SIGMA-ALDRICH MATERIAL SAFETY DATA SHEET Date Printed: 10/10/2008 Date Updated: 01/30/2006 Version 1.3 Section 1 - Product and Company Information Product Name (+/-)-THALIDOMIDE Product Number T144 Brand SIGMA Company Sigma-Aldrich Address 3050 Spruce Street SAINT LOUIS MO 63103 US Technical Phone: 800-325-5832 Fax: 800-325-5052 Emergency Phone: 314-776-6555 Section 2 - Composition/Information on Ingredient Substance Name CAS # SARA 313 (+-)-THALIDOMIDE 50-35-1 No Formula C13H10N2O4 Synonyms Algosediv * Asidon 3 * Asmadion * Asmaval * Bonbrain * Contergan * Corronarobetin * 2,6-Dioxo-3-phthalimidopiperidine * N-(2,6-Dioxo-3-piperidyl)phthalimide * Distaval * Ectiluran * Enterosediv * Gastrinide * Glutarimide, 2-phthalimido- * Grippex * Hippuzon * Imida-lab * Imidan (peyta) * Imidene * 1H-Isoindole-1,3(2H)-dione, 2-(2,6-dioxo-3-piperidinyl)- * Isomin * K 17 * Kevadon * Neaufatin * NeO * Nibrol * Noctosediv * Noxodyn * NSC-66847 * Pangul * Pantosediv * alpha-Phthalimidoglutarimide * alpha-(N-Phthalimido)glutarimide * 3-Phthalimidoglutarimide * N-Phthaloylglutamimide * N-Phthalylglutamic acid imide * N-Phthalyl-glutaminsaeure-imid (German) * alpha-N-Phthalylglutaramide * Poly-giron * Polygripan * Predni-sediv * Pro-Bam M * Profarmil * Psycholiquid * Psychotablets * Quetimid * Quietoplex * Sandormin * Sedalis sedi-lab * Sedimide * Sedin * Sedisperil * Sedoval * Shin-naito S * Shinnibrol * Sleepan * Slipro * Softenil * Softenon * Talargan * Talimol * (+-)-Thalidomide * Yodomin RTECS Number: TI4375000 Section 3 - Hazards Identification EMERGENCY OVERVIEW Toxic. May cause harm to the unborn child. May cause heritable genetic damage. Possible risk of impaired fertility. Toxic if swallowed. Harmful in contact with skin. Calif. Prop. 65 developmental hazard. HMIS RATING HEALTH: 4 FLAMMABILITY: 0 REACTIVITY: 0 NFPA RATING FLAMMABILITY: 0 REACTIVITY: 0 For additional information on toxicity, please refer to Section 11. Section 4 - First Aid Measures ORAL EXPOSURE If swallowed, wash out mouth with water provided person is conscious. Call a physician immediately. INHALATION EXPOSURE If inhaled, remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. DERMAL EXPOSURE In case of skin contact, flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing and shoes. Call a physician. EYE EXPOSURE 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. Section 5 - Fire Fighting Measures FLASH POINT N/A AUTOIGNITION TEMP N/A FLAMMABILITY N/A EXTINGUISHING MEDIA Suitable: Water spray. Carbon dioxide, dry chemical powder, or appropriate foam. FIREFIGHTING Protective Equipment: Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Specific Hazard(s): Emits toxic fumes under fire conditions. EXPOSURE HAZARD(S) Material: Not to be handled by women of child-bearing age. Section 6 - Accidental Release Measures PROCEDURE 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 SIGMA - T144 www.sigma-aldrich.com Page 2 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. Section 7 - Handling and Storage HANDLING User Exposure: Do not breathe dust. Do not get in eyes, on skin, on clothing. Avoid prolonged or repeated exposure. STORAGE Suitable: Keep tightly closed. Section 8 - Exposure Controls / PPE ENGINEERING CONTROLS Use only in a chemical fume hood. Safety shower and eye bath. PERSONAL PROTECTIVE EQUIPMENT Respiratory: Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Where risk assessment shows air-purifying respirators are appropriate use a full-face particle respirator type N100 (US) or type P3 (EN 143) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a full-face supplied air respirator. Hand: Compatible chemical-resistant gloves. Eye: Chemical safety goggles. GENERAL HYGIENE MEASURES Wash contaminated clothing before reuse. Wash thoroughly after