110547 DARAPRIM TABLETS Approved/Revised 21-Jan-2005 Material SDS Number Version 06 DARAPRIM TABLETS Material Synonyms DARAPRIM TABLETS 25MG * DARAPRIM COMPRIMES * DARAPRIM COMPRIMIDOS * DARAPRIM TABLETAS * DARAPRIM TABLETKI * DARAPRIM TABLETTEN * NDC NO 0173-0201-55 * PYRIMETHAMINE, FORMULATED PRODUCT GlaxoSmithKline, Corporate Environment, Health & Safety Company Name 980 Great West Road +44-20-8047-5000 UK General Information: +44-1865-407333 Transport Emergency (EU) +1-612-221-3999, Ext 221 Medical Emergency US number, available 24 hours Information and Advice: Multi-language response Brentford, Middlesex TW8 9GS UK +1-888-825-5249 US General Information: +1-703-527-3887 Transport Emergency (non EU) US number, available 24 hours Multi-language response 2200 Renaissance Blvd, Suite 105 GlaxoSmithKline, Corporate Environment, Health & Safety King of Prussia, PA 19406 US Percentage CAS RN Ingredients 17.5 58-14-0 PYRIMETHAMINE 82.5 Unassigned NON-HAZARDOUS INGREDIENTS Fire and Explosion Expected to be non-combustible. Health Caution - Pharmaceutical agent. Exposure might occur via skin; eyes; ingestion. May produce mutagenic effects in human cells. May produce adverse effects on the development of human offspring. May impair the quantity or quality of human milk production. Health effects information is based on hazards of components. Environment Dangerous for the environment. Harmful to aquatic organisms. May cause long-term adverse effects in the aquatic environment. SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING 2. COMPOSITION / INFORMATION ON INGREDIENTS 3. HAZARDS IDENTIFICATION 4. FIRST-AID MEASURES Page 1 / 6 110547 DARAPRIM TABLETS Approved/Revised 21-Jan-2005 Material SDS Number Version 06 Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention. Inhalation Physical form suggests that risk of inhalation exposure is negligible. Skin Contact Using appropriate personal protective equipment, remove contaminated clothing and flush exposed area with large amounts of water. Obtain medical attention if skin reaction occurs, which may be immediate or delayed. Eye Contact Wash immediately with clean and gently flowing water. Continue for at least 15 minutes. Obtain medical attention. NOTES TO HEALTH PROFESSIONALS Medical Treatment Medical treatment in cases of overexposure should be treated as an overdose of an inhibitor of folic acid metabolism. Treat according to locally accepted protocols. For additional guidance, refer to the current prescribing information or to the local poison control information centre. Medical Conditions Caused or Aggravated by Exposure None for occupational exposure. Health Surveillance Procedures Pre-placement and periodic health surveillance is not usually indicated. The final determination of the need for health surveillance should be determined by local risk assessment. Antidotes No specific antidotes are recommended. Fire and Explosion Hazards Not expected for the product, although the packaging is combustible. Extinguishing Media Water, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers may be ineffective. Special Firefighting Procedures For single units (packages): No special requirements needed. For larger amounts (multiple packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved from fires involving this product and associated packaging, self contained breathing apparatus and full protective equipment are recommended for firefighters. If possible, contain and collect firefighting water for later disposal. Hazardous Combustion Products Toxic, corrosive or flammable thermal decomposition products are expected when the product is exposed to fire. Personal Precautions Wear protective clothing and equipment consistent with the degree of hazard. Environmental Precautions Prevent entry into waterways, sewers, surface drainage systems and poorly ventilated areas. Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or disposal. Decontamination Procedures No specific decontamination or detoxification procedures have been identified for this product. HANDLING General Requirements Avoid breaking or crushing tablets. 5. FIRE-FIGHTING MEASURES 6. ACCIDENTAL RELEASE MEASURES 7. HANDLING AND STORAGE Page 2 / 6 110547 DARAPRIM TABLETS Approved/Revised 21-Jan-2005 Material SDS Number Version 06 STORAGE No storage requirements necessary for occupational hazards. Follow product information storage instructions to maintain efficacy. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION INGREDIENT PYRIMETHAMINE GSK Occupational Hazard Category 4 GSK Occupational Exposure Limit 7 mcg/m3 (8 HR TWA) REPRODUCTIVE HAZARD ENGINEERING CONTROLS Containment Open handling may result in overexposure. Consider use of enclosures. Administrative Entry to the working area should be controlled. Restrict access to authorised personnel. New or expectant mothers might be at greater risk from overexposure. Risk assessments must take this into consideration. Female employees anticipating pregnancy or with a confirmed pregnancy must be encouraged to notify an occupational health professional or their line manager. This will act as the trigger for individual re-assessment of the employee's work practices. Other Equipment or Procedures Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after handling. Appearance Physical Form Tablet. Stability This product is expected to be stable. Conditions to Avoid None for normal handling of this product. 