listed

Toxicologically SynergisticProducts

No information available

Respiratory Protection Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European StandardEN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator ifexposure limits are exceeded or if irritation or other symptoms are experienced.

Hygiene Measures

______________________________________________________________________________________________

Page 4 / 7

Handle in accordance with good industrial hygiene and safety practice.

520


Delayed and immediate effects as well as chronic effects from short and long-term exposure

Irritation No information available

Sensitization No information available

Carcinogenicity The table below indicates whether each agency has listed any ingredient as a carcinogen.

Component CAS-No IARC NTP ACGIH OSHA MexicoPhenylephrinehydrochloride

61-76-7 Not listed Not listed Not listed Not listed Not listed

Mutagenic Effects No information available

Reproductive Effects No information available.

Developmental Effects No information available.

Teratogenicity No information available.

STOT - single exposure Respiratory systemSTOT - repeated exposure None known

Aspiration hazard No information available

Symptoms / effects,both acute anddelayed


Endocrine Disruptor Information No information available

Other Adverse Effects The toxicological properties have not been fully investigated.

12. Ecological informationEcotoxicity Do not empty into drains.

Persistence and Degradability No information available

Bioaccumulation/ Accumulation No information available.

Mobility No information available.

13. Disposal considerationsWaste Disposal Methods Chemical waste generators must determine whether a discarded chemical is classified as a

hazardous waste. Chemical waste generators must also consult local, regional, andnational hazardous waste regulations to ensure complete and accurate classification.

14. Transport informationDOT

UN-No UN2811Hazard Class 6.1Packing Group III

TDG UN-No UN2811Hazard Class 6.1Packing Group III

IATA Not regulatedIMDG/IMO Not regulated

______________________________________________________________________________________________

Page 5 / 7

15. Regulatory information

521


International Inventories

Component TSCA DSL NDSL EINECS ELINCS NLP PICCS ENCS AICS IECSC KECLPhenylephrine hydrochloride X X - 200-517-3 - X - X - X

Legend:X - ListedE - Indicates a substance that is the subject of a Section 5(e) Consent order under TSCA.F - Indicates a substance that is the subject of a Section 5(f) Rule under TSCA.N - Indicates a polymeric substance containing no free-radical initiator in its inventory name but is considered to cover the designatedpolymer made with any free-radical initiator regardless of the amount used.P - Indicates a commenced PMN substanceR - Indicates a substance that is the subject of a Section 6 risk management rule under TSCA.S - Indicates a substance that is identified in a proposed or final Significant New Use RuleT - Indicates a substance that is the subject of a Section 4 test rule under TSCA.XU - Indicates a substance exempt from reporting under the Inventory Update Rule, i.e. Partial Updating of the TSCA Inventory Data BaseProduction and Site Reports (40 CFR 710(B).Y1 - Indicates an exempt polymer that has a number-average molecular weight of 1,000 or greater.Y2 - Indicates an exempt polymer that is a polyester and is made only from reactants included in a specified list of low concern reactantsthat comprises one of the eligibility criteria for the exemption rule.

U.S. Federal Regulations

TSCA 12(b) Not applicable

SARA 313 Not applicable

SARA 311/312 Hazard CategoriesAcute Health Hazard YesChronic Health Hazard NoFire Hazard NoSudden Release of Pressure Hazard NoReactive Hazard No

CWA (Clean Water Act) Not applicable

Clean Air Act Not applicable

OSHA Occupational Safety and Health AdministrationNot applicable

CERCLANot applicable

California Proposition 65 This product does not contain any Proposition 65 chemicals

U.S. State Right-to-KnowRegulations

Not applicable

U.S. Department of Transportation

Reportable Quantity (RQ): NDOT Marine Pollutant NDOT Severe Marine Pollutant N

U.S. Department of Homeland SecurityThis product does not contain any DHS chemicals.

Other International Regulations

Mexico - Grade No information available

______________________________________________________________________________________________

Page 6 / 7

522


16. Other informationPrepared By Regulatory Affairs

Thermo Fisher ScientificEmail: [email protected]

Revision Date 25-May-2017Print Date 25-May-2017Revision Summary This document has been updated to comply with the US OSHA HazCom 2012 Standard

replacing the current legislation under 29 CFR 1910.1200 to align with the GloballyHarmonized System of Classification and Labeling of Chemicals (GHS).

DisclaimerThe information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at thedate of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage,transportation, disposal and release and is not to be considered a warranty or quality specification. The informationrelates only to the specific material designated and may not be valid for such material used in combination with any othermaterials or in any process, unless specified in the text

End of SDS

______________________________________________________________________________________________

Page 7 / 7

523

p. 1

3 1 0

He a lt h

Fire

Re a c t iv it y


2

3

0

H

Material Safety Data SheetIsopropyl alcohol MSDS


Product Name: Isopropyl alcohol

Catalog Codes: SLI1153, SLI1579, SLI1906, SLI1246,SLI1432

CAS#: 67-63-0

RTECS: NT8050000

TSCA: TSCA 8(b) inventory: Isopropyl alcohol

CI#: Not available.

Synonym: 2-Propanol

Chemical Name: isopropanol

Chemical Formula: C3-H8-O









Composition:


Isopropyl alcohol 67-63-0 100

Toxicological Data on Ingredients: Isopropyl alcohol: ORAL (LD50): Acute: 5045 mg/kg [Rat]. 3600 mg/kg [Mouse]. 6410mg/kg [Rabbit]. DERMAL (LD50): Acute: 12800 mg/kg [Rabbit].


Potential Acute Health Effects:Hazardous in case of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant,sensitizer, permeator).

Potential Chronic Health Effects:Slightly hazardous in case of skin contact (sensitizer). CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.)by ACGIH, 3 (Not classifiable for human.) by IARC. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Notavailable. DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Development toxin [POSSIBLE].The substance may be toxic to kidneys, liver, skin, central nervous system (CNS). Repeated or prolonged exposure to thesubstance can produce target organs damage.


524


p. 2


Skin Contact:Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Cold watermay be used.


Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention if symptoms appear.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medicalattention.




Flammability of the Product: Flammable.

Auto-Ignition Temperature: 399°C (750.2°F)

Flash Points: CLOSED CUP: 11.667°C (53°F) - 12.778 deg. C (55 deg. F) (TAG)

Flammable Limits: LOWER: 2% UPPER: 12.7%

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances:Highly flammable in presence of open flames and sparks, of heat. Flammable in presence of oxidizing materials. Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Explosive in presence of open flames andsparks, of heat.

Fire Fighting Media and Instructions:Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam,water spray or fog.

Special Remarks on Fire Hazards:Vapor may travel considerable distance to source of ignition and flash back. CAUTION: MAY BURN WITH NEAR INVISIBLEFLAME. Hydrogen peroxide sharply reduces the autoignition temperature of Isopropyl alcohol. After a delay, Isopropylalcohol ignites on contact with dioxgenyl tetrafluorborate, chromium trioxide, and potassium tert-butoxide. When heated todecomposition it emits acrid smoke and fumes.

Special Remarks on Explosion Hazards:Secondary alcohols are readily autooxidized in contact with oxygen or air, forming ketones and hydrogen peroxide. It canbecome potentially explosive. It reacts with oxygen to form dangerously unstable peroxides which can concentrate andexplode during distillation or evaporation. The presence of 2-butanone increases the reaction rate for peroxide formation.Explosive in the form of vapor when exposed to heat or flame. May form explosive mixtures with air. Isopropyl alcohol +phosgene forms isopropyl chloroformate and hydrogen chloride. In the presence of iron salts, thermal decompositon canoccur, whicn in some cases can become explosive. A homogeneous mixture of concentrated peroxides + isopropyl alcohol arecapable of detonation by shock or heat. Barium perchlorate + isopropyl alcohol gives the highly explosive alkyl perchlorates.

525

p. 3

It forms explosive mixtures with trinitormethane and hydrogen peroxide. It produces a violent explosive reaction when heatedwith aluminum isopropoxide + crotonaldehyde. Mixtures of isopropyl alcohol + nitroform are explosive.


Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container.

Large Spill:Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth,sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confinedareas; dike if needed. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDSand with local authorities.


Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. Avoid contact with eyes. Wear suitable protective clothing. In case of insufficient ventilation,wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Keepaway from incompatibles such as oxidizing agents, acids.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame).


Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 983 STEL: 1230 (mg/m3) [Australia] TWA: 200 STEL: 400 (ppm) from ACGIH (TLV) [United States] [1999] TWA: 980STEL: 1225 (mg/m3) from NIOSH TWA: 400 STEL: 500 (ppm) from NIOSH TWA: 400 STEL: 500 (ppm) [United Kingdom(UK)] TWA: 999 STEL: 1259 (mg/m3) [United Kingdom (UK)] TWA: 400 STEL: 500 (ppm) from OSHA (PEL) [United States]TWA: 980 STEL: 1225 (mg/m3) from OSHA (PEL) [United States]Consult local authorities for acceptable exposure limits.


Physical state and appearance: Liquid.

Odor:Pleasant. Odor resembling that of a mixture of ethanol and acetone.

Taste: Bitter. (Slight.)


526

p. 4

Color: Colorless.


Boiling Point: 82.5°C (180.5°F)

Melting Point: -88.5°C (-127.3°F)

Critical Temperature: 235°C (455°F)

Specific Gravity: 0.78505 (Water = 1)

Vapor Pressure: 4.4 kPa (@ 20°C)

Vapor Density: 2.07 (Air = 1)


Odor Threshold:22 ppm (Sittig, 1991) 700 ppm for unadapted panelists (Verschuren, 1983).

Water/Oil Dist. Coeff.: The product is equally soluble in oil and water; log(oil/water) = 0.1


Dispersion Properties: See solubility in water, methanol, diethyl ether, n-octanol, acetone.

Solubility:Easily soluble in cold water, hot water, methanol, diethyl ether, n-octanol, acetone. Insoluble in salt solution. Soluble inbenzene. Miscible with most organic solvents including alcohol, ethyl alcohol, chloroform.




Conditions of Instability: Heat, Ignition sources, incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents, acids, alkalis.


Special Remarks on Reactivity:Reacts violently with hydrogen + palladium combination, nitroform, oleum, COCl2, aluminum triisopropoxide, oxidantsIncompatible with acetaldehyde, chlorine, ethylene oxide, isocyanates, acids, alkaline earth, alkali metals, caustics, amines,crotonaldehyde, phosgene, ammonia. Isopropyl alcohol reacts with metallic aluminum at high temperatures. Isopropyl alcoholattacks some plastics, rubber, and coatings. Vigorous reaction with sodium dichromate + sulfuric acid.

Special Remarks on Corrosivity: May attack some forms of plastic, rubber and coating



Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 3600 mg/kg [Mouse]. Acute dermal toxicity (LD50): 12800 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50):16000 8 hours [Rat].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH, 3 (Not classifiable for human.) by IARC.DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Development toxin [POSSIBLE]. May causedamage to the following organs: kidneys, liver, skin, central nervous system (CNS).

527

p. 5

Other Toxic Effects on Humans:Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, sensitizer, permeator).


Special Remarks on Chronic Effects on Humans:M a y c a u s e a d v e r s e r e p r o d u c t i v e / t e r a t o g e n i c e f f e c t s ( f e r t i l i t y , f e t o x i c i t y , d e v e l o p m en t a l abnormalities(developmental toxin)) based on animal studies. Detected in maternal milk in human.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: May cause mild skin irritation, and sensitization. Eyes: Can cause eye irritation.Inhalation: Breathing in small amounts of this material during normal handling is not likely to cause harmful effects. However,breathing large amounts may be harmful and may affect the respiratory system and mucous membranes (irritation), behaviorand brain (Central nervous system depression - headache, dizziness, drowsiness, stupor, incoordination, unconciousness,coma and possible death), peripheral nerve and senstation, blood, urinary system, and liver. Ingestion: Swallowing smallamouts during normal handling is not likely to cause harmful effects. Swallowing large amounts may be harmful. Swallowinglarge amounts may cause gastrointestinal tract irritation with nausea, vomiting and diarrhea, abdominal pain. It also mayaffect the urinary system, cardiovascular system, sense organs, behavior or central nervous system (somnolence, generallydepressed activity, irritability, headache, dizziness, drowsiness), liver, and respiratory system (breathing difficulty). ChronicPotential Health Effects: May cause defatting of the skin and dermatitis and allergic reaction. May cause adverse reproductiveeffects based on animal data (studies).


Ecotoxicity: Ecotoxicity in water (LC50): 100000 mg/l 96 hours [Fathead Minnow]. 64000 mg/l 96 hours [Fathead Minnow].








DOT Classification: CLASS 3: Flammable liquid.

Identification: : Isopropyl Alcohol UNNA: 1219 PG: II

Special Provisions for Transport: Not available.


Federal and State Regulations:Connecticut hazardous material survey.: Isopropyl alcohol Illinois toxic substances disclosure to employee act: Isopropylalcohol Rhode Island RTK hazardous substances: Isopropyl alcohol Pennsylvania RTK: Isopropyl alcohol Florida: Isopropylalcohol Minnesota: Isopropyl alcohol Massachusetts RTK: Isopropyl alcohol New Jersey: Isopropyl alcohol New Jersey spilllist: Isopropyl alcohol Director's list of Hazardous Substances: Isopropyl alcohol Tennesee: Isopropyl alcohol TSCA 8(b)inventory: Isopropyl alcohol TSCA 4(a) final testing order: Isopropyl alcohol TSCA 8(a) IUR: Isopropyl alcohol TSCA 8(d) H

528

p. 6

and S data reporting: Isopropyl alcohol: Effective date: 12/15/86 Sunset Date: 12/15/96 TSCA 12(b) one time export: Isopropylalcohol SARA 313 toxic chemical notification and release reporting: Isopropyl alcohol



WHMIS (Canada):CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2B: Material causing other toxic effects(TOXIC).

DSCL (EEC):R11- Highly flammable. R36- Irritating to eyes. S7- Keep container tightly closed. S16- Keep away from sources of ignition- No smoking. S24/25- Avoid contact with skin and eyes. S26- In case of contact with eyes, rinse immediately with plenty ofwater and seek medical advice.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: h


Health: 1

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.




Created: 10/09/2005 05:53 PM

Last Updated: 05/21/2013 12:00 PM


529

PRODUCT NAME: Methanol PAGE 1 OF 7REVISION DATE: 05/23/2001

1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT IDENTIFIER: Methanol

PRODUCT SYNONYMS: Methyl Alcohol, Methyl Hydrate, Wood Alcohol

GENERAL USE: Methanol has wide industrial use as a solvent and is extensivelyemployed as a paint and varnish remover, as a chemicalintermediate, and in the preparation of stains, enamels, plastics,and films. It is used to manufacture formaldehyde and methylesters of organic and inorganic acids; chemical synthesis;automotive antifreeze; denaturant for ethyl alcohol; dehydratorfor natural gas.

PRODUCT DESCRIPTION: Clear, colorless, flammable, poisonous, mobile, highly polarliquid with slight alcohol odor; miscible with water, alcohol, ether,ketones and most other organic solvents. Burns with anonluminous, bluish flame.

MANUFACTURER: EMERGENCY TELEPHONE NUMBERS:Dakota Gasification Company Dakota Gasification (701) 873-6600P. O. Box 1149 CHEMTREC (800) 424-9300Beulah, North Dakota 58523(701) 873-6677

2. COMPOSITION / INFORMATION ON INGREDIENTSINGREDIENTS WT. % CAS Registry #Methanol 98 67-56-1Water 1.8 7732-18-5

OSHA HAZARDOUS COMPONENTS (29 CFR 1910.1200):EXPOSURE LIMITS 8 hrs. TWA(ppm)OSHA PEL ACGIH TLV

Methanol 200 ppm 200 ppmWater Not Established Not Established

3. HAZARDS IDENTIFICATION / EMERGENCY OVERVIEWRoutes of entry for methanol are primarily absorption through the skin, eye contact,inhalation, or ingestion. Industrial exposures are primarily vapor exposures and skin contact. Initial symptoms from ingestion or inhalation may be only mild intoxication, but may becomesevere after 12-18 hours. Toxic effects from repeated over exposure to methanol have anaccumulative affect the central nervous system, especially the optic nerve. These symptomsmay linger for several days after exposure. Methanol can seriously impair vision and maycause blindness.

530


POTENTIAL HEALTH EFFECTS:

EYE CONTACT: Methanol can seriously impair vision and may cause blindness. Immediatesigns and symptoms include the following: vapors are slightly uncomfortableand splashes very irritating; irritation with painful burning or stingingsensation; watering of eyes; inflammation of the eyelids; eyes are sensitiveto and painful in the light.

SKIN CONTACT: Direct skin contact with methanol may cause irritation, dermatitis, erythema,and scaling. Methanol is highly volatile and will produce a feeling of cold. Alcohols remove oils form the skin, which becomes dry and eventuallydevelops cracks or dermatitis. Methanol which can be absorbed by the skin,causes headache, fatigue, and reduction of visual acuity.

INHALATION: Sign and symptoms of acute poisoning include the following: slight irritationof the nose and eyes; head feels hot and face is flushed; excitability andtalkativeness; drunken behavior; staggering and lack of coordination;headache; mental confusion and visual disturbance; tiredness.

INGESTION: Signs and symptoms of acute poisoning are gastrointestinal irritation; headfeels hot and face is flushed; excitability and talkativeness; drunkenbehavior; staggering and lack of coordination; headache; mental confusionand visual disturbance; tiredness.

4. FIRST AID MEASURESEYES: Remove the victim from the source of contamination and take him to the

nearest eye wash, shower, or other source of clean water. Gently rinse theaffected eye(s) with clean, lukewarm water for at least 15 minutes. Have thevictim lie or sit down and tilt his head back. Hold the eyelid(s) open and pourwater slowly over the eyeball(s) at the inner corners, letting the water run outof the outer corners. Ask the victim to look up, down and side to side as yourinse in order to better reach all parts of the eye(s). If the victim cannottolerate light, protect his eye(s) with a clean, loosely tied handkerchief orstrip of clean, soft cloth or bandage. Seek medical attention immediately.

SKIN: Remove the victim from the source of contamination. Remove clothing,shoes, socks, and jewelry from the affected areas. Be careful not to get anyof the chemical on your skin or clothing. Wash the affected area with tepidwater. Dry the skin gently with a clean, soft towel. Seek medical attentionimmediately.

INHALATION: Remove the victim from the contaminated area while protecting yourself fromexposure by wearing an appropriate respirator. Put a similar respirator onthe victim. Remove contaminated clothing and equipment, while wearinggloves, being careful not to contaminate yourself. Administer CPR ifnecessary. Seek medical attention immediately.

INGESTION: Remove the victim from the contaminated area to a quiet, well ventilatedarea. Call a poison control center, inform them of the chemical swallowedand follow their advice. Seek medical attention immediately.

531



FLASH POINT: 54oF (Tagliabue / Tag Closed Tester)AUTO-IGNITION TEMPERATURE: 725oF

FIRE AND EXPLOSION HAZARDS: Methanol burns with a clean, clear flame, beingalmost invisible in daylight.

UPPER EXPLOSIVE / FIRE LIMITS: 36.50%LOWER EXPLOSIVE / FIRE LIMITS: 6.72%

EXTINGUISHING MEDIA: Use dry chemical alcohol foam, or carbon dioxide;water spray may be ineffective as an extinguishingagent, but water should be used to keep fire-exposedcontainers cool.

SPECIAL FIRE FIGHTING PROCEDURES: Vapors are slightly heavier than air and may flowalong surfaces to ignition sources. Water may beineffective in “in-depth methanol fires”. Fire fightersshould use self-contained breathing apparatus andprotective clothing.


SPILL OR LEAK PROCEDURES: Eliminate all ignition sources. Stop spill source. Ifspill is small use absorbent material to soak up spill. Dike large spill areas. Recover large spills byrecovering the methanol or by diluting with water toreduce the fire hazard. Salvage the liquid by using arecommended absorbent material. Prevent methanolfrom entering sewers, drains, or waterways. Alwaysnotify proper authorities of spills.

WASTE DISPOSAL METHOD: Dispose of material in accordance with your local,state, federal or other applicable regulations.

7. HANDLING AND STORAGESTORAGE TEMPERATURE: Keep cool.

SHELF LIFE: Unknown.SPECIAL SENSITIVITY: Methanol is a flammable substance.HANDLING / STORAGE

PRECAUTIONS:Store containers in well-ventilated place. Large volumestorage should be remote from inhabited buildings orstructures. Keep away from all sources of ignition. Wearchemical goggles or face shield, supplied-air or selfcontained breathing apparatus, rubber gloves, apronsand boots.


532


RECOMMENDED WORK /HYGIENE PROCEDURES:

Adequate ventilation. Wear chemical goggles or face shield,supplied-air or self contained breathing apparatus, rubber gloves, aprons and boots.

EYE PROTECTIONREQUIREMENTS:

Chemical safety goggles or face shields should be worn.

HAND PROTECTIONREQUIREMENTS:

Natural rubber gloves.

PROTECTIVE CLOTHINGREQUIREMENTS:

Appropriate protective clothing, including gloves, aprons, suits,boots, and face shields that are impervious to methyl alcoholshould be worn to prevent repeated or prolonged skin contact.

RESPIRATORYREQUIREMENTS:

Supplied-air or self contained breathing apparatus operated in thepositive pressure mode.

WASH REQUIREMENTS: Soap and water should be available to clean contaminated skin. Wash thoroughly prior to consuming food or beverage, smoking, orusing restroom facilities.

9. PHYSICAL AND CHEMICAL PROPERTIESAPPEARANCE: Clear, colorless liquid.

ODOR: Alcohol odor.PHYSICAL STATE: Liquid.

VAPOR PRESSURE: (at 20oC ) 96 mmHgVAPOR DENSITY: (air = 1) 1.11MELTING POINT: -97.6oCBOILING POINT: (at 760 mmHg) 64.5oC

SPECIFIC GRAVITY: (water = 1) 0.7915 at 68oFEVAPORATION RATE: (Butyl Acetate = 1) 4.6

PERCENT VOLATILES: 100% (by volume)BULK DENSITY: 6.63 lbs. per gallon

SOLUBILITY IN WATER: Miscible.SOLVENT SOLUBILITY: Solubility in alcohols, ketones, esters, and halogenated hydrocarbons

- Miscible.MOLECULAR WEIGHT: 32.04CHEMICAL FORMULA: CH3OH

CHEMICAL FAMILY: Alcohols

10. STABILITY AND REACTIVITYINSTABILITY CONDITIONS: Stable.

INCOMPATIBILITIES: Beryllium hydride: Intense reaction at 200oCBromine: Intense exothermic reactionCalcium carbide: Violent reactionChloroform and sodium hydroxide: Explosive reactionChromic anhydride: Possible explosionCyanuric chloride: Uncontrollable violent reactionMagnesium: Violent reactionNickel: Possible ignition in the presence of nickel catalyst

DECOMPOSITION:Formaldehyde and carbon monoxide.

HAZARDOUSPOLYMERIZATION:

Will not occur.


533


ROUTES OF ENTRY: A human poison by ingestion. Poison experimentally by skin contact. Moderately toxic experimentally by intravenous and intraperitoneal routes. Mildlly toxic by inhalation.

EFFECTS OFACUTE EXPOSURE:

The main toxic effect is exerted upon the nervous system, particularly theoptic nerves and possible the retina which can progress to permanentblindness. Once absorbed, methanol is only very slowly eliminated.Coma resulting from massive exposures may last as long as 2-4 days. Inthe body, the products formed by its oxidation are formaldehyde and formicacid, both of which are toxic. Because of the slow elimination, methanolshould be regarded as a cumulative poison. Though single exposures tovapors may cause no harmful effect, daily exposure may result in theaccumulation of sufficient methanol in the body to cause illness.

SYMPTOMS: Gastrointestinal irritation; slight irritation of nose and eyes; head feels hotand face is flushed; excitability and talkativeness; drunken behavior;staggering and lack of coordination; headache; mental confusion and visualdisturbance; tiredness.

EYE EFFECTS: Methanol can seriously impair vision. It may cause blurred vision,constricted visual fields, blindness, changes in color perception, doublevision, and general visual disturbances. Eye examinations have shownsluggish pupils, pallid optic discs, retinal edema, papilledema, hyperemia tothe optic discs with blurred edges and dilated veins. 1200 ppm to 8300 ppm: visual disturbances, dilated unreactive pupils and dim vision.

SKIN EFFECTS: Skin exposure may cause irritation and dermatitis. Poison experimentally byskin contact. Skin - rabbit: LD50: 15,800 mg/kg

ACUTE ORALEFFECTS:

Ingestion of methanol may cause acidosis, headache, visual disturbances,dizziness, nausea and vomiting, severe upper abdominal pain, dilatednonreactive pupils and death. Death from 2 to 8 ounces has been reported.

ACUTE INHALATIONEFFECTS:

May cause headache, dizziness, nausea, vomiting, weakness, vertigo, chillsshooting pains in the lower extremities, unsteady gait, numbness, prickling,shooting pain in the back of the hands and forearms, nervousness, gastricpain, insomnia, acidosis, and formic acid in the urine. Inhalation - human: TCL0 = 86,000 mg/m3 ( lowest published toxic concentration). Concentrations of 200-375 ppm may cause severe, recurrent headaches. IDLH - 25,000 ppm.

CHRONIC EFFECTS /

CARCINOGENICITY:

This agent is not considered a carcinogen by NTP, IARCor OSHA. Effects from repeated over-exposure to methanol are consideredto be harmful . Because of the slow elimination, methanol should beregarded as a cumulative poison. Though single exposures to fumes maycause no harmful effect, daily exposure may result in the accumulation ofsufficient methanol in the body to cause illness.

MUTAGENICITY: Reproductive effects: an experimental teratogen in rats exposed to 20,000ppm. Reported to cause birth defects.

ORGANS AFFECTED BYLONG-TERM EXPOSURE:

Repeated exposure to methanol vapor may be manifested by conjunctivitis,headache, giddiness, insomnia, gastric disturbances, and bilateral blindness.


Aquatic Toxicity Rating: Tlm 96: Over 1000 ppmToxicity threshold (cell multiplication inhibition test): Trout: Tlm (48 hr) 8,000 mg/l

534


Bacteria (Pseudomonas) LD0: 0.6 g/l Algae (Chlorella pyrenoidosa) toxic: 31,100 mg/l

Low concentrations are biodegradable; therefore, long-term ecological effects are notanticipated.


Recycling/reuse of all methanol residuals is recommended. Discarded or spill cleanupmaterial may be considered hazardous waste as defined under RCRA 40 CFR 261 (MethanolF003, U154).

Please be advised that state and local requirements for waste disposal may be morerestrictive or otherwise different from federal regulations. Consult state and local regulationsregarding the proper disposal of the material.

14. TRANSPORTATION INFORMATION

D.O.T. SHIPPING NAME: Alcohol, N.O.S. (Contains Methanol)

D.O.T. HAZARD CLASS: Flammable Liquid, 3

U.N. NUMBER: 1987

D.O.T. PLACARD: Flammable Liquid

D.O.T. LABEL CODE: Flammable Liquid

PACKAGING CLASSIFICATION: Packing Group 2

D.O.T. REPORTABLE QUANTITY: 5000 lbs

15. REGULATORY REQUIREMENTS

EPA DETERMINATIONS

CERCLA, 40 CFR 302The material contains the following hazardous substance which, when released in quantitiesequal to or exceeding the Reportable Quantity, triggers National Response Center notificationrequirements.

Hazardous Substance Reportable QuantityMethanol 5000 lbs.

SUPERFUND AMENDMENTS AND REAUTHORIZATION ACT OF 1986,TITLE III - SECTIONS 302, 304, 311, 312, 313

SECTION 302 / 304 - Extremely Hazardous Substances (40 CFR 355)The material does not contain extremely hazardous substances at greater than 1.0 % concentration;however, it is possible that this material may contain extremely hazardous substances at a lowerconcentration so that a large enough spill could warrant an Emergency Release under section 304.

535


LIABILITY DISCLAIMER

The information contained in this Material Safety Data Sheet (MSDS) is believed to be correct since it was obtainedfrom sources we believe are reliable. However no representation, guarantees or warranties of any kind are made

as to its accuracy, suitability for particular applications, hazards connected with the use of the material, or the resultsto be obtained from the use thereof. User assumes all risks and liability of any use, processing or handling of any

material, variations in methods, conditions and equipment used to store, handle, or process the material andhazards connected with the use of the material are solely the responsibility of the user and remain at his sole

discretion.

