Material Safety Data Sheet: Clobetasol Propionate

Identification

Product Name: Clobetasol Propionate
Chemical Formula: C25H32ClFO5
CAS Number: 25122-46-7
Manufacturers: Pharmaceutical companies specialized in corticosteroids
Recommended Use: Topical corticosteroid medication
Restrictions: Not intended for ophthalmic, oral, or intravaginal use
Emergency Contact: Refer to local Poison Control or manufacturer-specific emergency hotline
Synonym: Clobetasol-17-propionate

Hazard Identification

GHS Classification: Not classified as hazardous under GHS criteria
Physical Hazards: Dust may cause mechanical irritation
Health Hazards: Prolonged skin or eye contact can cause irritation or allergic reactions
Environmental Hazards: Harmful to aquatic organisms, possible long-term adverse effects in the aquatic environment
Signal Word: Warning
Hazard Statements: May cause allergic skin reaction; may be harmful if swallowed or inhaled; may cause reproductive toxicity
Precautionary Statements: Avoid release to environment; avoid breathing dust/fume/gas/mist/vapors/spray; wear protective gloves and eye protection

Composition / Information on Ingredients

Substance: Clobetasol Propionate
Active Ingredient: Clobetasol Propionate (pure or topical preparation)
Content Percentage: Greater than 99% (pure powder); possible lower concentrations in topical formulations
Inert Ingredients: Not present in pure chemical; topical salves may include base oils, emulsifiers, and alcohols
Impurities and Stabilizing Additives: Trace process byproducts under regulated limits; absence of stabilizers in pure substance

First Aid Measures

Inhalation: Move affected person to fresh air; seek medical attention if symptoms persist
Skin Contact: Wash thoroughly with soap and water; seek medical advice for prolonged irritation
Eye Contact: Rinse cautiously with water for at least 15 minutes; remove contact lenses if present; consult physician if discomfort continues
Ingestion: Seek immediate medical advice; rinse mouth thoroughly; do not induce vomiting unless instructed by medical personnel
Most Important Symptoms: Skin irritation, allergic dermatitis, headache, dizziness upon overexposure
Protection for First Aiders: Use gloves and avoid direct contact with the material

Fire-Fighting Measures

Suitable Extinguishing Media: Use carbon dioxide, dry chemical powder, or foam; use water spray only to cool containers
Unsuitable Extinguishing Media: Avoid direct water jet as it may spread contamination
Specific Hazards: May release toxic fumes of chlorine, fluorine, and other decomposition products
Protective Equipment: Fire fighters should wear self-contained breathing apparatus and full protective gear
Special Procedures: Fight fire from a safe distance; control runoff to prevent entry into waterways

Accidental Release Measures

Personal Precautions: Wear appropriate personal protective equipment including gloves, eyewear, and mask
Spill Cleanup: Sweep up spillage with care to avoid dust formation; collect for safe disposal
Environmental Precautions: Prevent release to the environment; do not allow to enter drains, sewers, or waterways
Methods for Containment: Keep away from ignition sources; ventilate the area
Disposal: Place collected material in approved waste container for disposal according to local, regional, and national regulations

Handling and Storage

Handling: Handle in well-ventilated spaces; wear gloves, eye protection, and dust mask
Hygiene Measures: Wash hands after handling; do not eat, drink, or smoke during use
Storage Conditions: Keep container tightly closed in a dry, cool, and well-ventilated area away from incompatible substances such as strong acids or oxidizers
Storage Temperature: Store between 2ºC and 30ºC; avoid freezing
Packaging: Use original, properly labeled containers

Exposure Controls and Personal Protection

Exposure Limits: No established occupational exposure limits
Engineering Controls: Use general or local exhaust ventilation to minimize airborne dust
Personal Protective Equipment: Protective gloves (nitrile, latex, or vinyl), laboratory coat, safety goggles; in case of dust generation, use a suitable particulate respirator
Environmental Controls: Ensure procedures minimize runoff and prevent material from entering waterways

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Molecular Weight: 467.97 g/mol
pH: Not applicable (insoluble in water)
Melting Point: 195–200°C
Solubility: Practically insoluble in water; soluble in methanol, acetone, chloroform
Flash Point: Not determined
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log Pow): 2.37 estimated
Density: Not established

Stability and Reactivity

Chemical Stability: Stable under recommended handling and storage conditions
Possibility of Hazardous Reactions: May react with strong oxidizers
Conditions to Avoid: Extreme heat, exposure to strong light, incompatible materials such as acids or oxidizers
Hazardous Decomposition Products: May emit toxic fumes of hydrogen chloride, hydrogen fluoride, carbon oxides upon combustion
Incompatible Materials: Strong oxidizing agents

Toxicological Information

Acute Toxicity: Oral LD50 (Rat): >3000 mg/kg (estimated); low acute toxicity by dermal and inhalation routes
Chronic Effects: Possible suppression of hypothalamic-pituitary-adrenal (HPA) axis on excessive, prolonged skin exposure
Skin Irritation: May cause irritation, dryness, or allergic dermatitis from repeated contact
Eye Effects: Dust may cause eye irritation
Carcinogenicity: No component listed by ACGIH, IARC, NTP, or OSHA
Reproductive Toxicity: Potential hazard based on class; avoid use in pregnancy without medical supervision

Ecological Information

Aquatic Toxicity: Harmful to aquatic organisms with risk of long-term effects
Persistence and Degradability: Limited biodegradability; slow breakdown in environment
Bioaccumulation: Potential for bioaccumulation in aquatic life
Mobility in Soil: Low mobility predicted due to low water solubility
Other Ecological Risks: Avoid spread into environment; do not flush into surface water or sanitary sewer systems

Disposal Considerations

Waste Disposal Methods: Dispose of in accordance with local, state, and national regulations; incineration recommended for bulk material
Contaminated Packaging: Empty containers fully, triple rinse, and dispose via licensed waste contractor
Product Disposal: Do not release into environment; handle as hazardous pharmaceutical waste

Transport Information

UN Number: Not classified for transport under UN, IMDG, or IATA regulations
Proper Shipping Name: Not regulated as a hazardous material for ground, air, or sea transport
Transport Hazard Class: Not applicable
Packing Group: Not regulated
Special Precautions: Protect against physical damage during transport; keep containers upright and tightly closed

Regulatory Information

TSCA Status: Listed on the US TSCA Inventory
REACH Status: Registered under EU REACH regulation for industrial and pharmaceutical use
OSHA Status: Not listed as hazardous under OSHA Hazard Communication Standard
SARA Title III Information: Not subject to reporting under Sections 302, 304, 311, or 313
FDA Regulation: Approved as a drug substance; subject to pharmaceutical guidelines and controls
Other International Regulations: Controlled as a prescription pharmaceutical across major regulatory jurisdictions; strict distribution and handling protocols enforced