HYDROCORTISONE, USP (MICRONIZED) 1KG by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name HYDROCORTISONE 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) N/A 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. P281 Use personal protective equipment as required. P308+P313 IF exposed or concerned Get medical advice/attention. P405 Store locked up. Hazards Not Otherwise Classified Very strong dust explosion characteristic. Very high sensitivity to ignition. Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name N/A Common Name Hydrocortisone CAS Number 50-23-7 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice No data available If Inhaled Remove to fresh air and keep patient at rest. Seek medical attention immediately. In Case of Skin Contact Wash exposed area with soap and water, remove contaminated clothing and obtain medical assistance if irritation occurs.This material may not be completely removed by conventional laundering. Consult prof essional laundry service. Do not home launder. In Case of Eye Contact Flush eye(s) immediately with plenty of water. If irritation occurs or persists, get medical attention. If Swallowed Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately. Most Important Symptoms and Effects For inf ormation on potential signs and symptoms of exposure, See Section 2 - Hazards Identif ication. Medical Conditions Aggravated by Exposure: None known. Notes to Physician: None. Inf ormation on Toxicological Ef f ects: May cause minimal eye irritation (based on animal data). May be harmf ul if swallowed. May be harmf ul if absorbed through the skin. Accidental ingestion may cause ef f ects similar to those seen in clinical use. Long Term: Known Clinical Ef f ects: Animal studies have shown a potential to cause adverse ef f ects on the f etus. Ingestion of this material may cause ef f ects similar to those seen in clinical use including nausea, vomiting, muscle cramps, weakness, nervousness, restlessness, trouble sleeping. Clinical use has resulted in changes in electrolytes and/or blood chemistry changes. Drugs of this class may cause Cushing's syndrome, manif ested by moon f ace, obesity, headache, acne, thirst, increased urination, impotence, menstrual irregularities, f acial hair growth, and mental changes. Clinical use may cause an increase in blood pressure (hypertension). Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Extinguish f ires with CO2, extinguishing powder, f oam, or water. Special Hazards Arising From the Substance/Mixture Formation of toxic gases is possible during heating or f ire. May include oxides of carbon. Very strong dust explosion characteristic. Very high sensitivity of a dust cloud to ignition, based on minimum ignition energy. Special PPE and/or Precautions for Firefighters During all f ire f ighting activities, wear appropriate protective equipment, including self-contained breathing apparatus. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. Methods and Materials Used for Containment Place waste in an appropriately labeled, sealed container f or disposal. Care should be taken to avoid environmental release. Cleanup Procedures Contain the source of the spill if it is saf e to do so. Collect spilled material by a method that controls dust generation. Avoid use of a f iltered vacuum to clean spills of dry solids, due to the potential f or electrostatic discharge and the very strong dust explosion characteristic and very high sensitivity to ignition. Additional consideration f or Large Spills: Nonessential personnel should be evacuated from af f ected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel. Section 7: Handling and Storage Precautions for Safe Handling Ground and bond all bulk transf er equipment. Avoid open handling. Minimize dust generation. All conductive elements of the system that contact the dry substance should be properly bonded and grounded and equipped with proper explosion relief or suppression systems. This material should not be f lowed through nonconductive ducts or pipes because of the potential f or electrostatic discharge ignition. Restricting the use of high resistivity materials, such as plastics, should be considered. Use local exhaust ventilation or perf orm work under f ume hood/f ume cupboard. Avoid inhalation and contact with skin, eye, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash hands and any exposed skin af ter removal of PPE. Releases to the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA f iltration systems or other equivalent controls. Conditions for Safe Storage Store at room temperature in properly labeled containers. Keep away from heat, sparks and f lames. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Manuf acturer OEL TWA-8 Hr: 100�?µg/m3, Skin Appropriate Engineering Controls Engineering controls should be used as the primary means to control exposures. Use process containment, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. PPE - Eye/Face Protection Wear saf ety glasses as minimum protection. PPE - Skin Protection Wear impervious gloves to prevent skin contact. Wear impervious protective clothing to prevent skin contact - consider use of disposable clothing where appropriate. PPE - Body Protection Wear impervious protective clothing to prevent skin contact - consider use of disposable clothing where appropriate. PPE - Respiratory Protection If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection f actor suf f icient to control exposures to below the OEL. Page 2 of 4 Section 9: Physical and Chemical Properties Appearance Form: Crystalline powder Color: White to of f-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 215 (decomposes) Solubility Solvent Solubility: Miscible: Acetone, Chlorof orm, Ethanol, Methanol Water Solubility: 0.28 mg/mL 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 (Method, pH, Endpoint, Value): Predicted 7.4 Log D 1.43 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 at normal conditions. Possibility of Hazardous Reactions No data available Conditions to Avoid Keep away from heat and other sources of ignition, including electrostatic discharge. Incompatible Materials As a precautionary measure, keep away from strong oxidizers Hazardous Decomposition Products No data available Section 11: Toxicological Information Acute Toxicity - LD50 Oral Rat Oral LD50 5000 mg/kg Mouse Oral LD50 5000 mg/kg Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal Rat Subcutaneous LD50 449 mg/kg Rat Intraperitoneal LD50 150 mg/kg Acute Toxicity - Eye No data available Skin Corrosion/Irritation No data available Serious Eye Damage/Irritation Eye Irritation Rabbit Minimal Respiratory or Skin Sensitazation No data available Germ Cell Mutagenicity Genetic Toxicity: (Study, Type, Cell Type/Organism, Result) Bacterial Mutagenicity (Ames) Salmonella Negative. Unscheduled DNA Synthesis Rat Negative Carcinogenicity IARC Not listed as a carcinogen by IARC. Carcinogenicity ACGIH No data available Carcinogenicity NTP Not listed as a carcinogen by NTP. Carcinogenicity OSHA Not listed as a carcinogen by US OSHA Reproductive Toxicity (Study Type, Species, Route, Dose, End Point, Ef f ect(s)) Embryo/Fetal Development Mouse Oral 10 mg/kg/day LOAEL Teratogenic. Reproductive & Fertility Rat Oral 210 mg/kg/day LOAEL Maternal Toxicity. Specific Target Organ Toxicity - Single Exposure No data available Specific Target Organ Toxicity - Repeated Exposure (Duration, Species, Route, Dose, End Point, Target Organ): 7 Day(s) Mouse Oral 140 mg/kg/day LOAEL Thymus. 4 Day(s) Mouse Subcutaneous 100 mg/kg/day LOAEL Liver. 2 Week(s) Mouse Subcutaneous 560 mg/kg/day LOAEL Liver, Bone Marrow. 85 Day(s) Rat Subcutaneous 175 mg/kg/day LOAEL Adrenal gland Aspiration Hazard No data available Page 3 of 4 Section 12: Ecological Information Toxicity Environmental properties have not been thoroughly investigated. Releases to the environment should be avoided. Persistence and Degradability No data available Bio-accumulative Potential Partition Coef f icient: (Method, pH, Endpoint, Value): Predicted 7.4 Log D 1.43 Mobility in Soil No data available Other Adverse Effects No data available Section 13: Disposal Considerations Waste Treatment Methods Product Dispose of waste in accordance with all applicable laws and regulations. Member State specif ic and Community specif ic provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques f or waste and wastewater. Waste Treatment Methods Packaging Dispose of waste in accordance with all applicable laws and regulations. Member State specif ic and Community specif ic provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques f or waste and wastewater. 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 Canada - WHMIS: Classif ications WHMIS hazard class: Class D, Division 2, Subdivision A CERCAL/SARA 313 Emission reporting: Not Listed. Calif ornia Proposition 65: Not Listed. Inventory - United States - TSCA - Sect. 8(b): Present. Australia (AICS): Present. Standard f or the Unif orm Scheduling f or Drugs and Poisons: Schedule 2, Schedule 3, Schedule 4. EU EINECS/ELINCS List: 200-020-1 Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/11/2019 14:02 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
