MEDROXYPROGESTERONE ACETATE, USP (MICRONIZED) 100GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name Medroxyprogesterone Acetate 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) Pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6a); Clinovir; Farlutal; Lutoral; Oragest; Perlutex; Provera; Repromap Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Muta. 1B, Carc. 2, Acute Tox. 4, Eye Irrit. 2, STOT SE 3, Skin Irrit. 2, Repr. 1A Signal Word Danger 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 H340 May cause genetic def ects H351 Suspected of causing cancer H360 May damage f ertility or the unborn child Pictogram(s) Precautionary Statement(s) P260 Do not breathe dust/f ume/gas/mist/vapours/spray. P262 Do not get in eyes, on skin, or on clothing. P280 Wear protective gloves/protective clothing/eye protection/f ace protection. P312 Call a POISON CENTER or doctor/physician if you f eel unwell. P403+P233 Store in a well ventilated place. Keep container tightly closed. Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-(6a) Common Name Medroxyprogesterone Acetate CAS Number 71-58-9 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Notes to Physician: Treat symptomatically. If Inhaled If breathing is dif f icult, give oxygen. If not breathing, give artif icial respiration. Remove from exposure, lie down. In Case of Skin Contact Wash of f immediately with soap and plenty of water removing all contaminated clothes and shoes. In Case of Eye Contact Rinse thoroughly with plenty of water f or at least 15 minutes and consult a physician. If Swallowed Clean mouth with water, only if the person is conscious. Get medical attention. Most Important Symptoms and Effects Irritation: May be irritant to eyes, skin and respiratory system. Eyes: May cause irritation. Skin: May cause, Erythema multif orme, Hair loss, Hirsutism. Inhalation: May cause, irritation, itching. Ingestion: May cause, irritation. Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Water spray, carbon dioxide (CO2). Foam. Dry powder. Special Hazards Arising From the Substance/Mixture Thermal decomposition can lead to release of irritating gases and vapors. Combustible material. Special PPE and/or Precautions for Firefighters As in any f ire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and f ull protective gear. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Use personal protective equipment. Avoid contact with dusts/f umes/mists/vapors. Evacuate the danger area and alert emergency team. Methods and Materials Used for Containment Prevent entry into waterways, sewers, basements or conf ined areas. Prevent f urther leakage or spillage if saf e to do so. Cleanup Procedures Contain spillage, and then collect with non-combustible absorbent material (e.g. sand, earth, diatomaceous earth, vermiculite) and place in container f or disposal according to local/national regulations. If emergency, enf orce internal emergency plan. Section 7: Handling and Storage Precautions for Safe Handling Avoid contact with skin, eyes and clothing. Handle in accordance with good industrial hygiene and saf ety practice. Do not breathe vapors/dust. Provide appropriate exhaust ventilation at places where dust is f ormed. Handle in accordance with good industrial hygiene and saf ety practice. Conditions for Safe Storage Store at room temperature. Keep away from heat. Keep container tightly closed. Protect from light. Store in accordance with local regulations. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Exposure Limits: Manuf acturer OEL (8hr-TWA): 0.25ug/m3. Biological occupational exposure limits: No inf ormation available. Appropriate Engineering Controls Provide appropriate exhaust ventilation at places where dust is f ormed. Ensure adequate ventilation, especially in conf ined areas. Handle in accordance with good industrial hygiene and saf ety practice. PPE - Eye/Face Protection Use eye protection appropriate f or the task. PPE - Skin Protection Use protective gloves. PPE - Body Protection Use protective clothing appropriate f or the task. PPE - Respiratory Protection Use appropriate respiratory protection. Section 9: Physical and Chemical Properties Appearance White-Of f-white crystalline powder Upper/Lower Flammability or Explosive Limits No inf ormation available Odor Odorless Vapor Pressure No inf ormation available Odor Threshold No inf ormation available Vapor Density No inf ormation available pH No inf ormation available Relative Density No inf ormation available Melting Point/Freezing Point About 204 °C Solubility Soluble in Alcohol Methanol and Chlorof orm Initial Boiling Point and Boiling Range No inf ormation available Flash Point No inf ormation available Evaporation Rate No inf ormation available Flammability (Solid, Gas) No inf ormation available Partition Coefficient No data available Auto-Ignition Temperature No inf ormation available Decomposition Temperature No inf ormation available Viscosity No data available Page 2 of 4 Section 10: Stability and Reactivity Reactivity No inf ormation available Chemical Stability Stable under normal conditions. Possibility of Hazardous Reactions Hazardous polymerization does not occur. Conditions to Avoid Heat, f lames and sparks. Incompatible Materials Strong oxidizing agents Hazardous Decomposition Products Toxic f umes of , Carbon monoxide (CO), Carbon dioxide (CO2) Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Oral - rat - > 6,400 mg/kg, LD50 Subcutaneous rat > 900mg/kg. LD50 Oral mouse >16000 mg/kg. LD50 Subcutaneous mouse >1500 mg/kg. LD50 Intraperitoneal rat >900 mg/kg. LD50 Intraperitoneal mouse > 1500 mg/kg. Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation No inf ormation available. Serious Eye Damage/Irritation May cause, irritation. Respiratory or Skin Sensitazation May cause, irritation, Itching. Germ Cell Mutagenicity The product was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays. Human and animal mutation data reported by RTECS. Carcinogenicity IARC Long-term intramuscular administration of product has been shown to produce mammary tumors in beagle dogs. There was no evidence of a carcinogenic ef f ects associated with oral administration to rats and mice. The product is reported by IARC as possibly carcinogenic to humans (group 2B). Carcinogenicity ACGIH No data available Carcinogenicity NTP No data available Carcinogenicity OSHA No data available Reproductive Toxicity Experimental data on reproductive ef f ects reported by RTECS. The product at high doses is an antif ertility drug and high doses would be expected to impair f ertility until the cessation of treatment. Specific Target Organ Toxicity - Single Exposure No inf ormation available. Specific Target Organ Toxicity - Repeated Exposure No inf ormation available Aspiration Hazard No inf ormation available. Other inf ormation; Central nervous system: May cause changes in libido, May cause reduced appetite, May cause headache, May cause nervousness, May cause dizziness, May cause f atigue. Section 12: Ecological Information Toxicity No inf ormation available Persistence and Degradability Hazard of persistence may be possible. Bio-accumulative Potential Bioaccumulation may be possible. Mobility in Soil No inf ormation available. Other Adverse Effects No inf ormation available Section 13: Disposal Considerations Waste Treatment Methods Product Dispose of in accordance with local regulations. Waste Treatment Methods Packaging Empty containers should be taken f or local recycling, recovery or waste disposal. Special Precautions Landfill or Incinerations No data available Other Information No data available Page 3 of 4 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 All of the components in the product are on the f ollowing inventory lists: TSCA-, EINECS/ELINCS-, DSL/NDSL-, PICCS-, ENCS-, IECSC-, AICS-, KECL-. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/11/2019 09:50 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
