Material Safety Data Sheet
NFPA HMIS PPE Transport Symbol
Issuing Date 26-Jan-2007 Revision Date 12-June-2007 Revision Number 1
* Indicates a chronic health hazard.
1. PRODUCT AND COMPANY IDENTIFICATION
Product Name Methotrexate Injection, USP, 25 mg/mL
Product Code(s) 10139-062-02 ?2 mL Vial
10139-062-10 ?10 mL Vial
10139-062-40 ?40 mL Vial
Recommended Use Antineoplastic, Antimetabolite Agent
Supplier Address GeneraMedix Inc.
150 Allen Road
Liberty Corner, New Jersey 07938, USA
TEL: 908-504-1300
Chemical Emergency Phone Number Chemtrec 1-800-424-9300
2. HAZARDS IDENTIFICATION
WARNING!
Emergency Overview
Harmful by inhalation, in contact with skin and if swallowed.
May cause skin, eye, and respiratory tract irritation.
May cause adverse cardiovascular effects.
May cause central nervous system depression.
May cause adverse liver effects.
May cause adverse kidney effects.
Contains a known or suspected mutagen.
Contains a known or suspected reproductive toxin.
Appearance Yellowish-orange Physical State Liquid Odor Odorless
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Potential Health Effects
Principle Routes of Exposure Inhalation, skin contact.
Acute Toxicity
Eyes May cause irritation.
Skin May cause skin irritation and/or dermatitis.
Inhalation Inhalation of vapors in high concentration may cause irritation of respiratory system. May
cause additional effects as listed under "Ingestion".
Ingestion Harmful if swallowed. Ingestion may cause gastrointestinal irritation, nausea, vomiting and
diarrhea. May cause central nervous system depression. May cause adverse cardiac effects,
blood disturbances, and metabolic acidosis. May cause adverse liver effects. May cause
adverse kidney effects. May cause adverse effects on the bone marrow and blood-forming
system.
Chronic Effects Prolonged or repeated exposure increases the risk. Experiments have shown reproductive
toxicity effects on laboratory animals.
Aggravated Medical Conditions Liver disorders, kidney disorders, central nervous system, cardiovascular, blood disorders, and
respiratory disorders. Overexposure may cause female and male reproductive disorder(s).
Environmental Hazard See Section 12 for additional Ecological information.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Chemical Name CAS-No Weight %
Methotrexate 59-05-2 2.5
Sodium Chloride (NaCl) 7647-14-5 0.49
Water for Injection 7732-18-5 97
Sodium Hydroxide and Hydrochloric Acid for pH adjustment of 8.5.
4. FIRST AID MEASURES
General Advice Call 911 or emergency medical service. Remove and isolate contaminated clothing and shoes.
Eye Contact In case of contact with substance, immediately flush skin or eyes with running water for at least
20 minutes.
Skin Contact For minor skin contact, avoid spreading material on unaffected skin.
Inhalation Move victim to fresh air. Apply artificial respiration if victim is not breathing. Administer oxygen
if breathing is difficult.
Ingestion Call a physician or Poison Control Center immediately. Drink 1 or 2 glasses of water. Never
give anything by mouth to an unconscious person. Do not induce vomiting without medical
advice.
Notes to Physician Keep victim warm and quiet. Effects of exposure (inhalation, ingestion or skin contact) to
substance may be delayed.
Protection of First-aiders Ensure that medical personnel are aware of the material(s) involved, and take precautions to
protect themselves. Do not use mouth-to-mouth method if victim ingested or inhaled the
substance; induce artificial respiration with the aid of a pocket mask equipped with a one-way
valve or other proper respiratory medical device.
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5. FIRE-FIGHTING MEASURES
Flammable Properties Not flammable.
Flash Point N/A .
Suitable Extinguishing Media Dry chemical, CO2 or water spray. Move containers from fire area if you can do it without risk.
Dike fire control water for later disposal; do not scatter the material.
Explosion Data
Sensitivity to mechanical impact No data available.
Sensitivity to static discharge No data available.
Specific Hazards Arising from the Chemical
When heated, vapors may form explosive mixtures with air: indoors, outdoors, and sewers explosion hazards. Those substances
designated with a "P" may polymerize explosively when heated or involved in a fire. Runoff may pollute waterways. Substance may be
transported in a molten form.
Protective Equipment and Precautions for Firefighters
As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective
gear.
NFPA Health Hazard 2 Flammability 0 Stability 0 Physical and Chemical
Hazards N/A
HMIS Health Hazard 2* Flammability 0 Stability 0 Personal Precautions B
* Indicates a chronic health hazard.
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions ELIMINATE all ignition sources (no smoking, flares, sparks or flames in immediate area). Do
not touch damaged containers or spilled material unless wearing appropriate protective
clothing. Stop leak if you can do it without risk.
Methods for Containment Absorb or cover with dry earth, sand or other non-combustible material and transfer to
containers.
Methods for Cleaning Up Soak up with inert absorbent material. Keep in suitable and closed containers for disposal.
7. HANDLING AND STORAGE
Handling Wear personal protective equipment. Handle in accordance with good industrial hygiene and
safety practice. Keep away from open flames, hot surfaces and sources of ignition.
Storage Store locked up. Keep container tightly closed in a dry and well-ventilated place. Protect from
light.
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Guidelines This product does not contain any hazardous materials with occupational exposure limits
established by the region specific regulatory bodies.
Engineering Measures Showers.
