Product Name: Betamethasone
Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione
Synonyms: Betamethasone base, Celestone
CAS Number: 378-44-9
Recommended Uses: Pharmaceutical corticosteroid for inflammatory and autoimmune disorders
Manufacturer/Supplier: Information provided on product label or packaging
Emergency Contacts: Refer to local poison control center or medical facility
Classification: Not classified as hazardous under GHS for general handling; possible local irritation to eyes or skin
Route of Exposure: Inhalation, skin contact, eye contact, ingestion
Health Risks: Prolonged exposure may suppress immune function, cause changes in blood sugar, affect adrenal gland function
Hazard Statements: May cause allergic skin reaction; can damage fertility or the unborn child during ongoing use; risk of irritation to respiratory system
Pictograms/Symbols: Exclamation mark, health hazard
Precautionary Statements: Avoid breathing dust or aerosols; wash hands thoroughly after handling; use protective gloves and eye protection
Label Elements: Read product label for full guidance prior to use
Chemical Substance: Betamethasone
Concentration: Typically over 98% purity for active pharmaceutical ingredient
Impurities/Additives: Trace solvents, moisture, related steroidal substances as per quality specification
Other Ingredients: Not applicable for pure substance; refer to formulation data for finished drug products
Inhalation: Move exposed individual to fresh air; seek medical attention for symptoms like shortness of breath, dizziness, or coughing
Skin Contact: Remove contaminated clothing; rinse exposed skin with plenty of water and mild soap; consult healthcare provider if irritation or redness persists
Eye Contact: Rinse eyes gently with water for several minutes; remove contact lenses if safe and easy; get medical advice if discomfort remains
Ingestion: Rinse mouth thoroughly; consult a medical professional immediately; do not induce vomiting unless instructed by healthcare personnel
Potential Symptoms: Headache, skin rashes, redness, allergic reactions, or steroid-related side effects such as mood changes or increased thirst
Suitable Extinguishing Media: Water spray, foam, dry chemical extinguisher, or carbon dioxide
Special Hazards: May release harmful fumes such as carbon oxides, fluorine, and chlorine compounds in case of combustion
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective clothing
Advice for Firefighters: Stay upwind; avoid inhaling smoke, fumes, or vapors; cool exposed containers with water spray
Explosion Risk: Product does not present an explosion risk under normal handling and storage conditions
Personal Precautions: Use appropriate personal protective equipment such as gloves, safety goggles, laboratory coat, or respirator if dust is generated
Environmental Precautions: Prevent further spillage or leakage; keep material away from watercourses, drains, and soil
Clean-up Methods: Sweep up or vacuum the powder carefully; avoid creating dust; dispose of collected material in sealed containers
Disposal: Follow local regulations for disposal as hazardous or pharmaceutical waste
Notification Procedures: Notify proper authorities if significant spill occurs impacting community or ecosystem
Precautions for Safe Handling: Handle in ventilated area; minimize dust generation and accumulation; avoid skin or eye contact
Hygiene Measures: Wash hands after handling; prohibit eating, drinking, or smoking in work area
Storage Requirements: Store in original container tightly closed, in a cool, dry, well-ventilated area away from moisture, light, and incompatible substances
Special Storage Conditions: Protect from excessive heat or freezing; secure area against unauthorized access
Incompatibilities: Strong oxidizing agents, acids, bases
Occupational Exposure Limits: No established ACGIH or OSHA limits for Betamethasone; minimize exposure with current technical controls
Engineering Controls: Use local exhaust ventilation, laminar flow hoods, or containment devices in handling areas
Personal Protective Equipment: Nitrile gloves, chemical safety goggles, protective lab coat; respiratory protection if airborne particles or aerosol formation
Environmental Control Measures: Prevent entry into drains or natural water bodies; implement spill containment strategies where necessary
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not determined
pH: Not applicable (sparingly soluble in water)
Melting Point/Freezing Point: 239–241°C
Boiling Point: Decomposes before boiling
Flash Point: Not flammable
Evaporation Rate: Not applicable
Flammability: Product does not ignite easily
Vapor Pressure: Negligible at ambient conditions
Vapor Density: Not applicable
Solubility in Water: Practically insoluble
Solubility in Other Solvents: Ethanol, acetone, chloroform (increased solubility)
Partition Coefficient (log Pow): Estimated 1.9
Decomposition Temperature: Above 250°C
Viscosity: Not relevant for solid form
Chemical Stability: Stable under recommended storage conditions
Hazardous Reactions: Product stays inert under normal conditions; can react with strong oxidizers or acids
Decomposition Products: Carbon oxides, hydrogen fluoride, minor steroidal fragments
Conditions to Avoid: Excessive moisture, strong sunlight, heat, incompatible chemicals
Polymerization: No hazard of hazardous polymerization
Acute Toxicity: Oral LD50 (rat) is over 3000 mg/kg indicating low acute toxicity
Skin Corrosion/Irritation: May cause mild skin irritation with prolonged contact
Serious Eye Damage/Irritation: May cause irritation, redness, or watering
Respiratory Sensitization: Inhalation of dust may trigger coughing or respiratory discomfort
Skin Sensitization: Allergic reactions possible with sensitized individuals
Mutagenicity/Carcinogenicity: No clear evidence of mutagenicity; not classified as carcinogenic in humans by IARC
Reproductive Toxicity: Prolonged or repeated use can disrupt hormonal balance and affect fertility or pregnancy outcomes
Long-term Exposure Effects: Suppression of adrenal function, changes in blood sugar, risk of bone thinning, or increased infection risk
Environmental Toxicity: Harmful to aquatic organisms due to hormonal effects
Persistence and Degradability: Moderately resistant to natural breakdown; can persist in soil and water for many weeks
Bioaccumulation Potential: Risk of accumulation in aquatic species exposed to multiple releases
Mobility in Soil: Moderate mobility; risk of leaching into groundwater if mismanaged
Other Adverse Effects: Possible risk to wastewater treatment plants and transfer to food chains if not properly managed
Waste Treatment Methods: Incineration as hazardous pharmaceutical waste or chemical waste
Disposal of Contaminated Packaging: Rinse containers thoroughly, then treat as hazardous waste
Precautions for Disposal: Avoid release to sewage or natural water bodies; do not landfill untreated material
Local/Regional Requirements: Comply with all applicable local, regional, and national regulations
UN Number: No UN designation for regular transport
Proper Shipping Name: No special requirement; transport as non-hazardous pharmaceutical raw material
Transport Hazard Class: Not classified as dangerous for road, rail, sea, or air under standard chemical transport guidelines
Packing Group: Not assigned
Environmental Hazards (ADR/RID/IMDG/IATA): No
Special Precautions: Prevent moisture ingress, protect from physical damage, use sealed containers
Relevant Regulations: Subject to regulations under controlled substances for pharmaceutical production and use
Occupational Safety Guidelines: No specific OSHA or ACGIH exposure limits; observe general safety and health recommendations
Inventory Status: Listed under various national drug and chemical inventories
Other Legal Obligations: Comply with documentation and reporting as required for controlled drugs and hazardous chemical management
Labeling Requirements: Follow all national and international label requirements for pharmaceutical substances including warning statements, classification, and first aid information
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