MATERIAL SAFETY DATA SHEET

Transcription

1 Page 1 of 6 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: DOMOSEDAN; DORMOSEDAN Mixture Veterinary product used as analgesic, sedative 2. HAZARDS IDENTIFICATION Appearance: Statement of Hazard: Additional Hazard Information: Short Term: Known Clinical Effects: EU Indication of danger: Blue Gel Non-hazardous in accordance with international standards for workplace safety. May be toxic if swallowed. May be absorbed through mucous membranes and cause systemic effects. May cause eye irritation. May cause skin irritation. May cause allergic skin reaction. (based on components). This material is an alpha-2 adrenergic receptor agonist intended for animal use only. Symptoms reported after accidental human exposure have included drowsiness, decrease in blood pressure (hypotension), increase in blood pressure (hypertension), decreased heart rate (bradycardia), tingling sensation, numbness, pain, headache, sleepiness (somnolence), dilated pupils, and vomiting. Not classified Australian Hazard Classification (NOHSC): Note: Non-Hazardous Substance. Non-Dangerous Goods. 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.

2 Page 2 of 6 3. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous Ingredient CAS Number EU EINECS/ELINCS List Classification % Detomidine Hydrochloride Not listed T;R23/25 < Not * Ingredient CAS Number EU EINECS/ELINCS List Classification % Hydroxypropyl cellulose Not listed Not * Not * FD & C Blue No Not * Water 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. Formation of toxic gases is possible during heating or fire. During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus. Not determined 6. ACCIDENTAL RELEASE MEASURES Health and Safety Precautions: Measures for Cleaning / Collecting: Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. Absorb spills with non-combustible absorbent material and transfer into a labeled container for disposal.

3 Page 3 of 6 Measures for Environmental Protections: Additional Consideration for Large Spills: 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: Avoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. Use only in wellventilated areas. When handling, use appropriate personal protective equipment (see Section 8). Wash hands and any exposed skin after removal of PPE. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent controls. Releases to the environment should be avoided. Store as directed by product packaging. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Refer to available public information for specific member state Occupational Exposure Limits. Australia TWA 10 mg/m ppm 474 mg/m 3 Ireland OEL - TWAs Latvia OEL - TWA Lithuania OEL - TWA Pfizer OEL TWA-8 Hr: Engineering Controls: Environmental Exposure Controls: Personal Protective Equipment: Hands: Eyes: Skin: Respiratory protection: 0.3 mg/m³ 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: Gel Color: Blue Molecular Formula: Mixture Molecular Weight: Mixture

4 Page 4 of 6 9. PHYSICAL AND CHEMICAL PROPERTIES Polymerization: Not expected to occur 10. STABILITY AND REACTIVITY Stability: Stable under normal conditions of use. Conditions to Avoid: None for the normal use of this material Incompatible Materials: None known Hazardous Decomposition Products: None expected under normal conditions. 11. TOXICOLOGICAL INFORMATION General Information: The information included in this section describes the potential hazards of the individual ingredients. Acute Toxicity: (Species, Route, End Point, Dose) Detomidine Hydrochloride Rat Oral LD50 60 mg/kg Mouse IV LD50 35 mg/kg Mouse Oral LD50 22,000 mg/kg Rat Oral LD50 20,000 mg/kg Rabbit Dermal LD50 20,800 mg/kg Rat Oral LD mg/kg Irritation / Sensitization: (Study Type, Species, Severity) Skin Irritation Rabbit Mild Eye Irritation Rabbit Mild Eye Irritation Rabbit Severe Skin Irritation Rabbit Severe Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) Detomidine Hydrochloride 3.5 Week(s) Rat Oral 1 mg/kg/day LOAEL Adrenal gland Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. FD & C Blue No. 1 IARC: Group 3

5 Page 5 of ECOLOGICAL INFORMATION Environmental Overview: The environmental characteristics of this mixture have not been fully evaluated. 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. 15. REGULATORY INFORMATION EU Indication of danger: Not classified OSHA Label: Non-hazardous in accordance with international standards for workplace safety. Canada - WHMIS: Classifications WHMIS hazard class: None required This product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the information required by the CPR. Hydroxypropyl cellulose

6 Page 6 of REGULATORY INFORMATION EU EINECS/ELINCS List EU EINECS/ELINCS List FD & C Blue No. 1 EU EINECS/ELINCS List Water REACH - Annex IV - Exemptions from the Present obligations of Register: EU EINECS/ELINCS List OTHER INFORMATION Text of R phrases mentioned in Section 3 R23/25 - Toxic by inhalation and if swallowed. Data Sources: Reasons for Revision: Prepared by: Publicly available toxicity information. Safety data sheets for individual ingredients. Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking. 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