Eyewash stations.
Ventilation systems.
Personal Protective Equipment
Eye/face Protection Safety glasses with side-shields.
Skin and body protection Impervious gloves.
Respiratory Protection If exposure limits are exceeded or irritation is experienced, NIOSH/MSHA approved respiratory
protection should be worn. Positive-pressure supplied air respirators may be required for high
airborne contaminant concentrations. Respiratory protection must be provided in accordance
with current local regulations.
Hygiene Measures Handle in accordance with good industrial hygiene and safety practice.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance Odor
Yellowish-orange. Odorless.
Physical State pH
Liquid. 8.5
Flash Point Autoignition Temperature
N/A. N/A
Boiling Point/Range Melting Point/Range
>100癈 / >212癋 >185-204癈 /265-399癋
Flammability Limits in Air Specific Gravity
No data available. 1
Solubility VOC Content
Insoluble in water. N/A.
10. STABILITY AND REACTIVITY
Stability Stable under recommended storage conditions.
Conditions to Avoid Do not freeze. Protect from light.
Incompatible Products Strong oxidizing agents. Strong acids.
Hazardous Decomposition Products Carbon monoxide (CO), carbon dioxide (CO2), nitrogen oxides (NOX).
Hazardous Polymerization Hazardous polymerization does not occur.
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11. TOXICOLOGICAL INFORMATION
Acute Toxicity
Product Information
Chemical Name LD50 Oral LD50 Dermal LC50 Inhalation
Methotrexate 135 mg/kg (rat) N/A N/A
146 mg/kg (mouse)
3
Sodium Chloride (NaCl) 3 g/kg (rat) 10 g/kg (rabbit) 42 g/m (rat) 1 h
N/A
Subchronic Toxicity (28 days)
Chronic Toxicity
Chronic Toxicity Prolonged or repeated exposure increases the risk. Experiments have shown reproductive
toxicity effects on laboratory animals.
Carcinogenicity There are no known carcinogenic chemicals in this product.
Mutagenicity
Mutagenic Effects Animal experiments showed mutagenic and teratogenic effects.
Reproductive Toxicity Crosses the placenta. Excreted in breast milk. May cause adverse reproductive effects,
including testicular and ovarian damage, sperm abnormalities, menstrual disorders,
fetotoxicity, embryotoxicity, and post-implantation mortality.
Teratogenic Effects Possible risk of harm to the unborn child.
Target Organ Effects Liver, kidney, respiratory system, skin, central nervous system (CNS), blood, gastrointestinal
tract (GI), cardiovascular system, bone marrow, and reproductive system.
Endocrine Disruptor Information This product does not contain any known or suspected endocrine disruptors.
12. ECOLOGICAL INFORMATION
Ecotoxicity Contains no substances known to be hazardous to the environment or that are not degradable
in waste water treatment plants.
13. DISPOSAL CONSIDERATIONS
Waste Disposal Method This material, as supplied, is not a hazardous waste according to Federal regulations (40 CFR
261). This material could become a hazardous waste if it is mixed with or otherwise comes in
contact with a hazardous waste, if chemical additions are made to this material, or if the
material is processed or otherwise altered. Consult 40 CFR 261 to determine whether the
altered material is a hazardous waste. Consult the appropriate state, regional, or local
regulations for additional requirements.
Contaminated Packaging Dispose of in accordance with local regulations.
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14. TRANSPORT INFORMATION
DOT Not regulated.
TDG Not regulated.
MEX Not regulated.
ICAO Not regulated.
IATA Not regulated.
IMDG/IMO Not regulated.
RID Not regulated.
ADR Not regulated.
ADN Not regulated.
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15. REGULATORY INFORMATION
International Inventories
TSCA Complies
DSL Does not Comply
EINECS/ELINCS Complies
ENCS Does not Comply
CHINA Does not Comply
KECL Complies
PICCS Does not Comply
AICS Complies
U.S. Federal Regulations
SARA 313
Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any
chemicals which are subject to the reporting requirements of the Act and Title 40 of the Code of Federal Regulations, Part 372.
SARA 311/312 Hazard Categories
Acute Health Hazard Yes
Chronic Health Hazard Yes
Fire Hazard No
Sudden Release of Pressure Hazard No
Reactive Hazard No
Clean Water Act
This product does not contain any substances regulated as pollutants pursuant to the Clean Water Act (40 CFR 122.21 and 40 CFR
122.42).
U.S. State Regulations
California Proposition 65
This product contains the following Proposition 65 chemicals:
Chemical Name CAS-No California Prop. 65
Methotrexate 59-05-2 Developmental
U.S. State Right-to-Know Regulations
Chemical Name Massachusetts New Jersey Pennsylvania Illinois Rhode Island
Methotrexate X X N/A N/A N/A
International Regulations
Mexico - Grade Moderate risk, Grade 2
Canada
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations (CPR) and the
MSDS contains all the information required by the CPR.
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WHMIS Hazard Class
D2B Toxic materials
16. OTHER INFORMATION
Revision Date 23-Feb-2007
Revision Note NO DATA AVAILABLE
Disclaimer
The information provided on this MSDS is correct to the best of our knowledge, information and belief at the date of its
publication. The information given is designed only as a guide for safe handling, use, processing, storage, transportation,
disposal and release and is not to be considered as a warranty or quality specification. The information relates only to the
specific material designated and may not be valid for such material used in combination with any other material or in any
process, unless specified in the text.
End of MSDS
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