Material Safety Data Sheet: Fluorometholone Acetate

Identification

Product Name: Fluorometholone Acetate
Chemical Formula: C24H31FO6
Synonyms: 6α-Methyl-9α-fluoro-11β,17α-dihydroxy-17-acetoxy-pregna-1,4-diene-3,20-dione
CAS Number: 3801-06-7
Manufacturer: Refer to supplier’s documentation
Intended Use: Pharmaceutical corticosteroid for anti-inflammatory applications
Contact Details: Phone, address, and emergency number of manufacturer or distributor should be included as per local regulations

Hazard Identification

Hazard Class: Not classified as hazardous under GHS criteria, but may cause irritation
Possible Health Effects: Eyes and skin exposed to the powder or dust may develop irritation or redness; inhalation of dust may affect breathing and cause discomfort; ingestion may upset gastrointestinal tract
Chronic Effects: Prolonged or repeated exposure to steroid compounds like fluorometholone acetate can potentially affect hormonal balance and immune response
Labelling: No standard GHS pictogram, but safety data highlights precaution for laboratory and production staff
Signal Word: Caution
Precautionary Statements: Avoid breathing dust, minimize contact with skin and eyes, practice good industrial hygiene
Environmental Hazard: Not expected to pose a significant risk to aquatic environments at low concentrations, though local guidelines may restrict disposal

Composition / Information on Ingredients

Chemical Name: Fluorometholone Acetate
Concentration: Typically pure active; excipients in commercial formulas not considered in MSDS
CAS Number: 3801-06-7
Impurities & Additives: None significant in pure material
Molecular Weight: 434.50 g/mol

First Aid Measures

Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, continue rinsing; seek medical advice if irritation persists
Skin Contact: Remove contaminated clothing, wash affected area with plenty of soap and water; medical attention recommended if skin irritation develops
Inhalation: Move to fresh air, support breathing if necessary, seek medical attention if experiencing respiratory discomfort
Ingestion: Rinse mouth, drink water; do not induce vomiting unless directed by medical staff; call for medical help if feeling unwell
Notes for Medical Professionals: Treat symptomatically and supportively based on exposure

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, CO2, foam, or water spray may be used based on surroundings
Specific Hazards: Combustion products could include carbon dioxide, carbon monoxide, and fluorine-containing fumes
Protective Equipment: Firefighters should wear self-contained breathing apparatus and chemical protective clothing
Special Precautions: Prevent contaminated run-off from entering drains or watercourses where possible
Unusual Fire & Explosion Hazards: Dust may form an explosive mixture with air in confined spaces under certain conditions; minimize airborne dust

Accidental Release Measures

Precautions: Clear area of unnecessary personnel, ventilate space, wear suitable personal protective equipment such as gloves, goggles, and dust mask
Spill Cleanup: Carefully sweep up to avoid dust formation, place in suitable container for disposal, wash area with water and detergent; avoid raising dust
Environmental Precautions: Prevent bulk quantities from entering drains, watercourses, or soil Disposal: Collect residues for proper disposal according to local authority regulations

Handling and Storage

Handling Recommendations: Use in well-ventilated areas, use local exhaust where dust may be generated, avoid direct contact with the material, adopt good hygiene practices, avoid eating or drinking around the product
Storage Conditions: Store in a tightly sealed container in a cool, dry, and well-ventilated place away from heat or direct sunlight
Incompatible Materials: Store away from strong oxidizing agents and reducing materials
Other Notes: Only trained employees should handle the substance under controlled conditions, keep records on batch and lots for traceability

Exposure Controls and Personal Protection

Engineering Controls: Fume hood or local exhaust required in laboratories or manufacturing sites handling powders
Personal Protection: Wear safety goggles, chemical-resistant gloves, laboratory coat and appropriate dust mask or respirator if powder becomes airborne
Hygiene Measures: Wash hands, arms, and face after handling; avoid inhalation and ingestion
Exposure Limits: No official occupational exposure limits assigned, but minimize dust exposure as for any pharmaceutical active ingredient
Environmental Controls: Prevent contamination of air, water, and soil during transfer and handling

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Faint
pH: Not determined for solid; in solution, neutral to slight acidic
Melting Point: Approximately 285-290°C
Boiling Point: Decomposes before boiling
Solubility: Practically insoluble in water; soluble in acetone, chloroform, and methanol
Flash Point: Not applicable; combustible but not highly flammable
Partition Coefficient (Log Pow): Not available
Vapor Pressure/Density: Negligible vapor pressure
Other Data: Stable as a solid at ambient temperatures under dry conditions

Stability and Reactivity

Chemical Stability: Stable under normal storage and handling conditions; avoid excessive heat or moisture
Hazardous Reactions: No dangerous reactions known if used according to recommendations
Conditions to Avoid: Exposure to moisture, strong oxidizers, heat sources
Incompatible Materials: Strong oxidizing agents such as peroxides, nitric acid
Hazardous Decomposition Products: May include carbon oxides and toxic fluorine compounds in fire or high-temperature decomposition

Toxicological Information

Acute Toxicity: Data in animals suggest low acute oral and dermal toxicity; lack of comprehensive human data; avoid unnecessary exposure
Skin and Eye Effects: Topical exposure may cause mild irritation or redness; minimize direct contact
Inhalation Risks: Prolonged inhalation of dust can cause irritation to respiratory tract
Sensitization: No confirmed reports of allergic reactions, although corticosteroids may provoke hypersensitivity in rare cases
Carcinogenicity/Mutagenicity: No definitive animal or epidemiological evidence of carcinogenicity; long-term repeated exposure may disrupt endocrine system
Potential Health Effects: Long-term or accidental large-dose exposure can suppress immune response, alter metabolism, or affect hormone balance

Ecological Information

Persistence and Degradability: Likely to persist in soil and water under certain conditions due to slow biodegradation
Bioaccumulation Potential: Potential to bioaccumulate is low based on molecular structure, though specific studies are limited
Aquatic Toxicity: Toxicity to aquatic organisms expected to be low at environmental concentrations from pharmaceutical products, but data remains limited
Mobility in Soil: Material shows low water solubility and binds to soil particles
Further Information: Avoid discharge of significant quantities into waterways, comply with pharmaceutical effluent regulations

Disposal Considerations

Disposal Methods: Incinerate in an approved facility or dispose of as pharmaceutical waste consistent with national and regional guidelines
Packing Waste: Triple rinse empty containers prior to disposal or recycling; manage as chemical waste
Precautions: Do not discharge to surface water, sewer, or soil
Special Instructions: Record and document disposal, follow transport and environmental agency requirements for hazardous pharmaceutical materials

Transport Information

UN Number: Not assigned for this pharmaceutical in most jurisdictions
UN Proper Shipping Name: Not regulated as a dangerous good
Transport Hazard Class: Non-hazardous for transport by road, rail, air, or sea under normal conditions
Packing Group: Not specified
Special Precautions: Ensure protection from physical damage, maintain packaging integrity
Environmental Hazards: Avoid spill during transport by appropriate packaging and documentation

Regulatory Information

Substance Regulation: Controlled as a prescription pharmaceutical in most countries; registration and reporting requirements for import, export, and handling by manufacturers, wholesalers, and pharmacies
Labelling Requirements: Follow national medicine act and hazardous substance code; standard workplace labelling and outer packaging
Chemical Inventory Status: May appear as registered substance in chemical inventories such as TSCA, REACH, AICS
Workplace Control: Subject to workplace safety and occupational health standards for pharmaceutical actives
Other Regulations: Check local and international drug, waste, and environmental legislation before disposal, transfer or export