Material Safety Data Sheet: Abiraterone

Identification

Product name: Abiraterone acetate
Synonyms: CB7630; Zytiga
Chemical formula: C26H33NO2
CAS number: 154229-18-2
Recommended use: Pharmaceutical intermediate, active pharmaceutical ingredient for androgen biosynthesis inhibition
Manufacturer contact: Refer to supplier’s safety department for up-to-date emergency contact information
Emergency phone: Chemtrec: +1-800-424-9300 (for US); international numbers for non-US residents
Address: Manufacturer or importer’s standard registered location as issued on original label; includes full address, city, state, and postal code

Hazard Identification

GHS classification: Harmful if swallowed, suspected of causing cancer, causes skin and eye irritation, may cause respiratory irritation
Signal word: Warning
Hazard statements: Harmful if inhaled, causes damage to organs through prolonged exposure, may cause allergy or asthma symptoms or breathing difficulties if inhaled, suspected reproductive hazard
Pictograms: Exclamation mark, health hazard, environment
Precautionary statements: Wear gloves, protective clothing, and eye protection. Use only outdoors or in a well-ventilated area. Avoid breathing dust or vapors.

Composition / Information on Ingredients

Chemical name: Abiraterone acetate
Concentration: Over 97% by weight
Impurities: Traces of related steroidal intermediates and excipients possible
Molecular weight: 391.54 g/mol
Other ingredients (if present): None listed in API; for formulated medicines, see specific product MSDS

First Aid Measures

Inhalation: Move exposed individual to fresh air immediately. Seek medical attention if symptoms develop (shortness of breath, persistent coughing).
Skin contact: Remove contaminated clothing and rinse affected skin with soap and plenty of water for at least 15 minutes. If irritation persists, consult physician.
Eye contact: Rinse eyes thoroughly with water for several minutes. Remove contact lenses if present and easy to do. Seek medical attention if irritation remains.
Ingestion: Do not induce vomiting. Rinse mouth with water. Seek immediate medical attention.
Acute symptoms: Irritation of eyes, skin, respiratory tract; headache or dizziness possible with high vapor exposure.
Delayed symptoms: Allergic response, delayed onset toxicity (possible hormonal or reproductive effects).

Fire-Fighting Measures

Suitable extinguishing media: Dry chemical, carbon dioxide, foam, or water spray may control minor fires.
Unsuitable extinguishing media: Direct water jet could spread product.
Special firefighting procedures: Wear full protective gear and self-contained breathing apparatus. Use personal protection to avoid inhalation of fumes, vapors, or dust.
Specific hazards: Toxic fumes may arise if product burns (COx, NOx, possibly unreacted abiraterone vapor).
Combustion products: Oxides of carbon and nitrogen, possible unidentified organic fragments.
Advice for firefighters: Approach upwind to minimize inhalation. Cool exposed containers with water.

Accidental Release Measures

Personal precautions: Evacuate personnel from affected area. Use personal protective equipment including gloves, respirator, and goggles.
Environmental precautions: Prevent further leakage or spillage if it's safe. Avoid release to environment, especially watercourses.
Containment: Cover spills with absorbent material (inert, non-combustible, such as clay or sand). Avoid dust formation.
Clean-up: Sweep up or shovel the solid product, place in a labeled waste container for disposal. Ventilate area.
Decontamination: Wash spill site with water after material pickup is complete.

Handling and Storage

Safe handling: Use only in an area with local exhaust ventilation. Wear standard laboratory PPE. Minimize formation and accumulation of dust.
Hygiene measures: Avoid contact with skin, eyes, and clothing. Wash hands thoroughly after handling.
Storage conditions: Keep tightly closed in original packaging. Store in a well-ventilated, cool, dry place. Protect from light and incompatible substances.
Incompatibilities: Strong oxidizers, acids, bases.
Special storage needs: Store below 25°C or as specified on the manufacturer's documentation.

Exposure Controls and Personal Protection

Engineering controls: Use with local exhaust ventilation, safety showers, and eyewash stations accessible.
Occupational exposure limits: No specific OSHA or ACGIH exposure limits for abiraterone acetate, but minimize exposure to lowest practicable levels.
Personal protection: Wear chemical-resistant gloves (nitrile preferred), safety glasses or goggles, long-sleeved laboratory coat, and disposable respirator or dust mask (NIOSH-certified) if dust or aerosols generated.
Respiratory protection: If engineering controls cannot keep dust levels below permissible limits, use appropriate respirator.
Environmental controls: Avoid uncontrolled environmental release; ensure compliant waste handling.

