Material Safety Data Sheet for Cyproterone Acetate Intermediate

Identification

Product Name: Cyproterone Acetate Intermediate
Chemical Family: Steroidal compound
CAS Number: Specific CAS assigned to the intermediate must be checked by supplier
SYNONYMS: Listed according to the specific batch
Recommended Use: Pharmaceutical synthesis and active pharmaceutical ingredient production
Supplier Details: Manufacturer contact, address, business phone, emergency contact number
Emergency Overview: White to off-white powder or crystalline solid, faint odor, primarily for professional lab applications

Hazard Identification

Hazard Classification: Harmful if swallowed, potential mutagenic effect, skin and respiratory sensitization risk
Signal Word: Warning
Pictogram: Exclamation mark, health hazard symbol
Hazard Statements: May cause respiratory irritation, harmful if inhaled or absorbed through skin, potential reproductive toxicity risk
Precautionary Statements: Avoid dust formation, wear protective gloves/clothing/eye protection, ensure ventilation in work areas
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Target Organs: Liver, endocrine tissues, reproductive system
Potential Health Effects: Repeated or prolonged exposure may affect liver function and disrupt hormonal balance

Composition / Information on Ingredients

Chemical Name: Cyproterone Acetate Intermediate
Concentration: Approximately 98-100% pure depending on batch
Impurities: Listed per certificate of analysis provided by supplier
Other Components: Residual solvents, processing by-products, not considered hazardous within standard handling
Molecular Formula: C24H29ClO4 or batch-specific molecular information
Molecular Weight: 416.94 g/mol (for reference, verify for intermediate)
EC Number: If available from manufacturer or supplier

First Aid Measures

Inhalation: Remove person to fresh air, provide oxygen if breathing is difficult, get medical attention for persistent symptoms
Skin Contact: Wash immediately with plenty of water and soap, remove contaminated clothing, seek medical care if irritation develops
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses, continue rinsing, obtain medical help
Ingestion: Rinse mouth with water, do not induce vomiting, seek immediate medical guidance
Most Important Symptoms: Drowsiness, nausea, headache, allergic reactions in sensitive individuals, disruption in hormonal cycles
Note to Physician: Treat symptomatically based on clinical assessment, monitor for potential endocrine side-effects

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical powder, carbon dioxide, foam, non-direct water spray for large fires
Unsuitable Extinguishing Media: Avoid direct water jets to prevent spread of combustible dust
Specific Hazards: Thermal decomposition releases toxic fumes, carbon monoxide, hydrogen chloride, and oxides of carbon
Protective Equipment: Full protective gear, self-contained breathing apparatus recommended for responders
Fire Fighting Instructions: Isolate area, use fire barriers if possible, cool containers exposed to fire with water spray to prevent rupture

Accidental Release Measures

Personal Precautions: Wear approved respirators, chemical-resistant gloves, safety goggles; evacuate unprotected personnel
Environmental Precautions: Prevent entry into drains, sewers, waterways, soil; avoid discharge into the environment
Cleanup Methods: Use inert absorbent material for spills, sweep up without generating dust, collect in suitable, labeled containers for disposal
Decontamination: Wash spill area with water and detergent after material pickup, ventilate affected area
Disposal: Follow regional and national regulations for pharmaceutical intermediates or hazardous waste

Handling and Storage

Safe Handling: Use in well-ventilated chemical fume hood, wear proper PPE including gloves, goggles, lab coat, minimize dust
Storage Conditions: Keep tightly sealed in original container, store in cool, dry, well-ventilated place, away from light and incompatible materials
Incompatibilities: Strong oxidizers, acids, bases, avoiding mixing with unknown chemicals
Specific Storage Advice: Label containers clearly, check regularly for signs of leaks or degradation, segregate from food and beverages
Hygiene Practices: Prohibit eating, drinking, smoking in storage areas, wash hands thoroughly after handling

Exposure Controls and Personal Protection

Occupational Exposure Limits: No ACGIH TLV or OSHA PEL established for the intermediate; handle under strict laboratory safety protocols
Engineering Controls: Local exhaust ventilation, closed processes, glove boxes recommended in production or research
Personal Protective Equipment: Chemical-resistant gloves, safety goggles, lab coats, respiratory protection in case of dust or aerosol formation
Other Protection: Emergency showers and eyewash stations available in workspaces
Environmental Exposure Controls: Prevent release to environment, use spill containment procedures, monitor effluent from laboratory or production settings