Compliance with all applicable federal, state, and local laws and regulations remains the responsibility of the user,and the user has the responsibility to provide a safe work place to examine all aspects of its operation and to

determine if or where precautions, in addition to those described herein, are required.

SECTION 311/312 - MSDS and Chemical Inventory Reporting Requirements (40 CFR 370)The material should be reported under the following EPA Hazard categories.

✔ Immediate (Acute Health Hazard)✔ Delayed (Chronic Health Hazard)✔ Fire Sudden Release of Pressure Reactive Not Applicable

SECTION 313 - List of Toxic Chemicals (40 CFR 372)The material contains the following chemical(s) at a level of 1.0% or greater (0.1% for carcinogens) onthe list of toxic Chemicals and is subject to toxic chemical release reporting requirements.

Toxic Chemical: MethanolCAS Registry Number: 67-56-1Approximate Concentration (Upper Bound): 98 wt %

TOXIC SUBSTANCES CONTROL ACT (TSCA) ( 40 CFR 710)The chemical ingredients in this material are in the Section 8(b) Chemical Substance Inventory (40CFR 710) and / or are otherwise in compliance with TSCA. In the case of ingredients obtained fromother manufacturers, Dakota Gasification Company relies on the assurance of responsible third partiesin providing this statement.

536

p. 1

0 3 1

He a lt h

Fire

Re a c t iv it y


3

0

1

Material Safety Data SheetHydrochloric acid MSDS


Product Name: Hydrochloric acid

Catalog Codes: SLH1462, SLH3154

CAS#: Mixture.

RTECS: MW4025000

TSCA: TSCA 8(b) inventory: Hydrochloric acid

CI#: Not applicable.

Synonym: Hydrochloric Acid; Muriatic Acid

Chemical Name: Not applicable.

Chemical Formula: Not applicable.









Composition:


Hydrogen chloride 7647-01-0 20-38

Water 7732-18-5 62-80

Toxicological Data on Ingredients: Hydrogen chloride: GAS (LC50): Acute: 4701 ppm 0.5 hours [Rat].


Potential Acute Health Effects:Very hazardous in case of skin contact (corrosive, irritant, permeator), of eye contact (irritant, corrosive), of ingestion, . Slightlyhazardous in case of inhalation (lung sensitizer). Non-corrosive for lungs. Liquid or spray mist may produce tissue damageparticularly on mucous membranes of eyes, mouth and respiratory tract. Skin contact may produce burns. Inhalation of thespray mist may produce severe irritation of respiratory tract, characterized by coughing, choking, or shortness of breath.Severe over-exposure can result in death. Inflammation of the eye is characterized by redness, watering, and itching. Skininflammation is characterized by itching, scaling, reddening, or, occasionally, blistering.

Potential Chronic Health Effects:Slightly hazardous in case of skin contact (sensitizer). CARCINOGENIC EFFECTS: Classified 3 (Not classifiable forhuman.) by IARC [Hydrochloric acid]. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to kidneys, liver, mucous membranes, upperrespiratory tract, skin, eyes, Circulatory System, teeth. Repeated or prolonged exposure to the substance can produce target

537


p. 2

organs damage. Repeated or prolonged contact with spray mist may produce chronic eye irritation and severe skin irritation.Repeated or prolonged exposure to spray mist may produce respiratory tract irritation leading to frequent attacks of bronchialinfection. Repeated exposure to a highly toxic material may produce general deterioration of health by an accumulation in oneor many human organs.


Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Cold water may be used. Get medical attention immediately.

Skin Contact:In case of contact, immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothingand shoes. Cover the irritated skin with an emollient. Cold water may be used.Wash clothing before reuse. Thoroughly cleanshoes before reuse. Get medical attention immediately.


Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention immediately.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It maybe hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious orcorrosive. Seek immediate medical attention.

Ingestion:If swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to anunconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately.



Flammability of the Product: Non-flammable.

Auto-Ignition Temperature: Not applicable.

Flash Points: Not applicable.

Flammable Limits: Not applicable.

Products of Combustion: Not available.

Fire Hazards in Presence of Various Substances: of metals

Explosion Hazards in Presence of Various Substances: Non-explosive in presence of open flames and sparks, of shocks.

Fire Fighting Media and Instructions: Not applicable.

Special Remarks on Fire Hazards:Non combustible. Calcium carbide reacts with hydrogen chloride gas with incandescence. Uranium phosphide reacts withhydrochloric acid to release spontaneously flammable phosphine. Rubidium acetylene carbides burns with slightly warmhydrochloric acid. Lithium silicide in contact with hydrogen chloride becomes incandescent. When dilute hydrochloric acid isused, gas spontaneously flammable in air is evolved. Magnesium boride treated with concentrated hydrochloric acid producesspontaneously flammble gas. Cesium acetylene carbide burns hydrogen chloride gas. Cesium carbide ignites in contact withhydrochloric acid unless acid is dilute. Reacts with most metals to produce flammable Hydrodgen gas.

Special Remarks on Explosion Hazards:

538

p. 3

Hydrogen chloride in contact with the following can cause an explosion, ignition on contact, or other violent/vigorous reaction:Acetic anhydride AgClO + CCl4 Alcohols + hydrogen cyanide, Aluminum Aluminum-titanium alloys (with HCl vapor), 2-Aminoethanol, Ammonium hydroxide, Calcium carbide Ca3P2 Chlorine + dinitroanilines (evolves gas), Chlorosulfonic acid Cesiumcarbide Cesium acetylene carbide, 1,1-Difluoroethylene Ethylene diamine Ethylene imine, Fluorine, HClO4 Hexalithiumdisilicide H2SO4 Metal acetylides or carbides, Magnesium boride, Mercuric sulfate, Oleum, Potassium permanganate,beta-Propiolactone Propylene oxide Rubidium carbide, Rubidium, acetylene carbide Sodium (with aqueous HCl), Sodiumhydroxide Sodium tetraselenium, Sulfonic acid, Tetraselenium tetranitride, U3P4 , Vinyl acetate. Silver perchlorate with carbontetrachloride in the presence of hydrochloric acid produces trichloromethyl perchlorate which detonates at 40 deg. C.


Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container. Ifnecessary: Neutralize the residue with a dilute solution of sodium carbonate.

Large Spill:Corrosive liquid. Poisonous liquid. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material.Do not get water inside container. Do not touch spilled material. Use water spray curtain to divert vapor drift. Use water sprayto reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal.Neutralize the residue with a dilute solution of sodium carbonate. Be careful that the product is not present at a concentrationlevel above TLV. Check TLV on the MSDS and with local authorities.


Precautions:Keep locked up.. Keep container dry. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Never add water to this product.In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and showthe container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, organicmaterials, metals, alkalis, moisture. May corrode metallic surfaces. Store in a metallic or coated fiberboard drum using a strongpolyethylene inner package.




Personal Protection:Face shield. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Boots.


Exposure Limits:CEIL: 5 (ppm) from OSHA (PEL) [United States] CEIL: 7 (mg/m3) from OSHA (PEL) [United States] CEIL: 5 from NIOSHCEIL: 7 (mg/m3) from NIOSH TWA: 1 STEL: 5 (ppm) [United Kingdom (UK)] TWA: 2 STEL: 8 (mg/m3) [United Kingdom(UK)]Consult local authorities for acceptable exposure limits.



539

p. 4

Odor: Pungent. Irritating (Strong.)


Molecular Weight: Not applicable.

Color: Colorless to light yellow.

pH (1% soln/water): Acidic.

Boiling Point:108.58 C @ 760 mm Hg (for 20.22% HCl in water) 83 C @ 760 mm Hg (for 31% HCl in water) 50.5 C (for 37% HCl in water)

Melting Point:-62.25°C (-80°F) (20.69% HCl in water) -46.2 C (31.24% HCl in water) -25.4 C (39.17% HCl in water)


Specific Gravity:1.1- 1.19 (Water = 1) 1.10 (20%and 22% HCl solutions) 1.12 (24% HCl solution) 1.15 (29.57% HCl solution) 1.16 (32% HClsolution) 1.19 (37% and 38%HCl solutions)

Vapor Pressure: 16 kPa (@ 20°C) average



Odor Threshold: 0.25 to 10 ppm



Dispersion Properties: See solubility in water, diethyl ether.

Solubility: Soluble in cold water, hot water, diethyl ether.




Conditions of Instability: Incompatible materials, water

Incompatibility with various substances:Highly reactive with metals. Reactive with oxidizing agents, organic materials, alkalis, water.

Corrosivity:Extremely corrosive in presence of aluminum, of copper, of stainless steel(304), of stainless steel(316). Non-corrosive inpresence of glass.

Special Remarks on Reactivity:Reacts with water especially when water is added to the product. Absorption of gaseous hydrogen chloride on mercuricsulfate becomes violent @ 125 deg. C. Sodium reacts very violently with gaseous hydrogen chloride. Calcium phosphideand hydrochloric acid undergo very energetic reaction. It reacts with oxidizers releasing chlorine gas. Incompatible with,alkali metals, carbides, borides, metal oxides, vinyl acetate, acetylides, sulphides, phosphides, cyanides, carbonates. Reactswith most metals to produce flammable Hydrogen gas. Reacts violently (moderate reaction with heat of evolution) withwater especially when water is added to the product. Isolate hydrogen chloride from heat, direct sunlight, alkalies (reactsvigorously), organic materials, and oxidizers (especially nitric acid and chlorates), amines, metals, copper and alloys (e.g.brass), hydroxides, zinc (galvanized materials), lithium silicide (incandescence), sulfuric acid(increase in temperature andpressure) Hydrogen chloride gas is emitted when this product is in contact with sulfuric acid. Adsorption of Hydrochloric Acidonto silicon dioxide results in exothmeric reaction. Hydrogen chloride causes aldehydes and epoxides to violently polymerize.Hydrogen chloride or Hydrochloric Acid in contact with the folloiwng can cause explosion or ignition on contact or

Special Remarks on Corrosivity:

540

p. 5

Highly corrosive. Incompatible with copper and copper alloys. It attacks nearly all metals (mercury, gold, platinium, tantalum,silver, and certain alloys are exceptions). It is one of the most corrosive of the nonoxidizing acids in contact with copper alloys.No corrosivity data on zinc, steel. Severe Corrosive effect on brass and bronze




Toxicity to Animals:Acute oral toxicity (LD50): 900 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50): 1108 ppm, 1 hours [Mouse]. Acute toxicity ofthe vapor (LC50): 3124 ppm, 1 hours [Rat].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: Classified 3 (Not classifiable for human.) by IARC [Hydrochloric acid]. May cause damage to thefollowing organs: kidneys, liver, mucous membranes, upper respiratory tract, skin, eyes, Circulatory System, teeth.

Other Toxic Effects on Humans:Very hazardous in case of skin contact (corrosive, irritant, permeator), of ingestion, . Hazardous in case of eye contact(corrosive), of inhalation (lung corrosive).

Special Remarks on Toxicity to Animals:Lowest Published Lethal Doses (LDL/LCL) LDL [Man] -Route: Oral; 2857 ug/kg LCL [Human] - Route: Inhalation; Dose: 1300ppm/30M LCL [Rabbit] - Route: Inhalation; Dose: 4413 ppm/30M

Special Remarks on Chronic Effects on Humans:May cause adverse reproductive effects (fetoxicity). May affect genetic material.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Corrosive. Causes severe skin irritation and burns. Eyes: Corrosive. Causes severeeye irritation/conjuntivitis, burns, corneal necrosis. Inhalation: May be fatal if inhaled. Material is extremely destructive totissue of the mucous membranes and upper respiratory tract. Inhalation of hydrochloric acid fumes produces nose, throat,and larryngeal burning, and irritation, pain and inflammation, coughing, sneezing, choking sensation, hoarseness, laryngealspasms, upper respiratory tract edema, chest pains, as well has headache, and palpitations. Inhalation of high concentrationscan result in corrosive burns, necrosis of bronchial epithelium, constriction of the larynx and bronchi, nasospetal perforation,glottal closure, occur, particularly if exposure is prolonged. May affect the liver. Ingestion: May be fatal if swallowed. Causesirritation and burning, ulceration, or perforation of the gastrointestinal tract and resultant peritonitis, gastric hemorrhage andinfection. Can also cause nausea, vomitting (with "coffee ground" emesis), diarrhea, thirst, difficulty swallowing, salivation,chills, fever, uneasiness, shock, strictures and stenosis (esophogeal, gastric, pyloric). May affect behavior (excitement), thecardiovascular system (weak rapid pulse, tachycardia), respiration (shallow respiration), and urinary system (kidneys- renalfailure, nephritis). Acute exposure via inhalation or ingestion can also cause erosion of tooth enamel. Chronic Potential HealthEffects: dyspnea, bronchitis. Chemical pneumonitis and pulmonary edema can also








Waste Disposal:

541

p. 6

Waste must be disposed of in accordance with federal, state and local environmental control regulations.


DOT Classification: Class 8: Corrosive material

Identification: : Hydrochloric acid, solution UNNA: 1789 PG: II



Federal and State Regulations:Connecticut hazardous material survey.: Hydrochloric acid Illinois toxic substances disclosure to employee act: Hydrochloricacid Illinois chemical safety act: Hydrochloric acid New York release reporting list: Hydrochloric acid Rhode Island RTKhazardous substances: Hydrochloric acid Pennsylvania RTK: Hydrochloric acid Minnesota: Hydrochloric acid MassachusettsRTK: Hydrochloric acid Massachusetts spill list: Hydrochloric acid New Jersey: Hydrochloric acid New Jersey spill list:Hydrochloric acid Louisiana RTK reporting list: Hydrochloric acid Louisiana spill reporting: Hydrochloric acid CaliforniaDirector's List of Hazardous Substances: Hydrochloric acid TSCA 8(b) inventory: Hydrochloric acid TSCA 4(a) proposed testrules: Hydrochloric acid SARA 302/304/311/312 extremely hazardous substances: Hydrochloric acid SARA 313 toxic chemicalnotification and release reporting: Hydrochloric acid CERCLA: Hazardous substances.: Hydrochloric acid: 5000 lbs. (2268 kg)



WHMIS (Canada):CLASS D-2A: Material causing other toxic effects (VERY TOXIC). CLASS E: Corrosive liquid.

DSCL (EEC):R34- Causes burns. R37- Irritating to respiratory system. S26- In case of contact with eyes, rinse immediately with plenty ofwater and seek medical advice. S45- In case of accident or if you feel unwell, seek medical advice immediately (show the labelwhere possible).

HMIS (U.S.A.):

Health Hazard: 3

Fire Hazard: 0

Reactivity: 1

Personal Protection:


Health: 3

Flammability: 0

Reactivity: 1

Specific hazard:

Protective Equipment:Gloves. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Face shield.


542

p. 7

References:-Hawley, G.G.. The Condensed Chemical Dictionary, 11e ed., New York N.Y., Van Nostrand Reinold, 1987. -SAX, N.I.Dangerous Properties of Indutrial Materials. Toronto, Van Nostrand Reinold, 6e ed. 1984. -The Sigma-Aldrich Library ofChemical Safety Data, Edition II. -Guide de la loi et du règlement sur le transport des marchandises dangeureuses au canada.Centre de conformité internatinal Ltée. 1986.


Created: 10/09/2005 05:45 PM

Last Updated: 05/21/2013 12:00 PM


543

p. 1

3 1 0

He a lt h

Fire

Re a c t iv it y


1

3

0

E

Material Safety Data SheetCharcoal, Activated, Powder MSDS


Product Name: Charcoal, Activated, Powder

Catalog Codes: SLC3982, SLC1189

CAS#: 7440-44-0

RTECS: FL7243500

TSCA: TSCA 8(b) inventory: Charcoal, Activated

CI#: Not available.

Synonym:

Chemical Name: Charcoal, Activated

Chemical Formula: C









Composition:


Charcoal, Activated 7440-44-0 100

Toxicological Data on Ingredients: Charcoal, Activated LD50: Not available. LC50: Not available.



Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Not available. The substance is toxic to mucous membranes. The substance may be toxic tolungs. Repeated or prolonged exposure to the substance can produce target organs damage.



544


p. 2




Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Seekmedical attention.








Products of Combustion: Not available.

Fire Hazards in Presence of Various Substances:Highly flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks.


Fire Fighting Media and Instructions:Flammable solid. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray or fog. Cool containing vesselswith water jet in order to prevent pressure build-up, autoignition or explosion.

Special Remarks on Fire Hazards:Flammable/combustible material. May be ignited by friction, heat, sparks, or flames. May reignite after fire is extinguished.Freshly prepared material may heat spontaneously in air, and presence of water accelerates this.

Special Remarks on Explosion Hazards:Material in powder form, capable of creating a dust explosion (forming explosive mixtures in air) when exposed to heat, flame,or ammonium nitrate + heat. ammonium tetrachloride at 240 C, bromates, Ca(OCl)2, chlorates, Cl2, (Cl2 + Cr(OCl)2), ClO, F2,iodates, IO5, (Pb(NO3)2, HgNO3, HNO3, (oils + air), (potassium + air), Na2S, Zn(NO3)2.


Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container.

Large Spill:Spontaneously combustible solid. Stop leak if without risk. Absorb with an inert material and put the spilled material in anappropriate waste disposal. Obtain advice on use of water as spilled material may react with it. Do not touch spilled material.Prevent entry into sewers, basements or confined areas; dike if needed. Eliminate all ignition sources. Cover with wet earth,sand or other non-combustible material. Call for assistance on disposal. Be careful that the product is not present at aconcentration level above TLV. Check TLV on the MSDS and with local authorities.

545

p. 3


Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not breathe dust.Keep away from incompatibles such as oxidizing agents, metals, acids.

Storage:Store in a segregated and approved area. Keep in a cool and ventilated area away from combustible materials. Keepcontainer in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possiblesources of ignition (spark or flame).





Exposure Limits:TWA: 3.5 (mg/m3) from ACGIH (TLV) [United States] TWA: 4 (mg/m3) [United Kingdom (UK)] Respirable. TWA: 10 (mg/m3)[United Kingdom (UK)] Total. TWA: 2 (mg/m3) [Canada] Respirable.Consult local authorities for acceptable exposure limits.


Physical state and appearance: Solid. (Solid powder.)

Odor: Odorless.



Color: Black



Melting Point: 3500°C (6332°F)









546

p. 4


Solubility: Insoluble in cold water, hot water.




Conditions of Instability: Heat, ignition sources (flames, sparks), air,incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents, metals, acids.


Special Remarks on Reactivity:Incompatible with air, unsaturated oils, 2-Nitrobenzaldehyde, strong oxidizers such as fluorine, chlorine trifluoride, andpotassium peroxide.





Toxicity to Animals:LD50: Not available. LC50: Not available.

Chronic Effects on Humans:Causes damage to the following organs: mucous membranes. May cause damage to the following organs: lungs.



Special Remarks on Chronic Effects on Humans: May cause adverse reproductive effects.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: May cause skin irritation. Eyes: May cause eye irritation. Inhalation: May causerespiratory tract irritation. Ingestion: May cause aspiration pneumonitis, vomiting, decreased gastrointestinal transit time,gastrointestinal obstruction, constipation, a charcoal-containing empyema, intestinal perforation, charcoal deposits in theesophageal and gastric mucosa, rectal ulcer. Chronic Potential Health Effects: Skin: Chronic skin exposure can result inclogging of hair follicles, rendering them black. Inhalation: Chronic inhalation can cause carbon particles to accumulate in thelungs. It may cause a pneumoconiosis called "Black Lung Disease" or "Coal Workers Pneumoconiosis". This is seen in coalworkers, but no evidence has been found for the equivalent with occupational exposure to activated carbon (charcoal).







547

p. 5




DOT Classification: CLASS 4.2: Spontaneously combustible substance.

Identification: : Carbon, activated UNNA: 1362 PG: III



Federal and State Regulations:Rhode Island RTK hazardous substances: Charcoal, Activated TSCA 8(b) inventory: Charcoal, Activated





HMIS (U.S.A.):

Health Hazard: 1

Fire Hazard: 3

Reactivity: 0



Health: 1

Flammability: 3

Reactivity: 0

Specific hazard:





Created: 10/09/2005 04:37 PM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume

548

p. 6

no liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

549

CAT# 15652Date Updated: Dec. 17, 2012

MATERIAL SAFETY DATA SHEETwww.capotchem.com [email protected]

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifiers

Product name : 3-(Aminomethyl)-5-methylhexanoic acidProduct Number : 15652CAS-No. : 128013-69-4

1.2 Relevant identified uses of the substance or mixture and uses advised against

Identified uses : Laboratory chemicals, Manufacture of substances1.3 Details of the supplier of the safety data sheet

Company : Capot Chemical Co.,Ltd.Joinhands Science Park, No.4028 Nanhuan RoadHangzhou, Zhejiang, China 310053

Telephone : 0086-571-85586718Fax : 0086-571-85864795E-mail address : [email protected]

1.4 Emergency telephone number

Emergency Phone # : 0086-571-85586718

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

Classification according to Regulation (EC) No 1272/2008

For the full text of the H-Statements mentioned in this Section, see Section 16.Classification according to EU Directives 67/548/EEC or 1999/45/EC

not availableFor the full text of the R-phrases mentioned in this Section, see Section 16.

2.2 Label elements

Labelling according Regulation (EC) No 1272/2008

Hazard statement(s)Precautionary statement(s)Supplemental Hazard Statements None

2.3 Other hazards

None

SECTION 3: Composition/information on ingredients

550

http://www.capotchem.com

http://www.capotchem.com/128013-69-4.html

3.1 Substances

Synonyms :Formula : C8H17NO2Molecular Weight : 159.23 g/molCAS-No. : 128013-69-4EC-No. : not available

Hazardous ingredients according to Regulation (EC) No 1272/2008

Component Classification Concentration

3-(Aminomethyl)-5-methylhexanoic acid

CAS-No. 128013-69-4EC-No. not available

<= 100 %

Hazardous ingredients according to Directive 1999/45/EC

Component Classification Concentration

3-(Aminomethyl)-5-methylhexanoic acid

CAS-No. 128013-69-4EC-No. not available

not available <= 100 %

For the full text of the H-Statements and R-Phrases mentioned in this Section, see Section 16

SECTION 4: First aid measures

4.1 Description of first aid measures

General adviceConsult a physician. Show this safety data sheet to the doctor in attendanc.If inhaledIf breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.In case of skin contactWash off with soap and plenty of water. Consult a physician.In case of eye contactRinse thoroughly with plenty of water for at least 15 minutes and consult a physician.If swallowedNever give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.

4.2 Most important symptoms and effects, both acute and delayed

The most important known symptoms and effects are described in the labelling (see section 2.2) and/or in section 11

4.3 Indication of any immediate medical attention and special treatment needed

no data available

SECTION 5: Firefighting measures

5.1 Extinguishing media

Suitable extinguishing mediaUse water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

5.2 Special hazards arising from the substance or mixture

551

carbon dioxide,nitrogen oxides (NOx),Hydrogen chloride gas

5.3 Advice for firefighters

Wear self contained breathing apparatus for fire fighting if necessary.

5.4 Further information

no data available

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust.For personal protection see section 8.

6.2 Environmental precautions

Do not let product enter drains.

6.3 Methods and materials for containment and cleaning up

Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal.

6.4 Reference to other sections

For disposal see section 13.

SECTION 7: Handling and storage

7.1 Precautions for safe handling

Avoid contact with skin and eyes. Avoid formation of dust and aerosols.Provide appropriate exhaust ventilation at places where dust is formed.For precautions see section 2.2.

7.2 Conditions for safe storage, including any incompatibilities

Store in cool place. Keep container tightly closed in a dry and well-ventilated place.Store under inert gas. Hygroscopic.

7.3 Specific end use(s)

Apart from the uses mentioned in section 1.2 no other specific uses are stipulated

SECTION 8: Exposure controls/personal protection

8.1 Control parameters

Components with workplace control parameters

8.2 Exposure controls

Appropriate engineering controls

Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.Personal protective equipment

Eye/face protectionSafety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).Skin protection

Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product.

552

technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands.The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.Body Protection

impervious clothing, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.Respiratory protection

For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator.For higher level protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges.Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).Control of environmental exposureDo not let product enter drains.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties

Appearance White to off-white powderpH Not availableMelting point 148-150oCBoiling point 274ºCAutoignition Temperature Not availableFlash Point 119ºCExplosion Limits: Lower Not availableExplosion Limits: Upper Not availableDecomposition Temperature Not availableSolubility in water Not availableSpecific Gravity/Density 0.997

9.2 Other safety information

no data available

SECTION 10: Stability and reactivity

10.1 Reactivity

no data available

10.2 Chemical stability

Stable under recommended storage conditions.

10.3 Possibility of hazardous reactions

no data available

10.4 Conditions to avoid

Avoid moisture.

10.5 Incompatible materials

acids, Acid chlorides, Acid anhydrides, Oxidizing agents

10.6 Hazardous decomposition products

Other decomposition products - no data availableIn the event of fire: see section 5

553

In the event of fire: see section 5

SECTION 11: Toxicological information

11.1 Information on toxicological effects

Acute toxicityno data availableSkin corrosion/irritationno data availableSerious eye damage/eye irritationno data availableRespiratory or skin sensitisationProlonged or repeated exposure may cause allergic reactions in certain sensitive individuals. The preceding data, or interpretation of data, was determined using Quantitative Structure Activity Relationship (QSAR) modeling.Germ cell mutagenicityno data availableCarcinogenicity

IARC : No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.Reproductive toxicityno data availableSpecific target organ toxicity - single exposureInhalation - May cause respiratory irritation.Specific target organ toxicity - repeated exposureno data availableAspiration hazardno data availableAdditional InformationRTECS: Not availableTo the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.

SECTION 12: Ecological information

12.1 Toxicity

no data available

12.2 Persistence and degradability

no data available

12.3 Bioaccumulative potential

no data available

12.4 Mobility in soil

no data available

12.5 Results of PBT and vPvB assessment

PBT/vPvB assessment not available as chemical safety assessment not required/not conducted

12.6 Other adverse effects

no data available

SECTION 13: Disposal considerations

13.1 Waste treatment methods

554

ProductBurn in a chemical incinerator equipped with an afterburner and scrubber but exert extra care in igniting as this material is highly flammable. Offer surplus and nonrecyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material.Contaminated packagingDispose of as unused product.

SECTION 14: Transport information

DOT (US) Not dangerous goodsIMDGNot dangerous goodsIATANot dangerous goods

SECTION 15: Regulatory information

This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture

no data available

15.2 Chemical Safety Assessment

For this product a chemical safety assessment was not carried out

SECTION 16: Other information

Full text of H-Statements referred to under sections 2 and 3.

Full text of R-phrases referred to under sections 2 and 3.

Further information

The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Capot Chemical Co., Ltd. shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale.Copyright © 2012-2016 Capot Chemical Co., Ltd. License granted to make unlimited paper copies for internal use only. If you have any comments and suggestions, please contact us by [email protected].

3-(Aminomethyl)-5-methylhexanoic acid SAFETY DATA SHEET

CAPOT CHEMICAL COMPANY LIMITEDJoinhands Science Park, No.4028 Nanhuan Road, Hangzhou, Zhejiang, P.R.China, 310053

Tel:+86-571-85586718 Fax:+86-571-85864795 [email protected] www.capotchem.comCopyright © 2012-2017 Capot Chemical Co., Ltd.

555

n-Propanol

Revision Date 08/19/2016 Version 1.2 Print Date 08/19/2016 110000000963 Page 1 of 9

SAFETY DATA SHEET

SECTION 1 IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

Trade name n-Propanol Synonyms 1-Propanol, Hydoxypropane, 1-Propyl alcohol, Ethyl carbinol, n-Propan-1-ol, Propylic

alcohol. Use Industrial use, Intermediate, Process/Extraction Solvent, Raw material for chemical

processes, Raw material for industry, Solvent Company Sasol Chemicals (USA) LLC

(an affiliate of Sasol Chemicals North America LLC) Address 12120 Wickchester Lane Houston TX 77079

Telephone CHEMTREC North America Transportation Emergency (24-hr) (800) 424-9300 CHEMTREC World Wide (703) 527-3887 Other Emergencies (24-hr) (337) 494-5142 SDS and Product Information (8:00am-4:30pm CST) (281) 588-3491 Health and Safety Information (7:30am-4:00pm CST) (281) 588-3492

E-mail address [email protected] SECTION 2 HAZARDS IDENTIFICATION

GHS Hazards Flammable liquids Category 2 Serious eye damage Category 1 Specific target organ toxicity - single exposure

Category 3 (Narcotic effects)

Hazard symbols

Signal word Danger

Hazard statements H225 Highly flammable liquid and vapour. H318 Causes serious eye damage. H336 May cause drowsiness or dizziness.

