1. identification of chemicals and information on a ...etg-group.org/docs/ecodis/msds_2013_pages...

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Disinfecting substance «Biopag» TU 9392-008-41547288-00 with changes № 1 Safety Data Sheet registration number № Valid until page. 3 out of 20 1. Identification of chemicals and information on a manufacturer and/or supplier 1.1. Identification of chemicals 1.1.1. Technical name: Disinfecting substance BIOPAG [1]. 1.1.2. Brief recommendations on application (incl. application restrictions) Desinfecting substance BIOPAG is intended for application as an active agent in manufacturing process of disinfectants [1]. 1.2. Information on a manufacturer and/or supplier 1.2.1. Developer 1.2.1.1. Full official name of the organisation: Regional public organisationInstitute of Ecotechnologies (short name: RPO IETP). 1.2.1.2. Postal address: Volzhskiy boulevard 113A, Moscow, 109462, Russia 1.2.1.3. Telephone (including emergency cunsultations) and time limitations: +7 (495) 921-43-61, from 9:00 to 17:00 1.2.1.4. Fax: +7 (495) 921-43-61 1.2.1.5. Е-mail: [email protected] 1.2.2. Manufacturer 1.2.2.1. Full official name of the organisation: Limited liability company «International Institute of Ecotechnologies» (short name: LLC «MIETP»). 1.2.2.2. Postal address: Electrolitniy proezd 9 bld.1, Moscow, 117638, Russia 1.2.2.3. Telephone (including emergency cunsultations) and time limitations: +7 (495) 921-43-61, from 9:00 to 17:00 1.2.2.4. Fax: +7 (495) 921-43-61 1.2.2.5. Е-mail: [email protected] 2. Hazard identification

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Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 1

Safety Data Sheet registration number №

Valid until

page. 3

out of 20

1. Identification of chemicals and information on a manufacturer and/or supplier

1.1. Identification of chemicals

1.1.1. Technical name: Disinfecting substance BIOPAG [1].

1.1.2. Brief recommendations on application

(incl. application restrictions)

Desinfecting substance BIOPAG is intended for

application as an active agent in manufacturing process

of disinfectants [1].

1.2. Information on a manufacturer and/or supplier

1.2.1. Developer

1.2.1.1. Full official name of the organisation: Regional public organisation– Institute of

Ecotechnologies (short name: RPO IETP).

1.2.1.2. Postal address: Volzhskiy boulevard 113A, Moscow, 109462, Russia

1.2.1.3. Telephone (including emergency

cunsultations) and time limitations:

+7 (495) 921-43-61, from 9:00 to 17:00

1.2.1.4. Fax: +7 (495) 921-43-61

1.2.1.5. Е-mail: [email protected]

1.2.2. Manufacturer

1.2.2.1. Full official name of the organisation: Limited liability company «International Institute of

Ecotechnologies» (short name: LLC «MIETP»).

1.2.2.2. Postal address: Electrolitniy proezd 9 bld.1, Moscow, 117638, Russia

1.2.2.3. Telephone (including emergency

cunsultations) and time limitations:

+7 (495) 921-43-61, from 9:00 to 17:00

1.2.2.4. Fax: +7 (495) 921-43-61

1.2.2.5. Е-mail: [email protected]

2. Hazard identification

page 4

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Safety Data Sheet registration number №

Valid until

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 11

2.1. Hazard class of chemicals in general:

(information on hazard classification in accordance

with the legal system of the Russian Federation

(GOST 12.1.007) and GHS (after confirmation))

In accordance with the acute toxicity parameters in the

classification GOST 12.1.007-76 BIOPAG substance

attributes to the 3th

class of moderately hazardous

substances when introduced into stomach, to the 4th

class

of low-hazard substances in case of a skin contact and to

the 4th class of low-toxic substances when inctroduced

into abdominal cavity. BIOPAG substance does not have

any sensitising or cumulative effect. When inhalating

vapours are low-hazard. The substance has a local

irritating effect when applied once on skin or eyes.

[Ошибка! Источник ссылки не найден., 37].

2.2. Hygienic normatives for products in general in

workspace area:

(MACwa. or Safe Reference Level of Impact

in workspace area)

MACwa – 2 mg/m3, aerosol, 3rd hazard class, a special

protection for skin and eyes is required [Ошибка!

Источник ссылки не найден., 37].

2.3. Information on labeling (according to GOST 31340-07)

2.3.1. Hazard description: Signal word: Be careful. Danger symbols: Exclamation

mark. - Harmful if swallowed (oral) [34].

- Causes serious eye irritation in the case of eye contact

[34].

2.3.2. Preventive measures: - Do not smoke, drink or eat when using product [34].

- Wash hands after working with product [34].

Emergency procedures:

- If swallowed, rinse mouth and immediately seek

medical help [34].

- After working with product wash hands with soap [34].

- Use rubber or plastic gloves according to GOST

20010-93 [34].

- Use eye protection means – eye-protective goggles of a

trade mark ZN with colourless glasses according to

GOST 12.4.013-97 [34].

- In the case of an eye contact, carefully wash eyes with

water for several minutes. Take contact lenses off, if any

and it is not difficult to do. Keep washing eyes [34].

- Seek medical assistance if irritation does not go away

[34].

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 1

Safety Data Sheet registration number №

Valid until

page. 5

out of 20

3. Composition (information on components)

3.1. Information on the product in general

3.1.1. Chemical name:

(according to IUPAC)

Poly (iminocarbonimidoylimino-1,6-hexandiyl)

hydrochloride

3.1.2. Chemical formula: Empirical formula: (C7H16ClN3)n, where n=5-50 [1].

Structural formula:

(CH2)6NH C NH

NH HCl n., where n=5-50

[1].