handling. Section 9 - Physical/Chemical Properties Appearance Physical State: Solid Color: White Property Value At Temperature or Pressure Molecular Weight 258.2 AMU pH N/A BP/BP Range N/A MP/MP Range 239.0 - 241.0 °C Freezing Point N/A Vapor Pressure N/A Vapor Density N/A Saturated Vapor Conc. N/A SG/Density N/A Bulk Density N/A Odor Threshold N/A Volatile% N/A VOC Content N/A Water Content N/A Solvent Content N/A Evaporation Rate N/A Viscosity N/A Surface Tension N/A SIGMA - T144 www.sigma-aldrich.com Page 3 Partition Coefficient N/A Decomposition Temp. N/A Flash Point N/A Explosion Limits N/A Flammability N/A Autoignition Temp N/A Refractive Index N/A Optical Rotation N/A Miscellaneous Data N/A Solubility N/A N/A = not available Section 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. HAZARDOUS POLYMERIZATION Hazardous Polymerization: Will not occur Section 11 - Toxicological Information ROUTE OF EXPOSURE Skin Contact: May cause skin irritation. Skin Absorption: Harmful if absorbed through skin. Eye Contact: May cause eye irritation. Inhalation: Material may be irritating to mucous membranes and upper respiratory tract. May be harmful if inhaled. Ingestion: Toxic if swallowed. SIGNS AND SYMPTOMS OF EXPOSURE To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated. TOXICITY DATA Oral Rat 113 mg/kg LD50 Skin Rat 1550 mg/kg LD50 Intraperitoneal Rat >6 GM/KG LD50 Oral Mouse 2000 mg/kg LD50 SIGMA - T144 www.sigma-aldrich.com Page 4 Subcutaneous Mouse >5 GM/KG LD50 CHRONIC EXPOSURE - CARCINOGEN Species: Mouse Route of Application: Subcutaneous Dose: 34 GM/KG Exposure Time: 57W Frequency: I Result: Tumorigenic:Equivocal tumorigenic agent by RTECS criteria. Tumorigenic:Tumors at site or application. Lungs, Thorax, or Respiration:Tumors. CHRONIC EXPOSURE - TERATOGEN Result: May cause congenital malformation in the fetus. Species: Woman Dose: 2 MG/KG Route of Application: Oral Exposure Time: (30D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Species: Woman Dose: 17500 UG/KG Route of Application: Oral Exposure Time: (1-5W PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Specific Developmental Abnormalities: Cardiovascular (circulatory) system. Species: Woman Dose: 2 MG/KG Route of Application: Oral Exposure Time: (29D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Species: Woman Dose: 16 MG/KG Route of Application: Oral Exposure Time: (28-35D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Specific Developmental Abnormalities: Other developmental abnormalities. Species: Rat Dose: 560 MG/KG Route of Application: Oral Exposure Time: (14D MALE) Result: Specific Developmental Abnormalities: Craniofacial (including nose and tongue). Species: Rat Dose: 500 MG/KG Route of Application: Oral Exposure Time: (7-11D PREG) Result: Effects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted fetus). Specific Developmental Abnormalities: SIGMA - T144 www.sigma-aldrich.com Page 5 Musculoskeletal system. Species: Rat Dose: 1050 MG/KG Route of Application: Oral Exposure Time: (1-21D PREG) Result: Effects on Embryo or Fetus: Extra embryonic structures (e.g., placenta, umbilical cord). Effects on Embryo or Fetus: Fetal death. Species: Rat Dose: 28 GM/KG Route of Application: Oral Exposure Time: (3D MALE/3D PRE-22D PREG) Result: Specific Developmental Abnormalities: Cardiovascular (circulatory) system. Specific Developmental Abnormalities: Urogenital system. Species: Rat Dose: 200 MG/KG Route of Application: Oral Exposure Time: (15D PRE) Result: Specific Developmental Abnormalities: Skin and skin appendages. Specific Developmental Abnormalities: Musculoskeletal system. Species: Rat Dose: 1200 MG/KG Route of Application: Intraperitoneal Exposure Time: (9-11D PREG) Result: Specific Developmental Abnormalities: Cardiovascular (circulatory) system. Specific Developmental Abnormalities: Musculoskeletal system. Specific Developmental Abnormalities: Central nervous system. Species: Rat Dose: 15 MG/KG Route of Application: Intravenous Exposure Time: (9-14D PREG) Result: Effects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted fetus). Species: Rat Dose: 45 MG/KG Route of Application: Intravenous Exposure Time: (12D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Species: Rat Dose: 1700 MG/KG Route of Application: Unreported Exposure Time: (6-22D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Species: Mouse Dose: 155 MG/KG Route of Application: Oral Exposure Time: (7-11D PREG) Result: Specific Developmental Abnormalities: Central nervous system. Specific Developmental Abnormalities: Musculoskeletal SIGMA - T144 www.sigma-aldrich.com Page 6 system. Species: Mouse Dose: 25 MG/KG Route of Application: Intraperitoneal Exposure Time: (9D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Species: Mouse Dose: 100 MG/KG Route of Application: Intraperitoneal Exposure Time: (13D PREG) Result: Effects on Embryo or Fetus: Other effects to embryo. Species: Mouse Dose: 2 GM/KG Route of Application: Intraperitoneal Exposure Time: (11-12D PREG) Result: Specific Developmental Abnormalities: Other developmental abnormalities. Species: Dog Dose: 2 GM/KG Route of Application: Unreported Exposure Time: (20-24D PREG) Result: Effects on Embryo or Fetus: Fetal death. Species: Dog Dose: 250 MG/KG Route of Application: Unreported Exposure Time: (20-24D PREG) Result: Specific Developmental Abnormalities: Cardiovascular (circulatory) system. Species: Monkey Dose: 10 MG/KG Route of Application: Oral Exposure Time: (28D PREG) Result: Specific Developmental Abnormalities: Eye, ear. Species: Monkey Dose: 60 MG/KG Route of Application: Oral Exposure Time: (24-26D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Specific Developmental Abnormalities: Central nervous system. Specific Developmental Abnormalities: Cardiovascular (circulatory) system. Species: Cat Dose: 110 MG/KG Route of Application: Oral Exposure Time: (10-20D PREG) Result: Specific Developmental Abnormalities: Cardiovascular (circulatory) system. Effects on Embryo or Fetus: Fetal death. Species: Rabbit Dose: 450 MG/KG Route of Application: Oral Exposure Time: (7-9D PREG) Result: Specific Developmental Abnormalities: Craniofacial SIGMA - T144 www.sigma-aldrich.com Page 7 (including nose and tongue). Specific Developmental Abnormalities: Respiratory system. Specific Developmental Abnormalities: Musculoskeletal system. Species: Rabbit Dose: 400 MG/KG Route of Application: Oral Exposure Time: (7-16D PREG) Result: Specific Developmental Abnormalities: Other developmental abnormalities. Effects on Embryo or Fetus: Fetal death. Effects on Newborn: Biochemical and metabolic. Species: Rabbit Dose: 833 MG/KG Route of Application: Oral Exposure Time: (6-11D PREG) Result: Specific Developmental Abnormalities: Urogenital system. Specific Developmental Abnormalities: Cardiovascular (circulatory) system. Specific Developmental Abnormalities: Gastrointestinal system. Species: Rabbit Dose: 125 MG/KG Route of Application: Oral Exposure Time: (8-12D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Species: Rabbit Dose: 1500 MG/KG Route of Application: Subcutaneous Exposure Time: (6-20D PREG) Result: Specific Developmental Abnormalities: Body wall. Specific Developmental Abnormalities: Other developmental abnormalities. Species: Rabbit Dose: 1700 MG/KG Route of Application: Subcutaneous Exposure Time: (1-17D PREG) Result: Effects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted fetus). Species: Rabbit Dose: 1800 MG/KG Route of Application: Subcutaneous Exposure Time: (3-20D PREG) Result: Specific Developmental