Material Safety Data Sheet: Betamethasone Dipropionate

Identification

Product Name: Betamethasone Dipropionate
Chemical Family: Corticosteroid
Synonyms: 9-Fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
Product Code: Specific to manufacturer
Intended Use: Pharmaceutical, topical and dermatological application
Supplier Information: Manufacturer details required on packaging, including emergency contact
CAS Number: 5593-20-4
Emergency Contact Number: Refer to local regulatory guidelines or supplier info

Hazard Identification

Classification: Classified as hazardous based on GHS criteria for skin and eye irritation
Health Hazards: May cause skin and eye irritation, possible allergic reactions, potential to affect adrenal gland function after repeated exposure
Acute Effects: Skin redness, stinging or burning sensation, eye discomfort
Chronic Effects: Hormonal imbalances, skin thinning, delayed wound healing
Label Elements: GHS pictogram with exclamation mark, signal word "Warning", hazard statements for irritation and allergic sensitization risks
Precautionary Statements: Avoid contact with skin and eyes, use appropriate protection, follow industrial hygiene policies

Composition / Information on Ingredients

Chemical Name: Betamethasone Dipropionate
Concentration: Typically 0.05% in formulated products, up to 100% pure in bulk material
CAS Number: 5593-20-4
Impurities or Stabilizers: Generally not present in significant amounts, consult manufacturing documentation for details
Physical Form: Powder, cream, or ointment formulations

First Aid Measures

Inhalation: Move person to fresh air, provide oxygen support if breathing becomes difficult, seek medical advice if symptoms develop
Skin Contact: Wash affected area thoroughly with soap and water, remove contaminated clothing, seek medical attention for irritation
Eye Contact: Rinse eyes with lukewarm water for at least 15 minutes, ensure eyelids are lifted, obtain medical help if discomfort persists
Ingestion: Rinse mouth with water, provide supportive care, seek medical attention immediately, do not induce vomiting unless advised
Important Symptoms and Effects: Immediate irritation, sensitization, dryness or swelling; delayed symptoms can include hormonal effects
Notes for Physician: Provide symptomatic treatment, monitor for adrenal suppression, manage allergic reactions as required

Fire-Fighting Measures

Suitable Extinguishing Media: Carbon dioxide, dry chemical, water spray, or foam
Unsuitable Extinguishing Media: None known for formulated product
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, possible toxic fumes from decomposition, including halogenated compounds
Special Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing
Specific Hazards: Combustion releases irritating or toxic gases, containers may rupture when heated
Special Procedures: Cool containers exposed to fire with water spray, prevent runoff into drains or watercourses

Accidental Release Measures

Personal Precautions: Wear suitable skin and eye protection, use gloves and goggles, avoid dust formation
Environmental Precautions: Prevent product from entering drains, sewers, or waterways; contain spill with absorbent material
Clean-up Methods: Collect material using appropriate tools, ventilate area, place waste in labelled, sealed containers for safe disposal
Decontamination: Wash spill site thoroughly with water and detergent after removal

Handling and Storage

Safe Handling Advice: Avoid unnecessary contact or inhalation, handle in well-ventilated area, use local exhaust if needed
Technical Measures: Use suitable personal protective equipment, keep container tightly closed
Storage Conditions: Store in cool, dry place away from direct light, heat, and moisture
Incompatible Materials: Strong oxidizers, acids, alkalis
Specific Storage Instructions: Keep separate from foodstuffs, secure from unauthorized access

Exposure Controls and Personal Protection

Exposure Limits: No established occupational limits for Betamethasone Dipropionate, minimize exposure based on pharmaceutical handling guidance
Engineering Controls: Maintain adequate ventilation, use fume hoods for powder handling
Personal Protection: Wear gloves, chemical splash goggles, protective clothing, use respiratory protection with high airborne concentrations
Hygiene Measures: Wash hands thoroughly after handling, do not eat, drink or smoke in work area
Environmental Exposure: Prevent release to environment, use proper containment practices

Physical and Chemical Properties

Appearance: White to off-white crystalline powder, often supplied as semi-solid creams or ointments
Odor: Odorless or slight characteristic smell in some formulations
pH: No data for bulk substance, pH determined by finished formulation
Boiling Point: Not applicable (decomposes before boiling)
Melting Point: Approximately 228-232°C (pure powder)
Solubility: Practically insoluble in water, soluble in acetone, slightly soluble in ethanol
Molecular Weight: 504.6 g/mol
Vapor Pressure: Negligible under standard conditions
Flash Point: Not available for bulk powder, assess risk in context of formulation
Partition Coefficient (log Pow): High, indicative of lipophilicity

Stability and Reactivity

Chemical Stability: Stable under standard storage conditions, light and moisture sensitive
Conditions to Avoid: Exposure to strong light, moisture, excessive heat, open flames
Incompatible Materials: Oxidizing agents, strong acids or bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, related toxic fumes
Reactivity: Not reactive under normal handling, reacts with oxidizers

Toxicological Information

Acute Toxicity: Oral LD50 (rat): >3500 mg/kg (estimated), low acute toxicity risk by dermal or inhalation routes
Skin Corrosion/Irritation: May cause mild to moderate irritation with repeated exposure
Eye Damage/Irritation: Risk of moderate irritation
Respiratory Sensitization: Not classified but avoid generating dust
Skin Sensitization: Can cause allergic contact dermatitis in sensitive individuals
Reproductive Effects: Known to cross placenta, caution advised during pregnancy
Carcinogenicity: No known classification as carcinogen based on current data
Other Information: Frequent or prolonged exposure can suppress adrenal function, risk increases with large-area or occlusive use

Ecological Information

Ecotoxicity: Toxic to aquatic organisms, long-term effects in aquatic environments
Persistence and Degradability: Not readily biodegradable, potential to persist in environment
Bioaccumulative Potential: Likely to bioaccumulate due to high lipid solubility
Mobility in Soil: Binds to soil, slow migration through groundwater
Other Adverse Effects: Avoid release into the environment; pharmaceutical residues may impact aquatic life and soil microorganisms

Disposal Considerations

Waste Treatment Methods: Handle as hazardous pharmaceutical waste, use authorized disposal contractor
Product Disposal: Incineration recommended, compliance with local regulations required
Packaging Disposal: Dispose of contaminated containers as hazardous waste, rinse thoroughly if possible before disposal
Special Precautions: Avoid landfill disposal, prevent contamination of water sources

Transport Information

UN Number: Not classified as a dangerous good under UN transport regulations
Transport Hazard Class: Not regulated for transport, check local guidelines for pharmaceutical substances
Packing Group: Not assigned
Environmental Hazards: Transport in secure, labelled packaging, prevent spillage
Special Precautions: Avoid extremes of temperature and mechanical stress during shipment

Regulatory Information

Labeling Required: Packaging must include hazard warnings, handling and storage requirements, emergency contact information
Regulatory Listings: Betamethasone Dipropionate regulated as a prescription pharmaceutical in most regions
GHS Compliance: Product classified per Globally Harmonized System guidelines
Specific Regulations: OSHA (USA hazards communication), REACH (EU), workplace safety standards apply
Other Safety Standards: Observe regional and international regulations for pharmaceutical handling, worker safety, and environmental emissions