Precautionary statements

Prevention P210 Keep away from heat/sparks/open flames/hot surfaces. No smoking. P233 Keep container tightly closed. P240 Ground/bond container and receiving equipment.

LABEL ELEMENTS

556

n-Propanol


SAFETY DATA SHEET

P241 Use explosion-proof electrical/ ventilating/ lighting/ equipment. P242 Use only non-sparking tools. P243 Take precautionary measures against static discharge. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection. P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray. P271 Use only outdoors or in a well-ventilated area.

Response P303 + P361 + P353 IF ON SKIN (or hair): Remove/ Take off immediately all contaminated clothing. Rinse skin with water/ shower. P370 + P378 In case of fire: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide for extinction. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310 Immediately call a POISON CENTER/doctor. P304 + P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. P312 Call a POISON CENTER/doctor if you feel unwell.

Storage P403 + P405 + P235 Store locked up in a well-ventilated place. Keep cool.

SECTION 3 COMPOSITION/INFORMATION ON INGREDIENTS

Components CAS-No. Weight percent n-Propanol 71-23-8 99.9

See Section 8 for Exposure Guidelines and Section 15 for Regulatory Classifications.

SECTION 4 FIRST AID MEASURES

Eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.

Skin contact Wash off immediately with soap and plenty of water while removing all contaminated

clothes and shoes. When symptoms persist or in all cases of doubt seek medical advice. Wash contaminated clothing before re-use.

Inhalation Remove to fresh air. If breathing is irregular or stopped, administer artificial respiration. In case of shortness of breath, give oxygen. Call a physician immediately.

Ingestion If swallowed, call a poison control centre or doctor immediately. Do not induce vomiting without medical advice. Never give anything by mouth to an unconscious person.

SECTION 5 FIREFIGHTING MEASURES

FLAMMABLE PROPERTIES

Fire/explosion

Vapours may form explosive mixture with air. Flash back possible over considerable distance. Use water spray to disperse the vapors. NFPA Class 1C flammable liquid.

557

n-Propanol


SAFETY DATA SHEET

Suitable extinguishing media

Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

Protective equipment and precautions for

firefighters

Wear self-contained breathing apparatus and protective suit. Keep containers and surroundings cool with water spray.

Further information

Beware of vapours accumulating to form explosive concentrations. Vapours can accumulate in low areas.

SECTION 6 ACCIDENTAL RELEASE MEASURES

Methods and materials for

containment and cleaning up

Evacuate personnel to safe areas. Remove all sources of ignition. Contain spillage, and then collect with non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite) and place in container for disposal according to local / national regulations (see section 13). Do not flush into surface water or sanitary sewer system.

SECTION 7 HANDLING AND STORAGE

Safe handling advice

Ensure all equipment is electrically grounded before beginning transfer operations. Keep away from heat and sources of ignition. Use only with adequate ventilation.

Storage/Transport pressure

Ambient

Load/Unload temperature

Ambient

SECTION 8 EXPOSURE CONTROLS/PERSONAL PROTECTION

ENGINEERING MEASURES

Air contaminant levels should be controlled below the PEL or TLV for this product (see Exposure Guidelines). Ensure adequate ventilation, especially in confined areas. Use explosion-proof equipment.

PERSONAL PROTECTIVE EQUIPMENT Eyes

Chemical resistant goggles must be worn., Face-shield

Skin

Wear suitable protective clothing, gloves and eye/face protection.

Inhalation

Respiratory protection is normally not required except in emergencies or when conditions cause excessive airborne levels of mists or vapors. Use NIOSH approved respiratory protection.

EXPOSURE GUIDELINES Components Exposure limit(s) n-Propanol OSHA PEL 200 ppm 500 mg/m3

ACGIH TLV (8-hour) 100 ppm

558

n-Propanol


SAFETY DATA SHEET

PEL= Permissible Exposure Limits TWA= Time Weighted Average (8 hr.) TLV= Threshold Limit Value STEL= Short Term Exposure Limit (15 min.) EL= Excursion Limit WEEL= Workplace Environmental Exposure Level

SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES

Appearance

liquid;

Colour

Clear, colorless

Form

liquid

Odour

alcohol-like

Odour Threshold

no data available

Flash point

24 °C, 75 °F;

Flammability

Upper explosion limit: 13.5 %(V)

Lower explosion limit: 2.1 %(V)

Boiling point/boiling range

97 °C, 207 F;

Melting point/range

-127.5 °C, -197.5 F;

Auto-ignition temperature

400 °C, 752 F;

Decomposition temperature

no data available

Flammability (solid, gas)

no data available

Vapour pressure

28.2 hPa @ 25 °C, 77 °F;

Vapour density

2.1

Density

0.804 g/cm3 @ 20 °C, 68 °F;

Specific gravity

no data available

Water solubility

completely miscible

Viscosity

no data available

Viscosity, dynamic

2.3 mPa.s @ 20 °C, 68 °F;

pH

no data available

559

n-Propanol


SAFETY DATA SHEET

Evaporation rate

no data available

Partition coefficient: n-octanol/water

log Pow: 0.2; @ 25 °C, 77 °F;

Volatile organic compounds (VOC)

content

100 %

SECTION 10 STABILITY AND REACTIVITY

Reactivity

No decomposition if stored and applied as directed.

Chemical stability

Stable under recommended storage conditions.

Conditions to avoid

Heat, flames and sparks. Avoid temperatures above 35°C, direct sunlight and contact with sources of heat.

Hazardous decomposition

products

Combustion products include carbon dioxide, carbon monoxide and possibly other unidentified organic compounds.

Materials to avoid

Can react with strong oxidizers, inorganic acids, and halogens.

Hazardous polymerisation

Vapours may form explosive mixture with air.

SECTION 11 TOXICOLOGICAL INFORMATION

Acute dermal toxicity

LD50 Rabbit: > 2,000 mg/kg(literature value)

Acute inhalation toxicity

LC50 Rat (4 hours): > 20 mg/l (literature value)

Acute oral toxicity

LD50 Rat: > 2,000 mg/kg (literature value)

Skin corrosion/irritation

(Rabbit): Draize Test Not irritating, (literature value)

Eye damage/irritation

(Rabbit): Draize Test Risk of serious damage to eyes., (literature value)

Respiratory or skin sensitization

Guinea pig: not sensitizing; Maximisation Test (literature value)

Germ cell mutagenicity Genotoxicity in vitro: Type: Ames test System: Salmonella typhimurium; with and without metabolic activation Result: In vitro tests did not show mutagenic effects (literature value)

560

n-Propanol


SAFETY DATA SHEET

Genotoxicity in vivo: no data available Assessment Mutagenicity: Based on available data, the classification criteria are not met.

Reproductive toxicity Reproductive toxicity: no data available Assessment Reproductive toxicity: no data available Teratogenicity: no data available Assessment teratogenicity: no data available

STOT - single exposure

The substance or mixture is classified as specific target organ toxicant, single exposure, category 3 with narcotic effects.

STOT - repeated exposure

no data available

Aspiration toxicity

no data available

Carcinogenicity

Assessment carcinogenicity: Contains no ingredient listed as a carcinogen

SECTION 12 ECOLOGICAL INFORMATION

Toxicity to fish

LC50 (Pimephales promelas (fathead minnow)) 96 hours: > 100 mg/l; flow-through test (literature value)

Toxicity to aquatic invertebrates

EC50 (Daphnia magna (Water flea)) 48 hours: > 100 mg/l; static test (literature value)

Toxicity to algae

EC50 (Pseudokirchneriella subcapitata (green algae)) 48 hours: > 100 mg/l (literature value)

Chronic toxicity to aquatic invertebrates

NOEC (Daphnia magna (Water flea)) 21 d: > 100 mg/l; semi-static test; OECD Test Guideline 211 (literature value)

Biodegradation

Readily biodegradable OECD Test Guideline 301D (15 d): > 60 % (literature value)

Bioaccumulation No bioaccumulation is to be expected (log Pow <= 4).

561

n-Propanol


SAFETY DATA SHEET

Mobility in soil

no data available

Other adverse effects

This substance is not considered to be persistent, bioaccumulating and toxic (PBT).;

SECTION 13 DISPOSAL CONSIDERATIONS

Waste Code D001 - Ignitability (RQ 100 LB). This product has the RCRA characteristic of ignitability. Re-evaluation of the product may be required by the user at the time of disposal, since the product uses, transformations, mixtures, contamination, and spillage may change the classification.

Disposal methods

Dispose of only in accordance with local, state, and federal regulations. Do not contaminate any lakes, streams, ponds, groundwater or soil. Land disposal of this product is restricted.

Empty containers.

Empty containers retain product residue (liquid and/or vapor) and can be dangerous. DO NOT PRESSURIZE, CUT, WELD, BRAZE, SOLDER, DRILL, GRIND, OR EXPOSE SUCH CONTAINERS TO HEAT, FLAME, SPARKS, STATIC ELECTRICITY, OR OTHER SOURCES OF IGNITION; THEY MAY EXPLODE AND CAUSE INJURY OR DEATH. Empty drums should be completely drained, triple-rinsed, properly bunged and promptly returned to a drum reconditioner, or properly disposed.

SECTION 14 TRANSPORT INFORMATION

DOT UN 1274, n-Propanol, 3, III

IATA UN 1274, n-Propanol, 3, III

IMDG UN 1274, n-Propanol, 3, III

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code

Remarks no data available SECTION 15 REGULATORY INFORMATION

U.S. FEDERAL REGULATIONS

OSHA Hazards (HCS 1994) no data available

TSCA Inventory Listing Components CAS-No. 1-Propanol 71-23-8

SARA 302 Status

562

n-Propanol


SAFETY DATA SHEET

Components CAS-No. Weight percent

No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302. SARA 311/312 Classification "Fire hazard", "Immediate (acute) health hazard"

SARA 313 Chemical Components CAS-No. Weight percent This material does not contain any chemical components with known CAS numbers that exceed the threshold

(De Minimis) reporting levels established by SARA Title III, Section 313. US. EPA CERCLA Hazardous Substances (40 CFR 302) Components Reportable Quantity Weight percent none

INTERNATIONAL REGULATIONS

WHMIS Classification Class B, Division 2: Flammable liquid.

Class D, Division 2, Subdivision B: Toxic material.

European Union Classification according to Regulation (EU) 1272/2008.

Flammable liquids, Category 2 Serious eye damage, Category 1 Specific target organ toxicity - single exposure, Category 3 (Narcotic effects)

Australia. Inventory of Chemical Substances (AICS)

Listed

Japan. Inventory of Existing and New Chemical Substances (ENCS)

Listed

Japan. Industrial Safety & Health Law (ISHL) Inventory

Listed

Canada. Domestic Substances List (DSL) Inventory

Listed

Canadian Non-Domestic Substance Listing (NDSL)

Not listed

European Inventory of Existing Commercial Chemical Substances (EINECS) Listing

Listed

Philippines. Inventory of Chemicals / Chemical Substances (PICCS)

Listed

Korea. Existing Chemicals Inventory (KECI)

Listed

China. Inventory of Existing Chemical Substances (IECSC)

Listed

Mexico. National Inventory of Chemical Substances (INSQ)

Listed

New Zealand. Inventory of Chemicals (NZIoC)

Listed

Switzerland. Inventory of Notified New Substances (CHINV) Listed

563

n-Propanol


SAFETY DATA SHEET

Taiwan. National Existing Chemical Inventory (NECI)

Listed

Please note: The names and CAS numbers which are used for this product in the stated inventories may deviate from the information which is listed in Section 3. STATE REGULATIONS

California Prop. 65 Components CAS-No. none

SECTION 16 OTHER INFORMATION

HAZARD RATINGS

Health Flammability Physical Hazard/

Instability HMIS® 3 3 0 NFPA 3 3 0

THE DATA AND INFORMATION CONTAINED HEREIN ARE BEING FURNISHED FOR INFORMATIONAL PURPOSES ONLY, UPON THE EXPRESS CONDITION THAT EACH CUSTOMER SHALL MAKE ITS OWN ASSESSMENT OF APPROPRIATE USE AND APPROPRIATE SHIPPING, TRANSFER AND STORAGE MATERIALS AND PROCEDURES FOR SASOL CHEMICALS (USA) LLC'S PRODUCTS. ALTHOUGH BASED ON INFORMATION SOURCES WHICH SASOL CHEMICALS (USA) LLC CONSIDERS ACCURATE AND RELIABLE, SASOL CHEMICALS (USA) LLC MAKES NO WARRANTY, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, REGARDING THE VALIDITY OF THIS INFORMATION, THE INFORMATION SOURCES UPON WHICH THE SAME ARE BASED, OR THE RESULTS TO BE OBTAINED, AND EXPRESSLY DISCLAIMS LIABILITIES FOR DAMAGES OR INJURIES RESULTING FROM THE USE THEREOF.

564


Material Name: Linezolid Injection

Trade Name: ZYVOX, ZYVOXID, ZYVOXAM; Relneu IVChemical Family: Mixture

Relevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use: Pharmaceutical product used as antibiotic agent



Classification of the Substance or MixtureGHS - Classification Not classified as hazardous

Label ElementsSignal Word: Not requiredHazard Statements: Non-hazardous in accordance with international standards for workplace safety.

Other Hazards An Occupational Exposure Value has been established for one or more of the ingredients (seeSection 8).

Note: This document has been prepared in accordance with standards for workplace safety, whichrequires the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warning included may not apply in all cases.Your needs may vary depending upon the potential for exposure in your workplace.



EINECS/ELINCSList

GHS Classification %

_______________________________________________________________________________________________________LINEZOLID INJECTION

Version: 3.2


SAFETY DATA SHEET

Page 1 of 8



Revision date: 20-Sep-2016



565

SAFETY DATA SHEET

_______________________________________________________________________________________________________

3. COMPOSITION / INFORMATION ON INGREDIENTSLinezolid 165800-03-3 Not Listed STOT RE 2 (H373) 0.2

Ingredient CAS Number EUEINECS/ELINCS

List


Sodium chloride 7647-14-5 231-598-3 Not Listed *Sodium citrate, anhydrous 68-04-2 200-675-3 Not Listed *Citric acid, anhydrous 77-92-9 201-069-1 Not Listed *Dextrose 14431-43-7 Not Listed Not Listed *


For the full text of the CLP/GHS abbreviations mentioned in this Section, see Section 16



immediately.







None known



Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water.


Formation of toxic gases is possible during heating or fire.




Revision date: 20-Sep-2016Material Name: Linezolid Injection


566

SAFETY DATA SHEET

_______________________________________________________________________________________________________





Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spillarea thoroughly.




Precautions for Safe HandlingAvoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. When handling, use appropriate personal protectiveequipment (see Section 8). Wash thoroughly after handling. Releases to the environment should be avoided. Review andimplement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure orenvironmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dustcollectors, HEPA filtration systems or other equivalent controls.




Refer to available public information for specific member state Occupational Exposure Limits.




Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE). Contact your safety and health professional or safety equipmentsupplier for assistance in selecting the correct protective clothing/equipment based on anassessment of the workplace conditions, other chemicals used or present in the workplace andspecific operational processes.

Hands: Impervious gloves (e.g. Nitrile, etc.) are recommended if skin contact with drug product ispossible and for bulk processing operations. (Protective gloves must meet the standards inaccordance with EN374, ASTM F1001 or international equivalent.)

Eyes: Wear safety glasses or goggles if eye contact is possible. (Eye protection must meet thestandards in accordance with EN166, ANSI Z87.1 or international equivalent.)


Version: 3.2

Lithuania OEL - TWA 5 mg/m3

Page 3 of 8

LinezolidPfizer OEL TWA-8 Hr: 750µg/m3

Sodium chloride


Latvia OEL - TWA 5 mg/m3

567

SAFETY DATA SHEET

_______________________________________________________________________________________________________

8. EXPOSURE CONTROLS / PERSONAL PROTECTIONSkin: Impervious protective clothing is recommended if skin contact with drug product is possible and

for bulk processing operations. (Protective clothing must meet the standards in accordancewith EN13982, ANSI 103 or international equivalent.)

Respiratory protection: Under normal conditions of use, if the applicable Occupational Exposure Limit (OEL) isexceeded, wear an appropriate respirator with a protection factor sufficient to control exposuresto below the OEL (e.g. particulate respirator with a half mask, P3 filter). (Respirators mustmeet the standards in accordance with EN140, EN143, ASTM F2704-10 or internationalequivalent.)


Solvent Solubility: No data availableWater Solubility: No data availablepH: No data available.Melting/Freezing Point (°C): No data availableBoiling Point (°C): No data available.Partition Coefficient: (Method, pH, Endpoint, Value)







No data available


Dextrose

Version: 3.2

No data available

Odor: No data available.

Page 4 of 8

Odor Threshold: No data available.Molecular Formula: Mixture

Sodium citrate, anhydrousNo data available

Molecular Weight: Mixture

Sodium chloride


No data available

Physical State: Liquid

Linezolid


Measured 6-8 Log D 0.55

Color: Clear, colorless

568

SAFETY DATA SHEET

_______________________________________________________________________________________________________


Information on Toxicological EffectsGeneral Information: The information included in this section describes the potential hazards of the individual

ingredients.Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on

reproductive system the developing fetus.Known Clinical Effects: The most common adverse effects reported with clinical use were diarrhea, nausea, rash, and

vomiting. Effects on blood and blood-forming organs have also occurred.


Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the test.





Antigenicity- Active anaphylaxis Guinea Pig Negative

Dog Oral Minimum Lethal Dose > 2000mg/kg

Rat Oral LD50 3000 mg/kg


Linezolid1 Month(s) Rat Oral 20 mg/kg/day NOAEL Blood forming organs, Blood

Mouse Oral LD50 4000 mg/kg

Version: 3.2

3 Month(s) Rat Oral 10 mg/kg/day NOAEL Blood forming organs, Blood

Sodium chloride

1 Month(s) Dog Oral 20 mg/kg/day NOAEL Blood forming organs, Blood, Gastrointestinal system

Page 5 of 8

3 Month(s) Dog Oral 20 mg/kg/day NOAEL Blood forming organs, Blood, Gastrointestinal system

Eye Irritation Rabbit Moderate

Linezolid

Skin Irritation Rabbit Mild

LinezolidReproductive & Fertility Rat Oral 50 mg/kg/day NOAEL Fertility

Linezolid

Rat (F) Oral Minimum Lethal Dose 5000 mg/kg

Embryo / Fetal Development Rat Oral 2.5 mg/kg/day NOAEL Fetotoxicity, Not TeratogenicEmbryo / Fetal Development Rat Oral 15 mg/kg/day NOAEL Maternal Toxicity


Sodium chloride

Embryo / Fetal Development Mouse Oral 150 mg/kg/day NOAEL Fetotoxicity, Maternal Toxicity, Not Teratogenic

Skin Irritation Rabbit Minimal

Rat (M) Oral Minimum Lethal Dose > 5000mg/kg

Antigenicity- Passive cutaneous anaphylaxis Mouse Negative


569

SAFETY DATA SHEET

_______________________________________________________________________________________________________



Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.


Environmental Overview: Environmental properties have not been investigated. Releases to the environment should beavoided.

Toxicity:Aquatic Toxicity: (Species, Method, End Point, Duration, Result)


Persistence and Degradability: No data available

Bio-accumulative Potential:Partition Coefficient: (Method, pH, Endpoint, Value)





Daphnia magna (Water Flea) OECD EC50 48 Hours > 100 mg/L

Bacterial Mutagenicity (Ames) Salmonella Negative

Linezolid

Oncorhynchus mykiss (Rainbow Trout) OECD LC50 96 Hours > 1.4 mg/L

Measured 6-8 Log D 0.55

Version: 3.2

Anabaena flos-aquae(Cyanobacteria) Algae OECD ErC50 72 Hours 1.5 mg/L

Page 6 of 8

In Vitro Chromosome Aberration Human Lymphocytes Negative

Linezolid



Linezolid


In Vitro Unscheduled DNA Synthesis Negative

Linezolid


570

SAFETY DATA SHEET

_______________________________________________________________________________________________________







Citric acid, anhydrous





Australia (AICS):


Present


Sodium chloride



Dextrose



Sodium citrate, anhydrous

California Proposition 65 Not ListedAustralia (AICS): Present

CERCLA/SARA 313 Emission reporting



Linezolid

Not Listed


California Proposition 65


Not Listed

Version: 3.2


Schedule 4





Page 7 of 8

571

SAFETY DATA SHEET

_______________________________________________________________________________________________________


Text of CLP/GHS Classification abbreviations mentioned in Section 3

Specific target organ toxicity, repeated exposure-Cat.2; H373 - May cause damage to organs through prolonged or repeated exposure

Data Sources: Pfizer proprietary drug development information. Safety data sheets for individual ingredients.

Reasons for Revision: Updated Section 3 - Composition / Information on Ingredients.









572

p. 1

3 1 0

He a lt h

Fire

Re a c t iv it y


2

3

0

H

Material Safety Data SheetAcetone MSDS


Product Name: Acetone

Catalog Codes: SLA3502, SLA1645, SLA3151, SLA3808

CAS#: 67-64-1

RTECS: AL3150000

TSCA: TSCA 8(b) inventory: Acetone


Synonym: 2-propanone; Dimethyl Ketone;Dimethylformaldehyde; Pyroacetic Acid

Chemical Name: Acetone

Chemical Formula: C3-H6-O









Composition:


Acetone 67-64-1 100

Toxicological Data on Ingredients: Acetone: ORAL (LD50): Acute: 5800 mg/kg [Rat]. 3000 mg/kg [Mouse]. 5340 mg/kg[Rabbit]. VAPOR (LC50): Acute: 50100 mg/m 8 hours [Rat]. 44000 mg/m 4 hours [Mouse].


Potential Acute Health Effects:Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case ofskin contact (permeator).

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. MUTAGENIC EFFECTS: Not available.TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female,Reproductive system/toxin/male [SUSPECTED]. The substance is toxic to central nervous system (CNS). The substance maybe toxic to kidneys, the reproductive system, liver, skin. Repeated or prolonged exposure to the substance can produce targetorgans damage.


573


p. 2

Eye Contact:Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelidsopen. Cold water may be used. Get medical attention.

Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Cold water may be used.Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medicalattention.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention.







Auto-Ignition Temperature: 465°C (869°F)

Flash Points: CLOSED CUP: -20°C (-4°F). OPEN CUP: -9°C (15.8°F) (Cleveland).

Flammable Limits: LOWER: 2.6% UPPER: 12.8%


Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Slightly explosive in presence of openflames and sparks, of oxidizing materials, of acids.


Special Remarks on Fire Hazards: Vapor may travel considerable distance to source of ignition and flash back.

Special Remarks on Explosion Hazards:Forms explosive mixtures with hydrogen peroxide, acetic acid, nitric acid, nitric acid + sulfuric acid, chromic anydride, chromylchloride, nitrosyl chloride, hexachloromelamine, nitrosyl perchlorate, nitryl perchlorate, permonosulfuric acid, thiodiglycol +hydrogen peroxide, potassium ter-butoxide, sulfur dichloride, 1-methyl-1,3-butadiene, bromoform, carbon, air, chloroform,thitriazylperchlorate.



574

p. 3



Precautions:Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Donot ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wearsuitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoidcontact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducing agents, acids, alkalis.

Storage:Store in a segregated and approved area (flammables area) . Keep container in a cool, well-ventilated area. Keep containertightly closed and sealed until ready for use. Keep away from direct sunlight and heat and avoid all possible sources of ignition(spark or flame).





Exposure Limits:TWA: 500 STEL: 750 (ppm) from ACGIH (TLV) [United States] TWA: 750 STEL: 1000 (ppm) from OSHA (PEL) [UnitedStates] TWA: 500 STEL: 1000 [Austalia] TWA: 1185 STEL: 2375 (mg/m3) [Australia] TWA: 750 STEL: 1500 (ppm) [UnitedKingdom (UK)] TWA: 1810 STEL: 3620 (mg/m3) [United Kingdom (UK)] TWA: 1800 STEL: 2400 from OSHA (PEL) [UnitedStates]Consult local authorities for acceptable exposure limits.



Odor: Fruity. Mint-like. Fragrant. Ethereal

Taste: Pungent, Sweetish


Color: Colorless. Clear



Melting Point: -95.35 (-139.6°F)



575

p. 4

Vapor Pressure: 24 kPa (@ 20°C)

Vapor Density: 2 (Air = 1)


Odor Threshold: 62 ppm

Water/Oil Dist. Coeff.: The product is more soluble in water; log(oil/water) = -0.2


Dispersion Properties: See solubility in water.

Solubility: Easily soluble in cold water, hot water.




Conditions of Instability: Excess heat, ignition sources, exposure to moisture, air, or water, incompatible materials.

Incompatibility with various substances: Reactive with oxidizing agents, reducing agents, acids, alkalis.







Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 3000 mg/kg [Mouse]. Acute toxicity of the vapor (LC50): 44000 mg/m3 4 hours [Mouse].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. DEVELOPMENTAL TOXICITY: ClassifiedReproductive system/toxin/female, Reproductive system/toxin/male [SUSPECTED]. Causes damage to the following organs:central nervous system (CNS). May cause damage to the following organs: kidneys, the reproductive system, liver, skin.

Other Toxic Effects on Humans:Hazardous in case of skin contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (permeator).


Special Remarks on Chronic Effects on Humans:May affect genetic material (mutagenicity) based on studies with yeast (S. cerevisiae), bacteria, and hamster fibroblast cells.May cause reproductive effects (fertility) based upon animal studies. May contain trace amounts of benzene and formaldehydewhich may cancer and birth defects. Human: passes the placental barrier.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: May cause skin irritation. May be harmful if absorbed through the skin. Eyes: Causeseye irritation, characterized by a burning sensation, redness, tearing, inflammation, and possible corneal injury. Inhalation:Inhalation at high concentrations affects the sense organs, brain and causes respiratory tract irritation. It also may affect theCentral Nervous System (behavior) characterized by dizzness, drowsiness, confusion, headache, muscle weakeness, andpossibly motor incoordination, speech abnormalities, narcotic effects and coma. Inhalation may also affect the gastrointestinaltract (nausea, vomiting). Ingestion: May cause irritation of the digestive (gastrointestinal) tract (nausea, vomiting). It may also

576

p. 5

affect the Central Nevous System (behavior), characterized by depression, fatigue, excitement, stupor, coma, headache,altered sleep time, ataxia, tremors as well at the blood, liver, and urinary system (kidney, bladder, ureter) and endocrinesystem. May also have musculoskeletal effects. Chronic Potential Health Effects: Skin: May cause dermatitis. Eyes: Eyeirritation.


Ecotoxicity:Ecotoxicity in water (LC50): 5540 mg/l 96 hours [Trout]. 8300 mg/l 96 hours [Bluegill]. 7500 mg/l 96 hours [Fatthead Minnow].0.1 ppm any hours [Water flea].









Identification: : Acetone UNNA: 1090 PG: II



Federal and State Regulations:California prop. 65: This product contains the following ingredients for which the State of California has found to causereproductive harm (male) which would require a warning under the statute: Benzene California prop. 65: This product containsthe following ingredients for which the State of California has found to cause birth defects which would require a warning underthe statute: Benzene California prop. 65: This product contains the following ingredients for which the State of California hasfound to cause cancer which would require a warning under the statute: Benzene, Formaldehyde Connecticut hazardousmaterial survey.: Acetone Illinois toxic substances disclosure to employee act: Acetone Illinois chemical safety act: AcetoneNew York release reporting list: Acetone Rhode Island RTK hazardous substances: Acetone Pennsylvania RTK: AcetoneFlorida: Acetone Minnesota: Acetone Massachusetts RTK: Acetone Massachusetts spill list: Acetone New Jersey: AcetoneNew Jersey spill list: Acetone Louisiana spill reporting: Acetone California List of Hazardous Substances (8 CCR 339):Acetone TSCA 8(b) inventory: Acetone TSCA 4(a) final test rules: Acetone TSCA 8(a) IUR: Acetone




577

p. 6

DSCL (EEC):R11- Highly flammable. R36- Irritating to eyes. S9- Keep container in a well-ventilated place. S16- Keep away from sources ofignition - No smoking. S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0



Health: 1

Flammability: 3

Reactivity: 0

Specific hazard:



References:-Material safety data sheet issued by: la Commission de la SantÃ© et de la SÃ©curitÃ© du Travail du QuÃ©bec. -The Sigma-Aldrich Library of Chemical Safety Data, Edition II. -Hawley, G.G.. The Condensed Chemical Dictionary, 11e ed., New YorkN.Y., Van Nostrand Reinold, 1987. LOLI, RTECS, HSDB databases. Other MSDSs


Created: 10/10/2005 08:13 PM

Last Updated: 05/21/2013 12:00 PM


578

10/03/2014Revision:

Page: 1 of 6





Olmesartan Medoxomil Product Name:






4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-(5-methyl-2-oxo-1,3-dioxol-4-(5-methyl-2-oxo-1,3-dioxol-4-(5-methyl-2-oxo-1,3-dioxol-4-(5-methyl-2-oxo-1,3-dioxol-4-y)methyl ester; Benicar; CS 866; Olmetec;

Synonyms:





Acute Toxicity: Inhalation, Category 4Acute Toxicity: Oral, Category 4Acute Toxicity: Skin, Category 4


2.1.2 Classification according to Directive 1999/45/EC:Xn: HarmfulRisk Phrases: R20/21/22For full text of R- phrases: see SECTION 15.

