Product Name: Fluocinolone Acetonide
Chemical Name: 6α,9α-Difluoro-16α,17,21-trihydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone
Trade Names: Synalar, Fluonid, Capex, various generics
CAS Number: 356-12-7
Molecular Formula: C24H30F2O6
Molecular Weight: 452.49 g/mol
Recommended Use: Active pharmaceutical ingredient in topical corticosteroid preparations
Manufacturer/Supplier: See product container or relevant manufacturer documentation
Contact Information: Refer to provided supplier or pharmacy contact, including emergency telephone information
GHS Classification: Not classified as hazardous by GHS standards under normal pharmaceutical use
Route of Entry: Skin, eyes, inhalation, ingestion
Health Hazards: May cause skin sensitization in rare cases; can irritate eyes or mucous membranes; toxic if swallowed in large amounts; long-term or repeated exposure may cause systemic corticosteroid effects
Label Elements: Not typically required for finished dose pharmaceutical forms; laboratory and industrial bulk handling may require precautionary labeling
Signal Word: Caution
Hazard Statements: Risk of corticosteroid side effects with exposure above clinical dose
Pictograms: Exclamation mark for laboratory or bulk chemical handling
Precautionary Statements: Avoid contact with eyes, mucous membranes; wear gloves for bulk or industrial use; wash hands after exposure
Active Substance: Fluocinolone Acetonide, 99% purity
Impurities: Related corticosteroid compounds (<1%)
Excipients: None in raw chemical form; present in formulated medicinal products
Other Information: No hazardous additives in active substance powder
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present. Continue rinsing. Seek medical advice if irritation occurs.
Skin Contact: Wash skin thoroughly with soap and water. Remove contaminated clothing. Seek medical attention for symptoms of irritation or allergic reaction.
Inhalation: Move person to fresh air and keep comfortable for breathing. Seek medical attention if symptoms develop.
Ingestion: Rinse mouth with water. Do not induce vomiting unless directed by medical personnel. Seek immediate medical attention with any signs of toxic effect.
Most Important Symptoms: Eye or skin irritation, sneezing, nausea, headache, possible signs of adrenocortical suppression with large accidental exposure
Note to Physicians: Symptomatic treatment; monitor for corticosteroid toxicity if substantial ingestion or systemic absorption occurs
Suitable Extinguishing Media: Carbon dioxide, dry chemical, foam, or water spray
Unsuitable Extinguishing Media: High pressure water jets may cause powder dispersal
Fire Hazards: Not particularly flammable, but toxic fumes including carbon oxides and fluorine compounds could form on combustion
Special Protective Equipment: Full protective clothing and self-contained breathing apparatus for large fires or confined spaces
Specific Firefighting Procedures: Prevent runoff from entering drains or water courses. Cool containers exposed to fire.
Personal Precautions: Avoid breathing dust. Wear respirator, gloves, protective goggles, and coveralls in case of large or bulk spills.
Environmental Precautions: Prevent spillage from entering drains, water systems, or soil.
Containment and Clean-up: Collect spillage with damp cloth or HEPA vacuum. Wipe surfaces with water. Place contaminated material in labeled waste container for proper disposal.
Decontamination: Wash area thoroughly with water and detergent after clean-up.
Handling: Use engineering controls to minimize dust generation. Avoid contact with eyes, skin, and clothing. Practice good industrial hygiene.
Storage: Store in tightly closed, light-resistant container. Store at controlled room temperature (15–30°C).
Storage Incompatibilities: Strong oxidizers, acids, alkalis
Hygiene Measures: Handle according to GMP for pharmaceuticals. Wash hands after handling. Do not eat, drink, or smoke where material is handled.
Engineering Controls: Ventilation systems or fume hoods for laboratory or bulk handling
Occupational Exposure Limits: No established OSHA or ACGIH limit; treat as occupational allergen and skin hazard
Personal Protective Equipment: Gloves (nitrile or latex), safety glasses or goggles, lab coat or protective suit, N95 or higher respirator for powder handling or spill response
Environmental Exposure Controls: Minimize dust and prevent environmental release during handling or disposal
Physical State: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: Not applicable (insoluble in water)
Melting Point/Range: 265–273°C
Boiling Point/Range: Decomposes before boiling
Flash Point: Not flammable under standard conditions
Solubility: Practically insoluble in water; soluble in acetone, alcohol, chloroform, and methanol
Density: 1.33 g/cm3
Vapor Pressure: Negligible
Partition Coefficient (log Pow): ~2.3
Stability: Stable under recommended storage conditions
Appearance: Crystalline solid
Chemical Stability: Stable at room temperature and under recommended storage conditions
Reactivity: No dangerous reactions known under normal use
Conditions to Avoid: Heat, light, strong acids or bases, oxidizing agents
Incompatible Materials: Strong oxidizing substances
Hazardous Decomposition Products: Fumes of carbon monoxide, carbon dioxide, hydrogen fluoride may be released in fire
Acute Toxicity: Low oral toxicity in small quantities typical for pharmaceuticals; LD50 (oral, rat) > 1000 mg/kg
Chronic Effects: Prolonged exposure can cause suppression of hypothalamus-pituitary-adrenal axis; skin atrophy with frequent skin contact in susceptible individuals
Sensitization: May cause hypersensitivity reactions
Carcinogenicity: Not classified as carcinogen by IARC; no known carcinogenic risk in humans at therapeutic doses
Mutagenicity: Not observed in bacterial mutagenicity assays
Other Relevant Effects: May alter immune response, delay wound healing, cause thinning of skin
Routes of Exposure: Skin, inhalation, accidental ingestion
Ecotoxicity: Harmful to aquatic organisms in large accidental releases; low predicted impact in routine pharmaceutical use
Persistence and Degradability: Not readily biodegradable, may persist in soil and water environments
Bioaccumulative Potential: Potential for moderate bioaccumulation in aquatic organisms (log Kow 2.3)
Mobility in Soil: Low mobility; binds to particles
Other Adverse Effects: Discharge into environment may affect endocrine systems of wildlife
Waste Treatment Methods: Incinerate in licensed facility or dispose of as pharmaceutical waste following local regulations
Handling of Contaminated Packaging: Dispose of containers as hazardous waste. Triple rinse and puncture packaging where regulations allow.
Precautions: Do not release to sewers or surface water
UN Number: Not listed as a dangerous good
Proper Shipping Name: Not regulated
Transport Hazard Class: Non-hazardous for ground, air, and sea shipment
Packing Group: Not assigned
Environmental Hazards: None expected under standard shipment
Special Precautions: Avoid temperature extremes and direct sunlight during transport
OSHA Status: Not classified as a hazardous chemical by OSHA for pharmaceutical use
TSCA: Not listed for commercial chemical use
REACH: Exempt for pharmaceutical substances manufactured and used under GMP
WHMIS (Canada): Not controlled
Other Regulations: Subject to FDA regulation under the Food, Drug, and Cosmetic Act
Labeling: Required labeling in accordance with Good Manufacturing Practice (GMP) and national or international drug safety protocols
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