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Product Name: Tretinoin
Chemical Name: (all-trans)-retinoic acid
Synonyms: Vitamin A Acid, Retinoic Acid
Molecular Formula: C20H28O2
Molecular Weight: 300.44 g/mol
CAS Number: 302-79-4
Use: Topical medication for acne and some skin conditions, treatment of acute promyelocytic leukemia, cosmetic anti-aging product in dermatology
Manufacturer / Supplier: Information available through pharmaceutical provider or distributor
GHS Classification: Acute Toxicity (Oral) Category 4, Eye Irritation Category 2A, Skin Irritation Category 2, Reproductive Toxicity Category 1B
Signal Word: Danger
Hazard Statements: Harmful if swallowed, causes skin irritation, causes serious eye irritation, may damage fertility or the unborn child
Pictograms: Health hazard, exclamation mark
Target Organs: Eye, skin, reproductive system, gastrointestinal tract
Routes of Exposure: Inhalation, ingestion, dermal contact, ocular contact
Precautionary Statements: Avoid contact with eyes and skin, avoid breathing dust or vapor, use only with protective equipment, do not handle if pregnant or planning pregnancy, wash thoroughly after handling
Chemical Identity: Tretinoin
Concentration: Typically 0.01%–0.1% in creams or gels, may appear in pure solid form or as part of a formulated product
Impurities/Additives: Creams and gels can include alcohols, mineral oil, stearic acid, emollients, preservatives, depending on product formulation
CAS Number (Main Ingredient): 302-79-4
Other Components: Purified water, butylated hydroxytoluene, synthetic wax, or petrolatum (refer to specific product for details)
Inhalation: Remove individual to fresh air, support breathing if necessary, seek medical attention for persistent symptoms
Skin Contact: Wash affected site thoroughly with soap and water, remove contaminated clothing, seek medical help for irritation or persistent reactions
Eye Contact: Rinse eyes gently with running water for several minutes, remove contact lenses if easy to do, continue flushing and seek immediate medical care
Ingestion: Rinse mouth, DO NOT induce vomiting, give water if person is conscious and alert, seek prompt medical attention
Most Important Symptoms: Redness, itching, irritation, potential blisters, eye pain, nausea, headache or drowsiness if swallowed
Indications for Physician: Treat symptomatically; monitor for allergic response or systemic toxicity, especially in pregnant individuals
Suitable Extinguishing Media: Use foam, dry chemical, carbon dioxide, or water spray for fires involving tretinoin-containing products
Fire Hazards: Fine dust can form flammable mixtures with air, combustion may produce toxic fumes, including carbon monoxide, carbon dioxide, and nitrogen oxides
Protective Equipment for Firefighters: Self-contained breathing apparatus, full protective gear to avoid inhalation of decomposition products
Specific Hazards: Burning may emit acrid smoke, avoid inhaling vapors, product does not support combustion directly, but carriers in formulations may burn
Special Precautions: Cool container with water spray if exposed to heat, prevent runoff from entering drains, sewers
Personal Precautions: Wear gloves, eye protection, disposable apron or laboratory coat, prevent skin and eye contact
Environmental Precautions: Prevent release to drains, water bodies, or soil, absorb spillage with inert material, prevent contamination of water sources
Methods for Cleanup: Scoop up solid material, wipe contaminated surfaces with damp disposable cloths, collect in appropriate labeled container for disposal, ventilate area, wash hands thoroughly after disposal
Spill Response: Separate people from area, restrict access, use chemical-resistant gloves and approved respirators if large quantities involved
Decontamination: Dispose contaminated material according to local and federal regulations
Handling: Use with adequate ventilation, avoid contact with eyes, skin, and clothing, minimize dust generation, avoid inhalation, wash after use, keep containers tightly closed
Storage Conditions: Store locked up, away from incompatible materials, shield from light to prevent degradation, keep at room temperature, avoid humidity
Incompatible Materials: Strong oxidizers, strong acids, bases, direct sunlight, high temperatures
Safe Storage Practices: Clearly label containers, store away from food and beverages, keep away from children, follow pharmaceutical storage requirements
Exposure Limits: No occupational exposure limits established specifically for tretinoin, typical in pharmaceutical settings
Engineering Controls: Handle under fume hood or with local exhaust ventilation in laboratory or compounding settings
Personal Protection Equipment (PPE): Use nitrile or latex gloves, safety goggles, laboratory coat, face mask or respirator if airborne dusts are present
Hygiene Measures: Do not eat, drink, or smoke during use, wash hands and face thoroughly after work, remove contaminated clothing promptly
