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Product Name: Raloxifene Hydrochloride
Synonyms: Evista, LY139481 HCl
Chemical Formula: C28H27NO4S·HCl
CAS Number: 82640-04-8
Use: Pharmaceutical compound for the treatment and prevention of osteoporosis in postmenopausal women, also used to reduce risk of invasive breast cancer.
Manufacturer Information: Provided by major pharmaceutical suppliers. Contact responsible distributor for batch-specific data and safe handling recommendations.
Emergency Contact: Refer to company emergency response line or poison control center for immediate help.
Classification: Not classified as hazardous according to GHS criteria for therapeutic use, but it can present health risk if mishandled in large quantities.
Routes of Exposure: Inhalation, ingestion, skin, and eye contact.
Symptoms: Possible irritation to skin, eyes, and respiratory tract. Overexposure by ingestion may impact blood clotting and liver function.
Signal Word: Warning
Hazard Statements: May cause respiratory and skin irritation, liver damage from prolonged or repeated exposure, not intended for direct consumption except as dispensed.
Pictograms: Exclamation mark (irritant), health hazard, specific target organ toxicity.
Chemical Name: Raloxifene Hydrochloride
Concentration: 98% or greater
Impurities: Trace amounts of related substances, high-purity pharmaceutical standard.
Additional Ingredients: Pharmaceutical grades may contain excipients; pure substance is typically handled in production or laboratory-scale environments.
Molecular Weight: 510.04 g/mol
Inhalation: Remove to fresh air, get medical attention if symptoms persist such as coughing or difficulty breathing.
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing and seek medical guidance if irritation persists.
Eye Contact: Flush immediately with plenty of clean water for at least 15 minutes, seek medical attention if redness or pain continues.
Ingestion: Do not induce vomiting. Rinse mouth and consult a physician, especially if large quantities have been swallowed.
Additional Advice: Show this sheet to the treating medical personnel.
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide.
Unsuitable Media: Direct water jets in confined areas can cause contamination spread.
Hazardous Combustion Products: May produce toxic fumes including nitrogen oxides, sulfur oxides, hydrochloric acid, carbon monoxide, and carbon dioxide when burned.
Protective Equipment: Firefighters must wear self-contained breathing apparatus and full protective clothing.
Special Precautions: Avoid breathing fumes, keep away from ignition sources, ventilate area after fire.
Spill Response: Evacuate area, prevent dust formation, ventilate, and clean up with non-sparking tools.
Personal Protection: Use respiratory protection, chemical-resistant gloves, protective goggles, and lab coat.
Containment: Prevent release to drains or watercourse, contain using absorbent materials like paper towels or inert sand.
Cleanup: Collect residue in suitable container for disposal, wash area thoroughly after material pick-up.
Precautions: Avoid contact with skin and eyes, minimize dust generation, ensure laboratory and industrial handling areas have adequate ventilation systems.
Safe Handling: Use engineering controls, avoid eating, drinking, or smoking when working with the material.
Storage Conditions: Store in tightly-closed containers, keep in a cool, dry, and well-ventilated place, protect from direct sunlight and incompatible substances.
Incompatible Materials: Strong oxidizing agents, acids, bases.
Special Guidelines: Maintain records for pharmaceutical traceability and environmental monitoring.
Occupational Exposure Limits: No established limit for Raloxifene Hydrochloride, but handle as potentially hazardous.
Engineering Controls: Use fume hoods, dust extraction systems, or local exhaust ventilation to maintain air concentration levels.
Personal Protective Equipment: Gloves (nitrile, latex), safety goggles, lab coats, NIOSH-approved respiratory protection if handling powder.
Hygiene Measures: Wash hands thoroughly after handling, no food or drinks in exposure areas.
Environmental Protection: Prevent spilled material from entering drains and water systems.
Appearance: White to pale yellow crystalline powder.
Odor: Odorless
Melting Point: Approx. 250°C (decomposes)
Solubility: Slightly soluble in water; more soluble in methanol, DMSO, and other organic solvents.
pH: Information available on request.
Boiling Point: Not determined (decomposes before boiling).
Vapor Pressure: Negligible at room temperature.
Partition Coefficient (Log Pow): Approx. 5.6
Other Data: Stable under recommended storage conditions, can degrade on exposure to heat or light.
Chemical Stability: Stable under normal laboratory and manufacturing conditions.
Conditions To Avoid: Excessive heat, moisture, acidic or basic environments, light exposure over long periods.
Incompatible Materials: Strong oxidizers, acids, alkalis.
Hazardous Decomposition Products: Nitrogen oxides, sulfur oxides, hydrochloric acid fumes.
Possibility of Hazardous Reactions: Little risk under normal handling; avoid conditions leading to dust formation or exposure to incompatible chemicals.
Likely Routes of Exposure: Inhalation, ingestion, skin and eye contact.
Symptoms: Potential irritant. Studies link high doses to changes in blood chemistry and liver injury. May alter hormone balance and blood clotting.
Acute Toxicity: Low acute oral and dermal toxicity in animal studies, but proprietary data may exist.
Chronic Effects: Risk of liver enzyme elevation, blood clotting disorders with repeated occupational exposure.
Carcinogenicity: Not classified as a human carcinogen by IARC or NTP.
Mutagenicity: Negative in most standard in vitro and in vivo tests.
Reproductive Effects: Can affect hormonal function; only use under medical supervision.
Ecotoxicity: Harmful to aquatic organisms at high concentrations.
Persistence and Degradability: Limited published data. Likely slow to biodegrade in water and soil.
Bioaccumulation Potential: Potential to bioaccumulate due to high log Pow.
Mobility in Soil: Limited mobility, binds to organic matter.
Other Information: Avoid uncontrolled discharge to environment. Decontaminate all equipment before disposal or reuse.
Disposal Method: Handle as hazardous waste according to local and national regulations.
Contaminated Packaging: Triple rinse containers before disposal, label as pharmaceutical waste.
Precautions: Prevent environmental release, use licensed waste management contractors.
Local Regulations: Check current EPA or equivalent guidance for pharmaceutical substances.
UN Number: Not classified for transport as a dangerous good under UN Model Regulations.
Proper Shipping Name: Raloxifene Hydrochloride (pharmaceutical compound).
Transport Hazard Class: Not regulated for air, road, or sea.
Packing Group: Not assigned
Special Precautions: Protect from moisture and light during shipment, avoid stacking to prevent breakage or physical damage.
Labeling Requirements: Subject to regulations by local workplace safety agencies and pharmaceutical law.
Chemical Inventory Status: Registered under regional chemical inventories where marketed as a drug.
OSHA Status: Not specifically regulated under OSHA hazard communication standard, general pharmaceutical handling rules apply.
SARA Section 313: Not listed.
California Proposition 65: Not listed.
EINECS/ELINCS: Listed in European chemical inventories.
Other Relevant Regulation: Finished pharmaceutical products governed by FDA or analogous health authorities in destination country.