3.1.3. General characteristics of the composition:

(taking to the account brand assortiment, with an

indication of admixtures and functional additives

that have an effect on hazard of productsопасность

продукции; methods of production)

«Disinfecting substance «BIOPAG» where there is not

more than 95% of polyhexamethyleneguanidine

hydrochloride, the rest to 100% is water [1] is called

«solid form».

Disinfecting substance BIOPAG can be manufactured as

a water solution of polyhexamethyleneguanidine

hydrochloride («liquid form») with its content up to 25%

under trade marks «Disinfecting substance

«Biopag-D» according to the technical specification TU

9392-020-41547288-02 [38], «Antimicrobial preparation

«Biopag» according to TU 9392-009-41547288-2000

[39].

3.2. Components

(name, CAS and EC numbers (if any), mass share,

MACwa or SRLIwa, hazard classes, refeences on data

sources)

Components

(name, CAS and EC numbers)

Mass share, % MACwa,

mg/m3

Hazard class Information

sources «Liquid

form»

«Solid

form»

Poly

(iminocarbonimidoylimino-

1,6-hexandiyl) hydrochloride

(polyhexamethyleneguanidine

hydrochloride, polyhexa-

iminoimidocarbonimono-

hexamethylene hydrochloride,

short name: PHMGHC)

CAS № 57029-18-2

20 ± 1,5 Not less

than 95%

2 mg/m3 for

substance in

aerosol form

3rd class of moderately

hazardous substances when

introduced into stomach, 4th

class of low-hazard

substances in the case of

skin contact

[1,

Ошибка!

Источник

ссылки не

найден., 37,

38, 39].

Water The rest to 100% - -

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Safety Data Sheet registration number №

Valid until

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 11

4. First aid measures

4.1. Observable symptoms

4.1.1. In case of respiratory exposure (inhalation): Vapours of BIOPAG substance in a «solid form» and as

a water solution do not have any general toxic or

irriteting effect on a human being [33].

In the case of respiratory exposure (aerosol inhalation)

cough, throat irritation or respiratory affection may be

observed. [Ошибка! Источник ссылки не найден.].

4.1.2. In case of skin exposure: In case of skin contact the product in a powder form

may have a low local irritating effect (in the case of a

single contact); water solution of the product may cause

first signs of local irritating action on the skin which

may appear after multiple contacts (at least three

applications). Intensity and severity of this action

depend on the concentration of the product [Ошибка!

Источник ссылки не найден.].

4.1.3. In case of eye exposure: In case of eye contact with the powder form of the

product a pronounced irritation, plethoric eye watering,

blepharospasm, edema, mucopurulent excrements,

leucoma formation or loss of vision may be observed. In

the case of eye contact with water solution of the

product eye watering, pronounced irritation or edema

may be observed, while they do not cause keratopathy

or loss of sight [Ошибка! Источник ссылки не

найден.].

Irritating effect on eye mucous tunics depends on

percentage composition of the active agent in water

solution. The effect may be from low to the pronounced

one [Ошибка! Источник ссылки не найден.].

4.1.4. In case of oral exposure (if swallowed): In case of oral exposure (if swallowed) breathing

problems, dystaxia, convulsions, cyanosis of mucous

membranes or skin may be observed [Ошибка!

Источник ссылки не найден.].

4.2. First aid measures

4.2.1. In case of inhalation poisoning: Inhalation poisoning with product vapours is

unlikely.[Ошибка! Источник ссылки не найден.].

Fresh air, warmth and repose. Seek medical assistance if

necessary [Ошибка! Источник ссылки не найден.].

4.2.2. In case of skin exposure: Wash skin with running water and soap. Seek medical

assistance if necessary [Ошибка! Источник ссылки

не найден., 37].

4.2.3. In case of eye exposure: Immediately wash eyes with running water during 10-15

minutes, then drop 30 % solution of sodium sulfacyl.

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 1

Safety Data Sheet registration number №

Valid until

page. 7

out of 20

Seek medical assistance if necessary [37].

4.2.4. In case of oral poisoning: Drink several glasses of water with adsorbent (10-20

crushed tablets of activated carbon per 1 glass of water).

Do not cause vomiting. Seek medical assistance if

necessary [Ошибка! Источник ссылки не найден.,

37]. Take salt laxative. [Ошибка! Источник ссылки

не найден.].

4.2.5. Contraindications: Do not cause vomiting [32, 37].

4.2.6. First aid equipment (first aid kit): Cotton wool, glass bath for eye washing, 30 % solution

of sodium sulfacyl, activated carbon, salt laxative

[Ошибка! Источник ссылки не найден.].

5. Measures and tools for prevention of fire and explosion hazard

5.1. General characteristics of fire and explosion

hazard:

The product is manufactured in granules that do not

form any dusty explosive mixtures [1].

The product is fire- and explosion-proof.

Ignition temperature: 400оС [Ошибка! Источник

ссылки не найден.].

Self-ignition temperature: 455 оС [Ошибка!

Источник ссылки не найден., Ошибка! Источник

ссылки не найден.].

5.2. Parameters of fire and explosion hazard:

(nomenclature of indicators according to GOST

12.1.044 and GOST R 51330.0)

Inflammability class: combustible, low flammable [5,

Ошибка! Источник ссылки не найден.].

Flash temperature is more than 400 оС [Ошибка!

Источник ссылки не найден.].