11. TOXICOLOGICAL INFORMATION Oral Toxicity Adverse effects might occur following ingestion. Skin Effects Minor irritation might occur following direct contact. Eye Effects Minor irritation might occur following direct contact with eyes. Target Organ Effects Adverse effects might occur in the following organ(s) following overexposure: kidney; bone marrow and formation of blood cells. Sensitisation Potential for inducing allergic reactions via the dermal or respiratory route is not known. Genetic Toxicity Possible human mutagen. Carcinogenicity No components are listed as carcinogens by GSK, IARC, NTP or US OSHA. Not expected to produce cancer in humans under occupational exposure conditions. Reproductive Effects Contains components which have been classified as: Possible risk of toxicity in developing human offspring. Possible risk of affecting the quantity or the quality of breast milk in humans. Pharmacological Effects This product contains active ingredient(s) with the following activity: an inhibitor of folic acid metabolism. * Other Adverse Effects None known for occupational exposure. 9. PHYSICAL AND CHEMICAL PROPERTIES 10. STABILITY AND REACTIVITY 12. ECOLOGICAL INFORMATION Page 3 / 6 110547 DARAPRIM TABLETS Approved/Revised 21-Jan-2005 Material SDS Number Version 06 * Summary This material contains an active pharmaceutical ingredient that has been tested and which may be harmful if released directly to the environment. This material contains an active pharmaceutical ingredient that may persist in the environment. Consult the MSDS of the active ingredient for specific information about potential environmental effects. Appropriate precautions should be taken to limit release of this material to the environment. Local regulations and procedures should be consulted prior to environmental release. Specific information on the active pharmaceutical ingredient is provided below. ECOTOXICITY Aquatic * Activated Sludge Respiration NOEC: 10 , 3 Hours IC50: > 3200 mg/l, 3 Hours, Activated sludge, Nominal This material contains an active pharmaceutical ingredient that is not toxic to activated sludge microorganisms. * Algal IC50: 20 mg/l, 48 Hours, Chlorella pyrenoidosa, green algae This material contains an active pharmaceutical ingredient that is harmful to algae. * Daphnid EC50: 4.8 mg/l, 48 Hours, Daphnia magna, Static test This material contains an active pharmaceutical ingredient that is toxic to daphids. * Fish Juvenile Oncorhyncus mykiss, rainbow trout EC50: 5.9 mg/l, 48 Hours, Static test This material contains an active pharmaceutical ingredient that is toxic to fish. MOBILITY * Solubility This material contains an active pharmaceutical ingredient that for environmental fate predictions has limited solubility in water. * Volatility This material contains an active pharmaceutical ingredient that will not readily enter into air from water. Henry's Law Constant 1.08E-10 atm m^3/mol, Estimated at 25 C * Partitioning This material contains an active pharmaceutical ingredient with octanol/water partition coefficient data that suggests that for environmental fate predictions the active pharmaceutical ingredient will not have the tendency to distribute into fats. PERSISTENCE/DEGRADATION * Hydrolysis This material contains an active pharmaceutical ingredient that has been shown to be chemically stable in water. Hydrolysis is unlikely to be a significant depletion mechanism. Half-Life, Neutral: 6 Months, Measured, Deionized Water * Biodegradation This material contains an active pharmaceutical ingredient that is not readily biodegradable (as defined by 1993 OECD Testing Guidelines). It may persist in the environment. Aerobic - Inherent Percent Degradation: 2 %, 28 days, Modified MITI (II) Test., Activated sludge 13. DISPOSAL CONSIDERATIONS Page 4 / 6 110547 DARAPRIM TABLETS Approved/Revised 21-Jan-2005 Material SDS Number Version 06 Disposal Recommendations Collect for recycling or recovery if possible. The disposal method for rejected products/returned goods must ensure that they cannot be re-sold or re-used. The recommended method of disposal is incineration. Regulatory Requirements Observe all local and national regulations when disposing of this product. The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous goods for transport. 14. TRANSPORT INFORMATION UN Classification and Labelling Transport Information Transportation and shipping of this product is not restricted. It has no known, significant hazards requiring special packaging or labelling for air, maritime, US or European ground transport purposes. 15. REGULATORY INFORMATION The information included below is an overview of the major regulatory requirements. It should not be considered to be an exhaustive summary. Local regulations should be consulted for additional requirements. * EU Classification and Labelling Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product, cosmetic product or medical device. US OSHA Standard (29 CFR Part 1910.1200) Classification This dosage form is exempt from the requirements of the OSHA Hazard Communication Standard. Other US Regulations TSCA Status Exempt 16. OTHER INFORMATION References GSK Hazard Determination 21-Jan-2005 Date Approved/Revised 6 SDS Version Number SDS Sections Updated Sections Subsections ECOLOGICAL INFORMATION Activated Sludge Respiration Algal Biodegradation Daphnid Fish Hydrolysis Partitioning Solubility Summary Volatility European Union Classification and Labelling Requirements REGULATORY INFORMATION Other Regulations Other US Regulations - California Proposition 65 Other US Regulations - TSCA Status State Regulations Summary Page 5 / 6 110547 DARAPRIM TABLETS Approved/Revised 21-Jan-2005 Material SDS Number Version 06 SDS Sections Updated Sections Subsections US Environmental (EPA) Requirements REGULATORY INFORMATION US OSHA Standard (29 CFR Part 1910.1200) - Classification US OSHA Standard (29 CFR Part 1910.1200) - Target Organ Stat Carcinogenicity TOXICOLOGY INFORMATION Eye Effects Genetic Toxicity Inhalation Toxicity Oral Toxicity Other Adverse Effects Pharmacological Effects Reproductive Effects Sensitisation Skin Toxicity Target Organ Effects The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine the applicability of this information and the suitability of the material or product for any particular purpose. Page 6 / 6