URSODIOL, USP 100GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name URSODIOL USP Supplier Information Letco Medical, LLC 1316 Commerce Drive NW Decatur, AL 35601 1 (800) 239-5288 +1 (734) 843-4693 IN CASE OF EMERGENCY: Chemtrec 1 (800) 424-9300 (24 hours) Product Synonym(s) Ursodeoxycholic Acid Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Not a hazardous substance or mixture. Signal Word None Hazard Statement(s) N/A Pictogram(s) N/A Precautionary Statement(s) N/A Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Ursodeoxycholic acid Common Name Usodiol CAS Number 128-13-2 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice No data available. If Inhaled If inhaled, remove to fresh air. If not breathing, give artif icial respiration or give oxygen by trained personnel. Get immediate medical attention. In Case of Skin Contact In case of skin contact, immediately wash skin with soap and plenty of water f or at least 20 minutes. Remove contaminated clothing. Get medical attention if symptoms occur. Wash clothing bef ore reuse. In Case of Eye Contact In case of contact with eyes, hold eyelids apart and f lush eyes with plenty of water f or at least 20 minutes. Have eyes examined and tested by medical personnel. If Swallowed If swallowed, wash out mouth with water provided person is conscious. Never give anything by mouth to an unconscious person. Get medical attention. Do NOT induce vomiting unless directed to do so by medical personnel. Most Important Symptoms and Effects No data available. Section 5: Fire Fighting Measures Suitable Extinguishing Media Use alcohol-resistant f oam, carbon dioxide, water, or dry chemical spray. Use water spray to cool f ire-exposed containers. Unsuitable Extinguishing Media: A solid water stream may be inef f icient. Special Hazards Arising From the Substance/Mixture No data available. Special PPE and/or Precautions for Firefighters As in any f ire, wear self-contained breathing apparatus pressure-demand (NIOSH approved or equivalent), and f ull protective gear to prevent contact with skin and eyes. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Avoid raising and breathing dust, and provide adequate ventilation. As conditions warrant, wear a NIOSH approved selfcontained breathing apparatus, or respirator, and appropriate personal protection (rubber boots, saf ety goggles, and heavy rubber gloves). Methods and Materials Used for Containment Avoid release into the environment. Cleanup Procedures Transf er to a proper chemical waste container f or disposal. Page 1 of 4 Section 7: Handling and Storage Precautions for Safe Handling Avoid contact with skin and eyes. Do not reuse this container. Use with adequate ventilation. Wash thoroughly af ter handling. Avoid breathing (dust, vapor, mist, gas). Avoid prolonged or repeated exposure. Conditions for Safe Storage Keep in tightly closed and light resistant containers, in a dry place. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters No data available. Appropriate Engineering Controls Do not take internally. Facilities storing or utilizing this material should be equipped with an eyewash f acility and a saf ety shower. Wash thoroughly af ter handling. Use process enclosures, local exhaust ventilation, or other engineering controls to control airborne levels below recommended exposure limits. PPE - Eye/Face Protection Saf ety glasses PPE - Skin Protection Compatible chemical-resistant gloves PPE - Body Protection Lab coat PPE - Respiratory Protection NIOSH approved respirator, as conditions warrant. Section 9: Physical and Chemical Properties Appearance Physical States: Solid. A crystalline white powder. Upper/Lower Flammability or Explosive Limits No data available Odor No data available Vapor Pressure No data available Odor Threshold No data available Vapor Density No data available pH No data available Relative Density No data available Melting Point/Freezing Point about 202C Solubility Insoluble in water. Soluble in ethanol. Initial Boiling Point and Boiling Range No data available Flash Point No data available Evaporation Rate No data available Flammability (Solid, Gas) No data available Partition Coefficient No data available Auto-Ignition Temperature No data available Decomposition Temperature No data available Viscosity No data available Section 10: Stability and Reactivity Reactivity No data available Chemical Stability Stable. Possibility of Hazardous Reactions No data available Conditions to Avoid No data available Incompatible Materials Strong oxidizing agents Hazardous Decomposition Products Hazardous Decomposition or byproducts: carbon dioxide, carbon monoxide. Hazardous Reactions will not occur. Page 2 of 4 Section 11: Toxicological Information Acute Toxicity - LD50 Oral Ursodeoxycholic Acid - Toxicity Data: Oral LD50 (rat): 10.00g/kg; Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation No data available Serious Eye Damage/Irritation No data available Respiratory or Skin Sensitazation No data available Germ Cell Mutagenicity Ursodeoxycholic Acid - Investigated as a teratogen, mutagen, and reproductive ef f ector. Only select Registry of Toxic Ef f ects of Chemical Substances (RTECS) data is presented here. See actual entry in RTECS f or complete inf ormation. Ursodeoxycholic Acid RTECS Number: FZ2000000 Carcinogenicity IARC No Carcinogenicity ACGIH No data available. Carcinogenicity NTP No Carcinogenicity OSHA No Reproductive Toxicity No data available Specific Target Organ Toxicity - Single Exposure No data available Specific Target Organ Toxicity - Repeated Exposure No data available Aspiration Hazard No data available Section 12: Ecological Information Toxicity Avoid release into the environment. Runof f from f ire control or dilution water may cause pollution. Persistence and Degradability No data available Bio-accumulative Potential No data available Mobility in Soil No data available Other Adverse Effects No data available Section 13: Disposal Considerations Waste Treatment Methods Product Dispose in accordance with local, state, and f ederal regulations. Waste Treatment Methods Packaging No data available Special Precautions Landfill or Incinerations No data available Other Information No data available Section 14: Transport Information UN Number Not dangerous goods. UN Proper Shipping Name N/A Transport Hazard Class(es) N/A Packaging Group N/A Environmental Hazards N/A Section 15: Regulatory Information European Community Hazard Symbol codes No data available. European Community Risk and Saf ety Phrases S24/25 - Avoid contact with skin and eyes. S37/39 - Wear suitable gloves and eye/f ace protection. US EPA SARA Title III Hazardous Components (Chemical Name) CAS # Sec.302 (EHS) Sec.304 RQ Sec.313 (TRI) Sec.110 Ursodeoxycholic acid 128-13-2 No No No No US EPA CAA, CWA, TSCA Hazardous Components (Chemical Name) CAS # EPA CAA EPA CWA NPDES EPA TSCA HPV/LPV Ursodeoxycholic acid 128-13-2 HAP, ODC () No No Section 16: Other Information Additional Information N/A Prepared By Scarlotte Smith Revision Date 02/06/2019 14:29 Page 3 of 4 Disclaimer Letco Medical, LLC believes that the above information is 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. If the product is used as a component in another product, this information may not be applicable. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED ABOVE. Letco Medical shall not be held liable for any loss or damage resulting from handling, storage, use or from contact with the above product. Page 4 of 4
