BUDESONIDE USP MICRONIZED 25GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name BUDESONIDE MICRONIZED 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) 11-beta, 16-alpha)-16,17-(Buthlidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione 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 11-beta, 16-alpha)-16,17-(Buthlidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione Common Name Budesonide CAS Number 51333-22-3 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Allow the victim to rest in a well-ventilated area. Seek immediate medical attention. If Inhaled Not available In Case of Skin Contact Af ter contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly caref ul to clean f olds, crevices, creases and groin. Cold water may be used. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. In Case of Eye Contact Check f or and remove any contact lenses. Immediately f lush eyes with running water f or at least 15 minutes, keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical attention. If Swallowed Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perf orm mouth-to-mouth resuscitation. Seek medical attention. Most Important Symptoms and Effects No data available. Section 5: Fire Fighting Measures Suitable Extinguishing Media Use water spray, alcohol-resistant f oam, dry chemical or carbon dioxide. Special Hazards Arising From the Substance/Mixture Hazardous decomposition products f ormed under f ire conditions--see section 10. Special PPE and/or Precautions for Firefighters A self-contained breathing apparatus f or f iref ighting if necessary. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Avoid dust f ormation. Avoid breathing vapors, mist or gas. Methods and Materials Used for Containment Do not let product enter drains. Cleanup Procedures Sweep up and shovel. Keep in suitable, closed containers f or disposal. Page 1 of 4 Section 7: Handling and Storage Precautions for Safe Handling Keep locked up. Keep away from heat. Keep away from sources of ignition. Empty containers pose a f ire risk, evaporate the residue under a f ume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. Wear suitable protective clothing in case of insuf f icient ventilation, wear suitable respiratory equipment if ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Conditions for Safe Storage Keep container dry. Keep in a cool place (room temperature 10C-30C). Ground all equipment containing material. Carcinogenic; teratogenic or mutagenic materials should be stored in a separate locked saf ety storage cabinet or room. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Contains no substances with occupational exposure limit values. Appropriate Engineering Controls General industrial hygiene practice. PPE - Eye/Face Protection Use equipment f or eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166 (EU). PPE - Skin Protection Choose body protection in relation to its type, to the concentration and amount of dangerous substances, and to the specif ic workplace. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specif ic workplace. PPE - Body Protection Choose body protection in relation to its type, to the concentration and amount of dangerous substances, and to the specif ic workplace. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specif ic workplace. PPE - Respiratory Protection Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an ef f ective respirator program in place (applicable US regulation OSHA 29 CFR 1910.134). Section 9: Physical and Chemical Properties Appearance White or almost white crystalline powder. Upper/Lower Flammability or Explosive Limits No data available Odor Odorless 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 226.5�C (439.7�F) Solubility Soluble in hot water. Partially soluble in cold water. Initial Boiling Point and Boiling Range No data available Flash Point Not applicable (solid) Evaporation Rate Not applicable (solid) 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 Not available Chemical Stability The product is stable. Possibility of Hazardous Reactions Not available Conditions to Avoid Not available Incompatible Materials Not available Hazardous Decomposition Products Not available Page 2 of 4 Section 11: Toxicological Information Acute Toxicity - LD50 Oral Acute oral toxicity (LD50): >3200 mg/kg [Rat]. Acute Toxicity - Inhalation Not available Acute Toxicity - Dermal No data available Acute Toxicity - Eye Not available Skin Corrosion/Irritation No data available Serious Eye Damage/Irritation Not available Respiratory or Skin Sensitazation Laboratory experiments have shown teratogenic ef f ects. Overexposure may cause reproductive disorder(s) based on tests with laboratory animals. Germ Cell Mutagenicity No data available Carcinogenicity IARC No component of this product presents at levels greater than or equal to 0.1% is identif ied as probable, possible, or conf irmed human carcinogenic by IARC. Carcinogenicity ACGIH No component of this product presents at levels greater than or equal to 0.1% is identif ied as probable, possible, or conf irmed human carcinogenic by ACGIH. Carcinogenicity NTP No component of this product presents at levels greater than or equal to 0.1% is identif ied as probable, possible, or conf irmed human carcinogenic by NTP. Carcinogenicity OSHA No component of this product presents at levels greater than or equal to 0.1% is identif ied as probable, possible, or conf irmed human carcinogenic by OSHA. 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 Not available. Persistence and Degradability Not available Bio-accumulative Potential Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. The product itself and its products of degradation are not toxic. Mobility in Soil Not available Other Adverse Effects No data available Section 13: Disposal Considerations Waste Treatment Methods Product No data available 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 TSCA 8(b) inventory: Not listed. Section 16: Other Information Additional Information N/A Prepared By Scarlotte Smith Revision Date 01/15/2019 15:53 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
