material safety data sheet - spectrum chemical · material safety data sheet 1. ... may cause skin...
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MATERIAL SAFETY DATA SHEET
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATIONProduct code: M1435Product Name: METHOTREXATE, USPChemical Name: Glutamic acid, N-(p-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-, L-
Synonyms: Amethopterin; (+)-Amethopterin; Amethopterine; 4-Amino-4-deoxy-N(sup 10)-methylpteroylglutamate; 4-Amino-4-deoxy-N(sup 10)-methylpteroylglutamic acid; 4-Amino-10-methylfolic acid; 4-Amino-N(sup 10)-methylpteroylglutamic acid; Antifolan;L-(+)-N-(p-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)glutamic acid; N-(p-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)-L-(+)-glutamic acid; N-(p-(((2,4-Diamino-6-pteridyl)methyl)methylamino)benzoyl)glutamic acid; N-Bismethylpteroylglutamic acid; Ledertrexate; Methylaminopterin;Methylaminopterinum; L-Glutamic acid, N-(4-(((2,4-diamino-6pteridinyl)methyl)methylamino)benzoyl)- (9CI); Glutamic acid, N-(p-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-, L-(+)-
Recommended use: Medication.CAS #: 59-05-2Formula: C20-H22-N8-O5RTECS # MA1225000CI#: Not availableSupplier: Spectrum Chemicals and Laboratory Products, Inc.
14422 South San Pedro St.Gardena, CA 90248(310) 516-8000
Emergency Telephone Number: CHEMTREC: 1-800-424-9300Contact Person: Martin LaBenz (West Coast)Contact Person: Regina Wachenheim (East Coast)
2. HAZARDS IDENTIFICATION
EMERGENCY OVERVIEWWARNING!. Harmful if swallowed. May cause skin and eye irritation. May cause irritation of respiratory tract.
Product code: M1435 Product name: METHOTREXATE, USP 1 / 11
Personal Protective Equipment
Odor:None.
Physical state:Solid.
Appearance:Crystalline powder.
NFPA
Color:Yellow.
See Section 8.
HMIS
2. HAZARDS IDENTIFICATIONOSHA Regulatory Status This material is considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200)
Chronic Potential Health Effects:
Component Carcinogen Status:Methotrexate59-05-2 (100)
Group 3- Not classifiable as to its carcinogenicity to humans by IARC
Target Organs: Bone Marrow. Blood. Liver. Kidneys.
Teratogenic Effects: Can cause birth defects
Mutagenic Effects: May affect genetic materialMutations in microorganismsExperiments with bacteria and/or yeast have shown mutagenic effectsMutagenic effects in mammalian somatic cellsExperiments with animal lymphocytes have shown mutagenic effects
Aggravated Medical Conditions: No information available
See Section 11 for additional Toxicological Information
POTENTIAL ENVIRONMENTAL EFFECTS
No information available
3. COMPOSITION/INFORMATION ON INGREDIENTS
Components CAS-No. Weight %Methotrexate 59-05-2 100
Eye Contact:Contact with eyes may cause irritation.
Acute Potential Health Effects:
Inhalation:May cause irritation of respiratory tract.
Principal Routes of Exposure:Ingestion. Inhalation.
Ingestion:Harmful if swallowed. Causes digestive (gastrointestinal) tract irritation. May cause abdominal pain. May cause nauseaand vomiting. May cause diarrhea. May cause constipation. It may affect the kidneys. May affect the blood. May affect thebone marrow. May affect respiration. May affect the liver. It may affect the brain. May cause central nervous systemeffects. May affect the cardiovascular system.
Product code: M1435 Product name: METHOTREXATE, USP
Skin Contact:May cause skin irritation.
2 / 11
POTENTIAL HEALTH EFFECTS
4. FIRST AID MEASURES
General Advice: Poison information centres in each State capital city can provide additionalassistance for scheduled poisons (13 1126). Ensure that medical personnel areaware of the material(s) involved and take precautions to protect themselves. Firstaider needs to protect himself.
Skin Contact: Wash off immediately with soap and plenty of water removing all contaminatedclothes and shoes. Get medical attention if irritation develops.
Eye Contact: Flush eye with water for 15 minutes. Get medical attention if irritation occurs. Ifsymptoms persist, call a physician.
Inhalation: Move to fresh air. If breathing is difficult, give oxygen. If not breathing, give artificialrespiration. WARNING! It may be hazardous to the person providing aid to givemouth-to-mouth resuscitation when the inhaled or ingested material is toxic,infectious or corrosive. Do not use mouth-to-mouth resuscitation if victim ingested orinhaled the substance; induce artificial respiration with the aid of a pocket maskequipped with a one-way valve or other proper respiratory medical device.Immediate medical attention is required.
Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to anunconscious person. Toxic if swallowed. Immediate medical attention is required.Call a physician or Poison Control Centre immediately.
Notes to Physician: Treat symptomatically
5. FIRE-FIGHTING MEASURES
Flammable Properties
Flashpoint (°C/°F): Not applicable
Flash Point Tested according to:Not available
Lower Explosion Limit (%): Not applicableUpper Explosion Limit (%): Not applicable
Autoignition Temperature (°C/°F): Not applicable.
