Material Safety Data Sheet: Fluorometholone

1. Identification

Product Name: Fluorometholone
Common Names: FML, 9α-Fluoro-11β,17α-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione
Recommended Use: Pharmaceutical ingredient in ophthalmic steroids
Supplier: Specify pharmaceutical supplier name and address
Emergency Contact: Local poison control center or toxicological information center

2. Hazard Identification

Classification: Not considered hazardous under GHS for standard concentrations
Label Elements: May cause eye, skin, or respiratory irritation
Signal Word: Warning
Hazard Statements: Prolonged contact may cause irritation, avoid inhalation
Precautionary Statements: Avoid exposure, use in a well-ventilated area, wear gloves and eye protection

3. Composition / Information on Ingredients

Chemical Name: Fluorometholone
CAS Number: 426-13-1
Formula: C22H29FO4
Synonyms: FML, Ophthalmic steroid
Impurities: May contain residual solvents (consult supplier documentation for details)

4. First Aid Measures

Eye Contact: Rinse thoroughly with water for at least 15 minutes, seek medical attention if irritation persists
Skin Contact: Wash with plenty of soap and water, remove contaminated clothing
Inhalation: Move to fresh air, seek medical attention if symptoms develop
Ingestion: Rinse mouth, seek immediate medical advice

5. Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Special Hazards: May release toxic fumes upon decomposition (carbon oxides, fluorine compounds)
Protective Equipment: Wear self-contained breathing apparatus, protective suit
Advice for Firefighters: Avoid inhaling combustion products, cool containers with water spray

6. Accidental Release Measures

Personal Precautions: Wear protective gloves, goggles, lab coat, and dust mask
Environmental Precautions: Prevent entry into drains, sewers, or water systems
Containment: Sweep or scoop up material carefully, avoid generating dust
Cleanup Procedures: Place in a suitable container for disposal, ventilate area, wash spill site after material pickup

7. Handling and Storage

Precautions for Safe Handling: Avoid breathing dust, minimize contact with skin and eyes, use in fume hood or well-ventilated space, keep containers tightly closed
Storage Conditions: Store at room temperature, protect from light and moisture, keep away from incompatible materials such as oxidizers
Incompatibilities: Store away from strong acids, bases, and oxidizing agents

8. Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation, safety shower, and eyewash station nearby
Respiratory Protection: NIOSH-approved respirator for dust if engineering controls do not maintain minimal exposure
Eye Protection: Safety goggles or face shield
Skin Protection: Chemical-resistant gloves, lab coat
Hygiene Measures: Wash hands thoroughly after use, avoid eating, drinking, or smoking in work areas

9. Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Melting Point: 269°C–273°C
Solubility: Sparingly soluble in water, more soluble in acetone, DMSO, ethanol
pH: Not applicable for solid
Boiling Point: Not established
Vapor Pressure: Not applicable
Partition Coefficient: logP ~2.2
Other Properties: Stable under standard conditions, sensitive to intense light and high temperatures

10. Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Reactivity: Reacts with strong oxidizers
Decomposition Products: Carbon monoxide, carbon dioxide, fluorine-containing gases
Conditions to Avoid: Excess heat, incompatible substances, moisture

11. Toxicological Information

Acute Toxicity: Low oral and dermal toxicity in animal studies
Routes of Exposure: Skin, eye contact, inhalation, ingestion
Symptoms: Irritation of eyes, skin, mucous membranes, headache, nausea with large exposures
Chronic Effects: Potential systemic effects from prolonged dermal or ocular exposure, risk increases with quantity and duration
Carcinogenicity: Not classified as carcinogenic by IARC or NTP
Mutagenicity: No data indicate mutagenic hazards at typical exposures

12. Ecological Information

Toxicity to Aquatic Life: Expected to be low at pharmaceutical concentrations but may disrupt aquatic organisms at high concentrations
Persistence and Degradability: Not readily biodegradable, persists in the environment
Bioaccumulation Potential: Potential to bioaccumulate is low, but studies are limited
Mobility in Soil: Limited mobility, binds to organic matter

13. Disposal Considerations

Waste Disposal Methods: Dispose of through licensed chemical waste contractor, do not discharge into the environment or sewer systems
Container Disposal: Rinse and destroy containers following regulatory requirements
Precautions: Follow local, regional, and national regulations for disposal of pharmaceutical waste

14. Transport Information

UN Number: Not regulated for transport as a hazardous material
Transport Hazard Class: Not classified as dangerous
Packing Group: Not assigned
Environmental Hazards: Not classified as marine pollutant
Transport Precautions: Protect from physical damage, keep sealed and dry during transit

15. Regulatory Information

OSHA Hazard Communication Standard: Not considered hazardous at pharmaceutical concentrations
TSCA Status: Not listed
REACH Registration: Active substance in medicinal products, exempt from registration
Other Listings: Check national inventories and controlled substance lists in destination jurisdiction
Labeling Requirements: Comply with regulations for pharmaceutical handling and storage