5.3. Hazard of combustion and/or decomposition

products:

Combustion products: carbon oxides, nitrogen oxides,

hydrochloride [Ошибка! Источник ссылки не

найден.].

Poisoning with a carbon monoxide causes headache,

dizzinness; buzzing in ears, breathlessness, heartbeating,

flickering before eyes, facial flushing, general faintness,

sickness, sometimes vomiting; in severe cases

convulsions, loss of consciousness, coma [36].

Depending on a content of various nitrogen oxides in

gas mixtures poisoning with nitrogen oxides in general

has irritating or nitrite action. After a contact of nitrogen

oxides with wet surfaces of lungs HNO3 and HNO2 are

formed. They attack alveolar tissue that cause

pulmonary edema and complex reflectory problems.

Nitrates and nitrites are formed in blood and cause

vessel distensibility, lack of oxygen and fall of blood

pressure [40].

In the case of high concentrations poisoning with

hydrochloride causes irritation of mucous tunics,

especially nasal; conjuctivitis; corneal opacity,

hoarseness, choking feeling, chest tingling, snuffles,

cough. Chronic intoxication causes catarrh of the

respiratory tract, dental decay, cankering of nasal

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Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 11

mucous tunics, gastroenteric upsets [40].

5.4. Recommended fire extinguishing substances: Aspirated foam, water[37].

In case of inflammation use sand, felt mat, asbestos

cloth, fire extinguishers of types ОП (lat. OP), ОУ (lat.

OU) [Ошибка! Источник ссылки не найден.,

Ошибка! Источник ссылки не найден.].

5.5. Forbidden fire extinguishing substances: None [Ошибка! Источник ссылки не найден.,

Ошибка! Источник ссылки не найден., Ошибка!

Источник ссылки не найден.].

5.6. Personal protection equipment (PPE) for fire

fighters and personnel

For a work manager– ПДУ-3 (lat. PDU-3) (during 20

minutes). For emergency brigades – an isolating

protective suit КИХ-5 (lat.KIH-5) complete with an

isolating gas mask ИП-4М (lat. IP-4M) or a breathing

apparatus АСВ-2 (lat.ASV-2). In the case of

inflammation – a fireproof suit complete with a self-

rescue device СПИ-20 (lat.SPI-20). If there is no such

an equipment – an all-service protective suit Л-1 (lat.L-

1) or Л-2 (lat. L-2) complete with an industrial gas mask

with cartridges of B type with an aerosol filter, small

box respirator. When concentrations in the air are low

(if MAC is up to hundredfold higher) – work clothes, an

industrial gas mask of a small size ПФМ-1 (lat.PFM-1)

with a universal protective cartridge ПЗУ (lat.PZU), an

independent protective individual set with a forced feed

of purified air to a breathing zone. Oil-and-petrol

resistant gloves, gloves made by dispersion of butyl-

rubber, special shoes [Ошибка! Источник ссылки не

найден., Ошибка! Источник ссылки не найден.].

5.7. Specific instructions for fire fighting: Wear protective clothes and use a breathing apparatus

before entering the zone of an accident. Extinguish fire

with sprayed water, air or chemical foam standing at a

maximum possible distance from a burning product. Do

not come too close to the product. Precipitate fire gases

and vapours with fine-sprayed water. Organise

evacuation of people from buildings that are situated

nearby taking to the account the direction of flowing of

toxic combustion products [6].

Pour water on containers with product located in the

vicinity of the fire area while standing possibly remote

from the containers in order to cool them. This is

required for prevention of product firing, as well as its

melting down and losing of its marketable condition (the

product has a low melting point - 120°С) [Ошибка!

Источник ссылки не найден.].

6. Measures for prevention and elimination of accidents and their consequences

6.1. Measures for prevention of harmful influence on people, environment, buildings, etc. in emergency

situations

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 1

Safety Data Sheet registration number №

Valid until

page. 9

out of 20

6.1.1. Required general recommendations: In a case of an emergency an executive officer is chief

engineer of a plant. A chief of a workshop where an

accident has happenned becomes responsible for all the

works for mitigation of the emergency. A chief of a shift

that was working when the accident has happenned

should immediately by himself or by responsible

subordinates call a gas safety or a fire brigade and notify

an on-duty dispatcher of the plant about the accident.

The responsibilities of foremen and equipment

workshop operators where the accident has happenned

include an immediate notification of a plant dispatcher

about the accident and taking measures for men

removing from work rooms.

In the case of an emergency alert (alarm, honk, ring) all

the workers except people who are participating in the

mitigation of the emergency in the workshop

(department, segment) must leave their work rooms and

follow a predetermined way to the emergency exits

[Ошибка! Источник ссылки не найден.].

People who are participating in emergency containment

should fulfil all the works using personal protective

equipment (wear work clothes according to GOST

12.4.031-84, protective goggles according to GOST

12.4.013-85, rubber or plastic gloves according to

GOST 20010-93) [1, 37].

6.1.2.Personal protective equipment:

(for emergency brigades and personnel)

See Clause 8.3. In the case of an emergency spillage all

the works should be fulfilled using personal protective

equipment: work clothes, rubber gloves, dust masks

[37], for protection of eyes protective goggles of a brand

ЗН (lat. ZN) with colourless glasses should be used [1,

Ошибка! Источник ссылки не найден., 13, 14,

Ошибка! Источник ссылки не найден.].

6.2. Measures for mitigation of emergencies

6.2.1. Emergency measures in case of spillage,

leakage or scattering of the product:

(including safety precautions that provide

environmental protection)

Scattered substance should be gathered and sent for

utilisation. Residuals should be washed out with water.