Suitable Extinguishing Media: Dry chemical. Carbon dioxide (CO2). Water spray mist orfoam. Alcohol-resistant foam.
Unsuitable Extinguishing Media: No information available.
Hazardous Combustion Products: Carbon monoxide; Carbon dioxide; Nitrogen oxides
Specific hazards: May be combustible at high temperatures.
Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatuspressure-demand, MSHA/NIOSH (approved or equivalent)and full protective gear
Specific Methods: Dike fire-control water for later disposal; do not scatter thematerial. Cool containers / tanks with spray water. For firesinvolving tanks or car/trailer loads, cool containers withflooding quantities of water until well after the fire is out.
3 / 11Product code: M1435 Product name: METHOTREXATE, USP
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions:Keep people away from and upwind of spill/leak. Ensure adequate ventilation. Do not touch damaged containers orspilled material unless wearing appropriate protective clothing. Use personal protective equipment. Avoid contact withskin, eyes and clothing. Avoid dust formation. Remove all sources of ignition.
Environmental Precautions:Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Prevent entry into waterways, sewers,basements or confined areas.
Methods for Cleaning Up:Sweep up and shovel into suitable containers for disposal. Clean contaminated surface thoroughly.
7. HANDLING AND STORAGE
Handling
Technical Measures/Precautions:Provide sufficient air exchange and/or exhaust in work rooms. Avoid dust formation. Keep away from incompatiblematerials.
Safe Handling Advice:Wear personal protective equipment. Avoid contact with skin, eyes and clothing. Do not ingest. Do not breathevapours/dust. Avoid dust formation. Keep away from heat and sources of ignition. Handle in accordance with goodindustrial hygiene and safety practice.
Storage
Technical Measures/Storage Conditions:Keep container tightly closed in a dry and well-ventilated place. Store away from incompatible materials. Protectfrom light. Sensitive to light. Store in light-resistant containers.
Incompatible Materials:Oxidizing agents. Acids.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering measures to reduce exposure: Use process enclosures, local exhaust ventilation, or otherengineering controls to keep airborne levels belowrecommended exposure limits. If user operations generatedust, fume or mist, use ventilation to keep exposure toairborne contaminants below the exposure limit.
Personal Protective Equipment
Eye protection: Safety glasses. Safety glasses with side-shields.
Skin and body protection: Long sleeved clothing. Chemical resistant apron. Gloves.
Respiratory protection: Wear respirator with dust filter..
Hygiene measures: Avoid contact with skin, eyes and clothing. Wash hands before breaks andimmediately after handling the product. When using, do not eat, drink or smoke.
National occupational exposure limits
4 / 11Product code: M1435 Product name: METHOTREXATE, USP
United StatesU.S Occupational Exposure Limits: Not determined
Components OSHA NIOSH ACGIH AIHA WHEEL
Methotrexate - 59-05-2None None None None
CanadaCanada Occupational Exposure Limits: Not determined
Components Alberta British Columbia Ontario QuebecMethotrexate
59-05-2None None None None
Australia and MexicoOccupational Exposure Limits for Australia and Mexico: Not determined
Components Australia MexicoMethotrexate
59-05-2None None
9. PHYSICAL AND CHEMICAL PROPERTIES
10. STABILITY AND REACTIVITY
Stability: Stable at normal conditions
Conditions to avoid: Heat. Avoid dust formation. Dust may form explosive mixture in air. Fine dustdispersed in air in sufficient concentrations, and in the presence of an ignition sourceis a potential dust explosion hazard. Exposure to light.
Bulk density:No information available
Vapor pressure @ 20°C (kPa):No information available
Flash point (°C):Not applicable
Evaporation rate:No information available
Color:Yellow.
Vapor density:No information available
VOC content (g/L):No information available
Lower Explosion Limit (%):Not applicable
Odor threshold (ppm):No information available
Partition coefficient(n-octanol/water):No information available
Miscibility:No information available
Upper Explosion Limit (%):Not applicable
Solubility:Insoluble in waterInsoluble in alcoholInsoluble in EtherInsoluble in Chloroform
Physical state:Solid.
Autoignition Temperature (°C/°F):Not applicable.
Odor:None.
pH:No information available
Melting point/range(°C/°F):185-204 °C/365-399 °F
Appearance:Crystalline powder.
Boiling point/range(°C/°F):No information available
TasteNo information available
Decomposition temperature(°C/°F):No information available
Specific gravity:No information available
Product code: M1435
Molecular/Formula weight:454.44
Product name: METHOTREXATE, USP 5 / 11
Density (g/cm3):No information available
Incompatible Materials: Oxidizing agents. Acids.
Hazardous decompositionproducts:
Carbon monoxide. Carbon dioxide. Nitrogen oxides (NOx). When heated todecomposition it emits toxic fumes.
