Material Safety Data Sheet (MSDS) for Beclomethasone

Identification

Product Name: Beclomethasone
Chemical Name: 9-Chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione
Synonyms: Beclometasone, Beclovent, Becotide, Vancenase
CAS Number: 4419-39-0
Recommended Use: Pharmaceutical corticosteroid, commonly prescribed for inflammation control in asthma, allergic rhinitis, or skin disorders
Manufacturer's Contact: Emergency telephone, local poison control information, and address available on product label

Hazard Identification

Classification: Not classified as hazardous under GHS for general consumers. Occupational exposure can cause skin or eye irritation, possible allergic skin reaction, or respiratory issues.
Signal Word: Warning
Hazard Statements: Steroid exposure can cause immunosuppressive effects, trigger pre-existing infections, may affect endocrine function
Precautionary Statements: Wear gloves, use eye protection when handling powder or high concentrations, avoid breathing dust, ensure area has adequate ventilation

Composition / Information on Ingredients

Main Ingredient: Beclomethasone (≥98% purity, pharmaceutical standard)
Impurities: May include residual solvents used in synthesis, trace levels of related corticosteroids
Excipients (for formulated medicines): Lactose monohydrate, microcrystalline cellulose, magnesium stearate, as per formulation

First Aid Measures

Inhalation: Move to fresh air. Seek medical attention if symptoms appear such as coughing, wheezing, or shortness of breath.
Skin Contact: Remove contaminated clothing. Wash skin thoroughly with soap and water. Seek treatment if irritation or allergic reaction develops.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. Seek medical attention if irritation persists.
Ingestion: Rinse mouth. Do not induce vomiting. Seek immediate medical assistance due to potential systemic effects of corticosteroid exposure.

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, or carbon dioxide. Adjust according to surrounding fire materials.
Specific Hazards: Combustion produces toxic fumes including carbon monoxide, carbon dioxide, hydrogen chloride, and possibly chlorine gas.
Protective Equipment for Firefighters: Wear full protective suit including self-contained breathing apparatus.
Other Advice: Prevent run-off from entering drains or waterways. Remove product from path of fire if safe to do so.

Accidental Release Measures

Personal Precautions: Avoid breathing dust. Ventilate area. Use protective gloves, goggles, and mask.
Environmental Precautions: Prevent material from entering water sources, sewers, or soil.
Clean-up Methods: Collect powder or solid with a damp cloth or absorbent material. Place in suitable container for disposal. Wash area with water and detergent after collection.

Handling and Storage

Handling: Avoid contact with skin, eyes, and clothing. Do not inhale powder or vapors. Use only in well-ventilated spaces.
Storage: Store in tightly sealed container. Keep away from moisture, heat, direct sunlight. Recommended temperature typically 15–25 °C. Separate from strong oxidizers and reactive chemicals.
Other Precautions: Store in original packaging or compatible container, away from food and drink.

Exposure Controls and Personal Protection

Exposure Limits: No specific occupational exposure limits established. Minimize exposure by using engineering controls.
Engineering Controls: Use fume hood or local exhaust if dust or vapor generation likely.
Personal Protective Equipment: Gloves (nitrile or latex), lab coat, splash goggles. Use particulate respirator mask for dust or large-scale handling.
Hygiene Measures: Wash hands after handling, before eating or drinking. Remove and wash contaminated clothing before reuse.

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or faint medicinal odor
Molecular Weight: 408.9 g/mol
Melting Point: 221-232 °C (varies slightly with hydrate content)
Solubility: Practically insoluble in water, soluble in chloroform and ethanol
pH: Not applicable
Flash Point: Not readily flammable under standard conditions
Vapor Pressure: Negligible at ambient temperature

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions.
Incompatible Materials: Strong oxidizing agents such as peroxides, strong acids.
Hazardous Decomposition Products: Includes carbon oxides, hydrogen chloride, possible chlorine-containing gases.
Conditions to Avoid: Excessive heat, open flame, prolonged exposure to light and moisture.

Toxicological Information

Acute Toxicity: Low acute oral and dermal toxicity; not likely to cause immediate life-threatening effects under standard laboratory exposure.
Chronic Toxicity: Long-term exposure can disrupt adrenal function, suppress immune system, cause hormonal imbalances.
Irritation and Sensitization: Can cause skin and eye irritation, possible allergic skin reactions with repeated contact.
Inhalation Effects: Risk of systemic corticosteroid effects if inhaled, including mood changes, blood pressure spikes, or electrolyte shifts.
Carcinogenicity: Not listed by IARC, NTP, OSHA as a known carcinogen.
Other Effects: Possible risk of fetal development interference at high concentrations (animal studies only); clinical judgment recommended for pregnant/lactating women.

Ecological Information

Ecotoxicity: May cause adverse effects in aquatic life at high concentrations due to its pharmacological action.
Persistence and Degradability: Not readily biodegradable. Tends to persist in the environment.
Bioaccumulative Potential: Potential for bioaccumulation not well-documented, but corticosteroids can build up in aquatic organisms.
Mobility in Soil: Low water solubility limits spread, mostly adsorbed on soil particles.

Disposal Considerations

Product Disposal: Treat as hazardous pharmaceutical waste. Destroy by incineration at approved facility. Do not dispose in household garbage, sewer, or regular landfill.
Container Disposal: Triple rinse containers. Dispose in accordance with local, state, and federal requirements.
Other Precautions: Avoid environmental contamination or uncontrolled release by ensuring proper waste channels and compliance with all disposal laws.

Transport Information

UN Number: Not assigned for pharmaceutical use.
Transport Hazard Class: Not regulated as dangerous good under IATA, IMDG, DOT for general transport.
Packing Group: Not regulated for this compound.
Special Precautions: Ship in original or approved container. Protect from physical damage, moisture, and light during transit.

Regulatory Information

Global Listings: Listed under various international pharmacopeias as prescription medication; not scheduled under controlled substance regulations.
OSHA Status: Non-hazardous for consumer use, but monitoring recommended for occupational exposures.
TSCA Status: Exempt for use in medicinal products.
Other Regulations: Follow federal, state, local, and international guidelines for pharmaceuticals. Consult with regulatory affairs or environmental health specialists for site-specific compliance.