BECLOMETHASONE DIPROPIONATE, USP (MICRONIZED) 1GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name BECLOMETHASONE DIPROPIONATE 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) 9-chloro-11b-hydroxy-16b-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Reproductive toxicity (Category 2) Signal Word Warning Hazard Statement(s) H361 Suspected of damaging f ertility or the unborn child Pictogram(s) Precautionary Statement(s) P201 Obtain special instructions bef ore use. P202 Do not handle until all saf ety precautions have been read and understood. P261 Avoid breathing dust/f ume/gas/mist/vapours/spray. P281 Use personal protective equipment as required. P308+P313 IF exposed or concerned Get medical advice/attention. Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name 9-Chloro-11�-hydroxy-16�-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate Common Name Beclomethasone dipropionate CAS Number 5534-09-8 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Consult a physician. Show this saf ety sheet to the doctor in attendance. Move out of dangerous area. If Inhaled If breathed in, move person into fresh air. If not breathing, give artif icial respiration. Call a physician. In Case of Skin Contact In case of contact, immediately wash skin with soap and copious amounts of water. Remove contaminated clothes. Call a physician. In Case of Eye Contact Separate the eyelids with f ingers and f lush with copious amounts of water f or 15 minutes. Call a physician. If Swallowed if swallowed, wash out mouth with water provided person is conscious. Never give anything by mouth to an unconscious person. Call a physician. Most Important Symptoms and Effects Treatment : Treat symptomatically. Section 5: Fire Fighting Measures Suitable Extinguishing Media Water spray, carbon dioxide, dry chemical powder or appropriate f oam. Special Hazards Arising From the Substance/Mixture Emits toxic f umes under f ire conditions: carbon monoxide, carbon dioxide and hydrogen chloryde As with all dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity. Special PPE and/or Precautions for Firefighters Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Page 1 of 4 Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Use personal protective equipment. Avoid breathing dust. Ensure adequate ventilation. Evacuate personnel to saf e areas. Methods and Materials Used for Containment Sweep up, place in a bag labelled and tightly closed f or disposal according to local / national regulations (see section 13). Avoid raising dust. Ventilate area and wash spill site af ter material pickup is complete. Prevent f urther leakage or spillage. Do not let product enter drains. Cleanup Procedures Sweep up, place in a bag labelled and tightly closed f or disposal according to local / national regulations (see section 13). Avoid raising dust. Ventilate area and wash spill site af ter material pickup is complete. Prevent f urther leakage or spillage. Do not let product enter drains. Section 7: Handling and Storage Precautions for Safe Handling Do not breathe dust. Do not get in eyes, on skin or on clothing. Avoid prolonged or repeated exposure. Provide appropriate exhaust ventilation at places where dust is f ormed. Wash thoroughly af ter handling. Conditions for Safe Storage No special conditions are required. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters No data available Appropriate Engineering Controls Use in a chemical f ume hood. Saf ety shower and eye bath. Wash contaminated clothing bef ore reuse. Wash thoroughly af ter handling and bef ore eating or drinking. PPE - Eye/Face Protection Chemical saf ety goggles, according to EN166. PPE - Skin Protection Rubber gloves, according to EU Directive 89/686/EEC and the standard EN374 derived from it. PPE - Body Protection Protect skin exposed. PPE - Respiratory Protection A exposure risk assessment should be done in order to choose appropriate respiratory protection. Use respirators and components tested and under appropriate government standards such as NIOSH (US) or CEN (EU). Section 9: Physical and Chemical Properties Appearance Crystalline solid white. 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 240�C Solubility No data available 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 inf ormation available. Chemical Stability Stable under recommended storage conditions. Possibility of Hazardous Reactions No inf ormation available Conditions to Avoid No inf ormation available Incompatible Materials Strong oxidizing agents Hazardous Decomposition Products carbon oxides and hydrogen chloride. Page 2 of 4 Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Oral - rat - > 3,750 mg/kg LD50 (orl, mus): >5 gm/kg Acute Toxicity - Inhalation LC50 (ihl, rat): >51600 ug/m3/2H 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 No data available Carcinogenicity IARC No inf ormation available Carcinogenicity ACGIH No inf ormation available Carcinogenicity NTP No inf ormation available Carcinogenicity OSHA No inf ormation available Reproductive Toxicity TDLo (orl, rat): 16 mg/kg (9W male/2W pre -7D preg) Reproductive Ef f ects : Ef f ects on Fertility : Female f ertility index (e.g., number f emales pregnant per number sperm positive f emales; number f emales pregnant per number f emales mated) Ef f ects on Embryo or Fetus: Extra embryonic structures (e.g., placenta, umbilical cord, etc.) Specif ic Developmental Abnormalities : Musculoskeletal system. Ef f ects on Fertility : Pre-implantation mortality (e.g., reduction in number of implants per f emale; total number implants per corpora lutea); Litter size (e.g., number f etuses per litter, measured bef ore birth). Maternal Ef f ects : Uterus, cervix, vagina; Menstrual cycle changes or disorders (menses, menstruation). Ef f ects on Fertility : Post-implantation mortality (e.g., dead and/or resorbed implants per total number implants). Ef f ects on Fertility : Post-implantation mortality (e.g., dead and/or resorbed implants per total number implants) Ef f ects on Embryo or Fetus: Fetal death Specif ic Developmental Abnormalities : Musculoskeletal system. 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 No data available 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 Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an af terburner and scrubber. Observe all f ederal, state, and local environmental regulations. Waste Treatment Methods Packaging Contaminated packaging must be handled in the same way as the material: it must be managed by an authorized external company according to all f ederal, state and local regulations. Uncontaminated packaging be treated as household waste or recyclable material. Certif icate of the f inal treatment must be submitted by the external company. 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 This saf ety data sheet complies with the requirements of Regulation (EC) n� 1907/2006 Page 3 of 4 Section 16: Other Information Additional Information Hazard statements; R-phrases mentioned in section 2 and 3. R61: May cause harm to the unborn child. The inf ormation in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate saf ety precautions. The user is responsible of using the product according to local and national regulations. Prepared By Lisa Russell Revision Date 01/15/2019 14:51 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