Possibility of HazardousReactions:
No information available
Polymerization: Hazardous polymerisation does not occur
Corrosivity: No information available
Special Remarks on Corrosivity: No information available
11. TOXICOLOGICAL INFORMATIONAcute Toxicity
Component Information
Product Information
LC50/inhalation/ratNo information availableLC50/Inhalation/mouse No information availableLD50/dermal/rabbitNo information availableLD50/dermal/rat No information availableLD50/oral/mouse 146mg/kgLD50/oral/rat135mg/kg
Local Effects
Skin irritation: May cause skin irritation in susceptible persons
Eye irritation: May cause eye irritation
Inhalation: May cause irritation of respiratory tract.
Methotrexate - 59-05-2
LD50/dermal/rat = No information availableLC50/inhalation/rat =No information available
LD50/oral/mouse 146 mg/kg
LC50/inhalation/mouse = No infomation available
LD50/oral/rat =135 mg/kg Oral LD50 Rat
Product code: M1435 Product name: METHOTREXATE, USP
Other LD50 or LC50information =No information available
6 / 11
LD50/dermal/rabbit = No information available
Ingestion: Harmful if swallowed. Causes digestive (gastrointestinal) tract irritation. Ingestionmay cause nausea, vomiting, diarrhea. May cause abdominal pain. May causestomatitis. May cause oral ulceration. May cause gastrointestinal bleeding. Maycause blurred vision. May cause skin rash, redness or itching. It may affect the bonemarrow (bone marrow depression). It may affect the blood (changes in white and redblood cell count). It may affect the blood (thrombocytopenia, leukocytopenia, anemia,pancytopenia. May cause easy bruising or bleeding. May affect the liver (fatty liverdegeneration, hepatitis, liver function tests impaired). May affect urinary system(kidneys). It may affect the brain. May affect respiration (difficult or labored breathingresulting in shortness of breath). May affect respiration (fibrosis, pneumoconiosis,respiratory obstruction). May affect behavior/central nervous system (fatigue,weakness). May affect behavior/central nervous system (dizziness, headache). Mayaffect behavior/central nervous system (somnolence, convulsions). May affectbehavior/central nervous system (moodiness, cognitive dysfunction). It may affect theimmune system and cause decreased immune response. May cause decreasedresistance to infection. May affect the cardiovascular system (hypotension).
Sensitization: No information available
Chronic Toxicity
Chronic Toxicity Prolonged or repeated ingestion may cause nausea, vomiting, diarrhea. Prolonged orrepeated ingestion may affect the liver, and kidneys. Prolonged or repeated ingestionmay affect the bone marrow. Prolonged or repeated ingestion may affect the blood(changes in red blood cell count). Prolonged or repeated ingestion may affect theblood (changes in white blood cell count). Prolonged or repeated ingestion mayaffect the blood (anemia). Prolonged or repeated ingestion may affect the blood(changes in clotting factors). Prolonged or repeated ingestion may affect the blood(leukopenia, thrombocytopenia). Prolonged or repeated ingestion may affect thebrain. Prolonged or repeated ingeston may affect behavior/central nervous system(headache, somnolence, convulsions/seizures). Prolonged or repeated ingestionmay cause loss of appetite.
Carcinogenic effects: Not classifiable as to its carcinogenicity to humans. Equivocal tumorigenic agent byRegistery of Toxic Effects of Chemical Substances (RTECS) criteria.
Components NTP IARC OSHA HCS -Carcinogens
ACGIH - Carcinogens Australia - ProhibitedCarcinogenicSubstances
Australia - NotifiableCarcinogenicSubstances
Methotrexate Not listed Group 3 -Supplement 7[1987]Monograph 26[1981]
Not listed Not listed Not listed Not listed
Mutagenic Effects: May affect genetic materialMutations in microorganismsExperiments with bacteria and/or yeast have shown mutagenic effectsMutagenic effects in mammalian somatic cellsExperiments with animal lymphocytes have shown mutagenic effects
Reproductive Effects: Can cause adverse reproductive effects
Teratogenic Effects: Can cause birth defects
Target Organs: Bone Marrow. Blood. Liver. Kidneys.
12. ECOLOGICAL INFORMATION
7 / 11Product code: M1435 Product name: METHOTREXATE, USP
12. ECOLOGICAL INFORMATIONECOTOXICITY
Toxicity to terrestrial and aquatic plants and animals: No information available
Ecotoxicity effects:
Aquatic toxicity:
Mobility: No information available
Persistence and degradability: No information available
Bioaccumulative potential: No information available
13. DISPOSAL CONSIDERATIONS
Waste from residues / unused products:Waste must be disposed of in accordance with Federal, State and Local regulation.