Physical and Chemical Properties

Physical State: Solid
Appearance: White to off-white crystalline powder
Odor: Mild, characteristic of steroidal intermediates
pH: Not readily measurable in water, refer to batch data
Melting Point: Variable, consult specific batch certificate or literature
Boiling Point: Not applicable for solid/thermolabile intermediate
Flash Point: Not determined, typically low risk under ambient conditions
Solubility: Insoluble or slightly soluble in water, soluble in organic solvents (e.g., methanol, ethanol, chloroform)
Vapor Pressure: Negligible under normal conditions
Partition Coefficient (log Kow): Not established; consider structure for risk assessment
Decomposition Temperature: Can decompose at elevated temperatures, releasing toxic fumes

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Reactivity: No dangerous reactions known under normal laboratory conditions
Conditions to Avoid: Extreme heat, open flame, strong acids or oxidizers, extended exposure to air and moisture
Incompatible Materials: Strong bases, reactive chemicals, oxidizing agents
Hazardous Decomposition Products: Hydrogen chloride, carbon oxides, other organochlorine compounds if burned or overheated
Polymerization Risk: No known risk of hazardous polymerization from this intermediate

Toxicological Information

Acute Toxicity: Harmful if swallowed, inhaled, or absorbed through skin; oral and dermal LD50 not clarified, handle with caution
Chronic Toxicity: Animal studies show potential for reproductive and endocrine disruption with prolonged exposure
Skin Corrosion/Irritation: May cause mild to moderate irritation
Eye Damage/Irritation: Can cause redness and discomfort
Respiratory Sensitization: Prolonged inhalation of dust may irritate lungs
Germ Cell Mutagenicity: Data limited, recommend avoiding unnecessary exposure; some steroidal intermediates have shown mutagenic effects
Carcinogenicity: Not listed as carcinogenic by IARC, NTP, OSHA, but handle as potentially carcinogenic due to hormonal activity
Reproductive Toxicity: Disrupts hormone activity, not safe in pregnancy or reproductive-age workers without protection
Other Effects: Hormonal imbalance, hepatic stress in chronic exposures

Ecological Information

Ecotoxicity: Harmful to aquatic organisms, possible long-term adverse effects in aquatic environments
Persistence and Degradability: Intermediate shows low biodegradability in standard sewage treatment
Bioaccumulative Potential: Likelihood of bioaccumulation is high due to lipophilicity; avoid release into natural ecosystems
Mobility in Soil: Limited mobility, can adhere to organic matter, risk of groundwater contamination with repeated spills
Other Adverse Effects: No specific environmental safety thresholds established; precautionary principle advised

Disposal Considerations

Waste Disposal: Collect and dispose of as hazardous chemical waste using properly approved incineration methods
Container Disposal: Triple rinse and dispose of following hazardous waste regulations
Special Precautions: Do not release to environment, avoid landfill disposal, comply with all federal, state, local requirements for pharmaceutical intermediate waste
Recommendation: Contact licensed chemical waste contractor for safe, legal disposal procedures

Transport Information

UN Number: Not assigned; treat as hazardous chemical if regulations require
Transport Hazard Class: Not specifically classified, but shipping as toxic, irritant material is prudent
Packing Group: Consult shipping agent or supplier; typically PG III if hazardous
Special Precautions: Protect from moisture, heat, and impact during transport; label as pharmaceutical intermediate, non-clinical use only
Shipping Label: Caution, handle with care, use correct hazard symbols per transit regulations

Regulatory Information

Safety, Health, and Environmental Regulations: Subject to chemical control acts such as OSHA Hazard Communication Standard, TSCA, or EU REACH if imported/exported
Inventory Status: Check status in national and regional chemical inventories
SARA/OSHA Classification: Not listed under SARA Title III but meets criteria for hazardous substance under OSHA standards
Workplace Labeling: Hazardous substance, requires standard laboratory chemical labeling
Other Guidance: Comply with prescription drug precursor regulations, special handling only by trained staff, maintain records of use, handling, and disposal for audit and inspection