110566 LEUKERAN TABLETS Approved/Revised 13-Jul-2004 Material SDS Number Version 10 LEUKERAN TABLETS Material Synonyms LEUKERAN TABLETS 2 MG * GR64465X * NDC NO 0173-0635-35 * CHLORAMBUCIL, 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 2.1 305-03-3 CHLORAMBUCIL 97.9 Unassigned NON-HAZARDOUS INGREDIENTS Fire and Explosion Expected to be non-combustible. * Health Caution - Potent pharmaceutical agent. Exposure might occur via ingestion; skin; eyes. May cause cancer. May produce adverse effects on human fertility. May produce adverse effects on the development of human offspring. Possible effects of overexposure in the workplace include: symptoms of hypersensitivity (such as skin rash, hives, itching, and difficulty breathing). Health effects information is based on hazards of components. Environment No information is available about the potential of this product to produce adverse environmental effects. 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 110566 LEUKERAN TABLETS Approved/Revised 13-Jul-2004 Material SDS Number Version 10 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 a cytotoxic agent. 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 The need for pre-placement and periodic health surveillance must be determined by risk assessment. Following assessment, if the risk of exposure is considered significant then exposed individuals should undergo appropriate health surveillance that may include symptom enquiry, clinical examination and monitoring of lead organ effects (e.g. full blood counts). In the event of overexposure, individuals should receive post exposure health surveillance focused on the most likely health effects (e.g. full blood counts). 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. For all spills, isolate the spill area, restrict access, post the area for a carcinogen and immediately implement emergency procedures for cleanup and control of occupational carcinogens. Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage systems. Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or disposal. 5. FIRE-FIGHTING MEASURES 6. ACCIDENTAL RELEASE MEASURES Page 2 / 6 110566 LEUKERAN TABLETS Approved/Revised 13-Jul-2004 Material SDS Number Version 10 Decontamination Procedures No specific decontamination or detoxification procedures have been identified for this product. HANDLING General Requirements Avoid breaking or crushing tablets. STORAGE No storage requirements necessary for occupational hazards. Follow product information storage instructions to maintain efficacy. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION INGREDIENT CHLORAMBUCIL GSK Occupational Hazard Category 4 GSK Occupational Exposure Limit 0.5 mcg/m3 (8 HR TWA) CARCINOGEN, REPRODUCTIVE HAZARD, SKIN SENSITISER, HIGHLY POTENT ENGINEERING CONTROLS * Containment Open handling may result in overexposure. Consider use of enclosures. * Administrative Entry to the working area should be controlled. New or expectant mothers are at greater risk if exposed to the active ingredient which is readily absorbed through the skin. They should not handle unpackaged product. 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. When isolation is not possible in production areas, appropriate personal protective equipment must be used. Consider additional control procedures for maintenance, cleaning and emergencies. Appearance Colour Physical Form Brown. 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. * Inhalation Toxicity No studies have been conducted. * Skin Effects No studies have been conducted. Eye Effects No studies have been conducted. * Target Organ Effects Adverse effects might occur in the following organ(s) following overexposure: bone marrow and formation of blood cells; gastro-intestinal tract; liver. 7. HANDLING AND STORAGE 9. PHYSICAL AND CHEMICAL PROPERTIES 10. STABILITY AND REACTIVITY Page 3 / 6 110566 LEUKERAN TABLETS Approved/Revised 13-Jul-2004 Material SDS Number Version 10 * Sensitisation Allergic skin reactions might occur following dermal exposure. Assessment based upon effects of structurally similar substances. * Genetic Toxicity Known or probable human mutagen. * Carcinogenicity Contains a material classified as a carcinogen by external agencies. Classification by external agencies: Human carcinogen; (IARC); (NTP). * Reproductive Effects Contains components which have been classified as: Known or presumed to impair fertility in humans. Known or presumed to cause toxicity in developing human offspring. * Pharmacological Effects This product contains active ingredient(s) with the following activity: a cytotoxic agent. * Other Adverse Effects None known for occupational exposure. Summary This material contains an active pharmaceutical ingredient that has been tested and which may be harmful if released directly to the environment. It should not be released into the environment without dilution, detoxification or other applicable pre-treatment. Local regulations and procedures should be consulted prior to environmental release. ECOTOXICITY Aquatic Activated Sludge Respiration This material contains an active pharmaceutical ingredient that is not toxic to activated sludge microorganisms. Daphnid This mixture contains an active pharmaceutical ingredient that is harmful to daphnids. MOBILITY Solubility This mixture 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 the air from hard surfaces or from a container of the pure substance. This material contains an active pharmaceutical ingredient that will not readily enter into air from water. Adsorption This material contains an active pharmaceutical ingredient that is not likely to adsorb to, or persist in, soil or sediment if released directly to the environment. Partitioning This mixture 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 unstable in water. Hydrolysis may be a significant depletion mechanism. Photolysis This material contains an active pharmaceutical ingredient that has been shown to be chemically unstable in the atmosphere. Atmospheric photolysis may be a significant depletion mechanism. 12. ECOLOGICAL INFORMATION 13. DISPOSAL CONSIDERATIONS Page 4 / 6 110566 LEUKERAN TABLETS Approved/Revised 13-Jul-2004 Material SDS Number Version 10 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. Wherever possible, disposal should be in an on-site licenced chemical incinerator, if allowed by the incinerator licence or permit. If no on-site incinerator is available, dispose of material in a licenced commercial chemical incinerator. 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 product is classified as hazardous according to the OSHA Hazard Communication Standard. * Target Organ Statement May cause adverse effects on bone marrow; gastrointestinal tract; liver. Other US Regulations TSCA Status Exempt 16. OTHER INFORMATION References GSK Hazard Determination 13-Jul-2004 Date Approved/Revised 10 SDS Version Number SDS Sections Updated Sections Subsections COMPOSITION / INFORMATION ON INGREDIENTS Administrative EXPOSURE CONTROLS / PERSONAL PROTECTION Containment Medical Conditions Caused or Aggravated by Exposure FIRST-AID MEASURES Medical Treatment Health HAZARDS IDENTIFICATION 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 Page 5 / 6 110566 LEUKERAN TABLETS Approved/Revised 13-Jul-2004 Material SDS Number Version 10 SDS Sections Updated Sections Subsections Genetic Toxicity TOXICOLOGY INFORMATION 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