Solutions that contain the substance can be poured into

drains only when diluted.

In the case of an accidental scattering cleaning can be

carried out only in work clothes, respiratory organs

should be protected with antidust respirators, hand skin -

with rubber gloves, eyes – with hermetical goggles.

It is allowed to work with the product only if workers

are older than 18 and they do not suffer from a

hypersensibility to chemicals or medicines or any

allergic desease.

If product is in an undamaged package, it should be

gathered and sent for the purpose intended [37].

6.2.2. Emergency measures in case of fire: In the case of fire a fire brigade should be called

immediately, an on-duty dispatcher should be notified

about the fire and measures for removing people from

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Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 11

their work places should be takes and the fire should be

mitigated.

Do not come to close to the burning product.

If the fire is detected all the workers from this shopfloor

should immediately use personal protective equipment

(a filtering gas mask) and leave their work rooms,

following the predetermined way to the emergency

exits. [Ошибка! Источник ссылки не найден.].

7. Safe storage and handling conditions for chemicals while loading-unloading operations

7.1. Protective measures when handling chemicals

7.1.1. Protective measures and collective protective

equipment:

(including measures for fire and explosion safety)

Avoid ingress of the substance into respiratory organs,

on skin, on mucous tunics of eyes, into stomach.

It is allowed to work with the substance (weigthing,

preparing of working solutions) only in work clothes,

respiratory organs should be protected with antidust

respirators, hand skin– rubber gloves, eyes – hermetical

goggles [37].

The product is fire- and explosion- safe, flash point is

more than 400°С [Ошибка! Источник ссылки не

найден., 37].

Support peronnel should be instructed with the labour

safety rules when working with the product and

provided with personal protective equipment [1, 13]. It

is not allowed to work with the product near the open

fire or heat sources. Take fire precautions[10].

7.1.2. Measures for environmental protection: Environmental protection is achieved by observance of

standards of technological regulations, encapsulation of

technological equipment and transport tare.

In industrial premises and the most essential work

places periodical control for the condition of the air in

the workspace area should be carried out [Ошибка!

Источник ссылки не найден., 9].

Solutions that contain the substance can be poured into

drains only when diluted. [37].

Do not allow the substance to get into ground and

surface waters in amounts that exceed maximum

allowed concentrations (MAC) [24, Ошибка!

Источник ссылки не найден.].

There are no wastes that are subject to a special disposal

at a stage of product preparation [1].

7.1.3. Recommendations on a safe transportation: Freight is non-hazardous [18].

The product can be transported by all modes of

transport, in roofed vehicles in conditions that

guarantee safety of package, in compliance with the

rules that are effective on each mode of transport.

In order to prevent scattering of the product avoid tare

tampering (shocks or heating) [1, 37].

7.2. Storage conditions of chemicals

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 1

Safety Data Sheet registration number №

Valid until

page. 11

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7.2.1. Conditions and time limits of safe storage:

(including guaranteed shelf life)

The product should be stored in hermetically sealed

producer’s containers in dry roofed indoor storage

facilities on wooden shelving or trays at the ambient

temperature from –40 оС to +40

оС.

Guaranteed shelf life is 7 years.

The substance should be stored apart from food products

and medicines in places not available for children [1,

37].

7.2.2. Substances and materials that are

incompatiable with the product when storing:

Oxidants, acids, alcali [Ошибка! Источник ссылки

не найден.]. The product should be stored apart from

food products and medicines in places not available for

children [1].

7.2.3. Materials that are recommended for tare and

packaging:

The substance is produced and packed in double-walled

polyethylene (PE) packages from 5 g to 10 kg according

to GOST 10354 [42] and hermetically sealed by fusion

welding. The PE film thickness is at least 0.6 mm. The

plastic packages are packed into transport tare:

corrugated paperboard, paper or PE sacks. It is

permissible to package the product into hermetically

sealed PE containers [1, 12, 37].

7.3. Safety precautions and storage conditions in

household use:

The product should be stored in hermetically sealed

producer’s containers at the ambient temperature from

from –40 оС to +40

оС. Shelf life is 7 years.

The product should be stored apart from food products

and medicines in places not available for children [1,

37].

8. Techniques of control for hazardous exposure and personal protective equipment

8.1. Parameters of working zone that are subject of

compulsory control (MACwa or SRLIwa):

MACwa – 2 mg/m3, aerosol, 3rd class of hazard, special

protection of skin and eyes is required [Ошибка!

Источник ссылки не найден.].

8.2. Measures for holding hazardous substances

content in permissible concentrations:

Observe all the safety precautions when working with

the product. Working premises should be equipped with

a communal combined extract and input ventilation and

local ventilation. Maintain hermecity of the equipment.

Control content of polyhexamethyleneguanidine

hydrochloride in the air of working area [8, 9].

8.3. Personal protective equipment

8.3.1. General recommendations: Working with the substance (weighting, preparation of

working solutions) should be carried out only in work

clothes, respiratory organs should be protected with

antidust respirators, hand skin – with rubber gloves,

eyes – with hermetical goggles.

It is prohibited for people who are younger than 18

years with a hypersensibility to chemicals and medicines

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or who are suffering from any allergic desease to work

with the product. [37].

8.3.2. Protection of respiratory organs (types of

personal protective equipment of respiratory

organs):

Antidust respirators according to GOST 12.4.034-2001

[37, 15].

8.3.3. Protective clothes (material, type): Protective goggles according to GOST 12.4.013-85 [1,

37, 14].

Rubber gloves according to GOST 20010-93 [1, 37, 41].

Work clothes according to GOST 12.4.031-84 [1, 37,

13].