Contaminated packaging:Empty containers should be taken for local recycling, recovery or waste disposal
Components RCRA - F Series Wastes RCRA - K Series Wastes RCRA - P Series Wastes RCRA - U Series WastesMethotrexate None None None None
14. TRANSPORT INFORMATION
DOTUN-No: UN2811Proper Shipping Name: Toxic solids, organic, n.o.s.Hazard Class: 6.1Packing Group: IIISubsidiary Risk: Not applicableMarine Pollutant No data availableERG No: 154DOT RQ (lbs): No information available
Symbol(s): G
TDG (Canada)UN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Packing Group: IIISubsidiary Risk: No information availableDescription: No information available
ADRUN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Packing Group: IIISubsidiary Risk: No information availableClassification Code: No information availableDescription: No information availableCEFIC Tremcard No: No information available
IMO / IMDG
8 / 11Product code: M1435 Product name: METHOTREXATE, USP
UN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Packing Group: IIISubsidiary Risk: No information availableDescription: No information availableIMDG Page: No information availableMarine Pollutant No information availableEMS: F-AMFAG: No information availableMaximum Quantity: No information available
RIDUN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Packing Group: IIISubsidiary Risk: 6.1Classification Code: No information availableDescription: No information available
ICAOUN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Packing Group: IIISubsidiary Risk: No information availableDescription: No information available
IATAUN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Packing Group: IIISubsidiary Risk: No information availableERG Code: 6LDescription: No information available
15. REGULATORY INFORMATION
International Inventories
Components U.S. TSCA Philippines(PICCS)
KOREA KECL Japan ENCS CHINA Australia(AICS)
EINECS-No.
Methotrexate Present Not present KE-09753 Not present Not present Present 200-413-8
U.S. Regulations
California Prop. 65: Safe Drinking Water and Toxic Enforcment Act of 1986.
Chemicals Known to the State of California to Cause Cancer:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)
Chemicals Known to the State of California to Cause Reproductive Toxicity:WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm (See table below)
Product code: M1435
Massachusetts RTK: Present
Product name: METHOTREXATE, USP 9 / 11
Methotrexate
Components Carcinogen Developmental Toxicity Male ReproductiveToxicity
Female ReproductiveToxicity:
Methotrexate Not Listed developmental toxicity Not Listed Not Listed
CERCLA/SARA
Components CERCLA - HazardousSubstances and theirReportable Quantities
Section 302 ExtremelyHazardous
Substances and TPQs
Section 302 ExtremelyHazardous
Substances and RQs
Section 313 -Chemical Category
Section 313 - Reporting de minimis
Methotrexate None None None None None
U.S. TSCA
Components TSCA Section 5(a)2 - Chemicals With SignificantNew Use Rules (SNURS)
TSCA 8(d) -Health and Safety Reporting
Methotrexate Not Applicable Not Applicable
Canada
WHMIS hazard class:D1B Toxic materialsD2A Very toxic materials
Canada Controlled Products Regulation:This product has been classified according to the hazard criteria of the CPR (Controlled Products Regulation) and the MSDS containsall of the information required by the CPR.
Inventory
Components Canada (DSL) Canada (NDSL)Methotrexate Not Listed Present
Components CEPA Schedule I - Toxic Substances CEPA - 2010 Greenhouse Gases Subject to ManditoryReporting
Methotrexate Not listed Not listed
EU Classification
R-phrase(s)R25 - Toxic if swallowed.R63 - Possible risk of harm to the unborn child.R68 - Possible risk of irreversible effects.
S -phrase(s)S36 - Wear suitable protective clothing.S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).S53 - Avoid exposure - obtain special instructions before use.
Components Classification Safety PhrasesMethotrexate R25
R63R68
364553
10 / 11Product code: M1435 Product name: METHOTREXATE, USP
The product is classified in accordance with Annex VI to Directive 67/548/EEC
Indication of danger:T - ToxicXn - Harmful.
16. OTHER INFORMATION
The MSDS format complies with ANSI Z400.1-2004 standards.
Preparation Date: 07-Mar-2013
Reason for revision: Not applicable
Prepared by: Sonia Owen
Literature reference: No information available
All chemicals may pose unknown hazards and should be used with caution. This Material Safety Data Sheet (MSDS)applies only to the material as packaged. If this product is combined with other materials, deteriorates, or becomescontaminated, it may pose hazards not mentioned in this MSDS. The physical properties reported in this MSDS areobtained from the literature and do not constitute product specifications. Information contained herein does not constitutea warranty, whether expressed or implied, as to the safety, merchantability or fitness of the goods for a particular purpose.Spectrum Chemicals & Laboratory Products, Inc. assumes no responsibility for results obtained or for incidental orconsequential damages, including lost profits, arising from the use of these data. No warranty against infringement of anypatent, copyright or trademark is made or implied. It shall be the user's responsibility to develop proper methods ofhandling and personal protection based on the actual conditions of use. While this MSDS is based on technical datajudged to be reliable, Spectrum assumes no responsibility for the completeness or accuracy of the information containedherein.