H332: Harmful if inhaled.H302: Harmful if swallowed.H312: Harmful in contact with skin.

GHS Hazard Phrases:



Multi-region format

579

10/03/2014Revision:

Page: 2 of 6


P261: Avoid breathing {dust/fume/gas/mist/vapours/spray}.P264: Wash {hands} thoroughly after handling.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.P362+364: Take off contaminated clothing and wash it before reuse.


P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.P312: Call a {POISON CENTER/doctor/...} if you feel unwell.P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.P330: Rinse mouth.P302+352: IF ON SKIN: Wash with plenty of soap and water.P321: Specific treatment {see ... on this label}.



Xn


2.3 Harmful if inhaled.Harmful if swallowed.Harmful in contact with skin.Material may be irritating to the mucous membranes and upper respiratory tract.May cause eye, skin, or respiratory system irritation.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




144689-63-4NA

Olmesartan 100.0 % 604-433-1 NA

Xn; R20/21/22Acute Tox.(O) 4: H302Acute Tox.(D) 4: H312Acute Tox.(I) 4: H332

Multi-region format

580

10/03/2014Revision:

Page: 3 of 6



Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

6.3

6.1

6.2







7.1

7.2









Multi-region format

581

10/03/2014Revision:

Page: 4 of 6




8.2.1







No data available.







Flash Pt: No data.



No data.







~0.5 mg/ml in 1:1 EtOH:PBS (pH 7.2); ~0.2 mg/ml in EtOH; ~20 mg/ml in DMSO; ~30mg/ml in DMF;

Solubility Notes:





10.4

10.5

10.6

10.110.210.3






HazardousDecomposition Or




Multi-region format

582

10/03/2014Revision:

Page: 5 of 6


Byproducts:

11.1

Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Olmesartan Medoxomil - Toxicity Data: Oral TDLO (rat): 12 mg/kg/14D (intermittent); Oral TDLO(woman): 4 mg/kg/10D (intermittent);


Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Olmesartan Medoxomil RTECS Number: NI4014200



12.1

12.2

12.3

12.4

12.5


Toxicity:



















S. 302 (EHS) S. 304 RQ S. 313 (TRI)


144689-63-4 Olmesartan No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 144689-63-4 Olmesartan CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No

Multi-region format

583

10/03/2014Revision:

Page: 6 of 6




Harmful by inhalation, in contact with skin and if swallowed.R20/21/22Avoid contact with skin and eyes.S24/25Wear suitable protective clothing, gloves and eye/face protection.S36/37/39








Multi-region format

584

06/20/2017Revision:

Page: 1 of 5

GabapentinSAFETY DATA SHEET





Gabapentin Product Name:






1-(aminomethyl)-cyclohexaneacetic acid; Neurontin®; Synonyms:





Skin Corrosion/Irritation, Category 2Serious Eye Damage/Eye Irritation, Category 2Toxic To Reproduction, Category 1BSpecific Target Organ Toxicity (single exposure), Category 3

2.1 Classification of the Substance or Mixture:

H315: Causes skin irritation.H319: Causes serious eye irritation.H335: May cause respiratory irritation.H360: May damage fertility or the unborn child.

GHS Hazard Phrases:

2.2 Label Elements:


P201: Obtain special instructions before use.P202: Do not handle until all safety precautions have been read and understood.P261: Avoid breathing {dust/fume/gas/mist/vapors/spray}.P264: Wash {hands} thoroughly after handling.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.


P302+352: IF ON SKIN: Wash with plenty of soap and water.P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P308+313: IF exposed or concerned: Get medical attention/advice.P312: Call a POISON CENTER or doctor/physician if you feel unwell.P332+313: If skin irritation occurs, get medical advice/attention.


Multi-region format

585

06/20/2017Revision:

Page: 2 of 5


04/16/2012Supersedes Revision:P337+313: If eye irritation persists, get medical advice/attention.P362+364: Take off contaminated clothing and wash it before reuse.


2.3 Causes serious eye irritation.Causes skin irritation.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause respiratory system irritation.May damage fertility or the unborn child.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




60142-96-3GU6496000

Gabapentin 100.0 % 262-076-3 NA

Skin Corr. 2: H315Eye Damage 2A: H319Toxic Repro. 1B: H360STOT (SE) 3: H335 H336










4.1

5.1

5.2


Flash Pt: No data.









5.3

No data available.

Multi-region format

586

06/20/2017Revision:

Page: 3 of 5



6.3

6.1

6.2







7.1

7.2





Section 8. Exposure Controls/Personal Protection8.1 Exposure Parameters:

8.2.1







No data available.







Flash Pt: No data.



No data.



pH: No data.




Multi-region format

587

06/20/2017Revision:

Page: 4 of 5





~10 mg/ml in PBS (pH 7.2);Solubility Notes:Octanol/Water PartitionCoefficient:

No data.

Decomposition Temperature: No data.Autoignition Pt: No data.

Viscosity: No data.



Molecular Formula & Weight: C9H17NO2 171.2

10.4

10.5

10.6

10.110.210.3






HazardousDecomposition orByproducts:




11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Gabapentin - Toxicity Data: Oral LD (rat): >8 gm/kg; Oral LD (mouse): >8053 mg/kg;Intraperitoneal TDLO (rat): 30 mg/kg; Subcutaneous TDLO (mouse): 30 mg/kg;


Gabapentin - Investigated as a drug, mutagen, and reproductive effector.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Gabapentin RTECS Number: GU6496000


IARC ACGIH OSHA

60142-96-3 Gabapentin n.a. n.a. n.a. n.a.

12.1

12.2

12.3

12.4

12.5


Toxicity:







Multi-region format

588

06/20/2017Revision:

Page: 5 of 5
















S. 302 (EHS) S. 304 RQ S. 313 (TRI)


60142-96-3 Gabapentin No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 60142-96-3 Gabapentin CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No








Multi-region format

589

p. 1

3 1 0

He a lt h

Fire

Re a c t iv it y


2

3

0

G

Material Safety Data SheetEthyl acetate MSDS


Product Name: Ethyl acetate

Catalog Codes: SLE2452, SLE2317

CAS#: 141-78-6

RTECS: AH5425000

TSCA: TSCA 8(b) inventory: Ethyl acetate

CI#: Not available.

Synonym: Acetic Acid, Ethyl Ester Acetic Ether

Chemical Name: Ethyl Acetate

Chemical Formula: C4-H8-O2









Composition:


Ethyl acetate 141-78-6 100

Toxicological Data on Ingredients: Ethyl acetate: ORAL (LD50): Acute: 5620 mg/kg [Rat]. 4100 mg/kg [Mouse]. 4935 mg/kg[Rabbit]. VAPOR (LC50): Acute: 45000 mg/m 3 hours [Mouse]. 16000 ppm 6 hours [Rat].


Potential Acute Health Effects:Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, permeator), of eye contact(irritant).

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. MUTAGENIC EFFECTS: Not available.TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance is toxic to mucousmembranes, upper respiratory tract. The substance may be toxic to blood, kidneys, liver, central nervous system (CNS).Repeated or prolonged exposure to the substance can produce target organs damage.


590


p. 2


Skin Contact:Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Cold watermay be used.








Auto-Ignition Temperature: 426.67°C (800°F)

Flash Points: CLOSED CUP: -4.4°C (24.1°F). (TAG) OPEN CUP: 7.2°C (45°F) (Cleveland).

Flammable Limits: LOWER: 2.2% UPPER: 9%


Fire Hazards in Presence of Various Substances:Highly flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizingmaterials, of acids, of alkalis. Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of static discharge: Not available. Slightly explosive in presence of heat. Non-explosive in presence of shocks.


Special Remarks on Fire Hazards:Vapor may travel considerable distance to source of ignition and flash back. When heated to decomposition it emits acridsmoke and irritating fumes.

Special Remarks on Explosion Hazards:The liquid produces a vapor that forms explosive mixtures with air at normal temperatures. Explosive reaction with lithiumtetrahydroaluminate.



591

p. 3



Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratoryequipment. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatiblessuch as oxidizing agents, acids, alkalis.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame). Moisture sensitive.



Personal Protection:Safety glasses. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.


Exposure Limits:TWA: 400 (ppm) from OSHA (PEL) [United States] TWA: 400 from ACGIH (TLV) [United States] TWA: 1400 (mg/m3) fromNIOSH [United States] TWA: 400 (ppm) from NIOSH [United States] TWA: 400 (ppm) [Canada] TWA: 1440 (mg/m3) [Canada]TWA: 1400 (mg/m3) from OSHA (PEL) [United States]3 Consult local authorities for acceptable exposure limits.



Odor: Ethereal. Fruity. (Slight.)

Taste: Bittersweet, wine-like burning taste


Color: Colorless.


Boiling Point: 77°C (170.6°F)

Melting Point: -83°C (-117.4°F)




592

p. 4



Odor Threshold: 3.9 ppm

Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 0.7


Dispersion Properties: See solubility in water, diethyl ether, acetone.

Solubility: Soluble in cold water, hot water, diethyl ether, acetone, alcohol, benzene.




Conditions of Instability: Heat, ignition sources (flames, sparks, static), incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents, acids, alkalis.


Special Remarks on Reactivity:Also incompatible with nitrates, chlorosulfonic acid, oleum, potassium-tert-butoxide, and lithium tetrahydroaluminate. Moisturesensitive. On storage, it is slowly decomposed by water.




Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 4100 mg/kg [Mouse]. Acute toxicity of the vapor (LC50): 45000 mg/m3 3 hours [Mouse].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. Causes damage to the following organs:mucous membranes, upper respiratory tract. May cause damage to the following organs: blood, kidneys, liver, central nervoussystem (CNS).

Other Toxic Effects on Humans:Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, permeator).

Special Remarks on Toxicity to Animals: LD50 [Rabbit] - Route: skin; Dose >20,000 ml/kg

Special Remarks on Chronic Effects on Humans:May affect genetic material (mutagenic). May cause adverse reproductive effects. based on animal test data. No human datafound at this time.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: May cause skin irritation. Eyes: Causes eye irritation. May cause irritation of theconjunctivia. Inhalation: May cause respiratory tract and mucous membrane irritation. May affect respiration and may causeacute pulmonary edema. May affect gastrointestinal tract (nausea, vomiting). May affect behavior/central nervous system(mild central nervous system depression - exhilaration, talkativeness, boastfulness, belligerancy, vertigo, diplopia, drowsiness,slurred speech, slowed reaction time, dizziness, lightheadedness, somnolence, ataxia, unconciousness, irritability, fatigue,sleep disturbances, reduced memory and concentration, stupor, coma), cardiovascular system (peripheral vascular collapse(shock) - rapid pulse, hypotension, cold pale skin, hypothermia). Other symptoms may include: flushing of face and sweating.

593

p. 5

Ingestion: May cause gastrointestinal tract irritation with nausea and vomiting. May affect blood, behavior/central nervoussystem (CNS depression - effects may be similar to that of inhalation). Chronic Potential Health Effects: Skin: Repeated orprolonged skin contact may cause drying and cracking of the skin. IngestIon: Prolonged or repeated ingestion may affectthe liver. Inhalation: Prolonged inhalation may affect behavior/central nervous system (symptoms similar to those of acuteinhalation), and cause liver, kidney, lung, and heart damage. It may also affect metabolism, and blood (anemia, leukocytosis).


Ecotoxicity:Ecotoxicity in water (LC50): 220 mg/l 96 hours [Fish (Fathead minnow)]. 212.5 ppm 96 hours [Fish (Indian catfish)].









Identification: : Ethyl Acetate UNNA: 1173 PG: II



Federal and State Regulations:Connecticut hazardous material survey.: Ethyl acetate Illinois toxic substances disclosure to employee act: Ethyl acetateIllinois chemical safety act: Ethyl acetate New York release reporting list: Ethyl acetate Rhode Island RTK hazardoussubstances: Ethyl acetate Pennsylvania RTK: Ethyl acetate Florida: Ethyl acetate Minnesota: Ethyl acetate MassachusettsRTK: Ethyl acetate Massachusetts spill list: Ethyl acetate New Jersey: Ethyl acetate New Jersey spill list: Ethyl acetateLouisiana spill reporting: Ethyl acetate California Director's list of Hazardous Substances: Ethyl acetate TSCA 8(b) inventory:Ethyl acetate TSCA 4(a) final test rules: Ethyl acetate TSCA 8(a) IUR: Ethyl acetate TSCA 12(b) annual export notification:Ethyl acetate CERCLA: Hazardous substances.: Ethyl acetate: 5000 lbs. (2268 kg)



WHMIS (Canada): CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F).

DSCL (EEC):R11- Highly flammable. R36- Irritating to eyes. S2- Keep out of the reach of children. S16- Keep away from sources of ignition- No smoking. S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S33-Take precautionary measures against static discharges. S46- If swallowed, seek medical advice immediately and show thiscontainer or label.

594

p. 6

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: g


Health: 1

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Safety glasses.




Created: 10/10/2005 08:18 PM

Last Updated: 05/21/2013 12:00 PM


595

07/16/2014Revision:

Page: 1 of 6





Levetiracetam Product Name:






(.alpha.S)-ethyl-2-oxo-1-pyrrolidineacetamide; UCB-L 059; Keppra®; Synonyms:





Acute Toxicity: Oral, Category 4Serious Eye Damage/Eye Irritation, Category 2


2.1.2 Classification according to Directive 1999/45/EC:Xn: HarmfulRisk Phrases: R22, R36For full text of R- phrases: see SECTION 15.

H302: Harmful if swallowed.H319: Causes serious eye irritation.

GHS Hazard Phrases:





P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.P330: Rinse mouth.P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P337+313: If eye irritation persists, get medical advice/attention.



Multi-region format

596

07/16/2014Revision:

Page: 2 of 6


Xn


2.3 Causes serious eye irritation.Harmful if swallowed.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation or skin absorption.May cause skin or respiratory system irritation.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




102767-28-2NA

1-Pyrrolidineacetamide, .alpha.-ethyl-2-oxo-,(.alpha.S)-

100.0 % 600-348-9 NA

Xn; R22-36Acute Tox.(O) 4: H302Eye Damage 2: H319


Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

Multi-region format

597

07/16/2014Revision:

Page: 3 of 6


6.3

6.1

6.2







7.1

7.2









No data.



No data.

8.2.1







No data available.



Multi-region format

598

07/16/2014Revision:

Page: 4 of 6






Flash Pt: No data.



No data.







~10 mg/ml in PBS (pH 7.2); ~16.7 mg/ml in EtOH; ~20 mg/ml in DMSO; ~20 mg/ml in DMF;Solubility Notes:Autoignition Pt: No data.




10.4

10.5

10.6

10.110.210.3




oxidizing agentsIncompatibility - MaterialsTo Avoid:






11.1

Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Levetiracetam - Toxicity Data: Oral TDLO (woman): 10 mg/kg; Intravenous LD50 (rat): 1038 mg/kg;Intravenous LD50 (mouse): 1081 mg/kg; Intraperitoneal TDLO (rat): 17 mg/kg; IntraperitonealTDLO (mouse): 17 mg/kg;


Levetiracetam - Investigated as a reproductive effector.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Levetiracetam RTECS Number: UX9656166



Multi-region format

599

07/16/2014Revision:

Page: 5 of 6


12.1

12.2

12.3

12.4

12.5


Toxicity:



















S. 302 (EHS) S. 304 RQ S. 313 (TRI)


102767-28-2 1-Pyrrolidineacetamide, .alpha.-ethyl-2-oxo-,(.alpha.S)-

No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 102767-28-2 1-Pyrrolidineacetamide, .alpha.-ethyl-2-oxo-,

(.alpha.S)-CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CAPROP.65: No



Harmful if swallowed.R22Irritating to eyes.R36Avoid contact with skin and eyes.S24/25Wear suitable protective clothing, gloves and eye/face protection.S36/37/39

Multi-region format

600

07/16/2014Revision:

Page: 6 of 6









Multi-region format

601


Material Name: Pantoprazole Sodium for Injection

Trade Name: PROTONIXChemical Family: Not determined

Relevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use: Pharmaceutical product for the treatment of gastrointestinal disorders




Acute Oral Toxicity: Category 4Carcinogenicity: Category 1BAcute aquatic toxicity: Category 3

US OSHA Specific - ClassificationPhysical Hazard: Combustible Dust

Label ElementsSignal Word: DangerHazard Statements: H302 - Harmful if swallowed

H350 - May cause cancerH402 - Harmful to aquatic lifeMay form combustible dust concentrations in air

_______________________________________________________________________________________________________PZ01408


Revision date: 20-Jun-2016



Version: 3.1


SAFETY DATA SHEET

Page 1 of 7


602

SAFETY DATA SHEET

_______________________________________________________________________________________________________

Precautionary Statements: P201 - Obtain special instructions before useP202 - Do not handle until all safety precautions have been read and understoodP281 - Use personal protective equipment as requiredP264 - Wash hands thoroughly after handlingP270 - Do not eat, drink or smoke when using this productP308 + P313 - IF exposed or concerned: Get medical attention/adviceP301+ P312 - IF SWALLOWED: Call a POISON CENTRE or doctor/physician if you feelunwellP330 - Rinse mouthP405 - Store locked upP273 - Avoid release to the environmentP501 - Dispose of contents/container in accordance with all local and national regulations

Other HazardsNote: This document has been prepared in accordance with standards for workplace safety, which

requires the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warning included may not apply in all cases.Your needs may vary depending upon the potential for exposure in your workplace.



EINECS/ELINCSList


Pantoprazole Sodium 138786-67-1 Not Listed Acute Tox.4 (H302)Carc.1B (H350)

Aquatic Acute 3 (H402)

100

Additional Information: Ingredient(s) indicated as hazardous have been assessed under standards for workplacesafety.

For the full text of the CLP/GHS abbreviations mentioned in this Section, see Section 16



immediately.




_______________________________________________________________________________________________________PZ01408

Revision date: 20-Jun-2016Material Name: Pantoprazole Sodium for Injection


603

SAFETY DATA SHEET

_______________________________________________________________________________________________________




None known



Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water.


Formation of toxic gases is possible during heating or fire.











Precautions for Safe HandlingMinimize dust generation and accumulation. Avoid breathing dust. Avoid contact with eyes, skin and clothing. When handling,use appropriate personal protective equipment (see Section 8). Wash hands and any exposed skin after removal of PPE. Referto Section 12 - Ecological Information, for information on potential effects on the environment. Releases to the environmentshould be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures toprevent occupational exposure or environmental releases. Potential points of process emissions of this material to theatmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent controls.




_______________________________________________________________________________________________________PZ01408


Revision date: 20-Jun-2016Material Name: Pantoprazole Sodium for Injection

604

SAFETY DATA SHEET

_______________________________________________________________________________________________________








for bulk processing operations.Respiratory protection: Under normal conditions of use, if the applicable Occupational Exposure Limit (OEL) is

exceeded, wear an appropriate respirator with a protection factor sufficient to control exposuresto below the OEL (e.g. particulate respirator with a half mask, P3 filter). (Respirators mustmeet the standards in accordance with EN140, EN143, ASTM F2704-10 or internationalequivalent.)


Solvent Solubility: No data availableWater solubility: 303 g/LWater Solubility: No data availablepH: No data available.Melting/Freezing Point (°C): 149-150Boiling Point (°C): No data available.Partition Coefficient: (Method, pH, Endpoint, Value)




_______________________________________________________________________________________________________PZ01408

Color: White to off-whiteOdor: No data available.

Pfizer OEL TWA-8 Hr:


300µg/m3

Pantoprazole Sodium

Molecular Formula:

No data available

C16H14F2N3NaO4S

Pantoprazole


Molecular Weight:

Predicted 7.4 Log P 2.05

405.4

Material Name: Pantoprazole Sodium for InjectionVersion: 3.1Page 4 of 7

Pantoprazole Sodium

Physical State: Freeze-dried powder

605

SAFETY DATA SHEET

_______________________________________________________________________________________________________




No data available


Information on Toxicological EffectsGeneral Information: The information included in this section describes the potential hazards of various forms of the

active ingredients.Short Term: Accidental ingestion may cause effects similar to those seen in clinical use.Known Clinical Effects: Adverse effects most commonly reported in clinical use include headache, diarrhea, nausea,

and flatulence. May cause mild skin rash. Additionally weight changes, fatigue, malaise,insomnia, sleepiness (somnolence), weakness, and electrolyte imbalance may occur.



Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))



_______________________________________________________________________________________________________PZ01408

Chromosome Aberration Human Lymphocytes Positive

Version: 3.1

Micronucleus Mouse Positive

Pantoprazole

Mammalian Cell Mutagenicity Chinese Hamster Ovary (CHO) cells Positive

Mouse Oral LD 50 > 1000mg/kg

In Vivo DNA Binding Assay Rat Equivocal

Reproductive & Fertility-Males Rat Oral 500 mg/kg/day NOEL No effects at maximum dose

In Vivo Chromosome Aberration Rat Bone Marrow Negative

Page 5 of 7

Reproductive & Fertility - Females Rat Oral 450 mg/kg/day NOEL No effects at maximum dose

Pantoprazole

Rat Intravenous LD 50 256mg/kg

24 Month(s) Rat Oral 0.5 mg/kg/day LOEL Tumors, Gastrointestinal system, Liver

Fertility and Embryonic Development Rat Oral 450 mg/kg/day NOEL Not Teratogenic

24 Month(s) Rat Oral 5 mg/kg/day LOEL Tumors, Gastrointestinal system24 Month(s) Mouse Oral 150 mg/kg/day LOEL Tumors, Liver

Fertility and Embryonic Development Rabbit Oral 40 mg/kg/day NOEL Not Teratogenic

24 Month(s) Rat Oral 200 mg/kg/day LOEL Tumors, Thyroid


Pantoprazole Sodium


Pantoprazole

Rat Oral LD 50 747 mg/kg

606

SAFETY DATA SHEET

_______________________________________________________________________________________________________


Carcinogen Status: Not listed as a carcinogen by IARC, NTP or US OSHA.


Environmental Overview: Environmental properties have not been investigated. Releases to the environment should beavoided.

Toxicity:Aquatic Toxicity: (Species, Method, End Point, Duration, Result)

Persistence and Degradability: No data available

Bio-accumulative Potential: No data availablePartition Coefficient: (Method, pH, Endpoint, Value)






_______________________________________________________________________________________________________PZ01408

Version: 3.1

Pseudokirchneriella subcapitata (Green Alga) OECD EC50 72 Hours 48 mg/L

Page 6 of 7

Daphnia magna (Water Flea) OECD EC50 48 Hours >95 mg/L


Pimephales promelas (Fathead Minnow) OECD LC50 96 Hours >95 mg/L

Pantoprazole


Predicted 7.4 Log P 2.05

Activated sludge OECD EC50 3 Hours > 1000 mg/L

Pantoprazole

607

SAFETY DATA SHEET

_______________________________________________________________________________________________________




Text of CLP/GHS Classification abbreviations mentioned in Section 3

Acute toxicity, oral-Cat.4; H302 - Harmful if swallowedCarcinogenicity-Cat.1B; H350 - May cause cancerHazardous to the aquatic environment, acute toxicity-Cat.3; H402 - Harmful to aquatic life

Data Sources: Pfizer proprietary drug development information. Publicly available toxicity information.

Reasons for Revision: Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information onIngredients. Updated Section 16 - Other Information.






_______________________________________________________________________________________________________PZ01408


Pantoprazole Sodium

Version: 3.1


Page 7 of 7

California Proposition 65 Not ListedEU EINECS/ELINCS List Not Listed


608

01/25/2016Revision:

Page: 1 of 5





Tapentadol (hydrochloride) RM Product Name:






3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol, monohydrochloride; Nucynta;Palexia;

Synonyms:





Toxic To Reproduction, Category 22.1 Classification of the Substance or Mixture:

H361: Suspected of damaging fertility or the unborn child.GHS Hazard Phrases:

2.2 Label Elements:


P201: Obtain special instructions before use.P202: Do not handle until all safety precautions have been read and understood.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.


P308+313: IF exposed or concerned: Get medical attention/advice.GHS Response Phrases:


2.3 Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause eye, skin, or respiratory system irritation.Suspected of damaging fertility or the unborn child.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


Multi-region format

609

01/25/2016Revision:

Page: 2 of 5


CAS # /RTECS #




175591-09-0SL1550000

Tapentadol (hydrochloride) RM 100.0 % NA NA

Toxic Repro. 2: H361










4.1

5.1

5.2


Flash Pt: No data.









5.3

No data available.

6.3

6.1

6.2







Multi-region format

610

01/25/2016Revision:

Page: 3 of 5


7.1

7.2











8.2.1







No data available.







Flash Pt: No data.



No data.



A neat solidAppearance and Odor:






Multi-region format

611

01/25/2016Revision:

Page: 4 of 5




Molecular Formula & Weight: C14H23NO • HCl 257.8

10.4

10.5

10.6

10.110.210.3









11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Tapentadol (hydrochloride) - Toxicity Data: Intraperitoneal TDLO (rat): 10 mg/kg;


Tapentadol (hydrochloride) - Investigated as a drug.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Tapentadol (hydrochloride) RTECS Number: SL1550000


IARC ACGIH OSHA

175591-09-0 Tapentadol (hydrochloride) RM n.a. n.a. n.a. n.a.

12.1

12.2

12.3

12.4

12.5


Toxicity:









Multi-region format

612

01/25/2016Revision:

Page: 5 of 5













S. 302 (EHS) S. 304 RQ S. 313 (TRI)


175591-09-0 Tapentadol (hydrochloride) RM No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 175591-09-0 Tapentadol (hydrochloride) RM CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No








Multi-region format

613

SAFETY DATA SHEETCreation Date 27-Jan-2011 Revision Date 26-May-2017 Revision Number 2

1. IdentificationProduct Name L-Alanine methyl ester hydrochloride

Cat No. : AC308360000; AC308360050; AC308360250

Synonyms No information available

Recommended Use Laboratory chemicals.Uses advised against Not for food, drug, pesticide or biocidal product use

Details of the supplier of the safety data sheet

Emergency Telephone NumberFor information US call: 001-800-ACROS-01 / Europe call: +32 14 57 52 11Emergency Number US:001-201-796-7100 / Europe: +32 14 57 52 99CHEMTREC Tel. No.US:001-800-424-9300 / Europe:001-703-527-3887

2. Hazard(s) identificationClassification Classification under 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Label Elements None required

Hazards not otherwise classified (HNOC) None identified

3. Composition / information on ingredients

Component CAS-No Weight %Methyl L-alaninate hydrochloride 2491-20-5 >95

4. First-aid measures

Eye Contact Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes.Obtain medical attention.

CompanyFisher ScientificOne Reagent LaneFair Lawn, NJ 07410Tel: (201) 796-7100

Acros OrganicsOne Reagent LaneFair Lawn, NJ 07410

Based on available data, the classification criteria are not met

______________________________________________________________________________________________

Page 1 / 6

614

______________________________________________________________________________________________L-Alanine methyl ester hydrochloride Revision Date 26-May-2017

Skin Contact Wash off immediately with soap and plenty of water while removing all contaminatedclothes and shoes. Obtain medical attention.

Inhalation Remove from exposure, lie down. Move to fresh air. If breathing is difficult, give oxygen. Ifnot breathing, give artificial respiration. Obtain medical attention.

Ingestion Clean mouth with water. Get medical attention.

Most important symptoms/effects No information available.Notes to Physician Treat symptomatically

5. Fire-fighting measuresSuitable Extinguishing Media Water spray. Carbon dioxide (CO 2). Dry chemical. Chemical foam.

Unsuitable Extinguishing Media No information available

Flash Point No information availableMethod - No information available

Autoignition TemperatureExplosion Limits

Upper No data availableLower No data availableSensitivity to Mechanical Impact No information availableSensitivity to Static Discharge No information available

Specific Hazards Arising from the ChemicalKeep product and empty container away from heat and sources of ignition.