8.3.4. Personal protective equipment in household

use:

All the works with the product should be carried out

with hand skin protected with rubber gloves, respiratory

organs - with respirators, eyes - with hermetical goggles

[37, 1].

9. Physicochemical properties

9.1. Physical conditions:

(state of aggregation, colour, odour)

BIOPAG is a transparent glass-like solid substance,

from colourless to light yellow colour (in lumps or fine

crushed – «solid form»), when crushed – it is a powder

from white to light yellow colour that contains small

pieces of solid transparent substance. [37]. Odourless

[Ошибка! Источник ссылки не найден.], contains

not less than 95% of polyhexamethyleneguanidine

hydrochloride.. [1, 37].

9.2. Parameters characterizing basic properties of

chemicals, primarily hazardous:

(temperature indices, pH, solubility, coefficient n-

octanol/water, etc.)

Softening point: > 100 °С [Ошибка! Источник

ссылки не найден.].

Melting point: 120 °С [Ошибка! Источник ссылки

не найден.].

Density at 20C, g/cmЗ: ~1,0 [Ошибка! Источник

ссылки не найден.].

Water-solubility: soluble [1].

Alcohol- solubility: soluble [Ошибка! Источник

ссылки не найден.].

Thermal degradation temperature: 250 оС.

Inflammability class (fire risk): combustible, low-

flammable [Ошибка! Источник ссылки не

найден., 5, Ошибка! Источник ссылки не

найден.].

Ignition temperature: 400 оС [Ошибка! Источник

ссылки не найден.].

Self-ignition temperature: 455 оС [Ошибка!

Источник ссылки не найден.].

10. Stability and reacting capacity

10.1. Chemical stability:

(for non-stable products decomposition products

should be mentioned)

The product is stable in normal conditions of storage

and handling. The product is stable in abiotic conditions

[Ошибка! Источник ссылки не найден.].

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 1

Safety Data Sheet registration number №

Valid until

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out of 20

10.2. Reacting capacity: The product can be oxidized, alkylated or acidified [4].

10.3. Conditions that should be avoided:

(including hazard expressions upon contact with

incompatible substances and materials)

Incompatible with oxidants, acids, alkali or open fire

[Ошибка! Источник ссылки не найден.].

11. Information on toxicity

11.1. General characteristics of exposure:

(evaluation of hazard (toxicity) of exposure on

organisms)

In accordance with the acute toxicity parameters in the

classification GOST 12.1.007-76 BIOPAG substance

attributes to the 3th

class of moderately hazardous

substances when introduced into stomach, to the 4th

class of low-hazard substances in case of skin contact

and to the 4th

class of low-toxic substances when

introduced into abdominal cavity. BIOPAG substance

does not have any sensitising or cumulative effect.

When inhalating vapours are low-hazard. The substance

has a local irritating effect when applied once on skin or

eyes [37].

The BIOPAG substance attributes to the 4th

class of low

hazard substances according to the volatility level

[Ошибка! Источник ссылки не найден.].

No signs of irritating action of the substance on mucous

tunics of upper airway in conditions of saturating vapour

concentrations were found. An irritating effect was

detected when inhalating aerosol. [26].

11.2. Ways of exposure:

(inhalational, peroral, skin and eye contact)

Inhalational, peroral, skin and eye contact [Ошибка!

Источник ссылки не найден., Ошибка! Источник

ссылки не найден., 33].

11.3. Affected organs, tissues and systems of a

human being:

Central nervous and respiratory systems, hepar, kidneys,

morphological composition of peripheral blood, eyes,

skin, carbohydrate and protein metabolism, oxidation-

reduction processes [Ошибка! Источник ссылки не

найден.]. Local irritating action on skin and mucous

tunics of eyes depends on percentage composition of the

active agent in water solutions. The reaction on it that

may be from low to an expressed one [Ошибка!

Источник ссылки не найден.].

11.4. Information on dangerous to health exposures

upon direct contact with the substance as well as

consequences of these exposures: (irritating action on upper airways, eyes, skin,

including skin-resorbtive action; sensibilisation)

In conditions of saturating vapour concentrations, the

substance does not have any irritating action on mucous

tunics of the upper airways.[26].

The substance causes irritation of mucous tunics of eyes.

In the case of a skin contact may cause a local irritating

effect.

The substance does not have any sensibilising effect

[Ошибка! Источник ссылки не найден.].

11.5. Information on hazardous late effects of an exposure on organisms:

Cumulative properties are poorly marked [Ошибка!

Источник ссылки не найден.].

page 14

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Safety Data Sheet registration number №

Valid until

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 11

(influence on a reproduction function,

carcinogenecity, cumulativeness, etc.) The substance did not show any embryotoxic,

gonadotrophic, mutagenic and cancerogenic action in

experiments with animals [Ошибка! Источник

ссылки не найден., 33].

11.6. Acute toxicity parameters:

(DL50, route of entry (intragastrically, skin

application), animal specimen;

CL50, time of exposure (h), animal specimen)

DL50 – 1080 mg/kg, intragastrically, rats [Ошибка!

Источник ссылки не найден.].

DL50 – 906 mg/kg, intragastrically, mice [Ошибка!

Источник ссылки не найден.].

DL50 – 10500 mg/kg, skin application, rats, mice

[Ошибка! Источник ссылки не найден.].

СL50 is unreachable [Ошибка! Источник ссылки не

найден.].

11.7. Doses (concentrations) that have a minimal

toxic effect:

Threshold chronic effect:

Limcrcut

, mg/kg: 8 (rats) [Ошибка! Источник ссылки

не найден.].