Abnormalities: Urogenital system. Specific Developmental Abnormalities: Craniofacial (including nose and tongue). Species: Rabbit Dose: 12500 UG/KG Route of Application: Intravenous Exposure Time: (8-12D PREG) Result: Specific Developmental Abnormalities: Central nervous system. Specific Developmental Abnormalities: Body wall. Specific Developmental Abnormalities: Musculoskeletal system. Species: Rabbit Dose: 900 MG/KG Route of Application: Unreported SIGMA - T144 www.sigma-aldrich.com Page 8 Exposure Time: (7-12D PREG) Result: Specific Developmental Abnormalities: Body wall. Specific Developmental Abnormalities: Gastrointestinal system. Species: Rabbit Dose: 1050 MG/KG Route of Application: Unreported Exposure Time: (7-13D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Species: Rabbit Dose: 500 MG/KG Route of Application: Unreported Exposure Time: (7D PREG) Result: Specific Developmental Abnormalities: Central nervous system. Species: Pig Dose: 550 MG/KG Route of Application: Oral Exposure Time: (12-33D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Species: Hamster Dose: 300 MG/KG Route of Application: Oral Exposure Time: (8D PREG) Result: Effects on Embryo or Fetus: Fetal death. Species: Mammal Dose: 1500 MG/KG Route of Application: Oral Exposure Time: (8-12D PREG) Result: Effects on Embryo or Fetus: Fetal death. CHRONIC EXPOSURE - MUTAGEN Result: May alter genetic material. Species: Human Dose: 1 MG/L Cell Type: lymphocyte Mutation test: Cytogenetic analysis Species: Rat Route: Intraperitoneal Dose: 80 MG/KG Mutation test: Unscheduled DNA synthesis Species: Rat Route: Intraperitoneal Dose: 80 MG/KG Mutation test: Other mutation test systems Species: Rat Route: Oral Dose: 7600 MG/KG Exposure Time: 30D Mutation test: Cytogenetic analysis CHRONIC EXPOSURE - REPRODUCTIVE HAZARD SIGMA - T144 www.sigma-aldrich.com Page 9 Result: Overexposure may cause reproductive disorder(s) based on tests with laboratory animals. Species: Rat Dose: 500 MG/KG Route of Application: Oral Exposure Time: (10-14D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Species: Rat Dose: 22 MG/KG Route of Application: Intraperitoneal Exposure Time: (6-9D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Species: Rat Dose: 45 MG/KG Route of Application: Intravenous Exposure Time: (10D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Specific Developmental Abnormalities: Eye, ear. Effects on Embryo or Fetus: Fetal death. Species: Mouse Dose: 750 MG/KG Route of Application: Oral Exposure Time: (2-7D PREG) Result: Effects on Fertility: Pre-implantation mortality (e.g., reduction in number of implants per female; total number of implants per corpora lutea). Species: Mouse Dose: 600 MG/KG Route of Application: Oral Exposure Time: (1-7D PREG) Result: Effects on Newborn: Stillbirth. Species: Mouse Dose: 400 MG/KG Route of Application: Oral Exposure Time: (12-15D PREG) Result: Specific Developmental Abnormalities: Craniofacial (including nose and tongue). Maternal Effects: Parturition. Species: Mouse Dose: 124 MG/KG Route of Application: Oral Exposure Time: (7-10D PREG) Result: Effects on Fertility: Abortion. Specific Developmental Abnormalities: Eye, ear. Specific Developmental Abnormalities: Musculoskeletal system. Species: Mouse Dose: 25 MG/KG Route of Application: Intraperitoneal Exposure Time: (9D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). SIGMA - T144 www.sigma-aldrich.com Page 10 Species: Dog Dose: 390 MG/KG Route of Application: Oral Exposure Time: (8-20D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Specific Developmental Abnormalities: Musculoskeletal system. Species: Monkey Dose: 330 MG/KG Route of Application: Oral Exposure Time: (1-33D PREG) Result: Effects on Fertility: Female fertility index (e.g., # females pregnant per # sperm positive females; # females pregnant per # females mated ). Species: Cat Dose: 360 MG/KG Route of Application: Oral Exposure Time: (15-17D PREG) Result: Effects on Fertility: Abortion. Specific Developmental Abnormalities: Homeostasis Species: Rabbit Dose: 150 MG/KG Route of Application: Oral Exposure Time: (7D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Species: Rabbit Dose: 450 MG/KG Route of Application: Oral Exposure Time: (7-9D PREG) Result: Effects on Fertility: Litter size (e.g.; # fetuses per litter; measured before birth). Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Specific Developmental Abnormalities: Urogenital system. Species: Rabbit Dose: 1200 MG/KG Route of Application: Subcutaneous Exposure Time: (1-20D PREG) Result: Effects on Fertility: Litter size (e.g.; # fetuses per litter; measured before birth). Species: Rabbit Dose: 750 MG/KG Route of Application: Intravenous Exposure Time: (6-10D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Species: Rabbit Dose: 10 MG/KG Route of Application: Intravenous Exposure Time: (7D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Species: Mammal SIGMA - T144 www.sigma-aldrich.com Page 11 Dose: 1800 MG/KG Route of Application: Oral Exposure Time: (13-18D PREG) Result: Effects on Embryo or Fetus: Fetal death. Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Section 12 - Ecological Information No data available. Section 13 - Disposal Considerations APPROPRIATE METHOD OF DISPOSAL OF SUBSTANCE OR PREPARATION 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. Section 14 - Transport Information DOT Proper Shipping Name: Toxic solids, organic, n.o.s. UN#: 2811 Class: 6.1 Packing Group: Packing Group III Hazard Label: Toxic substances. PIH: Not PIH IATA Proper Shipping Name: Toxic solid, organic, n.o.s. IATA UN Number: 2811 Hazard Class: 6.1 Packing Group: III Section 15 - Regulatory Information EU ADDITIONAL CLASSIFICATION Symbol of Danger: T Indication of Danger: Toxic. R: 46-61-21-25-62 Risk Statements: May cause heritable genetic damage. May cause harm to the unborn child. Harmful in contact with skin. Toxic if swallowed. Possible risk of impaired fertility. S: 53-22-26-36/37/39-45 Safety Statements: Avoid exposure - obtain special instructions before use. 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). US CLASSIFICATION AND LABEL TEXT Indication of Danger: Toxic. Risk Statements: May cause harm to the unborn child. May cause heritable genetic damage. Possible risk of impaired fertility. Toxic if swallowed. Harmful in contact with skin. Safety Statements: In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). Wear suitable protective clothing, gloves, and eye/face protection. In case of contact with eyes, rinse immediately with SIGMA - T144 www.sigma-aldrich.com Page 12 plenty of water and seek medical advice. Do not breathe dust. US Statements: Calif. Prop. 65 developmental hazard. UNITED STATES REGULATORY INFORMATION SARA LISTED: No UNITED STATES - STATE REGULATORY INFORMATION CALIFORNIA PROP - 65 California Prop - 65: This product is or contains chemical(s) known to the state of California to cause developmental toxicity. CANADA REGULATORY INFORMATION WHMIS Classification: This product has been classified in accordance with the hazard criteria of the CPR, and the MSDS contains all the information required by the CPR. DSL: No NDSL: No Section 16 - Other Information DISCLAIMER For R&D use only. Not for drug, household or other uses. 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. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. 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 2008 Sigma-Aldrich Co. License granted to make unlimited paper copies for internal use only. SIGMA - T144 www.sigma-aldrich.com Page 13