MATERIAL SAFETY DATA SHEET

Transcription

1 Page 1 of 7 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, Kent CT13 9NJ United Kingdom (0) Emergency telephone number: ChemSafe (24 hours): +44 (0) Material Name: Insert, Animal Health Trade Name: Synonyms: Chemical Family: Intended Use: Eazi-breed (TM) CIDR (R) Cattle Insert; Eazi-breed (TM) CIDR (R) - Sheep and Goat CIDR Cattle Insert; CIDR Sheep and Goat Insert Mixture Veterinary product used for estrus synchronization 2. HAZARDS IDENTIFICATION Appearance: Signal Word: Solid DANGER Statement of Hazard: Additional Hazard Information: Long Term: Known Clinical Effects: May cause cancer. May damage fertility or the unborn child. EU Indication of danger: Carcinogenic: Category 2 Toxic to Reproduction: Category 2 EU Hazard Symbols: Repeat-dose studies in animals have shown a potential to cause adverse effects on the developing fetus. Adverse effects most commonly reported in clinical use include menstrual irregularities, weight changes, fluid retention, drowsiness, sleepiness, dizziness, sedation, and gastrointestinal disturbance. EU Risk Phrases: Australian Hazard Classification (NOHSC): R45 - May cause cancer. R60 - May impair fertility. Hazardous Substance. Non-Dangerous Goods.

2 Material Name: Insert, Animal Health Page 2 of 7 2. HAZARDS IDENTIFICATION Note: 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. 3. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous Ingredient CAS Number EU EINECS/ELINCS List Classification % Repr.Cat.2;R60 Carc.Cat.2;R45 5 Ingredient CAS Number EU EINECS/ELINCS List Classification % Silicone rubber Not listed Not Listed % Polyester rubber Not listed Not Listed % Nylon Not listed Not Listed % 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: 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. 5. FIRE FIGHTING MEASURES Extinguishing Media: Hazardous Combustion Products: Fire Fighting Procedures: Fire / Explosion Hazards: Use carbon dioxide, dry chemical, or water spray. Not available During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus. Not applicable 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 Material Name: Insert, Animal Health Page 3 of 7 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 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. 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: Minimize dust generation and accumulation. Avoid inhalation and contact with skin, eye, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash thoroughly after handling. Releases to the environment should be avoided. Store as directed by product packaging. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Pfizer OEL TWA-8 Hr: 30 µg/m 3 The exposure limit(s) listed for solid components are only relevant if dust or mist may be generated. Analytical Method: Engineering Controls: Personal Protective Equipment: Hands: Eyes: Skin: Respiratory protection: Analytical method available for. Contact Pfizer Inc for further information. 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 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: Solid Color: No data available. Molecular Formula: Mixture Molecular Weight: Mixture 10. STABILITY AND REACTIVITY Stability: Conditions to Avoid: Incompatible Materials: Stable under normal conditions of use. None known None known

4 Material Name: Insert, Animal Health Page 4 of TOXICOLOGICAL INFORMATION General Information: The information included in this section describes the potential hazards of the active ingredient(s). Acute Toxicity: (Species, Route, End Point, Dose) Rat Oral LD 50 >5000 mg/kg Rat Intraperitoneal LD 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. Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) 2 Year(s) Rabbit Intramuscular 13 mg/kg LOEL Female reproductive system 74 Week(s) Dog Subcutaneous mg/day (increased dose) LOEL Female reproductive system Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Reproductive & Fertility Rabbit No route specified Dose not specified Embryotoxicity Embryo / Fetal Development Rat No route specified Dose not specified Not Teratogenic Embryo / Fetal Development Monkey No route specified Dose not specified Not Teratogenic Genetic Toxicity: (Study Type, Cell Type/Organism, Result) Bacterial Mutagenicity (Ames) Negative In Vivo Dominant Lethal Assay Mouse Negative In Vivo Chromosome Aberration Rat Negative In Vitro Chromosome Aberration Human Negative In Vitro Cell Transformation Assay Rat Positive Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s)) 2 Year(s) Rabbit Intramuscular 13 mg/kg NOEL Not carcinogenic 18 Month(s) Mouse Subcutaneous mg/day LOEL Malignant tumors, Female reproductive system, Mammary gland 40 Week(s) Rat Subcutaneous 200 mg/kg/day LOEL Malignant tumors, Liver 19 Week(s) Female Mouse Subcutaneous 25 mg/kg (5 days/week) LOEL Tumors, Mammary gland Carcinogen Status: IARC: NTP: OSHA: See below Group 2B (Possibly Carcinogenic to Humans) Reasonably Anticipated To Be A Carcinogen Present

5 Material Name: Insert, Animal Health Page 5 of ECOLOGICAL INFORMATION Environmental Overview: Environmental properties have not been investigated. Releases to the environment should be avoided. 13. DISPOSAL CONSIDERATIONS Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater. 14. TRANSPORT INFORMATION Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.

6 Material Name: Insert, Animal Health Page 6 of REGULATORY INFORMATION EU Symbol: T EU Indication of danger: Carcinogenic: Category 2 Toxic to Reproduction: Category 2 EU Risk Phrases: EU Safety Phrases: R45 - May cause cancer. R60 - May impair fertility. S36/37 - Wear suitable protective clothing and gloves. S53 - Avoid exposure - obtain special instructions before use. OSHA Label: DANGER May cause cancer. May damage fertility or the unborn child. Canada - WHMIS: Classifications WHMIS hazard class: Class D, Division 2, Subdivision A Silicone rubber Australia (AICS): Listed California Proposition 65 carcinogen, initial date 1/1/88 Inventory - United States TSCA - Sect. 8(b) Australia (AICS): Present Present Standard for the Uniform Scheduling Schedule 4 for Drugs and Poisons: Schedule 5 EU EINECS/ELINCS List Nylon 66 Inventory - United States TSCA - Sect. 8(b) Australia (AICS): Listed Listed 16. OTHER INFORMATION Text of R phrases mentioned in Section 3

7 Material Name: Insert, Animal Health Page 7 of 7 R45 - May cause cancer. R60 - May impair fertility. Data Sources: Reasons for Revision: Pfizer proprietary drug development information. Publicly available toxicity information. Safety data sheets for individual ingredients. Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information on Ingredients. Updated Section 7 - Handling and Storage. Updated Section 13 - Disposal Considerations. Updated Section 15 - Regulatory Information. 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