Threshold acute effect:

Limacсut

, mg/kg: 1000 (rats) [Ошибка! Источник

ссылки не найден.].

Threshold of an irritant action on a rabbits’ skin

Limir – 20%, skin application, once [Ошибка!

Источник ссылки не найден., Ошибка! Источник

ссылки не найден.],

Limir – 1%, skin application, repeatedly [Ошибка!

Источник ссылки не найден., Ошибка! Источник

ссылки не найден.].

Threshold of an irritant action on mucous tunics of

rabbits’ eyes:

Limir -1%, eyes, once [Ошибка! Источник ссылки

не найден., Ошибка! Источник ссылки не

найден.].

12. Information on an environmental impact

12.1. General characteristics of exposures on

environmental objects:

(open air, water basins, ground)

Stable product in abiotic conditions. The substance

transforms in the environment. It has an effect on

organoleptic properties of water [Ошибка! Источник

ссылки не найден.].

12.2. Ways of exposure on the environment: In the case of infringement of rules of handling,

transportation, storage, accidents and emergency

situations [16].

12.3. Observable signes of exposure: If the concentrations are high, it has a negative effect on

growth and development of aquatic saprophytic

microflora and causes a slowdown of biochemical

oxygen consumption. It also causes foam formation

[33].

12.4. The most important characteristics of exposure on the environment

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 1

Safety Data Sheet registration number №

Valid until

page. 15

out of 20

12.4.1. Hygienic normatives:

(permissible concentrations in the open air, water, including

fishery water bodies, ground)

Componenets MAC open air.

or SRLI open

air, mg/m3

MAC water1

or APC water,

mg/l,

MAC fishery

water bodies.2

or SRLI

fishery water

bodies,

mg/l

MAC ground or

APC

ground,

mg/kg

Sources of data

Poly

(iminocarbonimidoylimino-

1,6-hexandiyl) hydrochloride

(polyhexamethyleneguanidine

hydrochloride, polyhexa-

iminoimidocarbonimono-

hexamethylene

hydrochloride, short name:

PHMGHC)

SRLIopen air

0.03 mg/m3

MAC water

0.1 mg/l,

general, 3

class of

hazard

MAC fish.bod.

0.01 mg/l,

sanitary-

toxicological,

3 class of

hazard

None [Ошибка!

Источник

ссылки не

найден.,

Ошибка!

Источник

ссылки не

найден., 24,

Ошибка!

Источник

ссылки не

найден.,

Ошибка!

Источник

ссылки не

найден.]

Water - - - -

12.4.2. Ecotoxicity indices:

(CL, EC for fishes, Daphnia magna,algae, etc.)

Toxicity for fishes:

Acipenser Linne/CL50 (96 h): 10.0 mg/l

[Ошибка! Источник ссылки не найден.],

Leuciscus idus/CL50 (96 h): 4.17 mg/l

[Ошибка! Источник ссылки не найден.].

Other aquatic invertebrates:

Daphnia magna/CL50 (48 h): 1.0 mg/l [Ошибка!

Источник ссылки не найден.].

Water plants:

Scenedrsmus quadricanda/EC50 (72 h): 1.0 mg/l

[Ошибка! Источник ссылки не найден.].

12.4.3. Migration and transformation in the environment due

to biodestruction and other processes (oxidation, hydrolysis,

etc.):

PHMG-H is quite a stable compound in the

water environment. If the concentrations are

higher than 1.0-1.5 mg/l, it intensifies water

foam formaation. It does not give water any

foreign odours, tastes or colours. If the

concentrations are higher than 0.1 mg/l, it does

not have any effect on processes of natural self-

purification of water bodies. If the

concentrations are high, it may have a negative

effect on growth and development of aquatic

saprophytic microflora and cause a slowdown of

1 Water from water bodies for household and drinking and cultural and general water use

2 Water from water bodies that have a commercial fishing importance (including seas)

page 16

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Safety Data Sheet registration number №

Valid until

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 11

biochemical oxygen consumption. [33].

13. Recommendations on waste disposal (residuals)

13.1. Protective measures when handling with wastea that

are formed during application, storage, transportation, etc.

Avoid penetration of substance wastes to the

respiratory organs, on skin, mucous tunics of

eyes, into stomach.

It is allowed to work with the substance wastes

and residuals only in work clothes, respiratory

organs should be protected with antidust

respirators, hand skin– rubber gloves, eyes –

hermetical goggles [37].

All the workers should know all the safety rules

when working with the produc and provided

with personal protective equipment [1, 13].

It is prohibited for people who are younger than

18 years with a hypersensibility to chemicals and

medicines or who are suffering from any allergic

desease to work with the product. [37].

Follow fire precautions. [10].

It is allowed to work with the product only for

personnel who have completed safety induction,

education and knowledge assessment on safe

working practice with the product [11].

13.2. Information on places and methods of deactivation,

utilisation and substance waste disposal (material), including

tare (package):

Wastes of pure product should be gathered to a

container and put back to the technological

process for further application [17].

Scattered substance wastes should be gathered

and sent for utilisation. Residuals should be

washed out with water. Solutions that contain

the substance can be poured into drains only

when diluted [37].

There are no residuals that are due to a special

deactivation and disposal at the stage of product

production [1].

13.3. Recommendations on disposal of wastes that are

formed when applying of products in the household use:

It is recommended to wash the empty tare from

used product before utilisation. Residuals of

unused product should be diluted and poured

into drains [37].

14. Information on transportation

14.1. UN number:

(in compliance with UN recommendations for transportation

of dangerous goods (standard rules), the latest version)

There is no UN serial number.