Product code: M1435 Product name: METHOTREXATE, USP 11 / 11
SAFETY DATA SHEET
1. IDENTIFICATION
Product identifierProduct code: M1435Product Name: METHOTREXATE, USP
Other means of identificationSynonyms: Amethopterin; (+)-Amethopterin; Amethopterine; 4-Amino-4-deoxy-N(sup 10)-
methylpteroylglutamate; 4-Amino-4-deoxy-N(sup 10)-methylpteroylglutamic acid; 4-Amino-10-methylfolic acid; 4-Amino-N(sup 10)-methylpteroylglutamic acid; Antifolan;L-(+)-N-(p-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)glutamic acid; N-(p-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)-L-(+)-glutamic acid; N-(p-(((2,4-Diamino-6-pteridyl)methyl)methylamino)benzoyl)glutamic acid; N-Bismethylpteroylglutamic acid; Ledertrexate; Methylaminopterin;Methylaminopterinum; L-Glutamic acid, N-(4-(((2,4-diamino-6pteridinyl)methyl)methylamino)benzoyl)- (9CI); Glutamic acid, N-(p-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-, L-(+)-
CAS #: 59-05-2RTECS # MA1225000CI#: Not available
Recommended use of the chemical and restrictions on useRecommended use: Medication.Uses advised against No information available
Supplier: Spectrum Chemicals and Laboratory Products, Inc.14422 South San Pedro St.Gardena, CA 90248(310) 516-8000
Order Online At: https://www.spectrumchemical.com
Emergency telephone number Chemtrec 1-800-424-9300Contact Person: Martin LaBenz (West Coast)Contact Person: Regina Wachenheim (East Coast)
2. HAZARDS IDENTIFICATION
Classification
This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)
Acute toxicity - Oral Category 3Reproductive toxicity Category 1B
Label elements
Revision Number: G1Preparation Date: 3/6//2013
Product code: M1435 Product name: METHOTREXATE, USP 1 / 12
Revision Date: 3/6/2013
Hazards not otherwise classified (HNOC)Not Applicable
Other hazardsNot available
Precautionary Statements - PreventionObtain special instructions before useDo not handle until all safety precautions have been read and understoodUse personal protective equipment as requiredWash face, hands and any exposed skin thoroughly after handlingDo not eat, drink or smoke when using this product
Precautionary Statements - ResponseIF exposed or concerned: Get medical advice/attentionSpecific treatment (see .? on this label)IF SWALLOWED: Immediately call a POISON CENTER or doctor/physicianRinse mouth
Precautionary Statements - StorageStore locked up
Precautionary Statements - DisposalDispose of contents/container to an approved waste disposal plant
3. COMPOSITION/INFORMATION ON INGREDIENTS
Components CAS-No. Weight % Trade SecretMethotrexate
59-05-259-05-2 100 *
4. FIRST AID MEASURES
First aid measuresGeneral Advice: Poison information centres in each State capital city can provide additional
assistance for scheduled poisons (13 1126). Ensure that medical personnel areaware of the material(s) involved and take precautions to protect themselves. Firstaider needs to protect himself.
Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothes andshoes. Get medical attention if irritation develops.
Eye Contact: Flush eye with water for 15 minutes. Get medical attention if irritation occurs. If symptomspersist, call a physician.
Hazard statementsToxic if swallowedMay damage fertility or the unborn child
Product code: M1435 Product name: METHOTREXATE, USP 2 / 12
Danger
Inhalation: Move to fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration.WARNING! It may be hazardous to the person providing aid to give mouth-to-mouthresuscitation when the inhaled or ingested material is toxic, infectious or corrosive. Do not usemouth-to-mouth resuscitation if victim ingested or inhaled the substance; induce artificialrespiration with the aid of a pocket mask equipped with a one-way valve or other properrespiratory medical device. Immediate medical attention is required.
Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to anunconscious person. Toxic if swallowed. Immediate medical attention is required. Call aphysician or Poison Control Centre immediately.
Most important symptoms and effects, both acute and delayedSymptoms Causes digestive (gastrointestinal) tract irritation. May cause nausea and vomiting. May cause
loss of appetite. Pale skin. redness. rash. May cause central nervous system effects.Convulsions. Dizziness. Drowsiness. Headache. Weakness. Fatigue. Blurred vision. Easybruising or bleeding. May cause cardiovascular effects. Hypotension.
Indication of any immediate medical attention and special treatment neededNotes to Physician: Treat symptomatically
Protection of first-aidersFirst-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose ofcontaminated clothing and equipment as bio-hazardous waste
5. FIRE-FIGHTING MEASURES
Extinguishing Media
Suitable Extinguishing Media: Dry chemical. Carbon dioxide (CO2). Water spray mist orfoam. Alcohol-resistant foam.
Unsuitable Extinguishing Media: No information available.
Specific hazards arising from the chemical
Hazardous Combustion Products: Carbon monoxide; Carbon dioxide; Nitrogen oxides
Specific hazards: May be combustible at high temperatures.
Special Protective Actions for Firefighters
Specific Methods: Dike fire-control water for later disposal; do not scatter thematerial. Cool containers / tanks with spray water. For firesinvolving tanks or car/trailer loads, cool containers withflooding quantities of water until well after the fire is out.
Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatuspressure-demand, MSHA/NIOSH (approved or equivalent)and full protective gear
6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protective equipment and emergency procedures
Personal Precautions: Keep people away from and upwind of spill/leak. Ensure adequate ventilation. Do not touchdamaged containers or spilled material unless wearing appropriate protective clothing. Usepersonal protective equipment. Avoid contact with skin, eyes and clothing. Avoid dustformation. Remove all sources of ignition.
Environmental precautions Prevent further leakage or spillage if safe to do so. Prevent product from enteringdrains. Prevent entry into waterways, sewers, basements or confined areas.
