ESTRADIOL, USP (MICRONIZED) 5 KG by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name ESTRADIOL USP (HEMIHYDRATE) 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 Carc. 1B, Repr. 1B, STOT RE 1, Lact Signal Word Danger Hazard Statement(s) H350 May cause cancer H360 May damage f ertility or the unborn child H362 May cause harm to breast-f ed children H372 Causes damage to organs through prolonged or repeated exposure 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. P260 Do not breathe dust/f ume/gas/mist/vapours/spray. P263 Avoid contact during pregnancy/while nursing. P264 Wash hands thoroughly af ter handling. P281 Use personal protective equipment as required. P314 Get Medical advice/attention if you f eel unwell. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified Exposure may produce an allergic reaction. Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Estradiol Hemihydrate Common Name Estradiol USP (Hemihydrate) CAS Number 35380-71-3 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice If you f eel unwell, seek medical advice (show the label where possible). Delayed adverse ef f ects possible. If Inhaled Move to fresh air in case of accidental inhalation. Assure fresh air breathing. Obtain medical attention if breathing dif f iculty persists. In Case of Skin Contact Rinse skin with water/shower. Wash with plenty of soap and water. In Case of Eye Contact Rinse with water while holding the eyes wide open. Contact lenses should be removed. Obtain medical attention if pain, blinking or redness persist. If Swallowed Rinse mouth out with water. The f ollowing symptoms may occur: (see section(s): 2, 4.2). If you f eel unwell, seek medical advice. Prolonged medical observation may be indicated. (See section(s): 4.3). Most Important Symptoms and Effects See Heading 2. Indication of any immediate medical attention and special treatment needed In all cases of doubt, or when symptoms persist, seek medical attention. If possible show this sheet, if not available show packaging or label. Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Suitable extinguishing media Small amounts: Use extinguishing media appropriate f or surrounding f ire. Extinguishing blanket. Carbon dioxide. Dry powder. Large amounts: Not applicable. Unsuitable extinguishing media: Water may be inef f ective in f iref ighting due to low solubility. Special Hazards Arising From the Substance/Mixture No additional inf ormation available Special PPE and/or Precautions for Firefighters Small amounts: Use normal individual f ire protective equipment. Large amounts: Not applicable. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Avoid raising dust. Wear suitable protective clothing, gloves and eye or f ace protection. Avoid any direct contact with the product. Evacuate unnecessary personnel. Large amounts: Not applicable. Methods and Materials Used for Containment Spill should be handled by trained cleaning personnel properly equipped with respiratory and eye protection. Wear suitable protective clothing and gloves. Cleanup Procedures Sweep spilled substance into containers; if appropriate, moisten f irst to prevent dusting. Ensure waste is collected and contained. Clean thoroughly. Poorly soluble in water. Clean with the help of detergents. Collect all waste in suitable and labelled containers and dispose according to local legislation. Wash the non-recoverable remainder with: Sodium hypochlorite solution. Section 7: Handling and Storage Precautions for Safe Handling Handle and open container with care. See Heading 8. Do not handle until all saf ety precautions have been read and understood. Avoid any direct contact with the product. Obtain special instructions bef ore use. Handle in accordance with good industrial hygiene and saf ety procedures. Small amounts: Material should be handled in a laboratory hood whenever possible. Conditions for Safe Storage Comply with applicable regulations. To guarantee the quality and properties of the product, keep: dry, Keep in a cool, well-ventilated place away from heat. Store in original container. Store according to local legislation. Incompatible products Strong oxidizing agents. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters No additional inf ormation available Appropriate Engineering Controls Material should be handled in a laboratory hood whenever possible. Gloves. Saf ety glasses. Protective clothing. Dust production: dust mask with f ilter type P3. PPE - Eye/Face Protection Wear eye protection. DIN EN 166. PPE - Skin Protection Gloves. Chemical resistant PVC gloves (to European standard EN 374 or equivalent). Lab coat. Wear suitable protective clothing. DIN EN 13034. PPE - Body Protection Lab coat. Wear suitable protective clothing. DIN EN 13034. PPE - Respiratory Protection Quarter mask (DIN EN 140). Wear appropriate breathing apparatus if air renewal not suf f icient to maintain dust/vapour under TLV. Page 2 of 4 Section 9: Physical and Chemical Properties Appearance White or creamy white, small crystals or 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 173 - 179 �C Solubility Soluble in dioxane, in acetone, sparingly soluble in ethanol. 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 Log Pow 3,94 at 20�C (6.10) Auto-Ignition Temperature No data available Decomposition Temperature No data available Viscosity No data available Section 10: Stability and Reactivity Reactivity Stable under normal conditions. Chemical Stability No additional inf ormation available Possibility of Hazardous Reactions Small amounts: When used and handled according to specif ications, the product does not have any harmf ul ef f ects according to our experience and the inf ormation provided to us. Large amounts: Not applicable. Conditions to Avoid No additional inf ormation available Incompatible Materials Small amounts: None under normal use. Large amounts: Not applicable. Hazardous Decomposition Products When heated to decomposition, emits dangerous f umes. Large amounts: Not applicable. Section 11: Toxicological Information Acute Toxicity - LD50 Oral Not classif ied Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation Not classif ied Serious Eye Damage/Irritation Not classif ied Respiratory or Skin Sensitazation Not classif ied Germ Cell Mutagenicity Not classif ied Carcinogenicity IARC May cause cancer. Carcinogenicity ACGIH May cause cancer. Carcinogenicity NTP May cause cancer. Carcinogenicity OSHA May cause cancer. Reproductive Toxicity May damage f ertility. May damage the unborn child. May cause harm to breast-f ed children. Specific Target Organ Toxicity - Single Exposure Not classif ied Specific Target Organ Toxicity - Repeated Exposure Causes damage to organs through prolonged or repeated exposure. Aspiration Hazard Not classif ied Page 3 of 4 Section 12: Ecological Information Toxicity Small amounts: See Heading 2. Poorly soluble in water. No data available on ecotoxicity. Hazardous waste. Use suitable disposal containers. Large amounts: Not applicable. Persistence and Degradability No additional inf ormation available Bio-accumulative Potential Log Pow 3,94 at 20�?°C (6.10) Mobility in Soil No additional inf ormation available Other Adverse Effects No additional inf ormation available Section 13: Disposal Considerations Waste Treatment Methods Product Dispose in a saf e manner in accordance with local/national regulations. Waste Treatment Methods Packaging Do not empty into drains, dispose of this material and its container at hazardous or special waste collection point. 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 No data available. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/11/2019 16:36 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
