Product Name: Dutasteride
Chemical Name: 5α,17β-N-{2,5-bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide
Synonyms: Avodart, GI198745
CAS Number: 164656-23-9
Molecular Formula: C27H30F6N2O2
Molecular Weight: 528.53 g/mol
Recommended Use: Pharmaceutical ingredient for treatment of benign prostatic hyperplasia
Supplier: Pharmaceutical manufacturers and chemical supply companies
Emergency Contact: Refer to supplier emergency number
GHS Classification: Reproductive toxicity (Category 1B), Specific target organ toxicity - repeated exposure (Category 2), Skin sensitization (Category 1)
Signal Word: Danger
Hazard Statements: May damage fertility; may damage the unborn child; may cause an allergic skin reaction; may cause damage to organs through prolonged or repeated exposure
Pictograms: Health hazard, exclamation mark
Routes of Exposure: Inhalation, skin contact, ingestion, eye contact
Target Organs: Reproductive system, liver
Symptoms of Exposure: Headache, dizziness, irritability, allergic skin reaction
Carcinogenicity: Not listed by OSHA, NTP or IARC as a carcinogen, but animal studies indicate reproductive toxicity risk
Chemical Name: Dutasteride
Concentration: >98%
CAS Number: 164656-23-9
Impurities: Trace synthesis byproducts (each <1%)
Additives: None for raw bulk substance
Other Components: No hazardous additives present
Inhalation: Move to fresh air; get medical help if symptoms persist; give artificial respiration if not breathing
Skin Contact: Wash affected area with soap and plenty of water; remove contaminated clothing and shoes; seek medical advice if irritation develops
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes holding eyelids apart; obtain medical attention
Ingestion: Rinse mouth with water; do not induce vomiting; seek immediate medical attention
Most Important Symptoms: Allergic reactions, reproductive risk symptoms, gastrointestinal discomfort, headache
Suitable Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical powder, carbon dioxide
Unsuitable Extinguishing Media: Direct high-pressure stream
Special Hazards: May emit toxic fumes of nitrogen oxides, carbon oxides, fluorine compounds on combustion
Protective Equipment: Wear self-contained breathing apparatus and full protective gear
Firefighting Instructions: Avoid inhaling smoke; prevent fire water from entering waterways; keep containers cool with water spray
Personal Precautions: Evacuate personnel from area; wear protective clothing, gloves, and respiratory protection
Environmental Precautions: Prevent further leakage or spillage; do not discharge into drains, surface water, or soil
Cleanup Methods: Scoop up solid into suitable container; avoid dust formation; ventilate area; wash spill site with detergent and water after material pickup
Disposal of Collected Material: Place collected material in appropriate waste disposal container for incineration or licensed chemical disposal
Handling Procedures: Avoid contact with skin, eyes, and clothing; prevent dust accumulation; use only in well-ventilated areas; do not breathe dust; keep container tightly closed
Storage Conditions: Store in a tightly sealed container; keep container in a cool, dry, well-ventilated setting; protect from light and moisture; segregate from food and feedstuffs
Incompatible Materials: Strong oxidizers, strong acids, strong bases
Hygiene Practices: Wash hands after handling; avoid eating, drinking, or smoking while handling material
Special Storage Instructions: Label containers for hazardous reproductive effects; restrict access to trained personnel
Occupational Exposure Limit: Not formally established; use pharmaceutical dust limits or control banding for OEB 4 substances
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits
Personal Protective Equipment: NIOSH-approved respirator for dust when ventilation is insufficient; chemical-resistant gloves, lab coat or protective suit, safety goggles
Hygiene Measures: Wash thoroughly after handling; remove contaminated clothing and gear before entering public areas
Environmental Controls: Prevent release to the environment with proper waste management and secondary containment
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: Not available (not soluble in water)
Melting Point/Range: 242–250°C
Boiling Point: Not available (decomposes on heating)
Flash Point: Not determined, combustible solid
Evaporation Rate: Not applicable
Flammability: Non-flammable solid
Vapor Pressure: Negligible at room temperature
Solubility: Practically insoluble in water, freely soluble in ethanol and methanol
Partition Coefficient (log Kow): Estimated >4 (lipophilic)
Vapor Density: Not applicable
Relative Density: Approximately 1.23 g/cm³
Decomposition Temperature: Decomposes above 250°C
Chemical Stability: Stable under normal temperatures and recommended storage conditions
Possibility of Hazardous Reactions: None expected with normal use
Conditions to Avoid: Moisture, light, excessive heat, incompatible materials
Incompatible Materials: Strong oxidizing agents, strong acids, alkali metals
Hazardous Decomposition Products: Emits nitrogen oxides, carbon oxides, toxic fluorine-containing compounds with thermal decomposition
Polymerization: Will not occur under recommended handling procedures
Acute Toxicity: Oral LD50 (rat) >2000 mg/kg (limited data)
Inhalation: May cause respiratory discomfort, headache, dizziness
Skin Contact: May cause allergic skin reaction in sensitized individuals
Eye Contact: Can cause mild irritation
Chronic Toxicity: Animal studies show reproductive and developmental toxicity at high doses; possible effects on liver enzymes; some risk of long-term organ toxicity with repeated exposure
Mutagenicity: Negative in standard in vitro and in vivo mutagenicity assays
Carcinogenicity: No evidence of carcinogenicity in standard animal models
Reproductive Effects: Teratogenicity and impairment of reproductive capability reported in animal models at relevant exposure levels
Sensitization: Potential for allergic reaction upon repeated skin exposure
Eco-toxicity: Harmful to aquatic organisms; long-term effects in aquatic environment possible
Persistence and Degradability: Not readily biodegradable; may persist in soil and sediment
Bioaccumulative Potential: Potential for bioaccumulation due to high log Kow
Mobility in Soil: Low mobility due to poor water solubility and strong adsorption to organic matter
Other Adverse Effects: Risk of endocrine disruption in aquatic species if released to waterways
Waste Disposal Methods: Incinerate at a licensed chemical waste facility; avoid release to environment; comply with all federal, state, and local regulations on pharmaceutical disposal
Contaminated Packaging: Dispose as hazardous waste
Precautions for Disposal: Wear proper PPE during handling, avoid contact with skin and eyes, prevent dust generation
Disposal Guidance: Contact licensed chemical disposal contractor for proper destruction
UN Number: Not regulated as dangerous goods under international transport regulations
Proper Shipping Name: Dutasteride, not classified as hazardous for transport
Transport Hazard Class: Not regulated
Packing Group: Not regulated
Environmental Hazards: Avoid spills into the environment during loading and unloading
Special Precautions: Protect from physical damage, keep container tightly closed and upright during transit
US Regulations: Not listed as a hazardous substance under CERCLA, SARA Title III, or TSCA
OSHA Status: Hazardous chemical for occupational exposure due to reproductive toxicity
EU Regulations: Classified under Regulation (EC) No 1272/2008 as Reproductive Toxicity, Category 1B; requires hazard labeling
Canadian Regulations: Controlled under WHMIS for reproductive risk, subject to workplace exposure controls
Labeling Requirements: Include hazard statements, precautionary statements, and pictograms as required by applicable jurisdiction
Other Rules: This material requires restricted access in workplaces, periodic medical surveillance, and detailed risk assessment prior to handling in research and manufacturing environments
Providing high-quality chemical products and logistics solutions for global trade partners.
