MATERIAL SAFETY DATA SHEET

Transcription

1 Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Greenstone LLC 100 Route 206 North Peapack, NJ Emergency telephone number: CHEMTREC (24 hours): Material Name: Chewable Dispersible Tablets Trade Name: Synonyms: Chemical Family: Intended Use: Not applicable None Triazine Pharmaceutical product for the treatment of, seizures and epilepsy 2. HAZARDS IDENTIFICATION Appearance: Signal Word: Statement of Hazard: White Tablets WARNING Suspected of damaging the unborn child. Known Clinical Effects: Adverse effects associated with therapeutic use include skin rash, severe allergic reaction, drowsiness, dizziness, headache, tremors, impaired balance, central nervous system disorder. Drugs of this class may cause effects on developing fetus. Clinical use may cause Stevens Johnson Syndrome (epidermal necrosis and exfoliative dermatitis). EU Indication of danger: Toxic to Reproduction: Category 3 EU Hazard Symbols: EU Risk Phrases: Australian Hazard Classification (NOHSC): Note: R63 - Possible risk of harm to the unborn child. 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. 3. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous Ingredient CAS Number EU EINECS/ELINCS List EU Classification % Xn;R22 Rep.Cat.3;R

2 Material Name: Chewable Dispersible Tablets Page 2 of 7 3. COMPOSITION/INFORMATION ON INGREDIENTS Not Listed * Ingredient CAS Number EU EINECS/ELINCS List EU Classification % Magnesium carbonate Not Listed Not Listed * Sucralose Not Listed * Flavor NOT ASSIGNED Not Listed Not Listed * Polacrilin potassium None known Not Listed Not Listed * Povidone 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: 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. 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.

3 Material Name: Chewable Dispersible Tablets 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: 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). Wash hands and any exposed skin after removal of PPE. Releases to the environment should be avoided. 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. Refer to Section 12 - Ecological Information, for information on potential effects on the environment. Store as directed by product packaging. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Refer to available public information for specific member state Occupational Exposure Limits. ACGIH Threshold Limit Value (TWA) 10 mg/m 3 Australia TWA 10 mg/m 3 Belgium OEL - TWA 10 mg/m 3 Estonia OEL - TWA 10 mg/m 3 France OEL - TWA 10 mg/m 3 Ireland OEL - TWAs 10 mg/m 3 4 mg/m 3 Latvia OEL - TWA 2 mg/m 3 OSHA - Final PELS - TWAs: 15 mg/m 3 Portugal OEL - TWA 10 mg/m 3 Romania OEL - TWA 10 mg/m 3 Spain OEL - TWA 10 mg/m 3 Manufacturer OEB: OEB3 (control exposure to the range of >10ug/m 3 to < 100ug/m 3 ) Engineering 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 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.

4 Material Name: Chewable Dispersible Tablets Page 4 of 7 9. PHYSICAL AND CHEMICAL PROPERTIES Physical State: Molecular Formula: Capsule-shaped Tablets Mixture Color: Molecular Weight: White Mixture (Calculated - Log Pow/Log Kow): (Calculated; ph Log D): () () 10. STABILITY AND REACTIVITY Chemical Stability: Conditions to Avoid: Incompatible Materials: Stable under normal conditions of use. 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: The information included in this section describes the potential hazards of the individual ingredients. Acute Toxicity: (Species, Route, End Point, Dose) Povidone Rat Oral LD g/kg Rat Oral LD50 > 5000 mg/kg Rabbit Dermal LD50 > 2000 mg/kg Rat Oral LD mg/kg Mouse Oral 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. Irritation / Sensitization: (Study Type, Species, Severity) Skin Irritation Rabbit Non-irritating Eye Irritation Rabbit Non-irritating Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Reproductive & Fertility Rat Oral Dose not specified Negative Embryo / Fetal Development Rat Oral 250 mg/kg/day LOAEL Not Teratogenic, Maternal Toxicity, Fetotoxicity Embryo / Fetal Development Mouse Oral 600 mg/kg/day LOAEL Not Teratogenic, Fetotoxicity, Maternal Toxicity Embryo / Fetal Development Mouse Intraperitoneal 75 mg/kg LOAEL Maternal Toxicity, Embryotoxicity Reproductive & Development ToxicityThe use of this drug during pregnancy has resulted in birth defects. Comments:

5 Material Name: Chewable Dispersible Tablets Page 5 of TOXICOLOGICAL INFORMATION Genetic Toxicity: (Study Type, Cell Type/Organism, Result) In Vitro Bacterial Mutagenicity (Ames) Salmonella Negative In Vitro Mammalian Cell Mutagenicity Mouse Lymphoma Negative In Vitro Cytogenetics Human Lymphocytes Negative In Vivo Chromosome Aberration Bone Marrow Negative Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s)) 2 Year(s) Rat Oral 15 mg/kg/day NOAEL Not carcinogenic 2 Year(s) Mouse Oral 30 mg/kg/day NOAEL Not carcinogenic Carcinogen Status: Povidone IARC: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. Group 3 (Not Classifiable) 12. ECOLOGICAL INFORMATION Environmental Overview: The active ingredient in this formulation may be harmful to aquatic organisms. Releases to the environment should be avoided. Mobility, Persistence and Degradability: Not readily biodegradable (0% in 28 days) ; Hydrolysis (half life >365 ph 7) () () (Calculated - Log Pow/Log Kow): () (Calculated; ph Log D): Aquatic Toxicity: (Species, Method, End Point, Duration, Result) Daphnia magna (Water Flea) EC50 48 Hours 56 mg/l Oncorhynchus mykiss (Rainbow Trout) EC50 96 Hours 85 mg/l Selenastrum capricornutum (Green Alga) IC50 72 Hours 39.7 mg/l Activated sludge IC50 3 Hours > 1000 mg/l Ceriodaphnia dubia (Daphnids) NOEC 7 Days 10 mg/l Bacterial Inhibition: (Inoculum, Method, End Point, Result) Nostoc sp. (Freshwater Cyanobacteria) MIC > 185 mg/l

6 Material Name: Chewable Dispersible Tablets Page 6 of DISPOSAL CONSIDERATIONS Waste Treatment Methods: 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 The following refers to all modes of transportation unless specified below. Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. 15. REGULATORY INFORMATION EU Symbol: Xn EU Indication of danger: Toxic to Reproduction: Category 3 EU Risk Phrases: EU Safety Phrases: R63 - Possible risk of harm to the unborn child. S53 - Avoid exposure - obtain special instructions before use. OSHA Label: WARNING Suspected of damaging the unborn child. Canada - WHMIS: Classifications WHMIS hazard class: D2a very toxic materials Standard for the Uniform Scheduling Schedule 4 for Drugs and Poisons: EU EINECS/ELINCS List Magnesium carbonate

7 Material Name: Chewable Dispersible Tablets Page 7 of REGULATORY INFORMATION Sucralose EU EINECS/ELINCS List Inventory - United States TSCA - Sect. 8(b) EU EINECS/ELINCS List Povidone Inventory - United States TSCA - Sect. 8(b) 16. OTHER INFORMATION Text of R phrases mentioned in Section 3 R22 - Harmful if swallowed. R63 - Possible risk of harm to the unborn child. R52/53 - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Data Sources: Reasons for Revision: Prepared by: The data contained in this MSDS may have been gathered from confidential internal sources, raw material suppliers, or from the published literature. Updated Section 2 - Hazard Identification. Product Stewardship Hazard Communication Global Environment, Health, and Safety Operations It is believed that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without a 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