PREDNISOLONE, USP (ANHYDROUS) (MICRONIZED) 25GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name PREDNISOLONE ANHYDROUS MIC 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) 1-Dehydrocortisol, 1-Dehydrohydrocortisone, 1,4-Pregnadiene-11�, 17a,21-triol-3,20-dione, 11�,17a,21-Trihydroxy1,4-pregnadiene-3,20-dione Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Acute toxicity, Oral (Category 4) Signal Word Warning Hazard Statement(s) H302 Harmf ul if swallowed Pictogram(s) Precautionary Statement(s) P264 Wash hands thoroughly af ter handling. P270 Do not eat, drink or smoke when using this product. P301+P312 IF SWALLOWED Call a POISON CENTER or doctor/physician if you f eel unwell. P330 Rinse mouth. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Prednisolone Common Name Prednisolone Anhydrous CAS Number 50-24-8 Impurities and/or Stabilizing Additives N/A Section 4: First Aid Measures General Advice Consult a physician. Show this saf ety data sheet to the doctor in attendance. If Inhaled Move person into fresh air. If not breathing give artif icial respiration. Consult a physician. In Case of Skin Contact Wash of f with soap and plenty of water. Consult a physician. In Case of Eye Contact Rinse thoroughly with plenty of water f or at least 15 minutes and consult a physician. If Swallowed Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. 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 No data available Special PPE and/or Precautions for Firefighters Wear self contained breathing apparatus f or f ire f ighting if necessary. Page 1 of 4 Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Use personal protective equipment. Avoid dust f ormation. Avoid breathing dust. Ensure adequate ventilation. Methods and Materials Used for Containment Do not let product enter drains. Cleanup Procedures Pick up and arrange disposal without creating dust. Keep in suitable, closed containers f or disposal. Section 7: Handling and Storage Precautions for Safe Handling Avoid f ormation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is f ormed. Normal measures f or preventative f ire protection. Conditions for Safe Storage Store in cool place. Keep container tightly closed in a dry and well-ventilated place. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters No data available. Appropriate Engineering Controls Hygiene measures: Handle in accordance with good industrial hygiene and saf ety practice. Wash hands bef ore breaks and at the end of workday. PPE - Eye/Face Protection Saf ety glasses with side-shields conf orming to EN166. PPE - Skin Protection The selected protective gloves have to satisf y the specif ications of EU Directive 89/686/EEC and the standard EN 374 derived from it. Handle with gloves. PPE - Body Protection Choose body protection according to the amount and concentration of the dangerous substance at the work place. PPE - Respiratory Protection Where risk assessment shows air-purif ying respirators are appropriate use a dust mask type N95 (US) or type P1 (EN143) respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Section 9: Physical and Chemical Properties Appearance Form: solid Upper/Lower Flammability or Explosive Limits No data available Odor No data availabel 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 - dec. 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 data available Chemical Stability Stable under normal recommended storage conditions. Possibility of Hazardous Reactions No data available Conditions to Avoid No data available Incompatible Materials Strong oxidizing agents. Hazardous Decomposition Products Products f ormed under f ire conditions. - Carbon oxide Page 2 of 4 Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Oral - mouse - 1.680 mg/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 No data available Carcinogenicity IARC IARC: No component of this product present at levels greater than or equal to 0.1% is identif ied as probable, possible or conf irmed human carcinogen by IARC. Carcinogenicity ACGIH No data available Carcinogenicity NTP No data available Carcinogenicity OSHA No data available Reproductive Toxicity Prednisolone can consistently cause clef t palate in rodent and rabbits, but this teratogenic ef f ect is not seen with the human use of prednisolone in therapeutic treatments. Retrospective epidemiology studies have associated oral clef ting with human pregnancy exposure to corticosteroids based on small numbers of af f ected children with exposures. 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 Observe all f ederal, state, and local environmental regulations. Contact a licensed prof essional 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 af terburner and scrubber. Waste Treatment Methods Packaging Dispose of as unused product. 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 No data available Section 15: Regulatory Information This saf ety datasheet complies with the requirements of Regulation (EC) No 1272/2008 (CLP Regulation) Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/09/2019 17:10 Disclaimer Page 3 of 4 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
