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Product Name: Fluocinolone Acetonide
Chemical Name: 6α,9α-Difluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone
CAS Number: 356-12-7
Intended Use: Pharmaceutical ingredient, topical corticosteroid for inflammatory and pruritic dermatoses
Synonyms: Synalar, Flucort, Fluocinolonacetonidum
Company Identification: Supplier or manufacturer’s name, address, phone number, email contact for emergencies
Emergency Overview: White crystalline powder, no significant odor, not expected to present significant immediate hazards in pharmaceutical quantities
GHS Classification: Not classified for acute toxicity in small, pharmaceutical doses
Health Hazards: May cause skin and eye irritation, respiratory irritation upon prolonged or repeated exposure; possible effects on adrenal axis with chronic use
Environmental Hazards: Harmful to aquatic life with long-lasting effects if released in large amounts
Label Elements: Signal word “Warning”, hazard statements regarding irritation and risk of environmental persistence, precaution statements to avoid inhalation, ingestion, contact with skin, eyes, and environment
Component: Fluocinolone Acetonide
Concentration: 98–100% (pharmaceutical grade)
Impurities: Residual solvents, related corticosteroids, degradation products typically below 0.5%
Molecular Formula: C24H30F2O6
Molecular Weight: 452.49 g/mol
Inhalation: Remove from exposure, move to fresh air, keep patient at rest, seek medical attention for symptoms
Skin Contact: Remove contaminated clothing, wash skin with soap and plenty of water, monitor for skin irritation
Eye Contact: Rinse cautiously with water for at least 15 minutes, remove contact lenses, get ophthalmological advice if irritation persists
Ingestion: Rinse mouth, do not induce vomiting, seek medical advice, monitor for symptoms such as nausea or headache
Important Symptoms: Watch for allergic reactions, difficulty breathing, persistent irritation, adrenal suppression symptoms with systemic uptake
Notes for Medical Personnel: Treat supportively, monitor adrenal function, symptomatic management for respiratory or allergic symptoms
Suitable Extinguishing Media: Dry chemical powder, carbon dioxide, foam, water spray for surrounding fires
Fire Hazard Characteristics: Non-flammable under normal conditions, may decompose to form toxic fumes including carbon oxides, hydrogen fluoride
Protective Equipment: Self-contained breathing apparatus, full-protective gear
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, hydrofluoric acid, other unidentified compounds possible
Advice for Firefighters: Withdraw to a safe distance, prevent runoff from entering drains or watercourses, cool closed containers exposed to fire
Personal Precautions: Use appropriate personal protective equipment, avoid inhalation of dust, prevent contact with skin and eyes, ventilate area
Spill Response: Carefully sweep up without creating dust, transfer to suitable container for disposal, clean spill area with wet cloth
Environmental Precautions: Prevent entry to drains, sewers, waterways; avoid release to the environment
Decontamination: Wash area with water, avoid dry sweeping to reduce airborne particles
Safe Handling: Wear gloves, goggles, lab coat in laboratory settings, avoid dust formation, do not eat, drink, or smoke during use, wash hands afterwards
Storage: Store in tightly sealed container under cool, dry, well-ventilated conditions, protect from light and moisture
Special Sensitivities: Keep away from strong oxidizers, acids, and bases; segregate from food and drink
Specific Requirements: Use pharmaceutical-grade storage procedures, maintain inventory control, handle in accordance with cGMP if used in manufacturing
Exposure Limits: No established occupational exposure limits for active pharmaceutical ingredient; minimize exposure as much as possible
Engineering Controls: Use local exhaust ventilation or process enclosure to limit airborne dusts
PPE for Workers: Gloves (nitrile recommended), safety goggles, lab coat, NIOSH-approved respiratory protection for excessive dust
Hygiene Practices: Wash hands after handling, do not touch face or mouth, change contaminated clothing, routine environmental monitoring
Appearance: White or almost white crystalline powder
Odor: Almost odorless
pH (saturated solution): Neutral to slightly acidic
Melting Point: 260–270°C (decomposes)
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Practically insoluble in water, freely soluble in acetone, ethanol, chloroform
Partition Coefficient (log Pow): Estimated: 2.4–2.7
Vapor Pressure: Negligible at room temperature
Stability in Light: Sensitive, gradual degradation possible
Density: Not well established due to powdery nature
Chemical Stability: Stable under recommended storage conditions, light and moisture sensitive
Hazardous Polymerization: Does not occur
Reactivity: May react with strong oxidizing agents, acids and bases, avoid exposure to excessive heat and light
Decomposition Products: Produces carbon oxides, hydrogen fluoride, and other potentially hazardous decomposition products under fire or extreme conditions
Conditions to Avoid: Exposure to strong light, excessive heat, humidity
Acute Toxicity: Low acute toxicity based on animal studies; LD50 oral (rat) > 5000 mg/kg
Irritation: May cause eye and skin irritation; repeated handling could cause sensitization
Inhalation Risks: Inhaled dusts may cause respiratory irritation
Chronic Exposure Effects: Long-term or repeated exposure can suppress adrenal gland function, cause Cushingoid symptoms
Carcinogenicity: Not classified as carcinogenic by IARC, OSHA, NTP
Reproductive/Developmental Effects: Animal studies indicate risk of fetal growth reduction at high dosages; avoid during pregnancy unless prescribed
Sensitization: Possible for individuals with steroid allergies
Aquatic Toxicity: Harmful to aquatic organisms, long-term persistence possible, possible endocrine disruption at low levels
Soil Mobilization: Low mobility in soil, possible bioaccumulation in aquatic environments
Persistence and Degradability: Slowly biodegradable, persistent in sediment or soil
Bioaccumulation Potential: Moderate—potential to accumulate in aquatic species
Other Adverse Effects: Corticosteroids may cause secondary effects on local flora and fauna when disposed improperly
Waste Treatment Methods: Dispose of in accordance with local, regional, and national regulations for hazardous pharmaceutical waste; do not discharge to sewer systems
Recommended Disposal: Incineration at a licensed facility, or landfilling approved hazardous waste in accordance with local regulations
Unused Product: Return to supplier or authorized waste contractor for destruction; do not flush unused materials or contaminated packaging down the drain
Contaminated Packaging: Triple rinse; treat as hazardous waste
UN Number: Not assigned (not regulated as hazardous for transport in pharmaceutical quantities)
Shipping Name: Fluocinolone Acetonide
Transport Hazard Class: Non-hazardous for most forms of transport at typical quantities
Packaging Group: Not applicable
Special Precautions: Keep container tightly closed, dry, and protected during transport
Marine Pollution: Avoid bulk shipping by water if possible due to risk of aquatic persistence
US Federal Regulations: Not listed as a hazardous substance under TSCA, CERCLA, SARA Title III; prescription-only drug ingredient
EU Regulations: Covered under REACH regulations if handled in bulk; classified as a prescription-only medicinal product
Workplace Regulation: Occupational exposure controls required for pharmaceutical handling; not a controlled substance
National Inventories: Listed on US, EU, Canada, Australia pharmaceutical ingredient registries
Additional Info: Label as per industry and health authority guidelines, comply with local environmental and safety laws, safety training required for handlers above laboratory scale