Hazardous Combustion ProductsHydrogen chloride gas Nitrogen oxides (NOx) Carbon monoxide (CO) Carbon dioxide (CO2)Protective Equipment and Precautions for FirefightersAs in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and fullprotective gear.

NFPA

6. Accidental release measuresPersonal Precautions Ensure adequate ventilation. Use personal protective equipment.Environmental Precautions See Section 12 for additional ecological information.

Methods for Containment and CleanUp

Sweep up or vacuum up spillage and collect in suitable container for disposal.

7. Handling and storageHandling Avoid contact with skin and eyes. Do not breathe dust.

Storage Keep in a dry, cool and well-ventilated place. Keep container tightly closed. Keep undernitrogen. Keep refrigerated.

8. Exposure controls / personal protectionExposure Guidelines This product does not contain any hazardous materials with occupational exposure

limitsestablished by the region specific regulatory bodies.

Health0

Flammability0

Instability0

Physical hazardsN/A

______________________________________________________________________________________________

Page 2 / 6

615


9. Physical and chemical propertiesPhysical State Powder SolidAppearance Off-whiteOdor No information availableOdor Threshold No information availablepH No information availableMelting Point/Range 109 - 111 °C / 228 - 232 °FBoiling Point/Range No information availableFlash Point No information availableEvaporation Rate Not applicableFlammability (solid,gas) No information availableFlammability or explosive limits

Upper No data availableLower No data available

Vapor Pressure No information availableVapor Density Not applicableSpecific Gravity No information availableSolubility No information availablePartition coefficient; n-octanol/water No data availableAutoignition TemperatureDecomposition Temperature No information availableViscosity Not applicableMolecular Formula C4 H9 N O2 . H ClMolecular Weight 139.58

10. Stability and reactivity

Reactive Hazard None known, based on information available

Stability Hygroscopic.

Conditions to Avoid Incompatible products. Exposure to moist air or water.

Incompatible Materials Strong oxidizing agents

Hazardous Decomposition Products Hydrogen chloride gas, Nitrogen oxides (NOx), Carbon monoxide (CO), Carbon dioxide(CO2)

Hazardous Polymerization No information available.

Hazardous Reactions None under normal processing.

Engineering Measures None under normal use conditions.

Personal Protective Equipment

Eye/face Protection Wear appropriate protective eyeglasses or chemical safety goggles as described byOSHA's eye and face protection regulations in 29 CFR 1910.133 or European StandardEN166.

Skin and body protection Wear appropriate protective gloves and clothing to prevent skin exposure.

Respiratory Protection No protective equipment is needed under normal use conditions.

Hygiene Measures

______________________________________________________________________________________________

Page 3 / 6

Handle in accordance with good industrial hygiene and safety practice.

616


11. Toxicological informationAcute Toxicity

Product Information No acute toxicity information is available for this productComponent InformationToxicologically SynergisticProducts


Delayed and immediate effects as well as chronic effects from short and long-term exposure

Irritation No information available

Sensitization No information available

Carcinogenicity The table below indicates whether each agency has listed any ingredient as a carcinogen.

Component CAS-No IARC NTP ACGIH OSHA MexicoMethyl L-alaninate

hydrochloride2491-20-5 Not listed Not listed Not listed Not listed Not listed

Mutagenic Effects No information available

Reproductive Effects No information available.

Developmental Effects No information available.

Teratogenicity No information available.

STOT - single exposure None knownSTOT - repeated exposure None known

Aspiration hazard No information available

Symptoms / effects,both acute anddelayed


Endocrine Disruptor Information No information available

Other Adverse Effects The toxicological properties have not been fully investigated.

12. Ecological informationEcotoxicity Do not empty into drains.

Persistence and Degradability No information available

Bioaccumulation/ Accumulation No information available.

Mobility No information available.

13. Disposal considerationsWaste Disposal Methods Chemical waste generators must determine whether a discarded chemical is classified as a

hazardous waste. Chemical waste generators must also consult local, regional, andnational hazardous waste regulations to ensure complete and accurate classification.

14. Transport informationDOT Not regulatedTDG Not regulatedIATA Not regulatedIMDG/IMO Not regulated

______________________________________________________________________________________________

Page 4 / 6

617


15. Regulatory information

International Inventories

Component TSCA DSL NDSL EINECS ELINCS NLP PICCS ENCS AICS IECSC KECLMethyl L-alaninate

hydrochloride- - - 219-652-4 - - - - - -

Legend:X - ListedE - Indicates a substance that is the subject of a Section 5(e) Consent order under TSCA.F - Indicates a substance that is the subject of a Section 5(f) Rule under TSCA.N - Indicates a polymeric substance containing no free-radical initiator in its inventory name but is considered to cover the designatedpolymer made with any free-radical initiator regardless of the amount used.P - Indicates a commenced PMN substanceR - Indicates a substance that is the subject of a Section 6 risk management rule under TSCA.S - Indicates a substance that is identified in a proposed or final Significant New Use RuleT - Indicates a substance that is the subject of a Section 4 test rule under TSCA.XU - Indicates a substance exempt from reporting under the Inventory Update Rule, i.e. Partial Updating of the TSCA Inventory Data BaseProduction and Site Reports (40 CFR 710(B).Y1 - Indicates an exempt polymer that has a number-average molecular weight of 1,000 or greater.Y2 - Indicates an exempt polymer that is a polyester and is made only from reactants included in a specified list of low concern reactantsthat comprises one of the eligibility criteria for the exemption rule.

U.S. Federal Regulations

TSCA 12(b) Not applicable

SARA 313 Not applicable

SARA 311/312 Hazard CategoriesAcute Health Hazard NoChronic Health Hazard NoFire Hazard NoSudden Release of Pressure Hazard NoReactive Hazard No

CWA (Clean Water Act) Not applicable

Clean Air Act Not applicable

OSHA Occupational Safety and Health AdministrationNot applicable

CERCLANot applicable

California Proposition 65 This product does not contain any Proposition 65 chemicals

U.S. State Right-to-KnowRegulations

Not applicable

U.S. Department of Transportation

Reportable Quantity (RQ): NDOT Marine Pollutant NDOT Severe Marine Pollutant N

U.S. Department of Homeland SecurityThis product does not contain any DHS chemicals.

Other International Regulations

______________________________________________________________________________________________

Page 5 / 6

618


Mexico - Grade No information available

16. Other informationPrepared By Regulatory Affairs

Thermo Fisher ScientificEmail: [email protected]

Creation Date 27-Jan-2011Revision Date 26-May-2017Print Date 26-May-2017Revision Summary This document has been updated to comply with the US OSHA HazCom 2012 Standard

replacing the current legislation under 29 CFR 1910.1200 to align with the GloballyHarmonized System of Classification and Labeling of Chemicals (GHS).

DisclaimerThe information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at thedate of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage,transportation, disposal and release and is not to be considered a warranty or quality specification. The informationrelates only to the specific material designated and may not be valid for such material used in combination with any othermaterials or in any process, unless specified in the text

End of SDS

______________________________________________________________________________________________

Page 6 / 6

619


Material Name: Voriconazole Film Coated Tablets

Trade Name: Vfend; SPIONIC; Voriconazole PfizerChemical Family: Mixture

Relevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use: Pharmaceutical product used as antifungal agent




Acute Oral Toxicity: Category 4Reproductive Toxicity: Category 1BCarcinogenicity: Category 2Specific target organ systemic toxicity (repeated exposure): Category 2Acute aquatic toxicity: Category 3

EU Classification:EU Indication of danger: Harmful

Toxic to Reproduction: Category 2Carcinogenic: Category 3

EU Risk Phrases:R22 - Harmful if swallowed.R40 - Limited evidence of a carcinogenic effect.R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed.R61 - May cause harm to the unborn child.

Label ElementsSignal Word: Danger

_______________________________________________________________________________________________________557


Version: 3.0


SAFETY DATA SHEET

Page 1 of 12





620

SAFETY DATA SHEET

_______________________________________________________________________________________________________

2. HAZARDS IDENTIFICATIONHazard Statements: H302 - Harmful if swallowed

H351 - Suspected of causing cancerH360D - May damage the unborn childH373 - May cause damage to organs through prolonged or repeated exposureH402 - Harmful to aquatic life

Precautionary Statements: P202 - Do not handle until all safety precautions have been read and understoodP264 - Wash hands thoroughly after handlingP270 - Do not eat, drink or smoke when using this productP281 - Use personal protective equipment as requiredP301+ P312 - IF SWALLOWED: Call a POISON CENTRE or doctor/physician if you feelunwellP330 - Rinse mouthP308 + P313 - IF exposed or concerned: Get medical attention/adviceP314 - Get medical attention/advice if you feel unwellP405 - Store locked upP501 - Dispose of contents/container in accordance with all local and national regulationsP273 - Avoid release to the environment

Other Hazards No data availableAustralian Hazard Classification(NOHSC):

Hazardous Substance. Non-Dangerous Goods.

Note: This document has been prepared in accordance with standards for workplace safety, whichrequire the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warnings included may not apply in all cases.Your needs may vary depending upon the potential for exposure in your workplace.



EINECS/ELINCSList


%

Voriconazole 137234-62-9 Not Listed Carc. Cat.3;R40Repr. Cat.2;R61

Xn;R22Xn;R48/22

Acute Tox.3 (H301)Carc. 2 (H351)

Repr. 1B (H360D)STOT RE 2 (H373)

Aquatic Acute 3(H402)

33.3

Titanium dioxide 13463-67-7 236-675-5 Not Listed Not Listed *Croscarmellose sodium 74811-65-7 Not Listed Not Listed Not Listed *Magnesium stearate 557-04-0 209-150-3 Not Listed Not Listed *Starch, pregelatinized 9005-25-8 232-679-6 Not Listed Not Listed *

_______________________________________________________________________________________________________557

Revision date: 04-Apr-2015Material Name: Voriconazole Film Coated Tablets


621

SAFETY DATA SHEET

_______________________________________________________________________________________________________

Ingredient CAS Number EUEINECS/ELINCS

List


%

Hydroxypropyl methylcellulose 9004-65-3 Not Listed Not Listed Not Listed *Triacetin 102-76-1 203-051-9 Not Listed Not Listed *Lactose NF, monohydrate 64044-51-5 Not Listed Not Listed Not Listed *Povidone 9003-39-8 Not Listed Not Listed Not Listed *Water, purified 7732-18-5 231-791-2 Not Listed Not Listed *


For the full text of the R phrases and CLP/GHS abbreviations mentioned in this Section, see Section 16



immediately.







None known



Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.


Carbon monoxide, carbon dioxide, nitrogen oxides and fluorine-containing compounds

Fire / Explosion Hazards: Not applicable




_______________________________________________________________________________________________________557



622

SAFETY DATA SHEET

_______________________________________________________________________________________________________







Precautions for Safe HandlingMinimize dust generation and accumulation. If tablets or capsules are crushed and/or broken, avoid breathing dust and avoidcontact with eyes, skin, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Washhands and any exposed skin after removal of PPE. Refer to Section 12 - Ecological Information, for information on potentialeffects on the environment. Releases to the environment should be avoided. Review and implement appropriate technical andprocedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potentialpoints of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systemsor other equivalent controls.




Refer to available public information for specific member state Occupational Exposure Limits.

_______________________________________________________________________________________________________557

100µg/m3

Bulgaria OEL - TWA 10.0 mg/m3


Denmark OEL - TWA 6 mg/m3

Titanium dioxide

Estonia OEL - TWA 5 mg/m3

Version: 3.0

France OEL - TWA 10 mg/m3

ACGIH Threshold Limit Value (TWA) 10 mg/m3

Greece OEL - TWA 10 mg/m3

5 mg/m3

Page 4 of 12

Ireland OEL - TWAs 10 mg/m3

4 mg/m3

Latvia OEL - TWA 10 mg/m3

ACGIH OELs - Notice of Intended Changes Listed


Voriconazole

OSHA - Final PELS - TWAs: 15 mg/m3

Australia TWA

Poland OEL - TWA 10.0 mg/m3

10 mg/m3

Portugal OEL - TWA 10 mg/m3


Romania OEL - TWA 10 mg/m3

Austria OEL - MAKs 5 mg/m3

Pfizer OEL TWA-8 Hr:

Belgium OEL - TWA 10 mg/m3

623

SAFETY DATA SHEET

_______________________________________________________________________________________________________








for bulk processing operations.Respiratory protection: If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate

respirator with a protection factor sufficient to control exposures to below the OEL.


Solvent Solubility: No data availableWater Solubility: No data availablepH: No data available.Melting/Freezing Point (°C): No data available

_______________________________________________________________________________________________________557

10 mg/m3

Slovakia OEL - TWA 4 mg/m3

Spain OEL - TWA 10 mg/m3

ACGIH Threshold Limit Value (TWA) 10 mg/m3

Switzerland OEL -TWAs 3 mg/m3


Spain OEL - TWA 10 mg/m3

Sweden OEL - TWAs 5 mg/m3


Starch, pregelatinizedACGIH Threshold Limit Value (TWA) 10 mg/m3

Sweden OEL - TWAs 5 mg/m3

Australia TWA 10 mg/m3


Belgium OEL - TWA 10 mg/m3

Switzerland OEL -TWAs

Bulgaria OEL - TWA

Physical State: Tablets

10.0 mg/m3

Color: White

3 mg/m3

Odor: No data available.

Version: 3.0


Czech Republic OEL - TWA

Molecular Formula: Mixture

4.0 mg/m3

Molecular Weight: Mixture

Page 5 of 12

Greece OEL - TWA 10 mg/m3

5 mg/m3

Vietnam OEL - TWAs 6 mg/m3

5 mg/m3

Ireland OEL - TWAs 10 mg/m3

4 mg/m3

OSHA - Final PELS - TWAs: 15 mg/m3

Russia OEL - TWA

Magnesium stearate

Portugal OEL - TWA 10 mg/m3

624

SAFETY DATA SHEET

_______________________________________________________________________________________________________

9. PHYSICAL AND CHEMICAL PROPERTIESBoiling Point (°C): No data available.Partition Coefficient: (Method, pH, Endpoint, Value)




Polymerization: Will not occur




No data available


Information on Toxicological Effects

_______________________________________________________________________________________________________557

Lactose NF, monohydrate

No data available

No data available

Titanium dioxide

No data available

No data available

Page 6 of 12

Croscarmellose sodium

Water, purified

No data availablePovidone

No data available

No data available


Voriconazole

Starch, pregelatinized


Magnesium stearate

Hydroxypropyl methylcellulose

No data available

No data available

Version: 3.0

Triacetin

625

SAFETY DATA SHEET

_______________________________________________________________________________________________________

11. TOXICOLOGICAL INFORMATIONGeneral Information: The information included in this section describes the potential hazards of the individual

ingredients.Short Term: May produce slight eye irritation. Accidental ingestion may cause effects similar to those seen

in clinical use.Long Term: Adverse reproductive effects seen in repeat-dose animal studies are consistent with the

pharmacologic action of this drug and are expected to be relevant to humans. Animal studiesindicate that this material may cause adverse effects on the liver, the developing fetus.

Known Clinical Effects: The most common adverse effects reported with clinical use of voriconazole include visualdisturbances, elevations of liver function tests and skin rash. Voriconazole has beenassociated with photosensitivity skin reactions especially during long term therapy.





_______________________________________________________________________________________________________557

Titanium dioxide

Page 7 of 12


Rat/Mouse Oral LD50 < 300 mg/kg

Rat Subcutaneous LD50 50 mg/kg


Rat/Mouse Oral LDmin. > 100mg/kg


Voriconazole

Rat IV LD50 > 100mg/kg


Rat Inhalation LC50 > 2000 mg/m3

Skin Sensitization - GPMT Guinea Pig Negative

Rat Dermal LD50 > 2000mg/kg




Voriconazole

Povidone

1 Month(s) Rat Oral30 mg/kg/day NOAEL Liver

Rat Oral LD50 > 10,000 mg/kg

6 Month(s) Rat Oral 3 mg/kg/day NOAEL Liver, Kidney

Version: 3.0


Triacetin

6 Month(s) Rat Intravenous 10 mg/kg/day NOAEL Liver

Rat Oral LD50 100 g/kg


Rat Oral LD 50 3000 mg/kg

Magnesium stearate

Mouse Oral LD 50 1100mg/kg

Voriconazole

626

SAFETY DATA SHEET

_______________________________________________________________________________________________________



Liver Reproductive system



Carcinogen Status: See below


Environmental Overview: In the environment, the active ingredient in this formulation is expected to remain in water ormigrate through the soil to groundwater and degrade slowly . Harmful effects to aquaticorganisms could occur.

Toxicity:

Aquatic Toxicity: (Species, Method, End Point, Duration, Result)

Aquatic Toxicity Comments: A greater than symbol (>) indicates that aquatic toxicity was not observed at the maximumdose tested.


_______________________________________________________________________________________________________557

Voriconazole


2 Year(s) Rat Oral 18 mg/kg/day NOEL Benign tumors, Liver

Voriconazole

2 Year(s) Mouse Oral 30 mg/kg/day NOAEL Malignant tumors, Liver

Voriconazole

Voriconazole

Version: 3.0

Bacterial Mutagenicity (Ames) Bacteria Negative

Mysidopsis bahia (Mysid Shrimp) NPDES LC50 48 Hours 62 mg/L

Reproductive & Fertility Rat Oral3 mg/kg/day NOAEL Fetotoxicity

Red Algae IC50 73 mg/L

Povidone

Skeletonema costatum (Marine Diatom) NPDES IC-50 48 Hours 74.7 mg/L

In Vitro Human Lymphocytes Equivocal

Green Algae OECD EbC50/72hr (OECD) EC50 72 Hours > 97 mg/L

IARC:

Oncorhynchus mykiss (Rainbow Trout) OECD LC50 96 Hours 110 mg/L

Group 3 (Not Classifiable)

Page 8 of 12

Titanium dioxide


IARC: Group 2B (Possibly Carcinogenic to Humans)

Embryo / Fetal Development Rat Oral 10 mg/kg/day LOAEL Teratogenic

627

SAFETY DATA SHEET

_______________________________________________________________________________________________________

Chronic Aquatic Toxicity: (Species, Method, Duration, Endpoint, Result, Adverse Endpoint)

Persistence and Degradability:Biodegradation: (Method, Inoculum, Biodeg Study, Result, Endpoint, Duration, Classification)

Bio-accumulative Potential:Partition Coefficient: (Method, pH, Endpoint, Value)








_______________________________________________________________________________________________________557

Polytox MIC > 100 mg/L


Voriconazole

Voriconazole

Voriconazole

OECD Activated sludge Ultimate (CO2 Evolution) -0.24% After 28 Day(s) Not Ready

Daphnia magna (Water Flea) OECD 21 Day(s) NOEC > 1 mg/L


Pimephales promelas (Fathead Minnow) OECD 32 Day(s) NOEC 1.2 mg/L


Voriconazole

Chironomus riparius (Sediment-Dwelling Midges) OECD 28 Day(s) NOEC 100 mg/L


628

SAFETY DATA SHEET

_______________________________________________________________________________________________________

15. REGULATORY INFORMATIONCanada - WHMIS: ClassificationsWHMIS hazard class:Class D, Division 2, Subdivision A

_______________________________________________________________________________________________________557


Schedule 4

CERCLA/SARA 313 Emission reporting Not ListedCalifornia Proposition 65 Not Listed

EU EINECS/ELINCS List


Not Listed


Voriconazole




Titanium dioxide




California Proposition 65 carcinogen initial date 9/2/11 airborne, unbound particles ofrespirable size


CERCLA/SARA 313 Emission reporting




Not Listed

Croscarmellose sodium

Inventory - United States TSCA - Sect. 8(b)


Present


Version: 3.0





Lactose NF, monohydrate

Not Listed



Schedule 4


Page 10 of 12



Triacetin

629

SAFETY DATA SHEET

_______________________________________________________________________________________________________



Text of R phrases and GHS Classification abbreviations mentioned in Section 3

Acute toxicity, oral-Cat.3; H301 - Toxic if swallowedCarcinogenicity-Cat.2; H351 - Suspected of causing cancerReproductive toxicity-Cat.1B; H360D - May damage the unborn childSpecific target organ toxicity, repeated exposure-Cat.2; H373 - May cause damage to organs through prolonged or repeated exposureHazardous to the aquatic environment, acute toxicity-Cat.3; H402 - Harmful to aquatic life

Carcinogenic: Category 3Toxic to Reproduction: Category 2Xn - Harmful

_______________________________________________________________________________________________________557


Water, purified



Not Listed


REACH - Annex IV - Exemptions from theobligations of Register:




Present


Present



Starch, pregelatinizedCERCLA/SARA 313 Emission reporting Not Listed

EU EINECS/ELINCS List


209-150-3




Povidone


Present




Magnesium stearate



Inventory - United States TSCA - Sect. 8(b) PresentAustralia (AICS): Present



630

SAFETY DATA SHEET

_______________________________________________________________________________________________________

R22 - Harmful if swallowed.R40 - Limited evidence of a carcinogenic effectR61 - May cause harm to the unborn child.R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed.

Data Sources: Pfizer proprietary drug development information. Safety data sheets for individual ingredients.

Reasons for Revision: Updated Section 2 - Hazard Identification. Updated Section 7 - Handling and Storage. UpdatedSection 11 - Toxicology Information. Updated Section 12 - Ecological Information. UpdatedSection 3 - Composition / Information on Ingredients. Updated Section 1 - Identification of theSubstance/Preparation and the Company/Undertaking. Updated Section 16 - OtherInformation.






_______________________________________________________________________________________________________557

Material Name: Voriconazole Film Coated TabletsVersion: 3.0

Page 12 of 12Revision date: 04-Apr-2015

631

p. 1

3 2 0

He a lt h

Fire

Re a c t iv it y


2

3

0

H

Material Safety Data SheetAcetonitrile MSDS


Product Name: Acetonitrile

Catalog Codes: SLA3625, SLA1279, SLA1942

CAS#: 75-05-8

RTECS: AL7700000

TSCA: TSCA 8(b) inventory: Acetonitrile


Synonym: Methyl Cyanide

Chemical Name: Acetonitrile

Chemical Formula: CH3CN









Composition:


Acetonitrile 75-05-8 100

Toxicological Data on Ingredients: Acetonitrile: ORAL (LD50): Acute: 2460 mg/kg [Rat.]. 269 mg/kg [Mouse]. DERMAL(LD50): Acute: 1250 mg/kg [Rabbit.].


Potential Acute Health Effects:Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case ofskin contact (permeator). Severe over-exposure can result in death.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Reproductive system/toxin/male [SUSPECTED].The substance is toxic to blood, kidneys, lungs, liver, mucous membranes, gastrointestinal tract, upper respiratory tract,skin, eyes, central nervous system (CNS). The substance may be toxic to the reproductive system. Repeated or prolongedexposure to the substance can produce target organs damage. Repeated exposure to a highly toxic material may producegeneral deterioration of health by an accumulation in one or many human organs.


632


p. 2

Eye Contact:Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelidsopen. Cold water may be used. Get medical attention.





Ingestion:If swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to anunconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately.





Flash Points: CLOSED CUP: 2°C (35.6°F). OPEN CUP: 5.6°C (42.1°F) (Cleveland).

Flammable Limits: LOWER: 4.4% UPPER: 16%


Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat, ofoxidizing materials.



Special Remarks on Fire Hazards: Store under nitrogen.




Large Spill:

633

p. 3

Flammable liquid. Poisonous liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk.Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Do not touch spilledmaterial. Use water spray to reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Callfor assistance on disposal. Be careful that the product is not present at a concentration level above TLV. Check TLV on theMSDS and with local authorities.


Precautions:Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Donot ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wearsuitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoidcontact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducing agents, acids, alkalis, moisture.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame). Do not store above 23°C (73.4°F).





Exposure Limits:TWA: 40 (ppm) from ACGIH (TLV) [United States] [1999] STEL: 60 from ACGIH (TLV) [United States] [1999] TWA: 20 (ppm)from NIOSH TWA: 40 STEL: 60 (ppm) from OSHA (PEL) [United States] Consult local authorities for acceptable exposurelimits.


Physical state and appearance: Liquid. (Liquid.)

Odor: Aromatic; Ether-like (Strong.)

Taste: Burning, sweetish


Color: Colorless.

pH (1% soln/water): 7 [Neutral.]

Boiling Point: 81.6 (178.9°F)

Melting Point: -46°C (-50.8°F)



Vapor Pressure: 9.7kPa (@ 20°C)

634

p. 4






Dispersion Properties: See solubility in water, methanol.

Solubility: Soluble in cold water, hot water, methanol.




Conditions of Instability: Not available.

Incompatibility with various substances: Reactive with oxidizing agents, reducing agents, acids, alkalis, moisture.


Special Remarks on Reactivity: High dielectric constant; high polarity; strongly reactive.




Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 269 mg/kg [Mouse]. Acute dermal toxicity (LD50): 1250 mg/kg [Rabbit.]. Acute toxicity of the vapor (LC50):7551 8 hours [Rat.].

Chronic Effects on Humans:DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Reproductive system/toxin/male [SUSPECTED].Causes damage to the following organs: blood, kidneys, lungs, liver, mucous membranes, gastrointestinal tract, upperrespiratory tract, skin, eyes, central nervous system (CNS). May cause damage to the following organs: the reproductivesystem.




Special Remarks on other Toxic Effects on Humans: Material is irritating to mucous membranes and upper respiratorytract.


Ecotoxicity: Ecotoxicity in water (LC50): 1020 mg/l 96 hours [Fish (Fathead Minnow)]. 1850 mg/l 96 hours [Fish (bluegill)].


635

p. 5





Waste Disposal:



Identification: : Acetonitrile UNNA: UN1648 PG: II



Federal and State Regulations:New York release reporting list: Acetonitrile Rhode Island RTK hazardous substances: Acetonitrile Pennsylvania RTK:Acetonitrile Florida: Acetonitrile Minnesota: Acetonitrile Massachusetts RTK: Acetonitrile New Jersey: Acetonitrile TSCA 8(b)inventory: Acetonitrile TSCA 8(a) PAIR: Acetonitrile TSCA 8(d) H and S data reporting: Acetonitrile: 1992 SARA 313 toxicchemical notification and release reporting: Acetonitrile CERCLA: Hazardous substances.: Acetonitrile: 5000 lbs. (2268 kg)



WHMIS (Canada):CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-1B: Material causing immediate andserious toxic effects (TOXIC). CLASS D-2B: Material causing other toxic effects (TOXIC).

DSCL (EEC):R11- Highly flammable. R23/24/25- Toxic by inhalation, in contact with skin and if swallowed. S16- Keep away from sources ofignition - No smoking. S27- Take off immediately all contaminated clothing. S45- In case of accident or if you feel unwell, seekmedical advice immediately (show the label where possible).

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0



Health: 2

Flammability: 3

Reactivity: 0

Specific hazard:

636

p. 6



References:-Hawley, G.G.. The Condensed Chemical Dictionary, 11e ed., New York N.Y., Van Nostrand Reinold, 1987. -Material safetydata sheet emitted by: la Commission de la SantÃ© et de la SÃ©curitÃ© du Travail du QuÃ©bec. -SAX, N.I. DangerousProperties of Indutrial Materials. Toronto, Van Nostrand Reinold, 6e ed. 1984. -The Sigma-Aldrich Library of Chemical SafetyData, Edition II. -Guide de la loi et du rÃ¨glement sur le transport des marchandises dangeureuses au canada. Centre deconformitÃ© internatinal LtÃ©e. 1986.


Created: 10/10/2005 08:35 PM

Last Updated: 05/21/2013 12:00 PM


637

p. 1

1 1 0

He a lt h

Fire

Re a c t iv it y


1

1

0

E

Material Safety Data SheetSucralfate MSDS


Product Name: Sucralfate

Catalog Codes: SLS3421, SLS1204

CAS#: 54182-58-0

RTECS: BD0900000


CI#: Not available.

Synonym: Ulcerlmin; Carafate; Sucrose Octasulfate-Aluminum Complex; Beta-D-Fructofuranosyl-alpha-D-glucopryanoside octakis aluminum

Chemical Name: Aluminum, hexadeca -mu-hydrosytetracosahydroxy(mu(sup 8)-(1,2,4,6-tetra-O-sulfo-beta-D-fructofuranosyl-alpha-D-glucopyranoside tetrakis(hydrogen sulfato)(8-)))hexadeca-

Chemical Formula: C12H54Al16O75S8









Composition:


Sucralfate 54182-58-0 100

Toxicological Data on Ingredients: Not applicable.