Methods and material for containment and cleaning up
Product name: METHOTREXATE, USP 3 / 12Product code: M1435
Methods for containment Stop leak if you can do it without risk. Cover with plastic sheet to prevent spreading.
Methods for cleaning up Sweep up and shovel into suitable containers for disposal. Avoid creating dust. Cleancontaminated surface thoroughly.
7. HANDLING AND STORAGE
Precautions for safe handling
Technical Measures/Precautions:Provide sufficient air exchange and/or exhaust in work rooms. Avoid dust formation. Keep away from incompatiblematerials.
Safe Handling Advice:Wear personal protective equipment. Avoid contact with skin, eyes and clothing. Do not ingest. Do not breathevapours/dust. Avoid dust formation. Keep away from heat and sources of ignition. Handle in accordance with goodindustrial hygiene and safety practice.
Conditions for safe storage, including any incompatibilities
Technical Measures/Storage Conditions:Keep container tightly closed in a dry and well-ventilated place. Store away from incompatible materials. Protectfrom light. Sensitive to light. Store in light-resistant containers.
Incompatible Materials:Oxidizing agents. Acids.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Control parameters
National occupational exposure limits
U.S Occupational Exposure Limits: Not determined
United StatesComponents OSHA NIOSH ACGIH AIHA WHEEL
Methotrexate - 59-05-2None None None None
CanadaCanada Occupational Exposure Limits: Not determined
Components Alberta British Columbia Ontario Quebec
Methotrexate - 59-05-2None None None None
Australia and MexicoOccupational Exposure Limits for Australia and Mexico: Not determined
Components Australia MexicoMethotrexate
59-05-2None None
Appropriate engineering controls
Product name: METHOTREXATE, USP 4 / 12Product code: M1435
Engineering measures to reduce exposure: Use process enclosures, local exhaust ventilation, or otherengineering controls to keep airborne levels belowrecommended exposure limits. If user operations generatedust, fume or mist, use ventilation to keep exposure toairborne contaminants below the exposure limit.
Individual protection measures, such as personal protective equipmentPersonal Protective Equipment
Eye protection: Safety glasses. Safety glasses with side-shields.
Skin and body protection: Long sleeved clothing. Chemical resistant apron. Gloves.
Respiratory protection: Wear respirator with dust filter..
Hygiene measures: Avoid contact with skin, eyes and clothing. Wash hands before breaks andimmediately after handling the product. When using, do not eat, drink or smoke.
9. PHYSICAL AND CHEMICAL PROPERTIES
10. STABILITY AND REACTIVITY
Reactivity
Specific gravity:No information available
Molecular/Formula weight:454.44
Density (g/cm3):No information available
Color:Yellow.
Bulk density:No information available
Vapor pressure @ 20°C (kPa):No information available
Flash point (°C):Not applicable
Evaporation rate:No information available
Vapor density:No information available
VOC content (g/L):No information available
Flashpoint (°C/°F):Not applicable
Odor threshold (ppm):No information available
Physical state:Solid.
Partition coefficient(n-octanol/water):No information available
Viscosity:No information available
Flash Point Tested according to:Not applicable
Miscibility:No information available
Odor:None.
Solubility:Insoluble in waterInsoluble in alcoholInsoluble in EtherInsoluble in Chloroform
Lower Explosion Limit (%):No information available
Upper Explosion Limit (%):No information available
Appearance:Crystalline powder.
Autoignition Temperature (°C/°F):No information available
TasteNo information available
Reactive with acidsReactive with oxidizing agents
pH:No information available
Melting point/range(°C/°F):185-204 °C/365-399 °F
Formula:C20-H22-N8-O5
Boiling point/range(°C/°F):No information available
Product code: M1435 Product name: METHOTREXATE, USP
Decomposition temperature(°C/°F):No information available
5 / 12
10. STABILITY AND REACTIVITYChemical stabilityStability: Stable at normal conditions
Possibility of Hazardous Reactions: Hazardous polymerization does not occur
Conditions to avoid: Heat. Avoid dust formation. Dust may form explosive mixture in air. Fine dustdispersed in air in sufficient concentrations, and in the presence of an ignition sourceis a potential dust explosion hazard. Exposure to light.
Incompatible Materials: Oxidizing agents. Acids.
Hazardous decomposition products: Carbon monoxide. Carbon dioxide. Nitrogen oxides (NOx). When heated to decomposition itemits toxic fumes.
Other Information
Corrosivity: No information available
Special Remarks on Corrosivity: No information available
11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Principal Routes of Exposure:Ingestion. Inhalation.