14.2. An appropriate shipping and/or transport name: «Disinfecting substance «BIOPAG» (active agent) TU 9392-008-41547288-2000 with

changes to TU № 1 [1], «Desinfectant

«BIOPAG-D» TU 9392-020-41547288-02 [38],

Antimicrobial preparation «BIOPAG» TU 9392-

009-41547288-2000 [39].

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 1

Safety Data Sheet registration number №

Valid until

page. 17

out of 20

14.3. Modes of transport that can be used: The product can be transported by all modes of

transport, in roofed vehicles in conditions that

guarantee safety of package, in compliance with

the rules that are effective on each mode of

transport [1, 37].

14.4. Classification of freight hazard:

(according to GOST 19433 and UN recommendations on

transportation hazard)

The product is a non-hazardous freight [1, 18, 37].

14.5. Transport labelling:

(handling symbols; basic, additional and explanatory texts)

«Keep dry» [20]. The following information should be written on the label: name of the

product and a producer, a lot number, netto

weight, content of the active agent, date of

production, shelf life, indication of technical

specification TU [20].

14.6. Packaging groups:

(in compliance with UN recommendations on transportation

hazard)

None.

14.7. Information on hazard when transporting by car: None, as substances with a low level of hazard should be transported by car without application

of system of information on hazard [18].

14.8. Emergency cards:

(in case of railway, marine and other transportation)

None.

14.9. Information on hazard at the international freight

traffic: (according to Agreement on International Goods

Transport by Rail, ADR, RID, IMDG Code, ICAO/IАTA,

etc., including information on hazard for the environment

including information about a «marine pollutant»)

None.

15. Information on national and international legislation

15.1. National legislation

15.1.1. Laws of the Russian Federation: In any case one should act in compliance with

the effective legislation of the Russian

Federation.

15.1.2. Documents regulating requirements on

protection of human being and the environment:

(certificates, Hygiene Certificates, licences, etc.)

State Registration Certificate for disinfecting

substance (active agent) «BIOPAG» №

RU.77.99.01.002.E.002182.10.10 dated

26.10.2010 [27], State Registration Certificate of

the desinfecting substance «BIOPAG-D» dated

05.10.2010 № RU.77.99.01.002.E.001633.10.10

[44], State Registration Certificate of the

desinfecting substance Antimicrobial preparation

«BIOPAG» № RU77.99.88.002.E.007468.03.11

dated 25.03.2011 [45].

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Safety Data Sheet registration number №

Valid until

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 11

15.2. International legislation

15.2.1. International сonventions and agreements:

(if the products are regulated by the Montreal Protocol, the

Stokholm Convention, etc.)

Not regulated.

15.2.2. Safety marking that is effective in the EU countries:

(danger symbols, risk and safety phrases, etc.)

Danger symbols: Xi – irritation

R-phrases:

R21/22 – dangerous in the case of skin contact

or if swallowed.

S-phrases

S22 – not to inhale powder.

S26 – in the case of eye contact immediately

wash them with water during 15 minutes.

S28 – in the case of skin contact wash it with

water.

S48 – if the product is swallowed immediately

seek medical help and show them an instruction

or a package.

16. Additional information

16.1. Informaion on revision (reedition) of MSDS:

(it is written: «MSDS is first-time elaborated » or other cases

with an indication of the main argument for revision of

MSDS)

MSDS was registered with a Safety Data Sheet

Registration number № 41547288-93-19816

dated 20 August 2008, was revised due to the

end of its effective date 20 August 2013 [35].

16.2. List of data sources that were used while preparing MSDS

1. TU (technical specifications) 9392-008-41547288-00 «Desinfecting substance «BIOPAG» with

changes 1.;

2. Report made by FGUE Research Disinfectology Institute of Rospotrebnadzor of the Russian

Federation «Reasons for maximum allowed polyguanidine levels when applied on skin». – Moscow.

2005. (RPO IETP is the holder of the document);

3. Explosion and fire hazard of materials and substances, and fire extinguishing equipment. Reference

guide. A.N. Baratov and A.Ya. Korolchenko, editors. Khimiya, Moscow, Russia. 1990;

4. Information card of a potentially hazardous chemical or a biological substance. Poly

(iminocarbonimidoilimino-1,6-hexandiil) hydrochloride. State registration certificate, series ВТ (lat.

VT) №002189, Russian Register of Hazardous Chemical and Biological Substances, Moscow, 2002.;

5. Russian State Standard GOST 12.1.044-89 Fire and explosion safety of substances and materials.

Nomenclature of characteristics and methods for their detection.;

6. Accident prevention rules and emergency management in railway transporting of hazardous cargo.

Railway Transport Ministry of Russian Federation, Moscow, Russia, 1997.;

7. Occupational safety in chemical industry. G.V. Makarov, editor. Khimiya, Moscow, Russia, 1989.;

8. Russian State Standard GOST 12.4.021-75. Ventilation systems. General requirements.;

9. Russian State Standard GOST 12.1.005-88. General sanitary and hygienic requirements to the air of

workspace area.;

10. Russian State Standard GOST 12.1.004-91. Fire safety. General requirements.;

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 1

Safety Data Sheet registration number №

Valid until

page. 19

out of 20

11. Russian State Standard GOST 12.0.004-90. Organization of training for accident prevention for

personnel. General requirements.;

12. Russian State Standard GOST 9980.3-86. Paint materials. Packaging.;

13. Russian State Standard GOST 12.4.103-83. Special protective clothes, personal protection equipment

for hands and feet. Classification.;

