Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone number: CHEMTREC (24 hours): 1-800-424-9300 Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom +00 44 (0)1304 616161 Emergency telephone number: ChemSafe (24 hours): +44 (0)208 762 8322 Trade Name: Chemical Family: Intended Use: Cytosar-U Mixture Pharmaceutical product used as Antineoplastic 2. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous Ingredient CAS Number EU EINECS List % 147-94-4 205-705-9 ~100 7647-01-0 231-595-7 * 1310-73-2 215-185-5 * Ingredient CAS Number EU EINECS List % Water for Injection 7732-18-5 231-791-2 * Nitrogen, NF 7727-37-9 231-783-9 * Additional Information: * Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. 3. HAZARDS IDENTIFICATION Appearance: Signal Word: Statement of Hazard: Additional Hazard Information: Short Term: Long Term: Known Clinical Effects: White to off-white crystalline powder WARNING May cause adverse effects on blood forming organs. May cause harm to the unborn child. Possible mutagen May cause eye and skin irritation (based on components). Not acutely toxic (based on animal data). Animal studies have shown a potential to cause adverse effects on the fetus. Bone marrow suppression is the most serious adverse effect seen during clinical use. Adverse effects seen in clinical use include gastrointestinal discomfort, dizziness, and headache.
Page 2 of 7 EU Indication of danger: Toxic to reproduction, Category 2 Mutagenic Category 2 EU Hazard Symbols: EU Risk Phrases: Note: R46 - May cause heritable genetic damage. R61 - May cause harm to the unborn child. This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace. 4. FIRST AID MEASURES Eye Contact: Skin Contact: Ingestion: Inhalation: Immediately flush eyes with water for at least 15 minutes. If irritation occurs or persists, get medical attention. Remove clothing and wash affected skin with soap and water. This material may not be completely removed by conventional laundering. Consult professional laundry service. Do not home launder. If irritation occurs or persists, get medical attention. Obtain medical attention. Do not induce vomiting unless directed by medical personnel. Never give anything by mouth to an unconscious person. Remove to fresh air. If not breathing, give artificial respiration. Get medical attention. 5. FIRE FIGHTING MEASURES Extinguishing Media: Hazardous Combustion Products: Fire Fighting Procedures: Fire / Explosion Hazards: Use carbon dioxide, dry chemical, or water spray. Emits toxic fumes of carbon monoxide, carbon dioxide, and nitrogen oxides. During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus. Fine particles (such as dust and mists) may fuel fires/explosions. 6. ACCIDENTAL RELEASE MEASURES Health and Safety Precautions: Measures for Cleaning / Collecting: Measures for Environmental Protections: Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. Contain the source of spill if it is safe to do so. Collect spilled material by a method that controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of dry solids. Clean spill area thoroughly. Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.
Page 3 of 7 Additional Consideration for Large Spills: Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel. 7. HANDLING AND STORAGE General Handling: Storage Conditions: Storage Temperature: Eliminate possible ignition sources (e.g., heat, sparks, flame, impact, friction, electricity), and follow appropriate grounding and bonding procedures. Avoid contact with eyes, skin and clothing. Avoid breathing dust. Minimize dust generation and accumulation. Use with adequate ventilation. Store in a cool, dry place away from light. Keep out of reach of children. Store at 25 C (77 F) 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Pfizer OEL TWA-8 Hr: 2 ug/m 3 ACGIH Ceiling Threshold Limit: Australia PEAK OSHA - Final PELS - TWAs: ACGIH Ceiling Threshold Limit: Australia PEAK Analytical Method: = 2 ppm Ceiling = 5 ppm Peak = 7.5 mg/m 3 Peak 2 mg/m³ = 2 mg/m 3 Ceiling = 2 mg/m 3 Peak Analytical method available for cytarabine. Contact Pfizer Inc for further information. Engineering Controls: Engineering controls should be used as the primary means to control exposures. Local exhaust ventilation is required unless used in a closed system. Personal Protective Equipment: Hands: Eyes: Skin: Respiratory protection: Rubber gloves Safety glasses or goggles Wear protective clothing with long sleeves to avoid skin contact. Wash hands and arms thoroughly after handling this product. If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL. 9. PHYSICAL AND CHEMICAL PROPERTIES: Physical State: Crystalline powder Color: White to off-white Molecular Formula: Mixture Molecular Weight: Mixture Solubility: Soluble: Water 10. STABILITY AND REACTIVITY Stability: Stable under normal conditions of use.
