Material Safety Data Sheet — Betamethasone Valerate

Identification

Product Name: Betamethasone Valerate
Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate
Common Synonyms: Betnovate, BMV
Use: Topical corticosteroid for skin conditions
CAS Number: 2152-44-5
Manufacturer: Pharmaceutical suppliers
Emergency Contact: Refer to local poison control or emergency services
Recommended Restrictions: Prescription only, use on intact skin, keep away from eyes and mucous membranes

Hazard Identification

Hazard Classification: Not classified as hazardous by GHS for general consumer use but may cause irritation and health effects in certain scenarios
Signal Word: Warning
Hazard Statements: May cause skin and eye irritation, long-term exposure risks include suppression of adrenal function and thinning of skin, inhalation or ingestion can lead to systemic effects
Precautionary Statements: Avoid contact with eyes, avoid inhaling dust, wear suitable protection during handling
Pictograms: Exclamation mark, health hazard symbol

Composition / Information on Ingredients

Active Ingredient: Betamethasone valerate
Concentration: Typically 0.1% in creams, ointments, lotions
Other Ingredients: May contain propylene glycol, white soft paraffin, cetostearyl alcohol, glyceryl monostearate, isopropyl myristate, chlorocresol as preservative, purified water
Impurities: Not anticipated in significant amounts in regulated pharmaceutical products

First Aid Measures

Inhalation: Move the affected individual to fresh air, seek medical advice if symptoms such as respiratory distress appear
Skin Contact: Wash thoroughly with soap and water in case of accidental exposure to large quantities, seek medical attention for rash or irritation
Eye Contact: Flush eyes with running water for at least 15 minutes, remove contact lenses, get prompt medical evaluation
Ingestion: Rinse mouth with water, seek immediate medical attention, do not induce vomiting unless directed by medical personnel

Fire-Fighting Measures

Suitable Extinguishing Media: Use foam, dry powder, carbon dioxide, or water spray
Hazards from Combustion: Forms toxic and irritating fumes under fire, including carbon oxides and fluorine-containing compounds
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Precautions: Avoid inhaling smoke, evacuate area if necessary, cool containers with water spray to prevent pressure build-up

Accidental Release Measures

Personal Protection: Wear gloves, safety goggles, and mask
Environmental Precautions: Keep out of drains and water sources, report large spills to environmental authorities
Cleanup Methods: Absorb with inert material such as sand or earth, sweep up and place in labeled waste containers, wash area with water but avoid splashing
Special Considerations: Prevent formation of dust, ventilate area well during cleanup

Handling and Storage

Safe Handling: Keep away from open wounds except as directed medically, avoid generating dust and inhaling powder, use with adequate ventilation
Hygiene Practices: Wash hands after handling, avoid eating or drinking around materials
Storage Conditions: Store at room temperature, out of direct sunlight, keep containers tightly closed
Incompatibilities: Avoid strong oxidizing agents, acids, and alkalis
Packaging Materials: Use original packaging to prevent contamination or degradation

Exposure Controls and Personal Protection

Occupational Exposure Limits: No official occupational exposure limits set, minimize exposure through engineering controls
Engineering Controls: Use local exhaust ventilation or work in well-ventilated spaces
Personal Protective Equipment: Gloves (nitrile or latex), lab coats, safety glasses with side shields, dust mask if powder
Environmental Controls: Prevent release into environment, use proper containment and waste procedures

Physical and Chemical Properties

Appearance: White or almost white powder
Odor: Odorless or faint medicinal smell
pH: Not applicable (insoluble in water)
Melting Point: About 185–194 °C
Boiling Point: Not determined (decomposes before boiling)
Solubility: Practically insoluble in water, soluble in alcohols and organic solvents
Partition Coefficient: Log P (octanol/water): Approximately 2.7
Vapor Pressure: Negligible under normal conditions
Density: Not readily available, low bulk density typical of steroid powders

Stability and Reactivity

Stability: Stable under normal use and storage conditions
Hazardous Polymerization: Will not occur
Incompatible Materials: Strong oxidizers, acids, alkalis
Decomposition Products: Emits toxic fumes of carbon oxides and hydrogen fluoride at high temperatures
Conditions to Avoid: Excessive heat, direct sunlight, freezing, moisture ingress

Toxicological Information

Acute Toxicity: Low toxicity in typical topical use, ingestion or inhalation of large amounts may be harmful
Chronic Effects: Long-term misuse can cause skin atrophy, adrenal suppression, systemic corticosteroid effects
Skin Sensitization: Prolonged or repeated exposure may cause allergic reactions
Carcinogenicity: Not listed as carcinogenic by IARC, NTP, or OSHA
Reproductive Toxicity: Not recommended for use in pregnancy or nursing unless prescribed
Medical Conditions Aggravated: May worsen existing skin infections, diabetes, Cushing’s syndrome

Ecological Information

Eco-toxicity: Potentially harmful to aquatic organisms, may cause long-term adverse effects in aquatic environments
Environmental Fate: Not easily biodegradable, may persist in soil and water
Mobility: Low mobility in soil due to low water solubility
Bioaccumulation: Possible due to lipophilicity
Toxicity to Microorganisms: Can disrupt microbial activity in sewage treatment
Recommendations: Prevent uncontrolled release, follow strict disposal methods

Disposal Considerations

Disposal Methods: Dispose of in accordance with local, regional, and national regulations
Unused Product: Incinerate in an approved facility or return to authorized waste handlers
Contaminated Packaging: Triple-rinse, dispose as hazardous material
Special Precautions: Do not discharge into sewers, soil, or surface water bodies

Transport Information

UN Number: Not classified as hazardous for ground, air, or sea transport
Transport Hazard Class: Not regulated
Packing Group: Not regulated
Special Precautions for Transport: Prevent breakage and leakage, lock containers securely, temperature control prevents degradation
Labeling: Not a dangerous good per transport regulations

Regulatory Information

Global Inventories: Registered as active ingredient for pharmaceutical use in many countries
Labeling Requirements: Must state prescription status, warning statements about misuse, storage, and disposal
Safety, Health, and Environmental Regulations: Subject to drug control laws; workplace and environmental hygiene regulations apply if handled in bulk
Other Restrictions: Only available through medical prescription, not to be used except as indicated for medical conditions
Worker Protection: Safety guidelines published by occupational health agencies for manufacturing or compounding settings
Additional Notes: National and local regulations may require reporting of significant spills or releases