PREDNISOLONE SODIUM PHOSPHATE, USP 5GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name PREDNISOLONE SODIUM PHOSPHATE 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) (11b)-11,17-Dihydroxy-21-(phosphonooxy)-pregna-1,4-diene-3,20- dione disodium salt; Disodium prednisolone 21- phosphate Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Reproductive toxicity (Category 2), Specif ic target organ toxicity, repeated exposure (Category 1) endochrine system Signal Word Warning Hazard Statement(s) H302 Harmf ul if swallowed H312 Harmf ul in contact with skin H315 Causes skin irritation H319 Causes serious eye irritation H332 Harmf ul if inhaled H335 May cause respiratory irritation H361d Suspected of damaging the unborn child Pictogram(s) 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 (11b)-11,17-Dihydroxy-21-(phosphonooxy)-pregna-1,4-diene-3,20- dione disodium salt; Disodium prednisolone 21- phosphate Common Name Prednisolone Sodium Phosphate CAS Number 125-02-0 Impurities and/or Stabilizing Additives 96.0-103.0% Section 4: First Aid Measures General Advice No data available If Inhaled Remove from exposure. If not breathing give artif icial respiration. If breathing is dif f icult give oxygen. Get medical attention in case of adverse reactions. In Case of Skin Contact Remove contaminated clothing and shoes. Wash with water and soap. Get medical attention in case of adverse reactions. In Case of Eye Contact Flush with copius water f or at least 15 minutes. Get medical attention in case of adverse reactions. If Swallowed Flush out mouth with water provided is conscious. Get medical attention in case of adverse reactions. Most Important Symptoms and Effects No data available 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 Emit toxic f umes when heated to decomposition or under f ire conditions. Do not breathe f umes or dust. Special PPE and/or Precautions for Firefighters Keep containers cool with water spray. Wear boots, overalls, gloves, eye and f ace protection and breathing apparatus in compliance with law. Page 1 of 4 Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Protective equipment. Eye: Wear approved saf ety goggles. Skin: Wear approved clothing. Respiration: Wear approved f ull f ace respirator P3. Methods and Materials Used for Containment Contain spillage, and then collect with non-combustible absorbent material, (e.g. sand, earth, distomaceous earth, vermiculite) and place in container f or disposal according to local/national regulations (see section 13.) If emergency, enf orce internal emergency plan. Cleanup Procedures Contain spillage, and then collect the non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite) and place in container f or disposal according to local/national regulations (see section 13) If emergency, enf orce internal emergency, enf orce internal emergency plan. In case of accidental release or spill, keep away from drains, surf ace and ground water. Section 7: Handling and Storage Precautions for Safe Handling Keep away from heat and f lames. Avoid powder dispersion. Avoid contact with incompatible substances. Avoid: direct contact with skin and eyes; inhalation of vapours and f umes. Wear appropriate PPE (See Section 8). Do not eat, drink or smoke in work areas. Conditions for Safe Storage Store at room temperature. Keep away from heat, sparks and ignition sources. Keep in well-sealed labeled containers away from light. Keep in ventilated place. Avoid direct sun light. Avoid static discharges f ormation. Store in accordance with all current regulations and standards. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters No data available Appropriate Engineering Controls Provide adequate engineering control measures in conf ined plants or with local exhaust ventilation systems. PPE - Eye/Face Protection Wear eye protection. PPE - Skin Protection Wear protective gloves. PPE - Body Protection Wear Protective clothing and protective gloves. PPE - Respiratory Protection Wear f ace protection. Section 9: Physical and Chemical Properties Appearance Form: Crystalline Hygroscopic powder Colour: White or almost 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 About 8.0 Relative Density No data available Melting Point/Freezing Point No data available Solubility Water solubility Freely soluble in water. 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 Page 2 of 4 Section 10: Stability and Reactivity Reactivity The substance is an organic compound may create in particular conditions (ex. Temperature, pressure, powder granulometry, humidity, oxygen concentration) explosive mixtures with air. In case of accidental release remove all sources of ignition and ventilate gradually the area. Chemical Stability The substance is stable in normal conditions of temperature and pressure and if stocked in closed containers in cold and ventilated area. Possibility of Hazardous Reactions The substance is an organic compound, may create in particular conditions (ex. Temperature, pressure, powder granulometry, humidity, oxygen concentration) explosive mixtures with air. In case of accidental release, remove all sources of ignition and ventilate gradually the area. Conditions to Avoid Keep away from heat, f lames, sources of ignition and static discharges. Incompatible Materials Strong oxidizing agents, acids and bases. Hazardous Decomposition Products When heated to decomposition or under f ire conditions material emits toxic f umes of carbon moNOxide and carbon dioxide gas. Section 11: Toxicological Information Acute Toxicity - LD50 Oral No data available Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye Causes serious eye irritation. Skin Corrosion/Irritation Causes skin burns. Serious Eye Damage/Irritation Causes serious eye irritation. Respiratory or Skin Sensitazation No data available Germ Cell Mutagenicity No data available Carcinogenicity IARC No data available Carcinogenicity ACGIH No data available Carcinogenicity NTP No data available Carcinogenicity OSHA No data available 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 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 Dispose of in accordance with local regulations. 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 in accordance with local regulations. 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 Page 3 of 4 Section 15: Regulatory Information Dir. 67/548/CE and modif ies: n. 1907/2006/CE (REACH) Regulation, n. 1272/2008/CE (CLP) Regulation, n. 790/2009/CE Regulation. D.Lgs. 81/2008 and modif ies and Dir. 2009/161/UE. D.Lgs. 334/1999 and modif ies. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/09/2019 17:09 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