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Odor threshold: Not determined
pH: Not applicable
Melting point/range: Approximately 225–240°C
Boiling point: Not applicable (decomposes before boiling)
Flash point: Not available
Evaporation rate: Not available
Flammability: Not highly flammable; non-explosive
Vapor pressure: Negligible at room temperature
Relative density: 1.12 g/cm3 (approximately)
Solubility: Slightly soluble in water, freely soluble in organic solvents (methanol, ethanol, DMSO)
Partition coefficient (log Pow): 5.12 (approximate)
Decomposition temperature: Not established
Other data: Stable under recommended storage conditions.

Stability and Reactivity

Chemical stability: Product remains stable under intended storage and handling conditions.
Reactivity: Not reactive under normal conditions of use.
Potential hazardous reactions: Reaction with strong oxidizing agents may produce hazardous decomposition products.
Conditions to avoid: Excessive heat, formation of dust clouds, moisture, direct sunlight.
Incompatible materials: Strong acids, bases, oxidizers.
Hazardous decomposition products: Combustion may release carbon monoxide, carbon dioxide, nitrogen oxides, other toxic vapors.

Toxicological Information

Routes of exposure: Inhalation, skin contact, eye contact, ingestion
Acute toxicity: Data in rodents (oral LD50 >2000 mg/kg); minimal acute toxicity recorded during animal testing
Skin corrosion/irritation: May cause mild to moderate irritation with prolonged exposure
Serious eye damage/irritation: Can cause redness, stinging, and discomfort
Respiratory or skin sensitization: May produce allergic reactions in sensitized individuals
Germ cell mutagenicity: No significant evidence across standard screening tests
Carcinogenicity: Animal testing inconclusive, classified as possible carcinogen based on mode of action
Reproductive toxicity: Known reproductive toxicity; can cause birth defects or harm to fetus during pregnancy
Specific organ toxicity - single exposure: No significant findings in standard tests
Specific organ toxicity - repeated exposure: Hormonal disturbance in animal studies
Aspiration hazard: Not expected based on physical properties
Chronic effects: Potential effects on endocrine, reproductive, and metabolic systems with long-term or occupational exposure.

Ecological Information

Aquatic toxicity: No comprehensive ecotoxicological data; moderate hazard to aquatic organisms is suggested based on steroidal structure
Persistence and degradability: Moderately persistent in soil and water; biodegradable over several weeks under aerobic laboratory conditions
Bioaccumulative potential: May bioaccumulate in aquatic organisms; log Kow above 5
Soil mobility: Low solubility in water suggests limited soil mobility
Other adverse effects: Pharmaceuticals, hormones, and related compounds can disrupt aquatic life cycles and reproductive patterns at low concentrations
Precaution: Prevent entry into waterways, soil, and drains.

Disposal Considerations

Waste disposal method: Dispose of contents and container in accordance with local, regional, national, and international regulations.
Hazardous waste: Treat as hazardous chemical waste due to potential pharmacological and ecological harm.
Contaminated packaging: Treat empty containers like unused product. Triple-rinse or incinerate, as permitted by law.
Special precautions: Use authorized chemical waste handler.
Do not dispose: With regular trash or sewage systems.

Transport Information

UN number: Not regulated for road, rail, sea, or air transportation under UN transport rules
UN proper shipping name: Not assigned for standard shipments
Transport hazard class: Not classified as dangerous for transport
Packing group: Not applicable
Environmental hazards: No special hazards for standard transport; environmental risk if large quantity spills occur
Special transport precautions: Ship in containers designed to safeguard integrity and prevent dispersal; avoid exposure to heat and moisture
DOT, IATA, IMDG regulations: Not listed as hazardous under these frameworks

Regulatory Information

OSHA hazard classification: Hazardous, as defined by OSHA Hazard Communication Standard (29 CFR 1910.1200)
TSCA inventory: Exempt as pharmaceutical product
REACH status: Substance registration required for EU, see ECHA database
WHMIS: D2A (Very Toxic Material Causing Other Toxic Effects) in Canada
California Proposition 65: Not listed as known carcinogen or reproductive toxin, but clinical caution applies
Other regulations: Listed as controlled active ingredient in major markets (USA, EU, Japan)
Global chemical lists: Check import/export documentation for restriction notices
Labeling requirements: Product label must include hazard pictograms, signal word, hazard/precautionary statements, supplier contact