MATERIAL SAFETY DATA SHEET

Transcription

1 Page 1 of 8 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Animal Health Pfizer Inc 235 East 42nd Street New York, NY Poison Control Center Phone: Technical Services Phone: Emergency telephone number: CHEMTREC (24 hours): Contact pfizer-msds@pfizer.com Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom (0) Emergency telephone number: ChemSafe (24 hours): +44 (0) Trade Name: Chemical Family: Intended Use: CERENIA Mixture Veterinary product used as Anti-emetic. 2. HAZARDS IDENTIFICATION Appearance: Signal Word: Statement of Hazard: Additional Hazard Information: Short Term: Long Term: Known Clinical Effects: EU Indication of danger: Clear, colorless to pale yellow solution WARNING May cause allergic skin reaction. May cause cardiovascular system effects. May cause eye irritation. Not expected to cause skin irritation (based on components). May cause respiratory tract irritation. Based on findings in animal studies, this compound may cause rare but potentially serious cardiac effects in human clinical use. has been associated with toxic effects in the kidney. Irritant EU Hazard Symbols: EU Risk Phrases: Note: R43 - May cause sensitization by skin contact. R52/53 - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients 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.

2 Page 2 of 8 3. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous Ingredient CAS Number EU EINECS/ELINCS List Classification % Not listed N;R50/ Xn;R48/22 Xi;R41 Sulfobutylether b-cyclodextrin sodium Xi;43 * (SBECD) C;R34 T;R24/25 <0.5% Ingredient CAS Number EU EINECS/ELINCS List Classification % Water for injection Not * Additional Information: * Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. For the full text of the R phrases mentioned in this Section, see Section FIRST AID MEASURES Eye Contact: Skin Contact: Ingestion: Inhalation: Symptoms and Effects of Exposure: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately. Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention. Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately. Remove to fresh air and keep patient at rest. Seek medical attention immediately. For information on potential signs and symptoms of exposure, See Section 2 - Hazards Identification and/or Section 11 - Toxicological Information. 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: Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.

3 Page 3 of 8 Measures for Cleaning / Collecting: Measures for Environmental Protections: Additional Consideration for Large Spills: Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill area thoroughly. Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release. 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: Avoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. When handling, use appropriate personal protective equipment (see Section 8). Keep container tightly closed when not in use. Store as directed by product packaging. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Refer to available public information for specific member state Occupational Exposure Limits. Pfizer OEL TWA-8 Hr: 20µg/m 3 Pfizer OEL TWA-8 Hr: 3000µg/m 3 ACGIH Threshold Limit Value (TWA) 5 ppm TWA ACGIH OELs - Notice of Intended Changes ACGIH - Skin Absorption Designation Australia TWA 22 mg/m 3 5 ppm Austria OEL - MAKs Belgium OEL - TWA Bulgaria OEL - TWA Cyprus OEL - TWA Czech Republic OEL - TWA Denmark OEL - TWA Estonia OEL - TWA Finland OEL - TWA France OEL - TWA Greece OEL - TWA Hungary OEL - TWA Ireland OEL - TWAs Latvia OEL - TWA Lithuania OEL - TWA Luxembourg OEL - TWA Malta OEL - TWA OSHA - Final PELS - TWAs: 22 mg/m 3 5 ppm OSHA - Final PELs - Skin Notations: Poland OEL - TWA Portugal OEL - TWA

4 Page 4 of 8 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Romania OEL - TWA Slovenia OEL - TWA Spain OEL - TWA Sweden OEL - TWAs The exposure limit(s) listed for solid components are only relevant if dust or mist may be generated. Engineering Controls: Environmental Exposure Controls: Personal Protective Equipment: Hands: Eyes: Skin: Respiratory protection: Engineering controls should be used as the primary means to control exposures. General room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne contamination levels below the exposure limits listed above in this section. Refer to specific Member State legislation for requirements under Community environmental legislation. Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE). Impervious gloves are recommended if skin contact with drug product is possible and for bulk processing operations. Wear safety glasses or goggles if eye contact is possible. Impervious protective clothing is recommended if skin contact with drug product is possible and for bulk processing operations. 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: Aqueous solution Color: Clear, colorless to pale yellow Molecular Formula: Mixture Molecular Weight: Mixture Polymerization: Will not occur 10. STABILITY AND REACTIVITY Stability: Stable at ambient temperatures Conditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions. Incompatible Materials: As a precautionary measure, keep away from strong oxidizers Hazardous Decomposition Products: None known 11. TOXICOLOGICAL INFORMATION General Information: The information included in this section describes the potential hazards of CJ-11,972 in free base, citrate and/or methanesulfonate salt forms. The remaining information describes the potential hazards of the individual ingredients. Acute Toxicity: (Species, Route, End Point, Dose) Rat Oral LD mg/kg Rabbit Dermal LD mg/kg

