Exemestane Material Safety Data Sheet (MSDS)

Identification

Product Name: Exemestane
Chemical Name: 6-methyleneandrosta-1,4-diene-3,17-dione
Synonyms: Aromasin, Exemestan
CAS Number: 107868-30-4
Recommended Use: Pharmaceutical active substance
Manufacturer/Supplier: Contact relevant supplier’s safety officer
Emergency Telephone: Supplier’s emergency contact

Hazard Identification

Globally Harmonized System (GHS) Classification: Skin Sensitizer, Reproductive Toxicity, Specific Target Organ Toxicity
Label Elements: Pictograms showing health hazard and exclamation mark
Signal Word: Danger
Hazard Statements: May cause allergic skin reaction; Suspected of damaging fertility or the unborn child; Causes damage to organs through prolonged or repeated exposure
Precautionary Statements: Wear protective equipment; Avoid inhalation, ingestion, and contact with skin or eyes; Obtain special instructions before use; Do not handle until all safety precautions have been read and understood

Composition / Information on Ingredients

Chemical Ingredient: Exemestane
Chemical Formula: C20H24O2
Concentration: Pure substance or as outlined on packaging
Impurities/Additives: None expected for pharmaceutical grade
Other Ingredients: No significant non-hazardous components reported

First Aid Measures

Inhalation: Move person to fresh air; seek medical attention for persistent symptoms
Skin Contact: Remove contaminated clothing; wash affected area thoroughly with soap and water; seek medical attention if irritation persists
Eye Contact: Flush open eyes continuously with plenty of water for at least 15 minutes; obtain medical assistance if discomfort continues
Ingestion: Rinse mouth; never give anything by mouth to an unconscious person; seek immediate medical advice
Most Important Symptoms/Effects: Irritation, allergic reaction, possible reproductive risks depending on dose and exposure route

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, CO2 extinguishers
Unsuitable Extinguishing Media: Strong water jet
Specific Hazards: May emit toxic fumes under fire conditions including carbon monoxide, carbon dioxide, and unidentified organic compounds
Protective Equipment for Firefighters: Full protective suit and self-contained breathing apparatus
Special Precautions: Fight fire from a safe distance; avoid inhaling combustion products

Accidental Release Measures

Personal Precautions: Wear respirator and full protective clothing; prevent contact with skin and eyes
Environmental Precautions: Prevent entry into drains, sewers, and waterways; notify relevant authorities for large releases
Clean-up Methods: Scoop up spilled material using appropriate tools; transfer to suitable container for disposal; clean area with water after all material is removed
Emergency Procedures: Evacuate area for significant spills; ventilate enclosed spaces

Handling and Storage

Precautions for Safe Handling: Avoid dust generation; minimize exposure; use only in well-ventilated areas; handle using recommended PPE
Advice on Storage: Keep container tightly closed in a dry, cool, and well-ventilated space; store away from incompatible substances like strong acids, bases, and oxidizers; protect from light and moisture
Incompatible Materials: Strong oxidizing agents, acids, alkalis
Hygiene Measures: Do not eat, drink, or smoke when using; wash hands thoroughly after handling

Exposure Controls and Personal Protection

Exposure Limits: No occupational exposure limits established specifically for Exemestane
Engineering Controls: Use local exhaust ventilation to minimize exposure
Personal Protective Equipment: Respiratory protection such as NIOSH-approved respirator for dusty processes, chemical-resistant gloves, safety goggles, and laboratory coat
Environmental Controls: Keep waste and residues separate and prevent discharge to natural environment

Physical and Chemical Properties

Physical State: Solid (powder or crystalline solid)
Color: White to off-white
Odor: Odorless
Molecular Weight: 296.4 g/mol
Melting Point: 155–156°C
Solubility: Practically insoluble in water; soluble in methanol and DMSO
Boiling Point: Data not available
Density: Approx 1.2 g/cm³
pH: Not applicable
Other Properties: Stable under normal storage and usage conditions

Stability and Reactivity

Chemical Stability: Stable at room temperature when stored as recommended
Reactivity: Not particularly reactive under recommended storage and handling conditions
Conditions to Avoid: Excess moisture, extended exposure to air, extreme heat
Materials to Avoid: Strong oxidizers, strong acids, strong bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, other toxic fumes when subjected to fire or decomposition

Toxicological Information

Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: Low acute toxicity by oral or dermal exposure based on animal data
Chronic Toxicity: May impair fertility and be harmful to fetal development
Skin and Eye Contact: Possible irritation, redness, itching or rash
Ingestion Effects: Nausea, abdominal distress, possible hormonal effects
Sensitization: May cause allergic reaction in certain individuals
Carcinogenicity: Not classified by IARC; insufficient human data
Mutagenicity: Negative in standard tests
Reproductive Effects: Animal studies show decreased fertility and developmental risk

Ecological Information

Ecotoxicity: Expected to be hazardous to aquatic organisms at certain concentrations; data limited
Persistence and Degradability: Not readily biodegradable under standard test conditions
Bioaccumulative Potential: Potential for bioaccumulation in aquatic organisms due to lipophilicity
Mobility in Soil: Likely limited due to low solubility
Other Adverse Effects: Avoid dispersal into environment, consult regional statutes for discharge regulations

Disposal Considerations

Waste Disposal Methods: Collect and dispose of product and contaminated materials in accordance with local, regional, and national laws
Container Disposal: Empty containers may retain hazardous residues; manage as hazardous waste
Precautions: Avoid release to waterways; consider incineration for significant quantities; consult regulations for pharmaceutical waste

Transport Information

UN Number: Not assigned for pharmaceutical small quantities
Proper Shipping Name: Exemestane
Transport Hazard Class: Not classified as hazardous for transport
Packing Group: Not assigned
Marine Pollutant: Not listed, but avoid release to environment
Special Precautions: Secure packaging to prevent leaks; protect from excessive heat and moisture in transit

Regulatory Information

Safety, Health and Environmental Regulations: Subject to pharmaceutical handling regulations
US TSCA: Not listed for non-commercial use
EU REACH: Exempt as active pharmaceutical ingredient
Other International Inventories: Country-specific regulation for scheduling and reporting
OSHA: Not listed as hazardous but handle with universal precautions
WHMIS Classification (Canada): Not classified for consumer quantities; consider reproductive effects
Other Regulation: Use in certified laboratories and industrial settings only; follow workplace exposure guidance