14. Russian State Standard GOST R 12.4.013-97. Protective goggles. General technical specifications.;

15. Russian State Standard GOST 12.4.034-2001. Personal equipment for protection of respiratory

system. Classification and marking.;

16. Russian State Standard GOST 17.2.3.02-78. Environment protection. Atmosphere. Rules for

determination of maximum allowable emissions of hazardous substances by industrial facilities.;

17. СанПиН (lat. SanPiN) (sanitary regulations and standards) 2.1.7.1322-03. Hygienic requirements to

placing and disposal of industrial wastes and consumption residues. Approved by the Decree №80 by

Onischenko G.G., the Principal state sanitary doctor of Russian Federation, dated 30 April 2003.;

18. Russian State Standard GOST 19443-88. Dangerous freight. Classification and marking.;

19. Russian State Standard GOST 123009-76. Loading and unloading operations. General safety

requirements.;

20. Russian State Standard GOST 14192-96. Cargo marking.;

21. Reference catalogue. Personal protection equipment for industrial workers at oil-refining, chemical

and petrochemical facilities. Moscow, 1983.;

22. Safe Reference Levels of Impact (SRLI) for pollutants in ambient air for populated territories.

Appendix №3 to the Hygienic norms, State number 2.1.6.1339-03. Approved on 10 July 2006 by

Onischenko G.G., the Principal state sanitary doctor of Russian Federation.;

23. Maximum Allowable Concentrations (MAC) of hazardous substances in the air of the working area.

Appendix № 1 to the Hygienic norms, State number 2.2.5.1313-03. Approved on 21 December 2003

by G.G. Onischenko, the Principal state sanitary doctor of Russian Federation. State

number 2.2.5.1827-03.;

24. Maximum Allowable Concentrations (MAC) of hazardous substances in water sources for drinking,

household, and recreational use. Hygienic norms State number 2.1.5.1315-03. Approved by the

Decree №79 of the Principal state sanitary doctor of Russian Federation on 30 April 2003, № 79.;

25. List of norms for the fishing industry: maximum Allowable Concentrations (MAC) and Safe

Reference Levels of Impact (SRLI) of hazardous substances in water of natural fish breeding

reservoirs. Russian Federation State Committee for Fishing Industry. Approved on 28 April 1999,

№96. Russian Federal Research Institute of Fisheries and Oceanography (VNIRO), Moscow 1999.;

26. Hygienic norm substantiation for the two substances: polyhexamethylene guanidine hydrochloride

(«Biopag») and polyhexamethylene guanidine phosphate («Phosphopag») in the air of the workspace

area. Scientific report of the Disinfectology Institute of the Public Health ministry of Russian

Federation. Moscow, 2001. Page 20.;

27. State Registration Certificate for the disinfecting substance (active agent) «BIOPAG» №

RU.77.99.01.002.Е.002182.10.10 dated 26 October 2010.;

28. Report prepared by the FGU VNIIPO of EMERCOM of Russia «Parameters of fire risk of the

disinfecting substance BIOPAG», – Moscow, 2006 (RPO IETP is the document holder).;

29. Report prepared by the Russian Federal Research Institute of Fisheries and Oceanography (VNIRO)

«Ecological fishery estimation of the preparation «Biopag» for sweet water», – Moscow, 2006.;

30. Letter to FGU VNIIPO of EMERCOM of Russia from RPO IETP. About results of the research work

concerning combustibility of Biopag and Biopag-D in a solid form.;

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Safety Data Sheet registration number №

Valid until

Disinfecting substance «Biopag»

TU 9392-008-41547288-00 with changes № 11

31. «Maximum Allowable Concentrations (MAC) of chemical substances». Reference book. Yu.A.

Krotov, A.O. Karelin, A.O. Lait.;

32. Report on toxicity and a hazard effect of the active agent of «Biopag» (IETP, Russia). The Research

Disinfectology Institute, 2000.;

33. Scientific report prepared by FGUE Research Disinfectology Institute of Rospotrebnadzor of the

Russian Federation based on the results of investigation of polyhexamethyleneguanidine

hydrochloride, substance (BIOPAG) and disinfecting substance ("BIOPAG-D") on its basis, 2010.;

34. Russian State Standard GOST 31340-2007. Warning marking for chemicals. General requirements.;

35. Russian State Standard GOST 30333-2007. Safety certificate (MSDS) for chemicals. General

requirements.;

36. Carbonic oxide. Russian book of reference for work safety: In 3 books. — Second edition., revised

and enlarged. — Moscow, Publishing house of the Novation Center ENAS, 2007.;

37. Instruction №5/2005 on application of disinfecting substance (active agent) «Biopag».;

38. Technical specification TU 9392-020-41547288-02 «Disinfecting substance «Biopag-D».;

39. Technical specification TU 9392-009-41547288-2000 «Antimicrobial preparation «Biopag».;

40. Hazardous substances in industry. Reference book for chemists, engineers and doctors. Seventh

edition, revised and enlarged. In 3 books. 1977.;

41. Russian State Standard GOST 20010-93. Technical rubber gloves. Technical specifications.;

42. Russian State Standard GOST 10354. Polyethylene film. Technical conditions.;

43. Russian State Standard GOST 19433. Dangerous cargo. Classification and labelling.;

44. State Registration Certificate of a disinfecting substance «BIOPAG-D» dated 05.10.2010 №

RU.77.99.01.002.E.001633.10.10.;

45. State Registration Certificate of a disinfectant «Antimicrobial preparation «BIOPAG» №

RU77.99.88.002.E.007468.03.11 dated 25.03.2011.