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Material Safety Data Sheet: Adapalene

Identification

Product Name: Adapalene
Chemical Formula: C28H28O3
CAS Number: 106685-40-9
Synonyms: 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Manufacturer: Pharmaceutical companies using adapalene as an active ingredient in topical acne medications
Recommended Use: Topical acne treatment, dermatological use
Emergency Contact: Refer to local Poison Control Center or emergency medical services for chemical exposures

Hazard Identification

GHS Classification: Not classified as hazardous under normal conditions used in consumer products
Physical Hazards: Dust formation possible with bulk powder; may cause mechanical irritation
Health Hazards: Skin irritation, eye irritation, inhalation may cause irritation to respiratory tract
Environmental Hazard: Harmful to aquatic life in high concentrations; avoid uncontrolled environmental release
Label Elements: Avoid inhalation, contact with skin and eyes; if dust exists, minimize exposure

Composition / Information on Ingredients

Ingredient: Adapalene
Chemical Identity: 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Concentration: Varies by formulation, often below 0.3% in gels and creams
Impurities/Stabilizers: Other pharmaceutical excipients according to specific manufacturer’s list; may include polymeric gelling agents, solvents, preservatives

First Aid Measures

Eye Contact: Immediately flush with plenty of water for at least 15 minutes; seek medical advice if irritation persists
Skin Contact: Wash affected area with large amounts of water and soap; remove contaminated clothing
Inhalation: Move affected person to fresh air, monitor for signs of respiratory distress; seek medical attention for persistent symptoms
Ingestion: Rinse mouth with water; never induce vomiting unless instructed by medical personnel; get medical help if large amounts are ingested or symptoms develop

Fire-Fighting Measures

Extinguishing Media: Use water spray, dry chemical, CO2, or foam suitable for surrounding materials
Specific Hazards: May release irritating or toxic fumes under fire conditions, including carbon oxides
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing
Precautions: Keep containers cool using water spray to prevent rupture, avoid inhalation of decomposition products

Accidental Release Measures

Personal Precautions: Wear gloves, lab coats, eye protection; avoid inhalation of dust or fumes
Environmental Precautions: Avoid release to drains, surface water, and soil
Methods for Cleanup: Sweep up powder without generating dust, collect residues in suitable containers for disposal, ventilate area

Handling and Storage

Handling: Use only in well-ventilated environments, avoid unnecessary exposure, practice good personal hygiene after handling
Storage: Store in a tightly closed original container in a cool, dry, and well-ventilated place; keep away from heat, incompatible chemicals, and direct light
Incompatibilities: Avoid strong oxidizers and acids

Exposure Controls and Personal Protection

Control Parameters: Occupational exposure limit values not established for adapalene, general pharmaceutical handling applies
Engineering Controls: Provide local exhaust ventilation in workplaces where dust or vapor may be generated
Personal Protection: Wear chemical-resistant gloves, safety goggles, lab coats; use respiratory protection if airborne concentrations are significant
Hygiene Measures: Wash hands thoroughly after handling; remove contaminated clothing before eating or drinking

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not determined
pH: Not applicable for powder
Melting Point: Approximately 318°C
Boiling Point: Not available
Solubility: Practically insoluble in water, soluble in some organic solvents
Vapor Pressure: Negligible
Density: Not documented
Partition Coefficient (log Kow): Approximately 8.162
Flash Point: Not applicable
Explosive Properties: None expected under normal conditions
Decomposition Temperature: Not documented, but may decompose at high temperatures

Stability and Reactivity

Chemical Stability: Stable under prescribed storage conditions
Reactivity: Does not react rapidly with water, air or common organic substances
Incompatible Materials: Strong oxidizers, strong acids
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, other toxic fumes upon combustion
Conditions to Avoid: Excess heat, light, and moisture

Toxicological Information

Likely Routes of Exposure: Skin, eyes, inhalation, accidental ingestion
Acute Toxicity: Low acute toxicity in animal studies; skin irritation in sensitive individuals
Chronic Toxicity: No evidence of chronic systemic toxicity in humans at therapeutic doses; prolonged use may cause skin dryness, redness, and irritation
Sensitization: Not classified as a sensitizer; rare cases of hypersensitivity possible
Carcinogenicity: No data indicating carcinogenic potential in humans; not listed by IARC, NTP, or OSHA as carcinogen
Mutagenicity: No evidence from standard testing
Reproductive Toxicity: Animal studies do not suggest reproductive toxicity at therapeutic doses

Ecological Information

Toxicity to Aquatic Life: Limited aquatic toxicity information; high concentrations may be harmful to aquatic organisms
Persistence and Degradability: Low solubility in water may limit biodegradability; environmental persistence possible
Bioaccumulation Potential: Possible due to high log Kow value
Mobility in Soil: Expected to have limited mobility in soil due to low solubility
Other Adverse Effects: Avoid large or uncontrolled environmental releases of adapalene-containing products

Disposal Considerations

Disposal Methods: Dispose of unused or unwanted adapalene as pharmaceutical waste in accordance with local, state, and federal regulations; incineration preferred for bulk amounts
Container Handling: Rinse empty containers before disposal, puncture to prevent reuse
Precautions: Do not discharge waste into wastewater or natural water sources; avoid landfilling large amounts

Transport Information

UN Number: Not regulated as a hazardous material for transport
Proper Shipping Name: Not a dangerous good according to transport regulations
Transport Hazard Class: None
Packing Group: Not assigned
Special Precautions: Protect containers from physical damage and moisture during transport

Regulatory Information

U.S. Regulations: Not classified as hazardous by OSHA; adapalene is FDA-approved for dermatological use
European Union: Not classified as hazardous according to REACH and CLP regulations for end-user formulations
Other Regulatory Listings: Not listed by major international chemical inventories as restricted or banned substance
Labeling Requirements: Follow product labeling and safety instructions for user protection; observe national workplace safety regulations
Workplace Safety: Follow established pharmaceutical handling practices and employer safety protocols for exposure risk management