SIGMA-ALDRICH Material Safety Data Sheet Date Printed: 09/OCT/2003 Date Updated: 15/SEP/2003 Version 1.1 According to 91/155/EEC 1 - Product and Company Information Product Name PACLITAXEL, 95% Product Number 417017 Company Sigma-Aldrich Chemie GmbH Riedstrasse 2 89555 Steinheim Germany Technical Phone # 49-89-6513(0)-1444 Fax 49-7329-97-2319 Emergency Phone # 49 7329 97 2323 2 - Composition/Information on Ingredients Product Name CAS # EC no PACLITAXEL FROM TAXUS BREVIFOLIA 33069-62-4 None Ingredient Name Percent CAS # EC no Annex I Index Number The hazards identified None None None with this product are those associated with the residual solvents that are used in the manufacturing process. METHANOL <= 4 67-56-1 200-659-6 603-001-00-X Symbols: F T R-Phrases: 11 23/24/25 39/23/24/25 Highly flammable. Toxic by inhalation, in contact with skin and if swallowed. Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed. ISOPROPANOL <= 4 67-63-0 200-661-7 603-117-00-0 Symbols: F Xi R-Phrases: 11 36 67 Highly flammable. Irritating to eyes. Vapors may cause drowsiness and dizziness. ETHYL ALCOHOL, <= 1 64-17-5 200-578-6 603-002-00-5 NON-DENATURED Symbols: F R-Phrases: 11 Highly flammable. Formula C47H51NO14 Molecular Weight 853.93 AMU Synonyms BMS 181339-01,NSC-125973,Paclitaxel,Taxol,Taxol A 3 - Hazards Identification SPECIAL INDICATION OF HAZARDS TO HUMANS AND THE ENVIRONMENT Harmful by inhalation, in contact with skin and if swallowed. Harmful: danger of serious damage to health by prolonged exposure through inhalation in contact with skin, and if swallowed. Irritating to respiratory system and skin. Risk of serious damage to eyes. May cause sensitization by inhalation and skin contact. Possible risk of impaired fertility. Possible risk of irreversible effects. 4 - First Aid Measures AFTER INHALATION If inhaled, remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. AFTER SKIN CONTACT In case of skin contact, flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing and shoes. Call a physician. AFTER EYE CONTACT In case of contact with eyes, flush with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating the eyelids with fingers. Call a physician. AFTER INGESTION If swallowed, wash out mouth with water provided person is conscious. Call a physician immediately. 5 - Fire Fighting Measures EXTINGUISHING MEDIA Suitable: Water spray. Carbon dioxide, dry chemical powder, or appropriate foam. SPECIAL RISKS Specific Hazard(s): Emits toxic fumes under fire conditions. SPECIAL PROTECTIVE EQUIPMENT FOR FIREFIGHTERS Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. 6 - Accidental Release Measures PERSONAL PRECAUTION PROCEDURES TO BE FOLLOWED IN CASE OF LEAK OR SPILL Evacuate area. PROCEDURE(S) OF PERSONAL PRECAUTION(S) Wear self-contained breathing apparatus, rubber boots, and heavy rubber gloves. Wear disposable coveralls and discard them after use. METHODS FOR CLEANING UP Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete. 7 - Handling and Storage HANDLING Directions for Safe Handling: Do not breathe dust. Do not get in eyes, on skin, on clothing. Avoid prolonged or repeated ALDRICH - 417017 www.sigma-aldrich.com Page 2 exposure. Do not use if skin is cut or scratched. Wash thoroughly after handling. STORAGE Conditions of Storage: Keep tightly closed. Store in a cool dry place. 8 - Exposure Controls / Personal Protection ENGINEERING CONTROLS Use only in a chemical fume hood. Safety shower and eye bath. Mechanical exhaust required. GENERAL HYGIENE MEASURES Wash contaminated clothing before reuse. Wash thoroughly after handling. PERSONAL PROTECTIVE EQUIPMENT Respiratory Protection: Government approved respirator. Hand Protection: Compatible chemical-resistant gloves. Eye Protection: Chemical safety goggles. 9 - Physical and Chemical Properties Appearance Physical State: Solid Property Value At Temperature or Pressure pH 3 - 8 BP/BP Range N/A MP/MP Range 213 °C Flash Point N/A Flammability N/A Autoignition Temp N/A Oxidizing Properties N/A Explosive Properties N/A Explosion Limits N/A Vapor Pressure N/A SG/Density 0.2 g/cm3 Partition Coefficient Log Kow: > 99 Viscosity N/A Vapor Density N/A Saturated Vapor Conc. N/A Evaporation Rate N/A Bulk Density N/A Decomposition Temp. > 100 °C Solvent Content N/A Water Content N/A Surface Tension N/A Conductivity N/A Miscellaneous Data N/A Solubility Solubility in Water:Insoluble. 