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Chemical Name: Isotretinoin
Common Names: 13-cis-Retinoic Acid, Accutane
Use: Prescription medication for severe acne, active ingredient in topical and oral pharmaceutical products
Appearance: Yellow-orange crystalline powder
Odor: Odorless
Molecular Formula: C20H28O2
Molecular Weight: 300.44 g/mol
Classification: Hazardous by GHS standards, considered a teratogen, toxic to reproduction
Key Hazards: Highly toxic if swallowed, may cause birth defects, targets skin and mucous membranes, serious risk to developing fetus, also harmful via inhalation or skin absorption
GHS Symbols: Health hazard pictogram, exclamation mark
Risk Phrases: May cause irreversible effects, may impair fertility, may cause harm to unborn child
Precautions: Strict controls for users of reproductive age, avoid exposure if pregnant or planning pregnancy
Main Ingredient: Isotretinoin (active compound)
Purity: Typically above 98% pure for pharmaceutical forms
Other Substances: Capsule form may contain gelatine, glycerol, soya bean oil, various colorants (inactive components classified as non-hazardous in most forms)
Inhalation: Remove to fresh air, seek medical attention if symptoms like headache, nausea, or respiratory irritation occur
Skin Contact: Wash with soap and water, remove contaminated clothing, seek care for rash or persistent irritation
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses, continue rinsing, consult a healthcare provider
Ingestion: Do not induce vomiting, rinse mouth, seek emergency medical treatment immediately due to high toxicity risk, especially in children and pregnant women
Suitable Extinguishing Media: Dry chemical powder, carbon dioxide, foam; water spray for larger fires
Hazards from Combustion: Can produce carbon monoxide, carbon dioxide, possible irritant vapors or toxic fumes if burning in bulk
Protective Equipment for Firefighters: Full protective clothing, self-contained breathing apparatus due to risk of inhaling breakdown products
Personal Precautions: Avoid breathing dust, wear appropriate gloves and mask, avoid skin contact, evacuate area if large quantities spilled
Environmental Precautions: Prevent entry into sewers, soil, or waterways due to potential harm to aquatic life and persistence
Spill Response: Scoop up without generating dust using tools intended for pharmaceuticals, collect in sealed containers for disposal, ventilate area after cleanup
Handling: Use in well-ventilated spaces, avoid generating and inhaling dust, wear gloves and eye protection, keep away from incompatible materials
Hygiene Rules: Hands washed thoroughly after handling, contaminated clothing laundered before reuse
Storage: Keep in original packaging, store away from light, moisture, and strong oxidizers, maintain at room temperature with humidity control, out of reach of children and pregnant women
Engineering Controls: Local exhaust ventilation, use of chemical fume hoods for laboratory-scale work
Respiratory Protection: NIOSH-approved respirators if dusting or aerosol generation anticipated
Skin Protection: Chemical-resistant gloves (nitrile or equivalent), lab coat, long sleeves
Eye/Face Protection: Safety goggles or face shield where splashing may occur
Work Practice: No eating, drinking, or smoking during handling
Physical State: Solid
Color: Yellow to orange
Melting Point: 174°C to 175°C
Solubility: Practically insoluble in water, soluble in methanol, ethanol, chloroform
Boiling Point: Decomposes prior to boiling
Vapor Pressure: Negligible at ambient temperatures
Chemical Stability: Stable when stored correctly, sensitive to light and heat
Reactivity: May react with strong oxidizing agents
Decomposition Products: Toxic fumes possible under fire conditions including carbon oxides
Polymerization: Not known to occur under normal circumstances
Routes of Exposure: Oral, inhalation, skin and eye contact
Acute Effects: Nausea, vomiting, dry skin, headaches, teratogenicity at very low doses
Chronic Effects: Liver toxicity, elevated lipid levels, risk of permanent effects from exposure in pregnancy
Carcinogenicity: Not classed as a carcinogen by major regulatory agencies
Reproductive Toxicity: Highly teratogenic, exposure in pregnancy may cause severe birth defects, miscarriage
Toxicity to Aquatic Life: Harmful to aquatic organisms, potential for bioaccumulation, long-term hazards possible
Persistence and Degradability: Limited environmental breakdown, persistence in soil and water
Mobility: May migrate in water due to low solubility
Precautions: Laboratories and pharmacies encouraged to prevent entry into environment due to documented risks with pharmaceuticals in wastewater
Waste Treatment Methods: Triple-check for local hazardous drug disposal rules, do not flush or drain, handle as hazardous waste
Incineration: Preferred option where possible with licensed pharmaceutical incinerators
Packaging Disposal: Decontaminate or incinerate containers, avoid recycling drug-contacted plastic or cardboard due to contamination
Hazard Class: Regarded and shipped as hazardous in bulk quantities with strict controls for pharmaceuticals
Packing Group: Special packaging requirements often apply, subject to extra labeling and documentation
Precautions in Transit: Prevent exposure to light, extreme temperatures; keep separate from foodstuffs and incompatible materials
International Regulation: Controlled under national and international pharmaceutical and hazardous substance laws; listed on the schedules for drugs in many countries
Workplace Regulation: Lab and pharmacy settings must use established protocols and oversight when handling
Prescription Control: Distribution restricted, monitoring programs required in most regions for patient safety, pregnancy avoidance, and environmental protection