638


p. 2













Products of Combustion: These products are carbon oxides (CO, CO2), sulfur oxides (SO2, SO3...). Some metallic oxides.





Special Remarks on Explosion Hazards:Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust explosionhazard.





Precautions:

639

p. 3

Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe dust. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatiblessuch as oxidizing agents.








Physical state and appearance: Solid. (Amorphous solid powder or lumps.)

Odor: Odorless.



Color: White.













Solubility:Insoluble in cold water. Practically insoluble in ethanol, chloroform. Soluble in dilute hydrochloric acid and sodium hydroxidesolution.


640

p. 4











Toxicity to Animals: Acute oral toxicity (LD50): >8000 mg/kg [Mouse].





Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: May cause skin irritation. Eyes: May cause eye irritation. Inhalation: May causerespiratory tract irritation. Ingestion: Low Hazard. It is not readily absorbed into the body. May cause abdominal pain/stomachcramps, indigestion, gas (flatulence), constipation. Other less common or rare symptoms may include diarrhea, headache,drowsiness, vertigo, dizziness or lightheadness, dry mouth, nausea, skin rash, hives or itiching, back pain, Medical ConditionsAggravated by Exposure: Gastrointestinal tract obstruction disease. Sucralfate may bind with other foods and drugs and causeobstruction of the gastrointestinal tract; Kidney failure or decreased kidney function. Use may leaed to a toxic increase ofaluminum blood levels; Use of the following drugs: Ciprofloxacin, Digoxin, Norfloxacin, Ofloxacin, Phenytoin, TheophypllineKetoconazole, Thyroxine, Warfarin, Lansoprazole, Amitriptyline. Sucralfate may prevent these medicines from workingproperly.










641

p. 5










HMIS (U.S.A.):

Health Hazard: 1

Fire Hazard: 1

Reactivity: 0



Health: 1

Flammability: 1

Reactivity: 0

Specific hazard:





Created: 10/09/2005 06:40 PM

Last Updated: 05/21/2013 12:00 PM


642

06/29/2015Revision:

Page: 1 of 5






Montelukast (sodium salt) Product Name:






1-[[[(1R)-1-[3-(1E)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]-methyl]-cyclopropaneacetic acid, monosodium salt; Singulair®;

Synonyms:





Serious Eye Damage/Eye Irritation, Category 12.1 Classification of the Substance or Mixture:

H318: Causes serious eye damage.GHS Hazard Phrases:

2.2 Label Elements:


P280: Wear {protective gloves/protective clothing/eye protection/face protection}.GHS Precaution Phrases:

P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P310: Immediately call a {POISON CENTER/doctor/...}.



2.3 Causes serious eye damage.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause skin or respiratory system irritation.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


Multi-region format

643

06/29/2015Revision:

Page: 2 of 5



CAS # /RTECS #




151767-02-1GZ0698000

Montelukast sodium 100.0 % 604-813-7 NA

Eye Damage 1: H318










4.1

5.1

5.2


Flash Pt: No data.









5.3

No data available.

6.3

6.1

6.2







Multi-region format

644

06/29/2015Revision:

Page: 3 of 5



7.1

7.2











8.2.1







No data available.







Flash Pt: No data.



No data.









Multi-region format

645

06/29/2015Revision:

Page: 4 of 5






Molecular Formula & Weight: C35H35ClNO3S · Na 608.2

10.4

10.5

10.6

10.110.210.3









11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Montelukast (sodium salt) - Toxicity Data: Intraperitoneal TDLO (mouse): 1 mg/kg;


Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Montelukast (sodium salt) RTECS Number: GZ0698000


IARC ACGIH OSHA

151767-02-1 Montelukast sodium n.a. n.a. n.a. n.a.

12.1

12.2

12.3

12.4

12.5


Toxicity:









Multi-region format

646

06/29/2015Revision:

Page: 5 of 5














S. 302 (EHS) S. 304 RQ S. 313 (TRI)


151767-02-1 Montelukast sodium No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 151767-02-1 Montelukast sodium CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No








Multi-region format

647

p. 1

3 2 0

He a lt h

Fire

Re a c t iv it y


2

3

0

H

Material Safety Data SheetToluene MSDS


Product Name: Toluene

Catalog Codes: SLT2857, SLT3277

CAS#: 108-88-3

RTECS: XS5250000

TSCA: TSCA 8(b) inventory: Toluene

CI#: Not available.

Synonym: Toluol, Tolu-Sol; Methylbenzene; Methacide;Phenylmethane; Methylbenzol

Chemical Name: Toluene

Chemical Formula: C6-H5-CH3 or C7-H8









Composition:


Toluene 108-88-3 100

Toxicological Data on Ingredients: Toluene: ORAL (LD50): Acute: 636 mg/kg [Rat]. DERMAL (LD50): Acute: 14100 mg/kg[Rabbit]. VAPOR (LC50): Acute: 49000 mg/m 4 hours [Rat]. 440 ppm 24 hours [Mouse].


Potential Acute Health Effects:Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case ofskin contact (permeator).

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH, 3 (Not classifiable for human.) by IARC.MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Notavailable. The substance may be toxic to blood, kidneys, the nervous system, liver, brain, central nervous system (CNS).Repeated or prolonged exposure to the substance can produce target organs damage.


648


p. 2

Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Get medical attention.

Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention.



Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It maybe hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious orcorrosive. Seek medical attention.





Auto-Ignition Temperature: 480°C (896°F)

Flash Points: CLOSED CUP: 4.4444°C (40°F). (Setaflash) OPEN CUP: 16°C (60.8°F).



Fire Hazards in Presence of Various Substances:Flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks.


Fire Fighting Media and Instructions:Flammable liquid, insoluble in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray or fog.


Special Remarks on Explosion Hazards:Toluene forms explosive reaction with 1,3-dichloro-5,5-dimethyl-2,4-imidazolididione; dinitrogen tetraoxide; concentrated nitricacid, sulfuric acid + nitric acid; N2O4; AgClO4; BrF3; Uranium hexafluoride; sulfur dichloride. Also forms an explosive mixturewith tetranitromethane.


Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal.

649

p. 3

Large Spill:Toxic flammable liquid, insoluble or very slightly soluble in water. Keep away from heat. Keep away from sources of ignition.Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container.Do not touch spilled material. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance ondisposal. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with localauthorities.


Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratoryequipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin andeyes. Keep away from incompatibles such as oxidizing agents.






Exposure Limits:TWA: 200 STEL: 500 CEIL: 300 (ppm) from OSHA (PEL) [United States] TWA: 50 (ppm) from ACGIH (TLV) [United States]SKIN TWA: 100 STEL: 150 from NIOSH [United States] TWA: 375 STEL: 560 (mg/m3) from NIOSH [United States] Consultlocal authorities for acceptable exposure limits.



Odor: Sweet, pungent, Benzene-like.



Color: Colorless.



Melting Point: -95°C (-139°F)

Critical Temperature: 318.6°C (605.5°F)


650

p. 4








Solubility:Soluble in diethyl ether, acetone. Practically insoluble in cold water. Soluble in ethanol, benzene, chloroform, glacial aceticacid, carbon disulfide. Solubility in water: 0.561 g/l @ 25 deg. C.




Conditions of Instability: Heat, ignition sources (flames, sparks, static), incompatible materials



Special Remarks on Reactivity:Incompatible with strong oxidizers, silver perchlorate, sodium difluoride, Tetranitromethane, Uranium Hexafluoride. FrozenBromine Trifluoride reacts violently with Toluene at -80 deg. C. Reacts chemically with nitrogen oxides, or halogens to formnitrotoluene, nitrobenzene, and nitrophenol and halogenated products, respectively.




Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 636 mg/kg [Rat]. Acute dermal toxicity (LD50): 14100 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50): 44024 hours [Mouse].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH, 3 (Not classifiable for human.) by IARC.May cause damage to the following organs: blood, kidneys, the nervous system, liver, brain, central nervous system (CNS).


Special Remarks on Toxicity to Animals:Lowest Published Lethal Dose: LDL [Human] - Route: Oral; Dose: 50 mg/kg LCL [Rabbit] - Route: Inhalation; Dose: 55000ppm/40min

Special Remarks on Chronic Effects on Humans:Detected in maternal milk in human. Passes through the placental barrier in human. Embryotoxic and/or foetotoxic in animal.May cause adverse reproductive effects and birth defects (teratogenic). May affect genetic material (mutagenic)

Special Remarks on other Toxic Effects on Humans:

651

p. 5

Acute Potential Health Effects: Skin: Causes mild to moderate skin irritation. It can be absorbed to some extent throughthe skin. Eyes: Cauess mild to moderate eye irritation with a burning sensation. Splash contact with eyes also causesconjunctivitis, blepharospasm, corneal edema, corneal abraisons. This usually resolves in 2 days. Inhalation: Inhalationof vapor may cause respiratory tract irritation causing coughing and wheezing, and nasal discharge. Inhalation of highconcentrations may affect behavior and cause central nervous system effects characterized by nausea, headache, dizziness,tremors, restlessness, lightheadedness, exhilaration, memory loss, insomnia, impaired reaction time, drowsiness, ataxia,hallucinations, somnolence, muscle contraction or spasticity, unconsciousness and coma. Inhalation of high concentration ofvapor may also affect the cardiovascular system (rapid heart beat, heart palpitations, increased or decreased blood pressure,dysrhythmia, ), respiration (acute pulmonary edema, respiratory depression, apnea, asphyxia), cause vision disturbancesand dilated pupils, and cause loss of appetite. Ingestion: Aspiration hazard. Aspiration of Toluene into the lungs may causechemical pneumonitis. May cause irritation of the digestive tract with nausea, vomiting, pain. May have effects similar to thatof acute inhalation. Chronic Potential Health Effects: Inhalation and Ingestion: Prolonged or repeated exposure via inhalationmay cause central nervous system and cardiovascular symptoms similar to that of acute inhalation and ingestion as well liverdamage/failure, kidney damage/failure (with hematuria, proteinuria, oliguria, renal tubular acidosis), brain damage, weightloss, blood (pigmented or nucleated red blood cells, changes in white blood cell count), bone marrow changes, electrolyteimbalances (Hypokalemia, Hypophostatemia), severe, muscle weakness and Rhabdomyolysis. Skin: Repeated or prolongedskin contact may cause defatting dermatitis.


Ecotoxicity:Ecotoxicity in water (LC50): 313 mg/l 48 hours [Daphnia (daphnia)]. 17 mg/l 24 hours [Fish (Blue Gill)]. 13 mg/l 96 hours [Fish(Blue Gill)]. 56 mg/l 24 hours [Fish (Fathead minnow)]. 34 mg/l 96 hours [Fish (Fathead minnow)]. 56.8 ppm any hours [Fish(Goldfish)].









Identification: : Toluene UNNA: 1294 PG: II



Federal and State Regulations:California prop. 65: This product contains the following ingredients for which the State of California has found to cause cancer,birth defects or other reproductive harm, which would require a warning under the statute: Toluene California prop. 65 (nosignificant risk level): Toluene: 7 mg/day (value) California prop. 65 (acceptable daily intake level): Toluene: 7 mg/day (value)California prop. 65: This product contains the following ingredients for which the State of California has found to cause birthdefects which would require a warning under the statute: Toluene Connecticut hazardous material survey.: Toluene Illinois

652

p. 6

toxic substances disclosure to employee act: Toluene Illinois chemical safety act: Toluene New York release reporting list:Toluene Rhode Island RTK hazardous substances: Toluene Pennsylvania RTK: Toluene Florida: Toluene Minnesota: TolueneMichigan critical material: Toluene Massachusetts RTK: Toluene Massachusetts spill list: Toluene New Jersey: Toluene NewJersey spill list: Toluene Louisiana spill reporting: Toluene California Director's List of Hazardous Substances.: Toluene TSCA8(b) inventory: Toluene TSCA 8(d) H and S data reporting: Toluene: Effective date: 10/04/82; Sunset Date: 10/0/92 SARA 313toxic chemical notification and release reporting: Toluene CERCLA: Hazardous substances.: Toluene: 1000 lbs. (453.6 kg)



WHMIS (Canada):CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2A: Material causing other toxic effects(VERY TOXIC).

DSCL (EEC):R11- Highly flammable. R20- Harmful by inhalation. S16- Keep away from sources of ignition - No smoking. S25- Avoidcontact with eyes. S29- Do not empty into drains. S33- Take precautionary measures against static discharges.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0



Health: 2

Flammability: 3

Reactivity: 0

Specific hazard:





Created: 10/10/2005 08:30 PM

Last Updated: 05/21/2013 12:00 PM


653

p. 1

3 1 0

He a lt h

Fire

Re a c t iv it y


1

3

0

G

Material Safety Data Sheetn-heptane MSDS


Product Name: n-heptane

Catalog Codes: SLH2152, SLH2998, SLH1675, SLH1948

CAS#: 142-82-5

RTECS: MI7700000

TSCA: TSCA 8(b) inventory: n-heptane

CI#: Not available.

Synonym: Dipropyl methane; Heptyl hydride

Chemical Name: Heptane

Chemical Formula: C7H16









Composition:


{n-}heptane 142-82-5 100

Toxicological Data on Ingredients: n-heptane: VAPOR (LC50): Acute: 103000 mg/m 4 hours [Rat].



Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to lungs, peripheral nervous system, upperrespiratory tract, skin, central nervous system (CNS). Repeated or prolonged exposure to the substance can produce targetorgans damage.



654


p. 2

Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention.




Ingestion:If swallowed, do NOT induce vomiting. Never give anything by mouth to an unconscious person. Aspiration hazard ifswallowed- can enter lungs and cause damage. Loosen tight clothing such as a collar, tie, belt or waistband. Get medicalattention.




Auto-Ignition Temperature: 203.89°C (399°F) - 223 C (433 F)

Flash Points: CLOSED CUP: -4°C (24.8°F). (TAG) OPEN CUP: -1.1111°C (30°F).



Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available. Slightly explosive in presence of heat.

Fire Fighting Media and Instructions:Flammable liquid, insoluble in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray or fog.

Special Remarks on Fire Hazards:Flaming occurs when liquid chlorine in n-Heptane is added to added to red phosphorous. Vapors may form explosive mixtureswith air. Vapor may travel considerable distance to source of ignition and flash back.

Special Remarks on Explosion Hazards: Vapors may form explosive mixtures in air.


Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal.

Large Spill:Flammable liquid, insoluble in water. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk.Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Do not touch spilledmaterial. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal. Be carefulthat the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities.


655

p. 3

Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. If ingested, seek medical advice immediately and show the container or the label. Keep awayfrom incompatibles such as oxidizing agents.




Personal Protection:Safety glasses. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.


Exposure Limits:TWA: 500 (ppm) from OSHA (PEL) [United States] TWA: 2000 (mg/m3) from OSHA (PEL) [United States] TWA: 350 CEIL:1800 (mg/m3) from NIOSH [United States] TWA: 85 CEIL: 440 (ppm) from NIOSH [United States] TWA: 400 STEL: 500 (ppm)from ACGIH (TLV) [United States] TWA: 500 (ppm) [United Kingdom (UK)] TWA: 400 STEL: 500 (ppm) [Canada] TWA: 1640STEL: 2049 (mg/m3) [Canada] TWA: 400 STEL: 500 (ppm) [Belgium] TWA: 200 (ppm) [Norway] TWA: 300 STEL: 500 (ppm)[Finland] TWA: 500 (ppm) [Austria]Consult local authorities for acceptable exposure limits.



Odor: Hydrocarbon. Gasoline-like



Color: Clear Colorless.


Boiling Point: 98.4 (209.1°F)










656

p. 4


Solubility:Soluble in diethyl ether, acetone. Insoluble in cold water. Soluble in alcohol. Solubility in Chloroform, Petroleum Ether, Ether,Acetone: >10% Floats on water.




Conditions of Instability: Heat, ignition sources (flames, sparks), incompatible materials


Corrosivity: Not considered to be corrosive for metals and glass.





Routes of Entry: Absorbed through skin. Inhalation.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute toxicityof the vapor (LC50): 103000 mg/m3 4 hours [Rat].

Chronic Effects on Humans:May cause damage to the following organs: lungs, peripheral nervous system, upper respiratory tract, skin, central nervoussystem (CNS).




Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Causes skin irritation. It can be absorbed through the skin. Eyes: Contact with liquid maycause eye irritation. Contact with vapors is not expected to cause eye irritation. Inhalation: Inhalation of vapor or mist causesrespiratory tract and mucous membrane irritation. It can affect behavior/central nervous system and cause central nervoussystem effects (mild excitement followed CNS depression which is characterized by headache, nausea, dizziness, hilarity,hallucinations, lightheadness, distorted perceptions, convulsions, weakness, loss of judgement and coordination, narcosis,semi-conciousness, coma and death at higher doses). It may cause cardiac effects (irregular heartbeat/cardiac arrhythmias, orheart to stop beating), and pulmonary edema. It is readily absorbed by the inhalation route. Ingestion: Causes gastrointestinaltract irritation with nausea, vomiting, swelling of the abdomen. Aspiration into the lungs can produce chemical pneumonitis.It can also affect behavior/central nervous system with symptoms paralleling those of inhalation. Chronic Potential HealthEffects: Skin: Prolonged or repeated skin contact can defat the skin and product irritation and dermatitis. Inhalation: Repeatedor prolonged inhalation may affect behavior/central nervous system (symptoms similar to acute inhalation) and may produceminimal peripheral nerve damage (polyneuropathy) with numbness and tingling of the extremities in a stocking-and -glovepattern. Reversible of polyneuropathy as been reversible by a year following removal from exposure. It may also affect thebrain, blood (anemia), and hearing (mild change in auditory threshold), and may also cause weight loss, Ingestion: Prolongedor repeated ingestion may affect the liver, urinary system, blood (changes in blood serum compostion).


657

p. 5










Identification: : Heptane UNNA: 1206 PG: II



Federal and State Regulations:Connecticut hazardous material survey.: n-heptane Illinois toxic substances disclosure to employee act: n-heptane RhodeIsland RTK hazardous substances: n-heptane Pennsylvania RTK: n-heptane Minnesota: n-heptane Massachusetts RTK: n-heptane Massachusetts spill list: n-heptane New Jersey: n-heptane California Director's List of Hazardous Substances: n-heptane TSCA 8(b) inventory: n-heptane TSCA 4(a) proposed test rules: n-heptane TSCA 8(d) H and S data reporting: n-heptane: Effective date: 1/26/94; Sunset date: 6/30/98




DSCL (EEC):

HMIS (U.S.A.):

Health Hazard: 1

Fire Hazard: 3

Reactivity: 0

Personal Protection: g


Health: 1

Flammability: 3

Reactivity: 0

658

p. 6

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Safety glasses.




Created: 10/09/2005 05:42 PM

Last Updated: 05/21/2013 12:00 PM


659

02/06/2015Revision:

Page: 1 of 6





Telmisartan Product Name:






4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylicacid; BIBR 277; Micardis; Pritor;

Synonyms:





Toxic To Reproduction, Category 2Aquatic Toxicity (Chronic), Category 2


H361: Suspected of damaging fertility or the unborn child.H411: Toxic to aquatic life with long lasting effects.

GHS Hazard Phrases:



P201: Obtain special instructions before use.P202: Do not handle until all safety precautions have been read and understood.P281: Use personal protective equipment as required.P273: Avoid release to the environment.


P308+313: IF exposed or concerned: Get medical attention/advice.P391: Collect spillage.



Multi-region format

660

02/06/2015Revision:

Page: 2 of 6


2.3 Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause eye, skin, or respiratory system irritation.Suspected of damaging fertility or the unborn child.Toxic to aquatic life with long lasting effects.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




144701-48-4DV2037500

Telmisartan 100.0 % NA NA

Toxic Repro. 2: H361Aquatic (C) 2: H411


Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

Multi-region format

661

02/06/2015Revision:

Page: 3 of 6


6.3

6.1

6.2







7.1

7.2











8.2.1







No data available.



Multi-region format

662

02/06/2015Revision:

Page: 4 of 6






Flash Pt: No data.



No data.







~0.5 mg/ml in 1:1 DMF:PBS (pH 7.2); ~1 mg/ml in DMSO; ~1.6 mg/ml in DMF;Solubility Notes:





10.4

10.5

10.6

10.110.210.3




acidsoxidizing agents

Incompatibility - MaterialsTo Avoid:






11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Telmisartan - Toxicity Data: Oral TDLO (man): 32 mg/kg; Intraperitoneal TDLO (mouse): 3 mg/kg;Oral TDLO (rat): 2 mg/kg;


Telmisartan - Investigated as a mutagen.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Telmisartan RTECS Number: DV2037500


IARC ACGIH OSHA

144701-48-4 Telmisartan n.a. n.a. n.a. n.a.

Multi-region format

663

02/06/2015Revision:

Page: 5 of 6


12.1

12.2

12.3

12.4

12.5


Toxicity:



















S. 302 (EHS) S. 304 RQ S. 313 (TRI)


144701-48-4 Telmisartan No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 144701-48-4 Telmisartan CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA

PROP.65: No





DISCLAIMER: This information is believed to be accurate and represents the best informationcurrently available to us. However, we make no warranty of merchantability or any other warranty,express or implied, with respect to such information, and we assume no liability resulting from its



Multi-region format

664

02/06/2015Revision:

Page: 6 of 6


use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes.

Multi-region format

665

p. 1

2 3 0

He a lt h

Fire

Re a c t iv it y


3

2

0

H

Material Safety Data SheetAcetic acid MSDS


Product Name: Acetic acid

Catalog Codes: SLA3784, SLA1438, SLA2101, SLA3604,SLA1258

CAS#: 64-19-7

RTECS: AF1225000

TSCA: TSCA 8(b) inventory: Acetic acid


Synonym: Acetic acid; glacial acetic acid

Chemical Name: Acetic Acid, Glacial

Chemical Formula: C2-H4-O2









Composition:


Acetic acid 64-19-7 100

Toxicological Data on Ingredients: Acetic acid: ORAL (LD50): Acute: 3310 mg/kg [Rat]. 4960 mg/kg [Mouse]. 3530 mg/kg[Rat]. DERMAL (LD50): Acute: 1060 mg/kg [Rabbit]. VAPOR (LC50): Acute: 5620 ppm 1 hours [Mouse].


Potential Acute Health Effects:Very hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Hazardous in case of skincontact (corrosive, permeator), of eye contact (corrosive). Liquid or spray mist may produce tissue damage particularly onmucous membranes of eyes, mouth and respiratory tract. Skin contact may produce burns. Inhalation of the spray mist mayproduce severe irritation of respiratory tract, characterized by coughing, choking, or shortness of breath. Inflammation of theeye is characterized by redness, watering, and itching. Skin inflammation is characterized by itching, scaling, reddening, or,occasionally, blistering.

Potential Chronic Health Effects:Hazardous in case of skin contact (irritant), of ingestion, of inhalation. CARCINOGENIC EFFECTS: Not available.MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. Mutagenic for bacteria and/or yeast. TERATOGENICEFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to kidneys, mucousmembranes, skin, teeth. Repeated or prolonged exposure to the substance can produce target organs damage. Repeated

666


p. 2

or prolonged contact with spray mist may produce chronic eye irritation and severe skin irritation. Repeated or prolongedexposure to spray mist may produce respiratory tract irritation leading to frequent attacks of bronchial infection.


Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Cold water may be used. Get medical attention immediately.










Flash Points: CLOSED CUP: 39°C (102.2°F). OPEN CUP: 43°C (109.4°F).

Flammable Limits: LOWER: 4% UPPER: 19.9%


Fire Hazards in Presence of Various Substances:Flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizingmaterials, of metals.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available. Slightly explosive in presence of oxidizing materials.

Fire Fighting Media and Instructions:Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam,water spray or fog. Cool containing vessels with water jet in order to prevent pressure build-up, autoignition or explosion.

Special Remarks on Fire Hazards:Reacts with metals to produces flammable hydrogen gas. It will ignite on contact with potassium-tert-butoxide. A mixture ofammonium nitrate and acetic acid ignites when warmed, especially if warmed.

Special Remarks on Explosion Hazards:

667

p. 3

Acetic acid vapors may form explosive mixtures with air. Reactions between acetic acid and the following materialsare potentially explosive: 5-azidotetrazole, bromine pentafluoride, chromium trioxide, hydrogen peroxide, potassiumpermanganate, sodium peroxide, and phorphorus trichloride. Dilute acetic acid and dilute hydrogen can undergo anexothermic reaction if heated, forming peracetic acid which is explosive at 110 degrees C. Reaction between chlorinetrifluoride and acetic acid is very violent, sometimes explosive.


Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container. Ifnecessary: Neutralize the residue with a dilute solution of sodium carbonate.

Large Spill:Flammable liquid. Corrosive liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. If theproduct is in its solid form: Use a shovel to put the material into a convenient waste disposal container. If the product is inits liquid form: Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Absorbwith an inert material and put the spilled material in an appropriate waste disposal. Do not touch spilled material. Use waterspray curtain to divert vapor drift. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistanceon disposal. Neutralize the residue with a dilute solution of sodium carbonate. Be careful that the product is not present at aconcentration level above TLV. Check TLV on the MSDS and with local authorities.


Precautions:\Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. Never add water to this product. In case of insufficient ventilation, wear suitable respiratoryequipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin andeyes. Keep away from incompatibles such as oxidizing agents, reducing agents, metals, acids, alkalis.




Personal Protection:Splash goggles. Synthetic apron. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves(impervious).


Exposure Limits:TWA: 10 STEL: 15 (ppm) [Australia] TWA: 25 STEL: 27 (mg/m3) [Australia] TWA: 10 STEL: 15 (ppm) from NIOSH TWA: 25STEL: 37 (mg/m3) from NIOSH TWA: 10 STEL: 15 (ppm) [Canada] TWA: 26 STEL: 39 (mg/m3) [Canada] TWA: 25 STEL: 37(mg/m3) TWA: 10 STEL: 15 (ppm) from ACGIH (TLV) [United States] [1999] TWA: 10 (ppm) from OSHA (PEL) [United States]TWA: 25 (mg/m3) from OSHA (PEL) [United States]Consult local authorities for acceptable exposure limits.


668

p. 4


Odor: Pungent, vinegar-like, sour (Strong.)

Taste: Vinegar, sour (Strong.)


Color: Colorless. Clear (Light.)

pH (1% soln/water): 2 [Acidic.]


Melting Point: 16.6°C (61.9°F)

Critical Temperature: 321.67°C (611°F)






Water/Oil Dist. Coeff.: The product is more soluble in water; log(oil/water) = -0.2



Solubility:Easily soluble in cold water, hot water. Soluble in diethyl ether, acetone. Miscible with Glycerol, alcohol, Benzene, CarbonTetrachloride. Practically insoluble in Carbon Disulfide.




Conditions of Instability: Heat, ignition sources, incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents, reducing agents, metals, acids, alkalis.

Corrosivity:Highly corrosive in presence of stainless steel(304). Slightly corrosive in presence of aluminum, of copper. Non-corrosive inpresence of stainless steel(316).

Special Remarks on Reactivity:Reacts violently with strong oxidizing agents, acetaldehyde, and acetic anhydride. Material can react with metals, strongbases, amines, carbonates, hydroxides, phosphates, many oxides,cyanides, sulfides, chromic acid, nitric acid, hydrogenperoxide, carbonates. ammonium nitrate, ammonium thiosulfate, chlorine trifluoride, chlorosulfonic acid, perchloric acid,permanganates, xylene, oleum, potassium hydroxide, sodium hydroxide, phosphorus isocyanate, ethylenediamine, ethyleneimine.

Special Remarks on Corrosivity: Moderate corrosive effect on bronze. No corrosion data on brass




669

p. 5

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 3310 mg/kg [Rat]. Acute dermal toxicity (LD50): 1060 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50): 56201 hours [Mouse].

Chronic Effects on Humans:MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. Mutagenic for bacteria and/or yeast. May cause damage tothe following organs: kidneys, mucous membranes, skin, teeth.

Other Toxic Effects on Humans:Extremely hazardous in case of inhalation (lung corrosive). Very hazardous in case of skin contact (irritant), of ingestion, .Hazardous in case of skin contact (corrosive, permeator), of eye contact (corrosive).