10 - Stability and Reactivity STABILITY Stable: Stable. Materials to Avoid: Strong oxidizing agents. HAZARDOUS DECOMPOSITION PRODUCTS Hazardous Decomposition Products: Carbon monoxide, Carbon dioxide, Nitrogen oxides. ALDRICH - 417017 www.sigma-aldrich.com Page 3 HAZARDOUS POLYMERIZATION Hazardous Polymerization: Will not occur 11 - Toxicological Information RTECS NUMBER: DA8340700 ACUTE TOXICITY LDLO Intravenous Woman 4,995 mg/kg LD50 Intraperitoneal Rat 32,530 mg/kg LD50 Intraperitoneal Mouse 128 mg/kg LD50 Intravenous Mouse 12 mg/kg LDLO Intravenous Woman 4995 MG/KG 3H-C Remarks: Cardiac:Cardiomyopathy including infarction. Blood:Leukopenia. Blood:Thrombocytopenia. LD50 Intraperitoneal Rat 32530 UG/KG Remarks: Behavioral:Somnolence (general depressed activity). Lungs, Thorax, or Respiration:Dyspnea. Nutritional and Gross Metabolic:Weight loss or decreased weight gain. LD50 Intraperitoneal Mouse 128 MG/KG Remarks: Skin and Appendages: Other: Hair. Nutritional and Gross Metabolic:Weight loss or decreased weight gain. LD50 Intravenous Mouse 12 MG/KG Remarks: Behavioral:Somnolence (general depressed activity). Behavioral:Ataxia. Lungs, Thorax, or Respiration:Respiratory depression. SENSITIZATION Respiratory: May cause allergic respiratory reaction. Skin: May cause allergic skin reaction. SIGNS AND SYMPTOMS OF EXPOSURE ALDRICH - 417017 www.sigma-aldrich.com Page 4 Exposure can cause: Damage to the liver. Alopecia. Nausea, headache, and vomiting. Damage to the kidneys. Can cause severe cardiotoxicity and bone marrow suppression. ROUTE OF EXPOSURE Skin Contact: Causes skin irritation. Skin Absorption: Harmful if absorbed through skin. Eye Contact: Causes severe eye irritation. Inhalation: Material is irritating to mucous membranes and upper respiratory tract. Harmful if inhaled. Ingestion: Harmful if swallowed. TARGET ORGAN INFORMATION Cardiovascular system. Heart. Nerves. Eyes. Kidneys. Liver. Bone marrow. Lungs. Blood. Skin. G.I. System. CHRONIC EXPOSURE - MUTAGEN Result: Laboratory experiments have shown mutagenic effects. Mouse 20 MG/KG Subcutaneous Micronucleus test Hamster 80 UG/L Cell Type: lung Cytogenetic analysis CHRONIC EXPOSURE - TERATOGEN Species: Rat Dose: 6600 UG/KG Route of Application: Intravenous Exposure Time: (7-17D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Effects on Newborn: Delayed effects. CHRONIC EXPOSURE - REPRODUCTIVE HAZARD Result: Overexposure may cause reproductive disorder(s) based on tests with laboratory animals. Species: Rat Dose: 84 MG/KG Route of Application: Intravenous Exposure Time: (9W MALE/2W PRE/1-7D PREG) Result: Maternal Effects: Other effects. Effects on Fertility: Pre-implantation mortality (e.g., reduction in number of implants per female; total number of implants per corpora lutea). Effects on Embryo or Fetus: Extra embryonic structures (e.g., placenta, umbilical cord). Species: Rat Dose: 26 MG/KG Route of Application: Intravenous Exposure Time: (17-21D PREG/21D POST) Result: Effects on Newborn: Growth statistics (e.g., reduced weight gain). Effects on Newborn: Behavioral. Effects on Newborn: Physical. 12 - Ecological Information ALDRICH - 417017 www.sigma-aldrich.com Page 5 No data available. 13 - Disposal Considerations SUBSTANCE DISPOSAL Contact a licensed professional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state, and local environmental regulations. 14 - Transport Information RID/ADR Non-hazardous for road transport. IMDG Non-hazardous for sea transport. IATA Non-hazardous for air transport. 15 - Regulatory Information CLASSIFICATION AND LABELING ACCORDING TO EU DIRECTIVES INDICATION OF DANGER: Xn Harmful. R-PHRASES: 20/21/22 48/20/21/22 37/38 41 42/43 62 68 Harmful by inhalation, in contact with skin and if swallowed. Harmful: danger of serious damage to health by prolonged exposure through inhalation in contact with skin, and if swallowed. Irritating to respiratory system and skin. Risk of serious damage to eyes. May cause sensitization by inhalation and skin contact. Possible risk of impaired fertility. Possible risk of irreversible effects. S-PHRASES: 22 26 36/37/39 45 Do not breathe dust. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing, gloves, and eye/face protection. In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). 16 - Other Information WARRANTY The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. Sigma-Aldrich Inc., shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale. Copyright 2003 Sigma-Aldrich Co. License granted to make unlimited paper copies for internal use only. DISCLAIMER For R&D use only. Not for drug, household or other uses. ALDRICH - 417017 www.sigma-aldrich.com Page 6