Environmental Controls: Implement procedures to limit emission into environment, use closed systems where possible
Appearance: Bright yellow to orange crystalline powder
Odor: Odorless or very faint chemical odor
Odor Threshold: Not established
pH: Not applicable in solid form; may be slightly acidic in solution
Melting Point: Around 180°C (356°F)
Boiling Point: Not applicable, decomposes before boiling
Flash Point: Not determined for solid drug
Solubility: Insoluble in water, readily soluble in organic solvents like ethanol, chloroform, DMSO
Vapor Pressure: Negligible at room temperature
Density: Approximately 1.3 g/cm³
Partition Coefficient (log Pow): Estimated 5.3 (highly lipophilic)
Stability: Sensitive to light and air, degrades with exposure to heat and oxidizers
Chemical Stability: Stable under recommended storage conditions, rapidly degrades upon exposure to light, heat, or oxidizers
Reactivity: Reacts with strong oxidizers, bases, and acids
Conditions to Avoid: Direct sunlight, elevated temperatures, contact with peroxides or oxidizing agents
Decomposition Products: Fumes of carbon oxides, potentially irritating gases upon burning or decomposition
Hazardous Reactions: Not known to undergo dangerous polymerization, risk lies in degradation and loss of therapeutic effectiveness
Acute Toxicity: Oral LD50 in rodents: ~2,000 mg/kg, higher exposures may cause nausea, vomiting, headache, drowsiness, ataxia
Chronic Toxicity: Prolonged skin exposure may cause redness, scaling, irritation, possible increased risk of phototoxic effects
Eye Effects: Serious irritation, burning, blurred vision possible upon direct contact
Skin Effects: Irritation, peeling, erythema, heightened sensitivity to UV radiation
Mutagenicity: No strong evidence for mutagenicity from animal or cell assays
Carcinogenicity: Classified as not carcinogenic, but excessive use may promote local degeneration
Reproductive / Developmental Toxicity: Strong evidence of teratogenicity in animal studies, human use in pregnancy has shown fetal risk
Target Organ Effects: Skin, mucous membranes, reproductive organs in high or chronic exposures
Sensitization: Not considered a primary sensitizer, but may worsen existing eczema or dermatitis
Toxicity to Aquatic Life: Harmful to aquatic organisms with long-lasting effects, due to persistence and low water solubility
Persistence and Degradability: Biodegradability in environment can be slow, susceptible to breakdown by light and air, but formulated products pose risk when discharged in bulk
Bioaccumulative Potential: Potential to bioaccumulate in aquatic organisms due to high log Pow
Mobility in Soil: Low to moderate, binds to organic matter in sediment, unlikely to leach into groundwater in significant amounts
Other Ecological Effects: Avoid disposal into environment, due to risk of chronic toxicity in aquatic and soil ecosystems
Avoidance Measures: Never flush unused product or contaminated materials into drains or waterways
Waste Disposal: Handle as hazardous pharmaceutical waste, incinerate in approved facility, comply with local, national, and federal regulations
Container Disposal: Triple rinse and render unusable before final disposal, recycle only if facility is approved for pharmaceutical containers
Environmental Precautions: Do not allow to enter surface water, groundwater, drains, avoid landfill disposal if more environmentally safe options exist
Product Disposal: Contact licensed chemical waste disposal service, follow institutional protocols for disposal of cytotoxic and teratogenic substances
UN Number: No specific UN number for tretinoin as a solid or cream
Proper Shipping Name: Pharmaceutical product, non-regulated when in finished dosage form
Transport Hazard Class: Not classified for transport as dangerous good under ADR, IMDG, IATA regulations
Packing Group: Not applicable
Labeling: Label as hazardous in bulk or raw active ingredient form, not as finished cream
Special Precautions: Shield from light and high temperatures during transit, avoid rough handling of containers, secure packaging to prevent leaks
Labelling Requirements: Satisfy national medicines regulations, OSHA Hazard Communication Standard, and EU CLP criteria where applicable
Risk Phrases: R22 (Harmful if swallowed), R36/37/38 (Irritating to eyes, respiratory system, and skin), R60/61 (May impair fertility, harm unborn child)
US Regulations: Prescription drug under Federal Food, Drug, and Cosmetic Act, Schedule III controlled substance in some formulations, listed by NIOSH as hazardous
EU Regulations: Prescription-only medicine, subject to REACH registration for raw chemical, must include appropriate pictograms and warnings
Other Regulations: Non-retail quantities require MSDS access, safe handling training, and hazard communication in workplace as per OSHA, WHMIS, and GHS guidelines
Additional Notes: Monitor for regional specifics such as California Proposition 65 (developmental toxicity), consult local authorities for unique rules