Special Remarks on Chronic Effects on Humans: May affect genetic material and may cause reproductive effects based onanimal data. No human data found.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Extremely irritating and corrosive. Causes skin irritation (reddening and itching,inflammation). May cause blistering , tissue damage and burns. Eyes: Extremely irritating and corrosive. Causes eye irritation,lacrimation, redness, and pain. May cause burns, blurred vision, conjunctivitis, conjunctival and corneal destruction andpermanent injury. Inhalation: Causes severe respiratory tract irritation. Affects the sense organs (nose, ear, eye, taste),and blood. May cause chemical pneumonitis, bronchitis, and pulmonary edema. Severe exposure may result in lung tissuedamage and corrosion (ulceration) of the mucous membranes. Inhalation may also cause rhinitis, sneezing, coughing,oppressive feeling in the chest or chest pain, dyspnea, wheezing, tachypnea, cyanosis, salivation, nausea, giddiness,muscular weakness. Ingestion: Moderately toxic. Corrosive. Causes gastrointestinal tract irritation (burning and pain of themouth, throat, and abdomen, coughing, ulceration, bleeding, nausea, abdomial spasms, vomiting, hematemesis, diarrhea.May Also affect the liver (impaired liver function), behavior (convulsions, giddines, muscular weakness), and the urinarysystem - kidneys (Hematuria, Albuminuria, Nephrosis, acute renal failure, acute tubular necrosis). May also cause dyspneaor asphyxia. May also lead to shock, coma and death. Chronic Potential Health Effects: Chronic exposure via ingestion maycause blackening or erosion of the teeth and jaw necrosis, pharyngitis, and gastritis. It may also behavior (similar to acuteingestion), and metabolism (weight loss). Chronic exposure via inhalation may cause asthma and/or bronchitis with cough,phlegm, and/or shortness of breath . It may also affect the blood (decreased leukocyte count), and urinary system (kidneys).Repeated or prolonged skin contact may cause thickening, blackening, and cracking of the skin.


Ecotoxicity:Ecotoxicity in water (LC50): 423 mg/l 24 hours [Fish (Goldfish)]. 88 ppm 96 hours [Fish (fathead minnow)]. 75 ppm 96 hours[Fish (bluegill sunfish)]. >100 ppm 96 hours [Daphnia].

BOD5 and COD: BOD-5: 0.34-0.88 g oxygen/g







DOT Classification:

670

p. 6

CLASS 3: Flammable liquid. Class 8: Corrosive material

Identification: : Acetic Acid, Glacial UNNA: 2789 PG: II



Federal and State Regulations:New York release reporting list: Acetic acid Rhode Island RTK hazardous substances: Acetic acid Pennsylvania RTK: Aceticacid Florida: Acetic acid Minnesota: Acetic acid Massachusetts RTK: Acetic acid New Jersey: Acetic acid California Director'sList of Hazardous Subtances (8 CCR 339): Acetic acid TSCA 8(b) inventory: Acetic acid CERCLA: Hazardous substances.:Acetic acid: 5000 lbs. (2268 kg)



WHMIS (Canada):CLASS B-3: Combustible liquid with a flash point between 37.8°C (100°F) and 93.3°C (200°F). CLASS E: Corrosive liquid.

DSCL (EEC):R10- Flammable. R35- Causes severe burns. S23- Do not breathe gas/fumes/vapour/spray [***] S26- In case of contact witheyes, rinse immediately with plenty of water and seek medical advice. S45- In case of accident or if you feel unwell, seekmedical advice immediately (show the label where possible).

HMIS (U.S.A.):

Health Hazard: 3

Fire Hazard: 2

Reactivity: 0

Personal Protection: H


Health: 3

Flammability: 2

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves (impervious). Synthetic apron. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wearappropriate respirator when ventilation is inadequate. Splash goggles.




Created: 10/09/2005 03:35 PM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume

671

p. 7

no liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

672

p. 1

1 2 0

He a lt h

Fire

Re a c t iv it y


2

1

0

E

Material Safety Data SheetAmlodipine Besylate MSDS


Product Name: Amlodipine Besylate

Catalog Codes: SLA3169

CAS#: 111470-99-6

RTECS: US7967700


CI#: Not available.

Synonym: Amlodipine benzenesulfonate; Amlodipinebesilate; Norvasc

Chemical Name: 3,5-Pyridinecarboxylic acid, 2-((aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl, 3-ethyl-5-methyl ester, monobenzenesulfonate

Chemical Formula: C20-H25-Cl-N-2-O5.C6-H6-O3-S









Composition:


Amlodipine Besylate 111470-99-6 100

Toxicological Data on Ingredients: Amlodipine Besylate: ORAL (LD50): Acute: 393 mg/kg [Rat]. 37 mg/kg [Mouse].


Potential Acute Health Effects:Hazardous in case of ingestion. Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of inhalation.



Eye Contact:

673


p. 2

Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Cold water may be used. WARM water MUST be used. Get medical attention if irritation occurs.












Products of Combustion: These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...), halogenatedcompounds.










Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe dust. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the container or thelabel.

674

p. 3








Physical state and appearance: Solid. (Crystalline powder.)




Color: White.













Solubility:Slightly soluble in cold water. Sparingly soluble in ethanol.




675

p. 4

Conditions of Instability: Excess heat

Incompatibility with various substances: Not available.

Corrosivity: Not available.






Toxicity to Animals: Acute oral toxicity (LD50): 37 mg/kg [Mouse].


Other Toxic Effects on Humans:Hazardous in case of ingestion. Slightly hazardous in case of skin contact (irritant), of inhalation.


Special Remarks on Chronic Effects on Humans: May cause adverse reproductive effects.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: May cause skin irritation. Eyes: May cause eye irritation. Inhalation: May causerespiratory tract irritation. Ingestion: Harmful if swallowed. May cause abdominal pain, nausea, vomiting, dry mouth, thirst,increasd sweating, rash, anorex/decreased weight or weight gain, constipation, diarrhea, dyspepsia, flatulence, flushing,edema, pancreatitis, gingival hyperplasia, malaise. It affects the cardiovascular system. Symptoms of cardiovasculareffects may include arrhythmia(including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension,peripheral ischemia, syncope, tachycardia, palpitations, postural dizziness, postural hypotension, vasculitis. It may alsoaffect behavior/central nervous system/peripherial nervous system, eyes/vision, ears, respiratory system, urinary system,blood, musculoskeletal system. Symptoms may include headache, hypoeasthesia, peripheral neuropathy, paresthesia,tremor, fatigue, vertigo, insomnia, sexual dysfunction, nervousness, somnolence, depression, abnormal dreams, anxiety,depersonalization, abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus, dyspnea, epistaxis, micturation frequency,micturition disorder, acute renal failure, acute tubular necrosis, nocturia, leukopenia, thrombocytopenia, purpura, arthralgia,arthrosis, muscle cramps, back pain, rigors, myalgia. Chronic Potential Health Effects: Ingestion: Prolonged or repeatedingestion may have similar effects to that of acute ingestion. Medical Conditions Aggravated by Exposure: Impaired liverfunction, congestive heart failure, allergy related to calcium channel blockers, unstable angina, aortic stenosis, cardiogenicshock, pregancy.





Toxicity of the Products of Biodegradation: The products of degradation are as toxic as the product itself.



Waste Disposal:

676

p. 5

Waste must be disposed of in accordance with federal, state and local environmental control regulations.







Other Regulations: OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200).



DSCL (EEC):R22- Harmful if swallowed. S46- If swallowed, seek medical advice immediately and show this container or label.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 1

Reactivity: 0



Health: 2

Flammability: 1

Reactivity: 0

Specific hazard:





Created: 10/09/2005 03:42 PM

Last Updated: 05/21/2013 12:00 PM


677

:RUOGZLGH +HOSOLQH ��)RU IXUWKHU HQTXLULHV �LQIR#FOHDUV\QWK�FRP)RU DQ RQOLQH TXRWH � FOLFN KHUH

� 0$7(5,$/ 6$)(7< '$7$ 6+((7 ��

6(&7,21 � � &+(0,&$/ 352'8&7 $1' &203$1< ,'(17,),&$7,21�

�

06'6 1DPH�� 6LORGRVLQ

&RPSDQ\ ,GHQWLILFDWLRQ�� &OHDUV\QWK /DEV 3YW� /WG�� /D[PL 0DOO� 1HZ /LQN 5RDG� $QGKHUL �:��

�� 0XPEDL�� ,1',$)RU LQIRUPDWLRQ FDOO�� )RU HPHUJHQFLHV FDOO�� )RU IXUWKHU HQTXLULHV�� LQIR#FOHDUV\QWK�FRP��6(&7,21 � � &20326,7,21� ,1)250$7,21 21 ,1*5(',(176

�&$6�� &KHPLFDO 1DPH�� (,1(&6�� +D]

6\PEROV5,6.3+5$6(6

�� 6LORGRVLQ !��

�� +D]DUG 6\PEROV� ;1�� 5LVN 3KUDVHV� ��6(&7,21 � � +$=$5'6 ,'(17,),&$7,21

��(0(5*(1&< 29(59,(:+DUPIXO LI VZDOORZHG��3RWHQWLDO +HDOWK (IIHFWV7KH WR[LFRORJLFDO SURSHUWLHV RI WKLV PDWHULDO KDYH QRW EHHQ LQYHVWLJDWHG� 8VH DSSURSULDWH SURFHGXUHV WR SUHYHQW RSSRUWXQLWLHVIRU GLUHFW FRQWDFW ZLWK WKH VNLQ RU H\HV DQG WR SUHYHQW LQKDODWLRQ� &RPSRXQG LV 1RQ�KD]DUGRXV�1RQ�7R[LF�1RQ�)ODPPDEOH��

6(&7,21 � � ),567 $,' 0($685(6

��(\HV�,PPHGLDWHO\ IOXVK H\HV ZLWK SOHQW\ RI ZDWHU IRU DW OHDVW �� PLQXWHV� RFFDVLRQDOO\ OLIWLQJ WKH XSSHU DQG ORZHU H\HOLGV�6NLQ�)OXVK VNLQ ZLWK SOHQW\ RI ZDWHU IRU DW OHDVW �� PLQXWHV ZKLOH UHPRYLQJ FRQWDPLQDWHG FORWKLQJ DQG VKRHV�,QJHVWLRQ�'R 127 LQGXFH YRPLWLQJ� ,I FRQVFLRXV DQG DOHUW� ULQVH PRXWK DQG GULQN �� FXSIXOV RI PLON RU ZDWHU�,QKDODWLRQ�5HPRYH IURP H[SRVXUH DQG PRYH WR IUHVK DLU LPPHGLDWHO\�1RWHV WR 3K\VLFLDQ�

�

6(&7,21 � � ),5( ),*+7,1* 0($685(6

�*HQHUDO ,QIRUPDWLRQ�$V LQ DQ\ ILUH� ZHDU D VHOI�FRQWDLQHG EUHDWKLQJ DSSDUDWXV LQ SUHVVXUH�GHPDQG� 06+$�1,26+ �DSSURYHG RU HTXLYDOHQW�� DQGIXOO SURWHFWLYH JHDU� 'XULQJ D ILUH� LUULWDWLQJ DQG KLJKO\ WR[LF JDVHV PD\ EH JHQHUDWHG E\ WKHUPDO GHFRPSRVLWLRQ RU

678


http://www.clearsynth.com/details.asp?id=16115&chemical=Silodosin










































































































































































































































































































































































FRPEXVWLRQ�([WLQJXLVKLQJ 0HGLD�,Q FDVH RI ILUH� XVH ZDWHU� GU\ FKHPLFDO� FKHPLFDO IRDP� RU DOFRKRO�UHVLVWDQW IRDP��

6(&7,21 � � $&&,'(17$/ 5(/($6( 0($685(6

��*HQHUDO ,QIRUPDWLRQ� 8VH SURSHU SHUVRQDO SURWHFWLYH HTXLSPHQW DV LQGLFDWHG LQ 6HFWLRQ ��6SLOOV�/HDNV�&OHDQ XS VSLOOV LPPHGLDWHO\� REVHUYLQJ SUHFDXWLRQV LQ WKH 3URWHFWLYH (TXLSPHQW VHFWLRQ� 6ZHHS XS� WKHQ SODFH LQWR D VXLWDEOHFRQWDLQHU IRU GLVSRVDO��

��

6(&7,21 � � +$1'/,1* DQG 6725$*(

�+DQGOLQJ�:DVK WKRURXJKO\ DIWHU KDQGOLQJ� 5HPRYH FRQWDPLQDWHG FORWKLQJ DQG ZDVK EHIRUH UHXVH� $YRLG FRQWDFW ZLWK H\HV� VNLQ� DQGFORWKLQJ� $YRLG LQJHVWLRQ DQG LQKDODWLRQ�6WRUDJH�6WRUH LQ D ZHOO FORVHG FRQWDLQHU�

�

6(&7,21 � � (;32685( &21752/6� 3(5621$/ 3527(&7,21

�(QJLQHHULQJ &RQWUROV�8VH DGHTXDWH JHQHUDO RU ORFDO H[KDXVW YHQWLODWLRQ WR NHHS DLUERUQH FRQFHQWUDWLRQV EHORZ WKH SHUPLVVLEOH H[SRVXUH OLPLWV�8VH SURFHVV HQFORVXUH� ORFDO H[KDXVW YHQWLODWLRQ� RU RWKHU HQJLQHHULQJ FRQWUROV ��WR FRQWURO DLUERUQH OHYHOV�3HUVRQDO 3URWHFWLYH (TXLSPHQW(\HV�:HDU VDIHW\ JODVVHV DQG FKHPLFDO JRJJOHV LI VSODVKLQJ LV SRVVLEOH�6NLQ�:HDU DSSURSULDWH SURWHFWLYH JORYHV DQG FORWKLQJ WR SUHYHQW VNLQ H[SRVXUH�&ORWKLQJ�:HDU DSSURSULDWH SURWHFWLYH FORWKLQJ WR PLQLPL]H FRQWDFW ZLWK VNLQ�5HVSLUDWRUV�:HDU D 1,26+�06+$ RU (XURSHDQ 6WDQGDUG (1 �� DSSURYHG IXOO�IDFHSLHFH DLUOLQH UHVSLUDWRU LQ WKH SRVLWLYH SUHVVXUH PRGHZLWK HPHUJHQF\ HVFDSH SURYLVLRQV��

6(&7,21 � � 3+<6,&$/ $1' &+(0,&$/ 3523(57,(6

�3K\VLFDO 6WDWH��0ROHFXODU )RUPXOD��&��+��)�1�2�0ROHFXODU :HLJKW��

��

6(&7,21 �� 67$%,/,7< $1' 5($&7,9,7<

�&KHPLFDO 6WDELOLW\�6WDEOH XQGHU QRUPDO WHPSHUDWXUHV DQG SUHVVXUHV�&RQGLWLRQV WR $YRLG�,QFRPSDWLEOH PDWHULDOV� VWURQJ R[LGDQWV�,QFRPSDWLELOLWLHV ZLWK 2WKHU 0DWHULDOV�6WURQJ R[LGL]LQJ DJHQWV� VWURQJ EDVHV�+D]DUGRXV 'HFRPSRVLWLRQ 3URGXFWV�1LWURJHQ R[LGHV� FDUERQ PRQR[LGH� LUULWDWLQJ DQG WR[LF IXPHV DQG JDVHV� FDUERQ GLR[LGH� QLWURJHQ�+D]DUGRXV 3RO\PHUL]DWLRQ� +DV QRW EHHQ UHSRUWHG�

��

6(&7,21 �� 72;,&2/2*,&$/ ,1)250$7,21

��

679


























































































































































































































































































































































































































































































































































57(&6��

&$6�� /'��/&��&$6��'UDL]H WHVW� UDEELW� H\H� �� PJ��+ 0RGHUDWH� 2UDO�PRXVH� /'�� PJ�NJ� 2UDO� UDEELW� /'�� PJ�NJ� 2UDO� UDW�/'�� PJ�NJ�&DUFLQRJHQLFLW\�6DOLF\ODPLGH �1RW OLVWHG E\ $&*,+� ,$5&� 1,26+� 173� RU 26+$�6HH DFWXDO HQWU\ LQ 57(&6 IRU FRPSOHWH LQIRUPDWLRQ��

6(&7,21 �� (&2/2*,&$/ ,1)250$7,21

��

6(&7,21 �� ',6326$/ &216,'(5$7,216

�'LVSRVH RI LQ D PDQQHU FRQVLVWHQW ZLWK IHGHUDO� VWDWH� DQG ORFDO UHJXODWLRQV��

6(&7,21 �� 75$163257 ,1)250$7,21

�,$7$ ��1R LQIRUPDWLRQ DYDLODEOH�,02 ��1R LQIRUPDWLRQ DYDLODEOH�,'�$'5 �� 1R LQIRUPDWLRQ DYDLODEOH��

6(&7,21 �� 5(*8/$725< ,1)250$7,21

�(XURSHDQ�,QWHUQDWLRQDO 5HJXODWLRQV(XURSHDQ /DEHOLQJ LQ $FFRUGDQFH ZLWK (& 'LUHFWLYHV+D]DUG 6\PEROV� ;15LVN 3KUDVHV�5 �� +DUPIXO LI VZDOORZHG�6DIHW\ 3KUDVHV�:*. �:DWHU 'DQJHU�3URWHFWLRQ�

&$6� 8QLWHG .LQJGRP 2FFXSDWLRQDO ([SRVXUH /LPLWV�� 8QLWHG .LQJGRP 0D[LPXP ([SRVXUH /LPLWV�&DQDGD�� &$6� LV OLVWHG RQ &DQDGDV '6/ /LVW�� &$6�LV QRW OLVWHG RQ &DQDGDV ,QJUHGLHQW 'LVFORVXUH /LVW�� ([SRVXUH /LPLWV�86 )('(5$/�� 76&$�� &$6� LV OLVWHG RQ WKH 76&$ LQYHQWRU\��

6(&7,21 �� $'',7,21$/ ,1)250$7,21

�7KH LQIRUPDWLRQ DERYH LV EHOLHYHG WR EH DFFXUDWH DQG UHSUHVHQWV WKH EHVW LQIRUPDWLRQ FXUUHQWO\ DYDLODEOH WR XV� +RZHYHU� ZHPDNH QR ZDUUDQW\ RI PHUFKDQWDELOLW\ RU DQ\ RWKHU ZDUUDQW\� H[SUHVV RU LPSOLHG� ZLWK UHVSHFW WR VXFK LQIRUPDWLRQ� DQG ZHDVVXPH QR OLDELOLW\ UHVXOWLQJ IURP LWV XVH� 8VHUV VKRXOG PDNH WKHLU RZQ LQYHVWLJDWLRQV WR GHWHUPLQH WKH VXLWDELOLW\ RI WKHLQIRUPDWLRQ IRU WKHLU SDUWLFXODU SXUSRVHV� ,Q QR ZD\ VKDOO WKH FRPSDQ\ EH OLDEOH IRU DQ\ FODLPV� ORVVHV� RU GDPDJHV RI DQ\WKLUG SDUW\ RU IRU ORVW SURILWV RU DQ\ VSHFLDO� LQGLUHFW� LQFLGHQWDO� FRQVHTXHQWLDO RU H[HPSODU\ GDPDJHV� KRZVRHYHU DULVLQJ�HYHQ LI WKH FRPSDQ\ KDV EHHQ DGYLVHG RI WKH SRVVLELOLW\ RI VXFK GDPDJHV��

680


























































































































































































































































































































































































































































































































































































03/05/2015Revision:

Page: 1 of 6





Olanzapine Product Name:






2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine; Zyprexa®; Synonyms:





Skin Corrosion/Irritation, Category 2Serious Eye Damage/Eye Irritation, Category 2Aquatic Toxicity (Chronic), Category 4


H315: Causes skin irritation.H319: Causes serious eye irritation.H413: May cause long lasting harmful effects to aquatic life.

GHS Hazard Phrases:



P264: Wash {hands} thoroughly after handling.P273: Avoid release to the environment.P280: Wear {protective gloves/protective clothing/eye protection/face protection}.


P302+352: IF ON SKIN: Wash with plenty of soap and water.P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.P332+313: If skin irritation occurs, get medical advice/attention.P337+313: If eye irritation persists, get medical advice/attention.P362: Take off contaminated clothing and wash before re-use.


GHS Storage and Disposal Phrases:

Multi-region format

681

03/05/2015Revision:

Page: 2 of 6


Please refer to Section 7 for Storage and Section 13 for Disposal information.

2.3 Causes serious eye irritation.Causes skin irritation.Material may be irritating to the mucous membranes and upper respiratory tract.May be harmful by inhalation, ingestion, or skin absorption.May cause respiratory system irritation.May cause long lasting harmful effects to aquatic life.To the best of our knowledge, the toxicological properties have not been thoroughly investigated.


CAS # /RTECS #




132539-06-1XJ9007750

10H-Thieno[2,3-b][1,5]benzodiazepine,2-methyl-4-(4-methyl-1-piperazinyl)-

100.0 % 603-618-4 NA

Skin Corr. 2: H315Eye Damage 2: H319Aquatic (C) 4: H413


Measures:









4.1

5.1

5.2


Flash Pt: No data.









5.3

Multi-region format

682

03/05/2015Revision:

Page: 3 of 6


6.3

6.1

6.2







7.1

7.2









No data.



No data.

8.2.1







No data available.



Multi-region format

683

03/05/2015Revision:

Page: 4 of 6






Flash Pt: No data.



No data.







~0.5 mg/ml in a 1:1 solution of DMSO:PBS (pH 7.2); ~1 mg/ml in EtOH; ~16 mg/ml inDMSO; ~20 mg/ml in DMF;

Solubility Notes:




Molecular Formula & Weight: C17H20N4S 312.4

10.4

10.5

10.6

10.110.210.3










Multi-region format

684

03/05/2015Revision:

Page: 5 of 6


11.1


Section 11. Toxicological InformationThe toxicological effects of this product have not been thoroughly studied.Olanzapine - Toxicity Data: Oral LDLO (man): 7067 ug/kg; Oral TDLO (woman): 400 ug/kg;Subcutaneous TDLO (rat): 625 ug/kg; Intraperitoneal TDLO rat 5 mg/kg;


Olanzapine - Investigated as a drug.Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here.See actual entry in RTECS for complete information.Olanzapine RTECS Number: XJ9007750


IARC ACGIH OSHA


n.a. n.a. n.a. n.a.

12.1

12.2

12.3

12.4

12.5


Toxicity:


















Multi-region format

685

03/05/2015Revision:

Page: 6 of 6




S. 302 (EHS) S. 304 RQ S. 313 (TRI)



No No No

CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists 132539-06-1 10H-Thieno[2,3-b][1,5]benzodiazepine,

2-methyl-4-(4-methyl-1-piperazinyl)-CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CAPROP.65: No








Multi-region format

686

p. 1

1 2 0

He a lt h

Fire

Re a c t iv it y


2

1

0

H

Material Safety Data SheetMethylene chloride MSDS


Product Name: Methylene chloride

Catalog Codes: SLM2398, SLM3772, SLM1297,SLM2677, SLM4054

CAS#: 75-09-2

RTECS: PA8050000

TSCA: TSCA 8(b) inventory: Methylene chloride

CI#: Not available.

Synonym: Dichloromethane

Chemical Name: Methylene Chloride

Chemical Formula: C-H2-Cl2









Composition:


Methylene chloride 75-09-2 100

Toxicological Data on Ingredients: Methylene chloride: ORAL (LD50): Acute: 1600 mg/kg [Rat].


Potential Acute Health Effects: Very hazardous in case of eye contact (irritant), of ingestion, of inhalation. Hazardous in caseof skin contact (irritant, permeator). Inflammation of the eye is characterized by redness, watering, and itching.

Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Classified + (Proven.) by OSHA. Classified 2B (Possiblefor human.) by IARC. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTALTOXICITY: Not available. The substance is toxic to lungs, the nervous system, liver, mucous membranes, central nervoussystem (CNS). Repeated or prolonged exposure to the substance can produce target organs damage.


Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for atleast 15 minutes. Cold water may be used. Get medical attention immediately.

687


p. 2

Skin Contact: In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient.Remove contaminated clothing and shoes. Cold water may be used.Wash clothing before reuse. Thoroughly clean shoesbefore reuse. Get medical attention.

Serious Skin Contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seekimmediate medical attention.

Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Getmedical attention if symptoms appear.

Serious Inhalation: Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt orwaistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seekmedical attention.

Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to anunconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing suchas a collar, tie, belt or waistband.






Flammable Limits: LOWER: 12% UPPER: 19%

Products of Combustion: These products are carbon oxides (CO, CO2), halogenated compounds.

Fire Hazards in Presence of Various Substances: Not available.

Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanicalimpact: Not available. Risks of explosion of the product in presence of static discharge: Not available.

Fire Fighting Media and Instructions: SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray, fog orfoam. Do not use water jet.




Small Spill: Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposalcontainer.

Large Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal. Be careful that theproduct is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities.


Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk,evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical adviceimmediately and show the container or the label. Avoid contact with skin and eyes.


688

p. 3


Engineering Controls: Provide exhaust ventilation or other engineering controls to keep the airborne concentrations ofvapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection: Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator orequivalent. Gloves.

Personal Protection in Case of a Large Spill: Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self containedbreathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient;consult a specialist BEFORE handling this product.

Exposure Limits: TWA: 50 from ACGIH (TLV) [United States] TWA: 174 from ACGIH (TLV) [United States] Consult localauthorities for acceptable exposure limits.





Molecular Weight: 84.93g/mole

Color: Not available.










Water/Oil Dist. Coeff.: The product is equally soluble in oil and water; log(oil/water) = 0.1


Dispersion Properties: See solubility in water, methanol, diethyl ether, n-octanol, acetone.

Solubility: Easily soluble in methanol, diethyl ether, n-octanol, acetone. Partially soluble in cold water.




Conditions of Instability: Not available.

Incompatibility with various substances: Not available.


689

p. 4






Toxicity to Animals: WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUREXPOSURE. Acute oral toxicity (LD50): 1600 mg/kg [Rat]. Acute toxicity of the vapor (LC50): 52000 1 hours [Rat].

Chronic Effects on Humans: CARCINOGENIC EFFECTS: Classified + (Proven.) by OSHA. Classified 2B (Possible forhuman.) by IARC. Causes damage to the following organs: lungs, the nervous system, liver, mucous membranes, centralnervous system (CNS).

Other Toxic Effects on Humans: Very hazardous in case of ingestion, of inhalation. Hazardous in case of skin contact(irritant, permeator).


Special Remarks on Chronic Effects on Humans: Human: passes through the placenta, excreted in maternal milk.

Special Remarks on other Toxic Effects on Humans: Not available.




Products of Biodegradation: Possibly hazardous short term degradation products are not likely. However, long termdegradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are more toxic.



Waste Disposal:


DOT Classification: CLASS 6.1: Poisonous material.

Identification: : Dichloromethane UNNA: 1593 PG: III



Federal and State Regulations: California prop. 65: This product contains the following ingredients for which the Stateof California has found to cause cancer, birth defects or other reproductive harm, which would require a warning underthe statute: Methylene chloride California prop. 65: This product contains the following ingredients for which the State ofCalifornia has found to cause cancer which would require a warning under the statute: Methylene chloride Pennsylvania

690

p. 5

RTK: Methylene chloride Massachusetts RTK: Methylene chloride TSCA 8(b) inventory: Methylene chloride SARA 313 toxicchemical notification and release reporting: Methylene chloride CERCLA: Hazardous substances.: Methylene chloride

Other Regulations: OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200).


WHMIS (Canada): CLASS D-1B: Material causing immediate and serious toxic effects (TOXIC). CLASS D-2A: Materialcausing other toxic effects (VERY TOXIC).

DSCL (EEC): R22- Harmful if swallowed. R38- Irritating to skin. R41- Risk of serious damage to eyes. R45- May causecancer.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 1

Reactivity: 0



Health: 2

Flammability: 1

Reactivity: 0

Specific hazard:

Protective Equipment: Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent.Wear appropriate respirator when ventilation is inadequate. Splash goggles.




Created: 10/10/2005 10:43 AM

Last Updated: 05/21/2013 12:00 PM


691

1: Identification of substance / mixture

Substance1. Product Identifier

Product Name

Product Code

CAS Number

Other Names

IUPAC

MFCD Number

EC/EINECS

REACH Number

4-[2-[(3-Ethyl-4-methyl-2-oxo-3-pyrrolin-1-yl)carboxamido]ethyl]benzenesulfonamide

213595

119018-29-0

MFCD02955393

2. Relevant identified uses of the substance or mixture and uses advised againstResearch and Development

3. Details of the supplier of the safety data sheet

Fluorochem Ltd

Unit 14,Graphite WayHadfieldDerbyshireSK13 1QH

UK

4. Emergency telephone number+44(0)7855 268577 -

Telephone:Fax:

Email:

+44(0)1457 860111+44(0)1457 892799

[email protected]

2. Hazards Identification

1. Classification of the substance or mixture

2. Label elements

Hazard Statements

Precautionary Phrases

3. Other HazardsAdditional precautionary phrases are located throughout the safety data sheet

3. Composition / Information on Ingredients

H302 Acute Tox. 4 R22, R20/22, R20/21/22, R21/22, R68/20/22, R68/21/22, R68/20/21/22

H315 Skin Irrit. 2 R38, R36/38, R36/37/38, R37/38

H319 Eye Irrit. 2 R36, R36/37, R36/38, R36/37/38

H335 STOT SE 3a R37, R36/37, R36/37/38, R37/38

H302 Harmful if swallowed.