Numerical measures of toxicity Product Information
Acute Toxicity
Component Information
Product Information
LD50/oral/ratVALUE- Acute Tox Oral = 135mg/kg
LD50/oral/mouseValue - Acute Tox Oral = 146mg/kg
LD50/dermal/rabbitVALUE-Acute Tox Dermal = No information available
LD50/dermal/rat
LD50/oral/rat =135 mg/kg Oral LD50 Rat
Other LD50 or LC50information =No information available
LD50/dermal/rabbit =No information available
Methotrexate - 59-05-2
LD50/dermal/rat = No information availableLC50/inhalation/rat = No information available
LD50/oral/mouse 146 mg/kg
Product code: M1435 Product name: METHOTREXATE, USP 6 / 12
LC50/inhalation/mouse = No infomation available
VALUE -Acute Tox Dermal = No information available
LC50/inhalation/ratVALUE-Vapor = No information availableVALUE-Gas = No information availableVALUE-Dust/Mist = No information available
LC50/Inhalation/mouseVALUE-Vapor = No information availableVALUE - Gas = No information availableVALUE - Dust/Mist = No information available
Symptoms
Skin Contact: May cause skin irritation.
Eye Contact: Contact with eyes may cause irritation.
Inhalation: May cause irritation of respiratory tract.
Ingestion Toxic if swallowed. Causes digestive (gastrointestinal) tract irritation. Ingestion maycause nausea, vomiting, diarrhea. May cause abdominal pain. May cause stomatitis.May cause oral ulceration. May cause gastrointestinal bleeding. May cause blurredvision. May cause skin rash, redness or itching. It may affect the bone marrow (bonemarrow depression). It may affect the blood (changes in white and red blood cellcount). It may affect the blood (thrombocytopenia, leukocytopenia, anemia,pancytopenia. May cause easy bruising or bleeding. May affect the liver (fatty liverdegeneration, hepatitis, liver function tests impaired). May affect urinary system(kidneys). It may affect the brain. May affect respiration (difficult or labored breathingresulting in shortness of breath). May affect respiration (fibrosis, pneumoconiosis,respiratory obstruction). May affect behavior/central nervous system (fatigue,weakness). May affect behavior/central nervous system (dizziness, headache). Mayaffect behavior/central nervous system (somnolence, convulsions). May affectbehavior/central nervous system (moodiness, cognitive dysfunction). It may affect theimmune system and cause decreased immune response. May cause decreasedresistance to infection. May affect the cardiovascular system (hypotension).
Aspiration hazard No information available
Delayed and immediate effects as well as chronic effects from short and long-term exposure
Chronic Toxicity Prolonged or repeated ingestion may cause nausea, vomiting, diarrhea. Prolonged orrepeated ingestion may affect the liver, and kidneys. Prolonged or repeated ingestionmay affect the bone marrow. Prolonged or repeated ingestion may affect the blood(changes in red blood cell count). Prolonged or repeated ingestion may affect theblood (changes in white blood cell count). Prolonged or repeated ingestion mayaffect the blood (anemia). Prolonged or repeated ingestion may affect the blood(changes in clotting factors). Prolonged or repeated ingestion may affect the blood(leukopenia, thrombocytopenia). Prolonged or repeated ingestion may affect thebrain. Prolonged or repeated ingeston may affect behavior/central nervous system(headache, somnolence, convulsions/seizures). Prolonged or repeated ingestionmay cause loss of appetite.
Sensitization: No information available
Mutagenic Effects: May affect genetic materialMutations in microorganismsExperiments with bacteria and/or yeast have shown mutagenic effectsMutagenic effects in mammalian somatic cellsExperiments with animal lymphocytes have shown mutagenic effects
Product name: METHOTREXATE, USP 7 / 12Product code: M1435
Carcinogenic effects: Not classifiable as to its carcinogenicity to humans. Equivocal tumorigenic agent byRegistery of Toxic Effects of Chemical Substances (RTECS) criteria.
Components ACGIH -Carcinogens
IARC NTP OSHA HCS -Carcinogens
Australia - ProhibitedCarcinogenicSubstances
Australia - NotifiableCarcinogenicSubstances
Methotrexate Not listed Group 3 -Supplement 7[1987]Monograph 26[1981]
Not listed Not listed Not listed Not listed
ACGIH (American Conference of Governmental Industrial Hygienists)IARC (International Agency for Research on Cancer)Not classifiable as a human carcinogenNTP (National Toxicology Program)OSHA (Occupational Safety and Health Administration of the US Department of Labor)
Reproductive toxicity May damage fertility or the unborn child
Reproductive Effects: Can cause adverse reproductive effects.
Developmental Effects: May cause harm to the unborn child.Teratogenic Effects: Can cause birth defects.
Specific Target Organ Toxicity
STOT - single exposure No information availableSTOT - repeated exposure No information availableTarget Organs: Bone Marrow. Blood. Liver. Kidneys.
12. ECOLOGICAL INFORMATION
Ecotoxicity
Ecotoxicity effects:
Persistence and degradability: No information available
Bioaccumulative potential: No information available
Mobility: No information available
13. DISPOSAL CONSIDERATIONS
Disposal Methods
Waste from residues / unused products:Waste must be disposed of in accordance with Federal, State and Local regulation.