Page 4 of 7 Conditions to Avoid: Incompatible Materials: Fine particles (such as dust and mists) may fuel fires/explosions. As a precautionary measure, keep away from strong oxidizers. 11. TOXICOLOGICAL INFORMATION General Information: There are no data for this formulation. The information included in this section describes the potential hazards of the individual ingredients. Acute Toxicity: (Species, Route, End Point, Dose) Rat Oral LD 50 > 3000 mg/kg Rat Intravenous LD 50 > 5000 mg/kg Mouse Oral LD 50 3150 mg/kg Mouse Intravenous LD 50 > 7000 mg/kg Mouse IP LD50 40 mg/kg Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable at the highest dose used in the test. Irritation / Sensitization: (Study Type, Species, Severity) Eye Irritation Rabbit Minimal Skin Irritation Rabbit Mild Eye Irritation Rabbit Severe Skin Irritation Rabbit Severe Skin Irritation Severe Eye Irritation Severe Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s)) Embryo / Fetal Development Mouse >= 2 mg/kg/day LOAEL Teratogenic Embryo / Fetal Development Rat 20 mg/kg LOAEL Teratogenic Embryo / Fetal Development Rat 50 mg/kg LOAEL Developmental toxicity Embryo / Fetal Development Mouse 8 mg/kg/day LOAEL Fetotoxicity Genetic Toxicity: (Study Type, Cell Type/Organism, Result) In Vivo Chromosome Aberration Rodent Bone Marrow Positive In Vivo Sister Chromatid Exchange Rodent Bone Marrow Positive In Vivo Micronucleus Mouse Positive In Vitro Chromosome Aberration Human Lymphocytes Positive In Vitro Human Lymphocytes Positive Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s)) 72 Week(s) Rat Oral 25 mg/kg/day NOAEL Not carcinogenic
Page 5 of 7 Carcinogen Status: IARC: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. See below Group 3 12. ECOLOGICAL INFORMATION Environmental Overview: Environmental properties have not been thoroughly investigated. Releases to the environment should be avoided. 13. DISPOSAL CONSIDERATIONS Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations. 14. TRANSPORT INFORMATION Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. 15. REGULATORY INFORMATION EU Symbol: T EU Indication of danger: Toxic to reproduction, Category 2 Mutagenic Category 2 EU Risk Phrases: EU Safety Phrases: R46 - May cause heritable genetic damage. R61 - May cause harm to the unborn child. S22 - Do not breathe dust. S36/37 - Wear suitable protective clothing and gloves. S53 - Avoid exposure - obtain special instructions before use. OSHA Label: WARNING May cause adverse effects on blood forming organs. May cause harm to the unborn child. Possible mutagen Canada - WHMIS: Classifications
Page 6 of 7 WHMIS hazard class: Class D, Division 2, Subdivision A California Proposition 65 Listed:Developmental Toxicity Standard for the Uniform Scheduling Schedule 4 for Drugs and Poisons: EU EINECS List 205-705-9 CERCLA/SARA 313 Emission reporting = 1.0 % de minimis concentration acid aerosols including mists, vapors, gas, fog, and other airborne forms of any particle size CERCLA/SARA Hazardous Substances = 2270 kg final RQ and their Reportable Quantities: = 5000 lb final RQ CERCLA/SARA - Section 302 Extremely Hazardous = 500 lb TPQ gas only TPQs CERCLA/SARA - Section 302 Extremely Hazardous = 5000 lb EPCRA RQ gas only Substances EPCRA RQs T Standard for the Uniform Scheduling Schedule 5 for Drugs and Poisons: Schedule 6 EU EINECS List 231-595-7 Water for Injection EU EINECS List 231-791-2 Nitrogen, NF EU EINECS List 231-783-9 CERCLA/SARA Hazardous Substances and their Reportable Quantities: = 1000 lb final RQ = 454 kg final RQ Standard for the Uniform Scheduling Schedule 5 for Drugs and Poisons: Schedule 6 EU EINECS List 215-185-5 16. OTHER INFORMATION Reasons for Revision: Updated Section 2 - Composition / Information on Ingredients. Updated Section 3 - Hazard Identification. Updated Section 6 - Accidental Release Measures. Updated Section 8 - Exposure Controls / Personal Protection. Updated Section 11 - Toxicology Information. Updated Section 13 - Disposal Considerations.
Page 7 of 7 Prepared by: Toxicology and Hazard Communication Pfizer Global Environment, Health, and Safety Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. End of Safety Data Sheet