Material Safety Data Sheet for Beclomethasone Dipropionate

Identification

Product Name: Beclomethasone Dipropionate
Chemical Name: 9-chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
Synonyms: Beclometasone dipropionate, BDP
CAS Number: 5534-09-8
Recommended Use: Pharmaceutical corticosteroid for inflammatory and allergic conditions
Manufacturer: Pharmaceutical producer or supplier contact details available on packaging
Emergency Contact: Medical Poison Information Center or local emergency services

Hazard Identification

Classification: Not classified as hazardous by GHS for handling in finished dosage form; raw active powder causes respiratory irritation, skin and eye irritation
Health Hazards: Inhalation of dust or prolonged skin contact can trigger allergic reactions, respiratory symptoms, irritation, and rare adrenal suppression
Environmental Hazards: Harmful to aquatic organisms; persistent in environment
Signal Word: Warning
Hazard Statements: Causes mild skin irritation; can aggravate respiratory system if inhaled; potentially sensitizing
Pictograms: Exclamation mark for irritancy

Composition / Information on Ingredients

Main Ingredient: Beclomethasone Dipropionate
Purity: >98% for raw active pharmaceutical ingredient
Impurities: Residual solvents (trace); organic and inorganic trace contaminants
Formulation Additives: Excipients in formulations not considered hazardous

First Aid Measures

Inhalation: Move to fresh air; seek medical attention for any breathing issues, wheezing, dizziness, or throat discomfort
Skin Contact: Remove contaminated clothing; wash with soap and copious amounts of water, consult medical staff if irritation persists
Eye Contact: Rinse gently under running water for at least 15 minutes, do not rub eyes, obtain medical advice promptly
Ingestion: Rinse mouth, drink water if possible, consult medical staff; do not induce vomiting unless directed by poison control
Advice To Physician: Treat symptomatically, monitor for allergic reactions, adrenal suppression symptoms

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, carbon dioxide, dry powder, or alcohol-resistant foam
Special Hazards: Releases fumes of hydrochloric acid, chlorine, carbon monoxide, carbon dioxide under combustion
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing
Hazard Combustion Products: Toxic gases possible; avoid inhaling smoke or fumes

Accidental Release Measures

Spill Cleanup: Isolate spill area, avoid dust generation, ventilate area, use disposable absorbent material and place waste in sealed containers
Personal Precautions: Wear gloves, eye protection, lab coat, and a particulate respirator mask; avoid skin and eye contact
Environmental Precautions: Prevent entry into drains or watercourses; inform authorities in case of large release
Decontamination: Clean surfaces with wet cloth followed by soap and water; dispose of rags securely

Handling and Storage

Handling: Minimize dust, work in well-ventilated area or fume hood, implement routine hand washing, avoid eating/drinking in areas of use
Storage Conditions: Keep container tightly closed, protect from light, moisture, and high temperatures, store in original packaging
Incompatibilities: Strong oxidizers, acids, and bases may cause degradation
Storage Location: Secure, dry pharmacy or chemical storeroom; restrict access to authorized personnel

Exposure Controls and Personal Protection

Exposure Limits: No established occupational exposure limit; minimize workplace airborne concentration
Engineering Controls: Local exhaust ventilation or laboratory fume hood
Personal Protection: Chemical-resistant gloves (nitrile/rubber), safety goggles, disposable lab coat, FFP2 or N95 respirators, avoid direct handling
Hygiene Practices: Wash hands, remove PPE before leaving workspace, prohibit food and beverage consumption in work area

Physical and Chemical Properties

Appearance: White or almost white crystalline powder
Odor: Odorless or faint characteristic odor
Odor Threshold: Not determined
pH: Not applicable (insoluble in water)
Melting Point: 217–220°C
Boiling Point: Not available (decomposes)
Solubility: Practically insoluble in water; soluble in acetone, chloroform, methanol
Specific Gravity: Not determined
Vapor Pressure: Negligible at room temperature
Partition Coefficient (Log Pow): Approximately 2.7–3.5
Flash Point: Not determined
Decomposition Temperature: Above 220°C

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions away from light and moisture
Reactivity: Not highly reactive; avoid strong acids, strong bases, and oxidizing agents
Hazardous Reactions: No dangerous reactions identified under normal conditions
Decomposition Products: Hydrochloric acid, chlorine, carbon oxides on burning or strong heating
Polymerization: No risk of hazardous polymerization

Toxicological Information

Acute Toxicity: Oral LD50 in rats estimated >3000 mg/kg; not acutely toxic by oral, dermal, or inhalation routes in non-sensitized individuals
Chronic Effects: Long-term or repeated exposure linked to possible adrenal suppression, skin atrophy, immunosuppression
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Mutagenicity: No significant genotoxic effects observed in in-vitro or animal tests
Reproductive Effects: High doses in animal studies showed possible delayed fetal growth; use with caution in pregnancy
Sensitization: Reports of rare allergic reactions in highly sensitive individuals
Target Organs: Adrenal cortex, skin, immune system

Ecological Information

Persistence: Stable in environment; unlikely to undergo rapid biodegradation
Bioaccumulation: Potential for bioaccumulation in aquatic environments
Aquatic Toxicity: Toxic to aquatic invertebrates and fish at high concentrations
Mobility in Soil: Binds to organic matter, not highly mobile
Other Effects: No significant effect on ozone depletion or global warming

Disposal Considerations

Waste Treatment: Collect and deliver unused or expired material to authorized hazardous waste disposal facilities; follow national and local drug disposal rules
Incineration: Appropriate method for large quantities; use properly permitted facility
Container Disposal: Triple-rinse containers, puncture, and dispose of according to regulatory requirements
Precautions: Never discharge into sewer, soil, or water bodies

Transport Information

UN Number: Not regulated as a hazardous substance for transport
Proper Shipping Name: Beclomethasone Dipropionate or pharmaceutical preparation
Hazard Class: Not classified as dangerous for road, sea, or air transport
Packing Group: Not assigned
Transport Precautions: Secure containers, protect from direct sunlight and extreme temperatures

Regulatory Information

US Regulations: Listed as prescription-only drug, subject to FDA rules, no specific OSHA classification
European Union: Covered by REACH as a pharmaceutical; subject to EMA product license
Safety Assessment: Handled only by trained personnel in authorized settings
Inventory Listing: Registered with chemical substance inventories such as EINECS, TSCA
Labeling Requirements: Provide clear hazard, precaution, and handling labels according to local pharmaceutical and chemical safety regulations