H315 Causes skin irritation.

H319 Causes serious eye irritation.

H335 May cause respiratory irritation.

P264 Wash hands thoroughly after handling.

P302 + P352 IF ON SKIN: Wash with plenty of soap and water.

P304 + P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.

P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P332 + P313 If skin irritation occurs: Get medical advice/attention.

P337 + P313 If eye irritation persists: Get medical advice/attention.

Signal Word Warning

No Resource File

Page 1 of 7Safety data sheet created using SDSOnline Creation Tool www.hanksolutions.co.uk

Safety Data Sheet Revision: 3.00

Modified: 2015-03-24

According to Regulation (EC) No. 1272/2008Language : English

692

2. Mixtures

1. Substances4-[2-[(3-Ethyl-4-methyl-2-oxo-3-pyrrolin-1-yl)carboxamido]ethyl]benzenesulfonamide Assay:100% CAS Number :119018-29-0

4. First Aid Measures

1. Description of first aid measures

Skin Contact P302 + P352: IF ON SKIN: Wash with plenty of soap and water.P332 + P313: If skin irritation occurs: Get medical advice/attention.

Eye Contact P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.P337 + P313: If eye irritation persists: Get medical advice/attention.

Ingestion Wash out mouth with water.

P304 + P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.Inhalation

2. Most important symptoms and effectsNo symptoms.

3. Indication of any immediate medical attentionP312: Call a POISON CENTER or doctor/physician if you feel unwell.No additional measures required

1. Extinguishing MediaCarbon dioxide.Dry chemical powder.Water.

Do not use water with a full water jetUnsuitable

Suitable

2. Special Hazards arising from the substance or mixture

In combustion toxic fumes may form.

3. Advice for Fire FightersWear protective clothing to prevent contact with skin and eyes.Wear self-contained breathing apparatus.

6. Accidental Release Measures

1. Personnal Precautions

Refer to section 8 of SDS for personal protection details.

Do not discharge into drains or rivers.

2. Environmental Precautions

Mix with sand or vermiculite.Transfer to a suitable container.

3. Methods & Materials

No Special Measures Required

4. Preventing the occurence of secondary hazards.

5. Firefighting measures

Not Relevant





693

P403 + P233: Store in a well-ventilated place. Keep container tightly closed.Other advice

Maintaining Integrity

Storage Controls

Managing Storage Risks

2. Conditions for safe storage, including any incompatibilitiesKeep container tightly closed.Store cold 2-8° C.

No special requirements

Keep in tightly closed container in cool area away from direct sunlight or heat sources.

7.Handling and Storage

1. Personnal PrecautionsHandle in fume hood.Wash hands immediately after contamination.P264: Wash hands thoroughly after handling.

P362: Take off contaminated clothing and wash before reuse.normal measures for preventive fire protection

Protection against explosions and fires

Safe Handling

General protective and hydgiene measures

P280: Wear protective gloves/protective clothing/eye protection/face protection.The standard precautionary measures should be adhered to when handlingWash hands during breaks and at the end of handling the materialImmediately remove any contaminated clothing

Engineering measures P271: Use only outdoors or in a well-ventilated area.Ensure there is sufficient ventilation of the area.

Eye / Face Protection Safety Glasses.

Hand protection Protective gloves.

Respiratory protection P261: Avoid breathing dust/fume/gas/mist/vapours/spray.Respiratory protection not required.

Other personal protection advice

no data

Skin protection Protective clothing.

2. Exposure Controls

The end use(s) have not been fully determined. The substance is supplied for Research and Development purposes by professionals only.

3. Specific End Uses

9. Physical and Chemical Properties

1. Physical and Chemical Properties

Appearance Solid

Odour No Data Available

Odour threshold No Data Available

PH No Data Available

Melting point / Freezing point No Data Available

Initial boiling point and boiling range No Data Available

Flash point No Data Available

Evaporation rate No Data Available

Flammability(solid,gas) No Data Available

Upper/lower flammability or explosive limits No Data Available

8. Exposure Controls/Personal Protection

1. Control ParametersNo Data Available





694

2. Other InformationNo additional information available

no unusual reactivity

1. Reactivity

10. Stability and Reactivity

2. StabilityStable under normal conditions.

3. Possibility of Hazardous Reactionsno hazardous reactions known

4.Conditions to Avoidno specific conditions to avoid

In combustion emits toxic fumes.In combustion emits toxic fumes of carbon dioxide / carbon monoxide.

6. Hazardous Decomposition Products

Strong oxidizing agents.

5. Incompatible Materials

1. InformationAcute Toxicity no data

irritant for skin and mucous membranesSkin corrosion/irritation

11. Toxicology information

Serious eye Damage/irritation

irritant effect

No sensitizing effect knownRespiratory or skin sensitisation

not knownGerm Cell mutagenicity

Aspiration hazard

STOT-repeated exposure

STOT-single exposure

Carcinogenicity not known

not known

not known

not known

Vapour pressure No Data Available

Vapour density No Data Available

Relative density No Data Available

Solubility(ies): No Data Available

Partition coefficient: n-octanol/water No Data Available

Auto-ignition temperature No Data Available

Decomposition temperature No Data Available

Viscosity No Data Available

Explosive properties No Data Available

Oxidising properties No Data Available

Reproductive toxicity not known

2. Additional





695

12. Ecological Information

1. Toxicitynot known

2. Persistance and degradabilitynot known

3. Bio-Accumulative Potentialnot known

4. Mobility and Soilnot known

5. Results of PBT & vPvB assessmentnot known

6. Other adverse effectsnot known

13. Disposal Considerations

1. Waste Treatment Methods

Consult state, local or national regulations for proper disposal.Hand over to authorised disposal company as hazardous waste.

Disposal must be made according to official regulations.Disposal of Packaging

Disposal Operations

14. Transport Information

Air (ICAO)

Road (ADR)

1. UN Number:

2. Shipping Name: Non Hazardous

3. Transport hazard class(es): : Sub Class :

4. Packing group:

5. Environmental hazards:

6. Special Precautions for user:

7. Transport in bulk:

To the best of our knowledge the acute and chronic toxicity of this substance is not fully known.No classification data on carcinogenic properties of this material is available from the EPA, IARC,NTP,OSHA or ACGIH

1. UN Number:

2. Shipping Name: None Hazardous


4. Packing group:








696

15. Safety, health, environmental and national regulations

1. Safety, health, environmental and national regulations:product is not subject to any additional regulations or provisions

2. Safety AssessmentNo Chemical Safety Assessment

16. Other Information

1. Other Information:ADR: Accord Europeen sur le transport des merchandises Dangereuses par Route(European Agreement concerning the International Carriage of Dangerous Goods by road)RID:Reglement International concernant le transport des merchandises dangereuses par chemin de fer (Regulations concerning the International transport of Dangerous Goods by Rail)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationIATA-DGR: Dangerous Goods Regulations by the International Air Transport AssociationICAO:International Civil Aviation OrganizationICAO-TI: Technical Instructions by the ICAOGHS: Globally Harmonized System of Classification and Labelling of ChemicalsCAS:Chemical Abstracts Service

Sea (IMDG)

3. Disclaimer

R20/21/22 Harmful by inhalation, in contact with skin and if swallowed.

R20/22 Harmful by inhalation and if swallowed.

R21/22 Harmful in contact with skin and if swallowed.

R22 Harmful if swallowed.

R36 Irritating to eyes.

R36/37 Irritating to eyes and respiratory system.

R36/37/38 Irritating to eyes, respiratory system and skin.

R36/38 Irritating to eyes and skin.

R37 Irritating to respiratory system.

R37/38 Irritating to respiratory system and skin.

R38 Irritating to skin.

R68/20/21/22 Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed.

R68/20/22 Harmful: possible risk of irreversible effects through inhalation and if swallowed.

R68/21/22 Harmful: possible risk of irreversible effects in contact with skin and if swallowed.

2. Associated risk phrases according to european directive 67/548/EEC

1. UN Number:

2. Shipping Name: Non Hazardous


4. Packing group:








697

The product listed is for research and development purposes only and not for human or animal use. As such, in most cases, the toxicological, ecological and physicochemical properties have not been fully determined and the product should be treated with respect and always handled under suitable conditions by appropriately qualified personnel. The responsible party shall use this datasheet only in conjunction with other sources of information gathered by them, and should make an independent judgement of suitability, to ensure proper use and protect the health and safety of employees. This information is furnished without warranty and any use of the product not in conformance with this material safety data sheet, or in combination with any other product or process, is the responsibility of the user.





698

/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 15.10.2014 Revision: 15.10.2014Version number 1

39.0.10

SECTION 1: Identification of the substance/mixture and of the company/undertaking

· 1.1 Product identifier

· Trade name: GLIMEPIRIDE FOR SYSTEM SUITABILITY

· Reference number: Cat 1141· 1.2 Relevant identified uses of the substance or mixture and uses advised againstNo further relevant information available.

· Application of the substance / the mixture Reference material for laboratory use only· Manufacturer/Supplier:British Pharmacopoeia Commission Tel : +44 (0)20 3080 6561MHRA eMail: [email protected] Buckingham Palace RoadLondon SW1W 9SZUnited Kingdom

· Further information obtainable from: eMail: [email protected]· 1.4 Emergency telephone number: +44 (0) 20 3080 6561 (Monday - Friday: 8am - 5pm)

SECTION 2: Hazards identification

· 2.1 Classification of the substance or mixture· Classification according to Regulation (EC) No 1272/2008

GHS08 health hazard

Repr. 1B H360 May damage fertility or the unborn child.

GHS07

Eye Irrit. 2 H319 Causes serious eye irritation.

· Classification according to Directive 67/548/EEC or Directive 1999/45/EC

T; Toxic

R60-61: May impair fertility. May cause harm to the unborn child.

Xi; Irritant

R36: Irritating to eyes.· Information concerning particular hazards for human and environment:The product has to be labelled due to the calculation procedure of the "General Classification guideline forpreparations of the EU" in the latest valid version.

· Classification system:The classification is according to the latest editions of the EU-lists, and extended by company and literaturedata.

· 2.2 Label elements· Labelling according to Regulation (EC) No 1272/2008The product is classified and labelled according to the CLP regulation.

· Hazard pictograms

GHS07 GHS08

· Signal word Danger(Contd. on page 2)

GB

699

/7



Trade name: GLIMEPIRIDE FOR SYSTEM SUITABILITY

(Contd. from page 1)

39.0.10

· Hazard-determining components of labelling:Glimepiride

· Hazard statementsH319 Causes serious eye irritation.H360 May damage fertility or the unborn child.

· Precautionary statementsP280 Wear protective gloves/protective clothing/eye protection/face protection.P281 Use personal protective equipment as required.P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if

present and easy to do. Continue rinsing.P308+P313 IF exposed or concerned: Get medical advice/attention.P405 Store locked up.P501 Dispose of contents/container in accordance with local/regional/national/international

regulations.· Additional information:Restricted to professional users.

· 2.3 Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

SECTION 3: Composition/information on ingredients

· 3.2 Chemical characterization: Mixtures· Description: Mixture: consisting of the following components.

· Dangerous components:CAS: 93479-97-1RTECS: UX9363950

Glimepiride T Repr. Cat. 2 R60-61; Xi R36 Repr. 1B, H360; Eye Irrit. 2, H319

> 99%

CAS: 119018-29-0ELINCS: 411-850-0RTECS: -

4-(2-((3-ethyl-4-methyl-2-oxopyrrolin-1-yl)carboxamido)ethyl)benzenesulfonamide)R52/53Aquatic Chronic 3, H412

< 0.25%

CAS: 119018-30-3RTECS: -

Glimepiride Carbamate Xn R20/21/22 Acute Tox. 4, H302; Acute Tox. 4, H312; Acute Tox. 4, H332

< 0.1%

· Additional information: For the wording of the listed risk phrases refer to section 16.

SECTION 4: First aid measures

· 4.1 Description of first aid measures· After inhalation: Supply fresh air; consult doctor in case of complaints.· After skin contact: Immediately wash with water and soap and rinse thoroughly.· After eye contact:Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.

· After swallowing: Rinse mouth. Do not induce vomiting.· 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.· 4.3 Indication of any immediate medical attention and special treatment neededNo further relevant information available.

GB

(Contd. on page 3)

700

/7





39.0.10

SECTION 5: Firefighting measures

· 5.1 Extinguishing media· Suitable extinguishing agents:CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

· 5.2 Special hazards arising from the substance or mixtureFormation of toxic gases is possible during heating or in case of fire.

· 5.3 Advice for firefighters· Protective equipment: Wear self-contained respiratory protective device.

SECTION 6: Accidental release measures

· 6.1 Personal precautions, protective equipment and emergency procedures Wear protective clothing.· 6.2 Environmental precautions: Do not allow to enter sewers/ surface or ground water.· 6.3 Methods and material for containment and cleaning up:Dispose of contaminated material as waste according to item 13.

· 6.4 Reference to other sectionsSee Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

SECTION 7: Handling and storage

· 7.1 Precautions for safe handlingStore in cool, dry place in tightly closed receptacles.Open and handle receptacle with care.

· Information about fire - and explosion protection: Keep respiratory protective device available.

· 7.2 Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles:Store in a cool location.Please refer to the manufacturer's certificate for specific storage and transport temperature conditions.Store only in the original receptacle.Keep container in a well-ventilated place. Keep away from sources of ignition and heat.

· Information about storage in one common storage facility: Store away from foodstuffs.· Further information about storage conditions: Keep container tightly sealed.· 7.3 Specific end use(s) No further relevant information available.

SECTION 8: Exposure controls/personal protection

· Additional information about design of technical facilities: No further data; see item 7.

· 8.1 Control parameters· Ingredients with limit values that require monitoring at the workplace:The product does not contain any relevant quantities of materials with critical values that have to bemonitored at the workplace.

· Additional information: Lists used were valid at the time of SDS preparation.

· 8.2 Exposure controls· Personal protective equipment:· General protective and hygienic measures:Keep away from foodstuffs, beverages and feed.Immediately remove all soiled and contaminated clothing

(Contd. on page 4) GB

701

/7





39.0.10

Wash hands before breaks and at the end of work.Store protective clothing separately.Avoid contact with the eyes.Avoid contact with the eyes and skin.

· Respiratory protection: Not required.· Protection of hands:

Protective gloves

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.Selection of the glove material on consideration of the penetration times, rates of diffusion and thedegradationThe protective gloves to be used must comply with the specifications of EC Directive 89/686/EEC and therelated standard EN374

· Material of gloves Only use chemical-protective gloves with CE-labelling of category III.· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.

· Eye protection:

Tightly sealed goggles

SECTION 9: Physical and chemical properties

· 9.1 Information on basic physical and chemical properties· General Information· Appearance:

Form: PowderColour: Off white

· Odour: Odourless· Odour threshold: Not determined.

· pH-value: Not applicable.

· Change in conditionMelting point/Melting range: 200-209 °CBoiling point/Boiling range: Not determined.

· Flash point: Not applicable.

· Flammability (solid, gaseous): Not determined.

· Ignition temperature:

Decomposition temperature: Not determined.

· Self-igniting: Product is not selfigniting.

· Danger of explosion: Not determined.

· Explosion limits:Lower: Not determined.Upper: Not determined.


702

/7





39.0.10

· Vapour pressure: Not applicable.

· Density: Not determined.· Relative density Not determined.· Vapour density Not applicable.· Evaporation rate Not applicable.

· Solubility in / Miscibility withwater: Insoluble.

· Partition coefficient (n-octanol/water): Not determined.

· Viscosity:Dynamic: Not applicable.Kinematic: Not applicable.

· 9.2 Other information No further relevant information available.

SECTION 10: Stability and reactivity

· 10.1 Reactivity Stable under normal conditions.· 10.2 Chemical stability Stable under normal conditions.· Thermal decomposition / conditions to be avoided:Formation of toxic gases is possible during heating or in case of fire.

· 10.3 Possibility of hazardous reactions No dangerous reactions known.· 10.4 Conditions to avoid Heat.· 10.5 Incompatible materials: Strong oxidizing agents.· 10.6 Hazardous decomposition products:Formation of toxic gases is possible during heating or in case of fire.

SECTION 11: Toxicological information

· 11.1 Information on toxicological effects· Acute toxicity:· LD/LC50 values relevant for classification:

93479-97-1 GlimepirideOral LD50 >10000 mg/kg (rat)

· Primary irritant effect:· on the skin: No irritating effect.· on the eye: Irritating effect.· Sensitization: No sensitizing effects known.· Additional toxicological information:The product shows the following dangers according to the calculation method of the General EUClassification Guidelines for Preparations as issued in the latest version:Irritant

· CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)93479-97-1 GlimepirideOral Reproductive 0.254 mg/kg (rabbit) (female 7-18 day(s) after conception)

Repr. 1B GB

(Contd. on page 6)

703

/7





39.0.10

SECTION 12: Ecological information

· 12.1 Toxicity· Aquatic toxicity: No further relevant information available.· 12.2 Persistence and degradability No further relevant information available.· 12.3 Bioaccumulative potential No further relevant information available.· 12.4 Mobility in soil No further relevant information available.· Additional ecological information:· General notes:Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for waterDo not allow undiluted product to reach ground water, water course or sewage system.

· 12.5 Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· 12.6 Other adverse effects No further relevant information available.

SECTION 13: Disposal considerations

· 13.1 Waste treatment methods· RecommendationMust not be disposed of together with household garbage. Do not allow product to reach sewage system.

· European waste catalogueWaste disposal key numbers from EWC have to be assigned depending on origin and processing.

· Uncleaned packaging:· Recommendation: Dispose of in accordance with national regulations.

SECTION 14: Transport information

· 14.1 UN-Number· ADR, ADN, IMDG, IATA Not applicable· ADR, ADN, IMDG, IATA Not applicable

· 14.3 Transport hazard class(es)

· ADR, ADN, IMDG, IATA· Class Not applicable

· 14.4 Packing group· ADR, IMDG, IATA Not applicable

· 14.5 Environmental hazards:· Marine pollutant: No

· 14.6 Special precautions for user Not applicable.

· 14.7 Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code Not applicable.

· UN "Model Regulation": -

GB

(Contd. on page 7)

704

/7





39.0.10

SECTION 15: Regulatory information

· 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture· Philippines Inventory of Chemicals and Chemical SubstancesNone of the ingredients is listed.

· Australian Inventory of Chemical SubstancesNone of the ingredients is listed.

· Standard for the Uniform Scheduling of Medicines and PoisonsNone of the ingredients is listed.

· 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

SECTION 16: Other informationThe information in this safety data sheet (SDS) has been prepared with due care and is true and accurate tothe best of our knowledge. The user must determine the suitability of the information for its particularpurpose, ensure compliance with existing laws and regulations, and be aware that other or additional safetyor performance considerations may arise when using, handling and/ or storing the material. The informationin this SDS does not purport to be all inclusive or a guarantee as to the properties of the material supplied,and should be used only as a guide. British Pharmacopoeia Commission Office makes no warranties orrepresentations as to the accuracy and completeness of the information contained herein, shall not be heldresponsible for the suitability of this information for the user's intended purposes or the consequences of suchuse, and shall not be liable for any damage or loss, howsoever arising, direct or otherwise.

· Relevant phrasesH302 Harmful if swallowed.H312 Harmful in contact with skin.H319 Causes serious eye irritation.H332 Harmful if inhaled.H360 May damage fertility or the unborn child.H412 Harmful to aquatic life with long lasting effects.

R20/21/22 Harmful by inhalation, in contact with skin and if swallowed.R36 Irritating to eyes.R52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.R60 May impair fertility.R61 May cause harm to the unborn child.

· Abbreviations and acronyms:ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonized System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentAcute Tox. 4: Acute toxicity, Hazard Category 4Eye Irrit. 2: Serious eye damage/eye irritation, Hazard Category 2Repr. 1B: Reproductive toxicity, Hazard Category 1BAquatic Chronic 3: Hazardous to the aquatic environment - Chronic Hazard, Category 3

· SourcesTables 3.1 and 3.2 from Annex 6 of EC 1272/2008, EC 1907/2006, EH40/2005 as amended 2011, Registry ofToxic Effects of Chemical Substances (RTECS), The Dictionary of Substances and their Effects, 1st Edition,IUCLID.

GB

705

/6



36.0.36

1 Identification of the substance/mixture and of the company/undertaking

· Product identifier

· Trade name: Chlortalidone (Chlorthalidone) Assay Standard

· Reference number: Cat 491· CAS Number:77-36-1

· EC number:201-022-5

· Relevant identified uses of the substance or mixture and uses advised againstNo further relevant information available.

· Application of the substance / the preparation Reference material for laboratory use only· Manufacturer/Supplier:British Pharmacopoeia Commission Tel : +44 (0)20 3080 6561MHRA eMail: [email protected] Buckingham Palace RoadLondon SW1W 9SZUnited Kingdom

· Further information obtainable from: eMail: [email protected]· Emergency telephone number: +44 (0) 20 3080 6561 (Monday - Friday: 8am - 5pm)

2 Hazards identification

· Classification of the substance or mixture· Classification according to Regulation (EC) No 1272/2008The substance is not classified according to the CLP regulation.

· Classification according to Directive 67/548/EEC or Directive 1999/45/EC Not applicable.· Information concerning particular hazards for human and environment: Not applicable.

· Label elements· Labelling according to Regulation (EC) No 1272/2008 Not applicable· Hazard pictograms Not applicable· Signal word Not applicable· Hazard statements Not applicable· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

3 Composition/information on ingredients

· Chemical characterization: Substances· CAS No. Description77-36-1 chlortalidone

· Identification number(s) -· EC number: 201-022-5

4 First aid measures

· Description of first aid measures· After inhalation: Supply fresh air; consult doctor in case of complaints.· After skin contact: Immediately wash with water and soap and rinse thoroughly.· After eye contact: Rinse opened eye for several minutes under running water.· After swallowing: Rinse mouth. Do not induce vomiting.


706

/6



Trade name: Chlortalidone (Chlorthalidone) Assay Standard


36.0.36

· Information for doctor:· Most important symptoms and effects, both acute and delayed No further relevant information available.· Indication of any immediate medical attention and special treatment neededNo further relevant information available.

5 Firefighting measures

· Extinguishing media· Suitable extinguishing agents:CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

· Special hazards arising from the substance or mixtureFormation of toxic gases is possible during heating or in case of fire.

· Advice for firefighters· Protective equipment: Wear self-contained respiratory protective device.

6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures Wear protective clothing.· Environmental precautions: Do not allow product to reach sewage system or any water course.· Methods and material for containment and cleaning up: Pick up mechanically.· Reference to other sectionsNo dangerous substances are released.See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

7 Handling and storage

· Handling:· Precautions for safe handling Store in cool, dry place in tightly closed receptacles.· Information about fire - and explosion protection: The product is not flammable.

· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles:Please refer to the manufacturer's certificate for specific storage and transport temperature conditions.Keep container in a well-ventilated place. Keep away from sources of ignition and heat.

· Information about storage in one common storage facility: Store away from foodstuffs.· Further information about storage conditions: None.· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection

· Additional information about design of technical facilities: No further data; see item 7.

· Control parameters· Ingredients with limit values that require monitoring at the workplace: Not required.· Additional information: Lists used were valid at the time of SDS preparation.

· Exposure controls· Personal protective equipment:· General protective and hygienic measures:The usual precautionary measures are to be adhered to when handling chemicals.

· Respiratory protection: Not required.(Contd. on page 3)

GB

707

/6





36.0.36

· Protection of hands:The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/the chemical mixture.Selection of the glove material on consideration of the penetration times, rates of diffusion and thedegradation

· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer.

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.

· Eye protection: Safety glasses

9 Physical and chemical properties

· Information on basic physical and chemical properties· General Information· Appearance:

Form: SolidColour: White

· Odour: Odourless· Odour threshold: Not determined.

· pH-value: Not applicable.

· Change in conditionMelting point/Melting range: 217 - 221 °C (dec)Boiling point/Boiling range: Not determined.

· Flash point: Not applicable.

· Flammability (solid, gaseous): Not determined.

· Ignition temperature:

Decomposition temperature: Not determined.

· Self-igniting: Not determined.

· Danger of explosion: Not determined.

· Explosion limits:Lower: Not determined.Upper: Not determined.

· Vapour pressure: Not applicable.

· Density: Not determined.· Relative density Not determined.· Vapour density Not applicable.· Evaporation rate Not applicable.

· Solubility in / Miscibility withwater: Not determined.

· Partition coefficient (n-octanol/water): Not determined.

· Viscosity:Dynamic: Not applicable.Kinematic: Not applicable.


708

/6





36.0.36

· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity Stable under normal conditions.· Chemical stability Stable under normal conditions.· Thermal decomposition / conditions to be avoided:Formation of toxic gases is possible during heating or in case of fire.

· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid Heat.· Incompatible materials: Strong oxidizing agents.· Hazardous decomposition products: Formation of toxic gases is possible during heating or in case of fire.

11 Toxicological information

· Information on toxicological effects· Acute toxicity:· LD/LC50 values relevant for classification:Oral LD50 > 5000 mg/kg (mouse)

· Primary irritant effect:· on the skin: No irritating effect.· on the eye: No irritating effect.· Sensitization: No sensitizing effects known.· Additional toxicological information:When used and handled according to specifications, the product does not have any harmful effects to ourexperience and the information provided to us.The substance is not subject to classification according to the latest version of the EU lists.

12 Ecological information

· Toxicity· Aquatic toxicity: No further relevant information available.· Persistence and degradability No further relevant information available.· Behaviour in environmental systems:· Bioaccumulative potential No further relevant information available.· Mobility in soil No further relevant information available.· Additional ecological information:· General notes: Generally not hazardous for water· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects No further relevant information available.

13 Disposal considerations

· Waste treatment methods· RecommendationMust not be disposed of together with household garbage. Do not allow product to reach sewage system.

· European waste catalogueWaste disposal key numbers from EWC have to be assigned depending on origin and processing.


709

/6





36.0.36

· Uncleaned packaging:· Recommendation: Dispose of in accordance with national regulations.

14 Transport information

· UN-Number· ADR, ADN, IMDG, IATA Not applicable· ADR, ADN, IMDG, IATA Not applicable

· Transport hazard class(es)

· ADR, ADN, IMDG, IATA· Class Not applicable

· Packing group· ADR, IMDG, IATA Not applicable

· Environmental hazards:· Marine pollutant: No

· Special precautions for user Not applicable.

· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code Not applicable.

· Transport/Additional information: Not dangerous according to the above specifications.

· UN "Model Regulation": -

15 Regulatory information

· Safety, health and environmental regulations/legislation specific for the substance or mixture· Philippines Inventory of Chemicals and Chemical Substances Substance is not listed.· Australian Inventory of Chemical Substances Substance is listed.· Standard for the Uniform Scheduling of Drugs and Poisons Substance is not listed.· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other informationThe information in this safety data sheet (SDS) has been prepared with due care and is true and accurate tothe best of our knowledge. The user must determine the suitability of the information for its particularpurpose, ensure compliance with existing laws and regulations, and be aware that other or additional safetyor performance considerations may arise when using, handling and/ or storing the material. The informationin this SDS does not purport to be all inclusive or a guarantee as to the properties of the material supplied,and should be used only as a guide. British Pharmacopoeia Commission Office makes no warranties orrepresentations as to the accuracy and completeness of the information contained herein, shall not be heldresponsible for the suitability of this information for the user's intended purposes or the consequences of suchuse, and shall not be liable for any damage or loss, howsoever arising, direct or otherwise.

· Abbreviations and acronyms:ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonized System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)LC50: Lethal concentration, 50 percent


710

/6





36.0.36

LD50: Lethal dose, 50 percent· SourcesTables 3.1 and 3.2 from Annex 6 of EC 1272/2008, EC 1907/2006, EH40/2005 as amended 2011, Registry ofToxic Effects of Chemical Substances (RTECS), The Dictionary of Substances and their Effects, 1st Edition,IUCLID.

GB

711

draft environmental impact assessment...

Documents