5 Page 5 of TOXICOLOGICAL INFORMATION Rat Dermal LDmin. > 2000 mg/kg Rat Oral LD50 > 2000 mg/kg Rat/Mouse IV LD50 > 2000 mg/kg CJ-11, (methanesulfonate salt) Rat Oral LDmin 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) Skin Irritation Rabbit Severe Eye Irritation Rabbit Severe Eye Irritation Rabbit Severe Skin Irritation Rabbit Non-irritating Skin Sensitization - GPMT Guinea Pig Negative Eye Irritation Rabbit Non-irritating Skin Irritation Rabbit Non-irritating Skin Sensitization - GPMT Guinea Pig Positive Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) 6 Month(s) Rat Intravenous 600 mg/kg/day NOAEL Kidney, Liver 1 Month(s) Rat Intravenous 160 mg/kg/day NOAEL Kidney 6 Month(s) Dog Intravenous 600 mg/kg/day NOAEL Kidney 1 Month(s) Dog Intravenous 120 mg/kg/day NOAEL Kidney CJ-11, (methanesulfonate salt) 3 Month(s) Rat Oral 5 mg/kg/day NOAEL Liver 3 Month(s) Dog Oral 5 mg/kg/day NOAEL Cardiovascular system Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s)) Embryo / Fetal Development Rat 150 mg/kg/day NOEL Not teratogenic Fertility and Embryonic Development Rat Intravenous 1500 mg/kg/day NOAEL No effects at maximum dose Embryo / Fetal Development Rabbit Intravenous 1500 mg/kg/day NOAEL Not Teratogenic Prenatal & Postnatal Development Rat Intravenous 600 mg/kg/day NOAEL Maternal Toxicity Genetic Toxicity: (Study Type, Cell Type/Organism, Result)

6 Page 6 of TOXICOLOGICAL INFORMATION Bacterial Mutagenicity (Ames) Salmonella, E. coli Negative In Vitro Chromosome Aberration Human Lymphocytes Negative Mammalian Cell Mutagenicity Chinese Hamster Ovary (CHO) cells HGPRT Negative In Vivo Micronucleus Mouse Bone Marrow Negative CJ-11, (methanesulfonate salt) Bacterial Mutagenicity (Ames) Salmonella Negative In Vitro Human Lymphocytes Negative In Vivo Micronucleus Mouse Bone Marrow Negative In Vitro Mammalian Cell Mutagenicity Chinese Hamster Ovary (CHO) cells Negative Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. 12. ECOLOGICAL INFORMATION Environmental Overview: This formulation has not been tested as a whole, the following apply to component substance(s): Harmful effects to aquatic organisms could occur. Releases to the environment should be avoided. Bioaccumulation and Toxicity: Acute toxicity to aquatic organisms could occur. This material has potential to bioaccumulate and long-term adverse effects to aquatic organisms are possible. See aquatic toxicity data, below. Aquatic Toxicity: (Species, Method, End Point, Duration, Result) Mysid Shrimp NPDES LC50 48 Hours 0.68 mg/l Sheepshead Minnow NPDES LC50 48 Hours 0.68 mg/l Red Algae NPDES IC50 7 Days 0.23 mg/l Daphnia magna (Water Flea) EC Hours 0.60 mg/l Rainbow Trout OECD LC50 96 Hours > 220 mg/l Daphnia magna OECD EC Hours > 96 mg/l Green algae OECD IC50 72 Hours > 100 mg/l Aquatic Toxicity Comments: The above aquatic toxicity studies were conducted with CJ-11,972 (free base). The effects of the two materials are predicted to be similar. A greater than symbol (>) indicates that aquatic toxicity was not observed at the maximum dose tested. 13. DISPOSAL CONSIDERATIONS Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations. This product contains trace quantities of m-cresol and may qualify as a RCRA Hazardous Waste. Status should be confirmed using the EPA Toxicity Characteristic Leaching Procedure (TCLP). RCRA - U Series Wastes 14. TRANSPORT INFORMATION Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.

7 Page 7 of TRANSPORT INFORMATION 15. REGULATORY INFORMATION EU Symbol: EU Indication of danger: EU Risk Phrases: EU Safety Phrases: Xi Irritant R43 - May cause sensitization by skin contact. R52/53 - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. S24/25 - Avoid contact with eyes and skin. S57 - Use appropriate containment to avoid environmental contamination. OSHA Label: WARNING May cause allergic skin reaction. May cause cardiovascular system effects. Canada - WHMIS: Classifications WHMIS hazard class: Class D, Division 2, Subdivision B Inventory - United States TSCA - Sect. 8(b) Australia (AICS): EU EINECS/ELINCS List CERCLA/SARA 313 Emission reporting 1.0% de minimis concentration CERCLA/SARA Hazardous Substances 100 lb final RQ and their Reportable Quantities: 45.4 kg final RQ Inventory - United States TSCA - Sect. 8(b) Australia (AICS): Standard for the Uniform Scheduling Schedule 6 for Drugs and Poisons: EU EINECS/ELINCS List Water for injection Inventory - United States TSCA - Sect. 8(b) Australia (AICS):

8 Page 8 of REGULATORY INFORMATION REACH - Annex IV - Exemptions from the Present obligations of Register: EU EINECS/ELINCS List OTHER INFORMATION Text of R phrases mentioned in Section 3 R34 - Causes burns. R41 - Risk of serious damage to eyes. R43 - May cause sensitization by skin contact. R24/25 - Toxic in contact with skin and if swallowed. R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed. R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Data Sources: Reasons for Revision: Prepared by: Pfizer proprietary drug development information. Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information on Ingredients. Updated Section 4 - First Aid Measures. Toxicology and Hazard Communication Pfizer Global Environment, Health, and Safety Operations Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known information at this time. End of Safety Data Sheet