MATERIAL SAFETY DATA SHEET

Transcription

1 Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Greenstone Limited 100 Route 206 North Peapack, NJ Emergency telephone number: Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom (0) Emergency telephone number: CHEMTREC (24 hours): Trade Name: Chemical Family: Intended Use: Not applicable Mixture Pharmaceutical product used as antibiotic agent 2. HAZARDS IDENTIFICATION Appearance: Signal Word: Statement of Hazard: 75 mg - Green 150 mg - Light Blue/Green 300 mg - Light Blue WARNING May cause allergic reaction. May cause eye irritation Additional Hazard Information: Short Term: Active ingredient is not a skin irritant. Not acutely toxic (based on animal data). Known Clinical Effects: Adverse effects associated with the therapeutic use include gastrointestinal disturbances such as nausea, dyspepsia, and vomiting and gastrointestinal irritation. Pseudomembranous colitis (manifested by watery diarrhea, urge to defecate, abdominal cramps, low-grade fever, bloody stools, and abdominal pain) may also occur. Individuals sensitive to this material or other materials in its chemical class may develop allergic reactions. EU Indication of danger: Irritant EU Hazard Symbols: EU Risk Phrases: R36 - Irritating to eyes. R43 - May cause sensitization by skin contact.

2 Page 2 of 7 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 % Xi;R Not Listed * EEC No Magnesium stearate Not Listed * Corn Starch Not Listed * Ingredient CAS Number EU EINECS/ELINCS List Classification % Lactose Not Listed * Additional Information: * Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. 4. 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. Formation of toxic gases is possible during heating or fire. May include oxides of carbon nitrogen sulfur and chlorine During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus. Not applicable 6. ACCIDENTAL RELEASE MEASURES

3 Page 3 of 7 Health and Safety Precautions: Measures for Cleaning / Collecting: Measures for Environmental Protections: Additional Consideration for Large Spills: 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. 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: Minimize dust generation and accumulation. If tablets or capsules are crushed and/or broken, avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Store at room temperature in properly labeled containers. Keep away from heat, sparks and flames C (68-77 F) 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Pfizer OEL TWA-8 Hr: 100 μg/m 3 ACGIH Threshold Limit Value (TWA) = 2 mg/m 3 TWA particulate matter containing no asbestos and <1% crystalline silica ACGIH OELs - Notice of Intended Changes Listed Australia TWA = 2.5 mg/m 3 TWA containing no asbestos fibers Belgium OEL - TWA Ireland OEL - TWAs OSHA - Final PELs - Table Z-3 Mineral D: Sweden OEL - TWAs = 2 mg/m 3 TWA = 0.8 mg/m 3 TWA = 20 mppcf TWA = 1 mg/m 3 LLV = 2 mg/m 3 LLV Magnesium stearate ACGIH Threshold Limit Value (TWA) except stearates of toxic metals Australia TWA Belgium OEL - TWA Ireland OEL - TWAs except lead stearate Sweden OEL - TWAs = 5 mg/m 3 LLV Corn Starch ACGIH Threshold Limit Value (TWA) Australia TWA Belgium OEL - TWA Ireland OEL - TWAs = 4 mg/m 3 TWA

4 Page 4 of 7 OSHA - Final PELS - TWAs: = 15 mg/m 3 TWA total = 5 mg/m 3 TWA The exposure limit(s) listed for solid components are only relevant if dust or mist may be generated. Engineering Controls: 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. Personal Protective Equipment: Hands: Eyes: Skin: Respiratory protection: 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: Molecular Formula: Capsule Mixture Color: Molecular Weight: (75 mg) Light blue / green (150 mg) light blue Green (300 mg) Mixture 10. STABILITY AND REACTIVITY Stability: Conditions to Avoid: Incompatible Materials: Stable under normal conditions of use. None known As a precautionary measure, keep away from strong oxidizers. 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) Rat Oral LD mg/kg Rat Intraperitoneal LD mg/kg Rat Subcutaneous LD mg/kg Mouse Oral LD mg/kg Mouse Intravenous LD mg/kg Lactose Rat Oral LD50 > 10 g/kg

5 Page 5 of 7 Rat Oral LD50 > 1600 mg/kg Magnesium stearate Rat Oral LD50 > 2000 mg/kg Rat Inhalation LC50 > 2000 mg/m 3 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 Rat No effect Eye Irritation Rabbit Moderate Skin Irritation Rat No effect Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) 6 Month(s) Rat Oral 600 mg/kg/day NOAEL No effects at maximum dose 6 Month(s) Dog Oral 600 mg/kg/day LOAEL Gastrointestinal system 1 Year(s) Rat Oral 300 mg/kg/day NOAEL No effects at maximum dose 1 Month(s) Dog Oral 300 mg/kg/day NOAEL No effects at maximum dose Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s)) Reproductive & Fertility Rat Oral 300 mg/kg/day NOAEL Fertility Embryo / Fetal Development Mouse Oral 600 mg/kg/day NOAEL Not Teratogenic Embryo / Fetal Development Rat Oral 600 mg/kg/day NOAEL Not Teratogenic Embryo / Fetal Development Rat Subcutaneous 250 mg/kg/day NOAEL Not Teratogenic Genetic Toxicity: (Study Type, Cell Type/Organism, Result) Bacterial Mutagenicity (Ames) Salmonella Negative In Vitro Micronucleus Negative Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. See below IARC: Group ECOLOGICAL INFORMATION Environmental Overview: Environmental properties have not been thoroughly investigated. Releases to the environment should be avoided.

6 Page 6 of 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. 14. TRANSPORT INFORMATION Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. 15. REGULATORY INFORMATION EU Symbol: EU Indication of danger: EU Risk Phrases: EU Safety Phrases: Xi Irritant R36 - Irritating to eyes. R43 - May cause sensitization by skin contact. S22 - Do not breathe dust. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S37 - Wear suitable gloves. OSHA Label: WARNING May cause allergic reaction. May cause eye irritation Canada - WHMIS: Classifications WHMIS hazard class: Class D, Division 2, and Subdivision B. EU EINECS/ELINCS List Lactose

7 Page 7 of 7 EU EINECS/ELINCS List EU EINECS/ELINCS List EEC No Magnesium stearate EU EINECS/ELINCS List Corn Starch XU REACH - Annex IV - Exemptions from the obligations of Register: EU EINECS/ELINCS List OTHER INFORMATION Text of R phrases mentioned in Section 3 R43 - May cause sensitization by skin contact. R36 - Irritating to eyes. 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. If data for a hazard are not included in this document there is no known information at this time. End of Safety Data Sheet