Contaminated packaging:Empty containers should be taken for local recycling, recovery or waste disposal
Components RCRA - F SeriesWastes
RCRA - K SeriesWastes
RCRA - PSeriesWastes
RCRA - U Series Wastes
Methotrexate None None None None
Product name: METHOTREXATE, USP 8 / 12Product code: M1435
14. TRANSPORT INFORMATION
DOTUN-No: UN2811Proper Shipping Name: Toxic solids, organic, n.o.s.Hazard Class: 6.1Subsidiary Risk: Not applicablePacking Group: IIIMarine Pollutant No data availableERG No: 154DOT RQ (lbs): No information available
Symbol(s): G
TDG (Canada)UN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Subsidiary Risk: No information availablePacking Group: IIIDescription: No information available
ADRUN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Packing Group: IIISubsidiary Risk: No information availableClassification Code: No information availableDescription: No information availableCEFIC Tremcard No: No information available
IMO / IMDGUN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Subsidiary Risk: No information availablePacking Group: IIIDescription: No information availableIMDG Page: No information availableMarine Pollutant No information availableEMS: F-AMFAG: No information availableMaximum Quantity: No information available
RIDUN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Subsidiary Risk: 6.1Packing Group: IIIClassification Code: No information availableDescription: No information available
ICAOUN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1
Product name: METHOTREXATE, USP 9 / 12Product code: M1435
14. TRANSPORT INFORMATIONSubsidiary Risk: No information availablePacking Group: IIIDescription: No information available
IATAUN-No: UN2811Proper Shipping Name: Toxic solid, organic, n.o.s.Hazard Class: 6.1Subsidiary Risk: No information availablePacking Group: IIIERG Code: 6LDescription: No information available
15. REGULATORY INFORMATION
International Inventories
Components U.S. TSCA Philippines(PICCS)
KOREA KECL Japan ENCS CHINA Australia(AICS)
EINECS-No.
Methotrexate Present Not present Present KE-09753
Not present Not present Present Present 200-413-8
U.S. Regulations
California Prop. 65: Safe Drinking Water and Toxic Enforcment Act of 1986.
Chemicals Known to the State of California to Cause Cancer:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)
Chemicals Known to the State of California to Cause Reproductive Toxicity:WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm (See table below)
Components Carcinogen Developmental Toxicity Male ReproductiveToxicity
Female ReproductiveToxicity:
Methotrexate Not Listed developmental toxicity Not Listed Not Listed
CERCLA/SARA
Components CERCLA - HazardousSubstances and theirReportable Quantities
Section 302 ExtremelyHazardous
Substances and TPQs
Section 302 ExtremelyHazardous
Substances and RQs
Section 313 -Chemical Category
Section 313 - Reporting de minimis
Methotrexate None None None None None
U.S. TSCA
Components TSCA Section 5(a)2 - Chemicals With SignificantNew Use Rules (SNURS)
TSCA 8(d) -Health and Safety Reporting
Methotrexate Not Applicable Not Applicable
Canada
WHMIS hazard class:D1B Toxic materialsD2A Very toxic materials
Product code: M1435
Methotrexate
Product name: METHOTREXATE, USP 10 / 12
Massachusetts RTK: Present
Canada Controlled Products Regulation:This product has been classified according to the hazard criteria of the CPR (Controlled Products Regulation) and the MSDS containsall of the information required by the CPR.
Inventory
Components Canada (DSL) Canada (NDSL)Methotrexate Not Listed Present
Components CEPA Schedule I - Toxic Substances CEPA - 2010 Greenhouse Gases Subject to ManditoryReporting
Methotrexate Not listed Not listed
EU Classification
R-phrase(s)R25 - Toxic if swallowed.R63 - Possible risk of harm to the unborn child.R68 - Possible risk of irreversible effects.
S -phrase(s)S36 - Wear suitable protective clothing.S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).S53 - Avoid exposure - obtain special instructions before use.
Components Classification Safety PhrasesMethotrexate R25
R63R68
364553
The product is classified in accordance with Annex VI to Directive 67/548/EEC
Indication of danger:T - ToxicXn - Harmful.
16. OTHER INFORMATION
Product code: M1435 Product name: METHOTREXATE, USP 11 / 12
16. OTHER INFORMATION
Revision Date: 3/6/2013Prepared by: Sonia Owen
Disclaimer: All chemicals may pose unknown hazards and should be used with caution. This Material Safety DataSheet (MSDS) applies only to the material as packaged. If this product is combined with other materials,deteriorates, or becomes contaminated, it may pose hazards not mentioned in this MSDS. The physical propertiesreported in this MSDS are obtained from the literature and do not constitute product specifications. Informationcontained herein does not constitute a warranty, whether expressed or implied, as to the safety, merchantability orfitness of the goods for a particular purpose. Spectrum Chemicals & Laboratory Products, Inc. assumes noresponsibility for results obtained or for incidental or consequential damages, including lost profits, arising from theuse of these data. No warranty against infringement of any patent, copyright or trademark is made or implied. Itshall be the user's responsibility to develop proper methods of handling and personal protection based on theactual conditions of use. While this MSDS is based on technical data judged to be reliable, Spectrum assumes noresponsibility for the completeness or accuracy of the information contained herein.
End of Material Safety Data Sheet
Product code: M1435
Preparation Date: 3/6//2013
Product name: METHOTREXATE, USP 12 / 12
See Section 8.
HMIS Personal Protective EquipmentNFPA