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Product Name: Fusidic Acid
Chemical Formula: C31H48O6
CAS Number: 6990-06-3
Molecular Weight: 516.7 g/mol
Synonyms: Fusidin, Fucidin
Recommended Use: Antibacterial agent for pharmaceutical formulations
Manufacturer: [Manufacturer Information Required]
Contact Details: [Contact Number and Address, Emergency Phone Number]
GHS Classification: Skin irritation (Category 2), Eye irritation (Category 2A)
Signal Word: Warning
Hazard Statements: Causes skin irritation, causes serious eye irritation
Precautionary Statements: Wear protective gloves and eye protection, avoid contact with skin and eyes, wash hands thoroughly after handling
Potential Health Effects: Inhalation—may cause respiratory irritation; Skin contact—may result in mild to moderate irritation or allergic response; Eye contact—moderate to severe irritation; Ingestion—nausea, vomiting possible; Chronic exposure—rare but possible liver impairment in highly sensitive individuals
Environmental Hazards: Toxic to aquatic life with long lasting effects
Main Component: Fusidic Acid
Concentration: >98% by weight
Impurities: None significant for hazard classification
Other Components: None deliberately added
Ingredient Notes: Pharmaceutical grade, manufactured under GMP compliance
Inhalation: Move person to fresh air, seek medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, wash area with soap and water, consult doctor if irritation develops
Eye Contact: Rinse immediately with plenty of clean water for at least 15 minutes, lift upper and lower eyelids occasionally, get medical help if discomfort remains
Ingestion: Rinse mouth thoroughly, do not induce vomiting unless directed by medical personnel, seek immediate medical assistance
Most Important Symptoms: Eye redness, itching, skin rash, breathing difficulty in rare situations
Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, water spray
Specific Hazards: May emit toxic fumes under fire conditions (carbon oxides, sulfur oxides); dust explosion not likely in ordinary handling
Firefighting Equipment: Self-contained breathing apparatus, full protective suit
Protective Actions: Evacuate area, cool containers exposed to fire with water spray
Hazardous Combustion Products: Irritating or toxic gases may be released during combustion (CO, CO2)
Personal Precautions: Use proper personal protection (gloves, goggles, respirator for dusty conditions)
Environmental Precautions: Prevent runoff into sewers and waterways, minimize contamination by collecting spillage
Cleanup Methods: Sweep up and place in a suitable container for disposal, avoid dust generation, ventilate area, clean contaminated surfaces thoroughly
Decontamination: Wash spill area with soap and water after material pickup
Handling: Operate in well-ventilated areas, minimize dust production, avoid inhalation, ingestion, and skin or eye contact, wash hands and face after handling
Storage Conditions: Store in tightly closed containers, keep at controlled room temperature (15–25°C), protect from light, moisture, and incompatible substances such as strong oxidizing agents
Storage Precautions: Keep away from food, drink, animal feed, and out of reach of children
Incompatibilities: Strong acids, bases, oxidizing materials
Occupational Exposure Limits: No ACGIH or OSHA exposure limit established, general industry exposure control applies
Engineering Controls: Use local exhaust ventilation, process enclosure for large scale handling
Personal Protective Equipment: Gloves (nitrile or chemical-resistant), safety goggles or face shield, lab coat or protective clothing
Hygiene Practices: Remove contaminated clothing, wash after handling, do not eat or drink while handling product
Respiratory Protection: Use approved mask or respirator if dust or aerosols are produced
Appearance: White to off-white crystalline powder
Odor: Odorless
pH (1% solution): Approximately 7
Melting Point: 183–185°C
Boiling Point: Not applicable (decomposes)
Flash Point: Not established
Solubility: Sparingly soluble in water, soluble in methanol, ethanol, chloroform
Partition Coefficient (log Pow): about 2.7
Vapor Pressure: Negligible at room temperature
Density: 1.25–1.30 g/cm3
Chemical Stability: Stable under recommended storage conditions
Reactivity: No dangerous reactions known under normal use
Conditions to Avoid: Excess heat, moisture, direct sunlight, strong oxidizers
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Hazardous Decomposition: Produces carbon oxides, sulfur oxides during combustion
Acute Toxicity: Low acute toxicity, oral LD50 (rat) >2000 mg/kg
Skin Corrosion/Irritation: Causes moderate skin irritation
Eye Damage/Irritation: Causes serious eye irritation
Respiratory Sensitization: May cause slight respiratory tract irritation with dust
Carcinogenicity: No classification by IARC, NTP, or OSHA
Reproductive Toxicity: Animal studies show no significant reproductive hazards
Repeated Dose Toxicity: No adverse effects observed at therapeutic levels, high repeated exposure not properly studied in humans
Other Chronic Effects: Allergic skin reactions possible in sensitive individuals
Aquatic Toxicity: Harmful to aquatic life, specific LC50 values for fish and invertebrates vary between 1–10 mg/L
Persistence and Degradability: Moderately biodegradable in soil and water (half-life days to weeks)
Bioaccumulative Potential: Moderate based on log Pow value
Mobility in Soil: Limited mobility due to partial adsorption
Other Adverse Effects: Disrupts microbial populations at environmental concentrations exceeding therapeutic levels
Waste Disposal Recommendations: Dispose according to local, regional, and national regulations for pharmaceutical waste
Contaminated Packaging: Triple rinse, then offer for recycling or disposal as hazardous material
Do Not Release: Do not allow product or rinse water to enter drains or waterways
Methods: Incineration in approved facility or chemical/biological treatment in hazardous waste disposal plant
Special Precautions: Wear protective equipment during disposal, avoid dust and contact
UN Number: Not classified as a dangerous good for transport
TDG Class: Not regulated
Packaging Group: Not applicable
Proper Shipping Name: Fusidic Acid (pharmaceutical product, non-hazardous for transport)
Special Transport Precautions: Avoid spillage, store in original, sealed packaging, protect from extreme temperatures
OSHA Status: Not hazardous as per 29 CFR 1910
TSCA Status: Not listed on US TSCA inventory, regulated as a pharmaceutical product
EU Regulations: Classified under regulation (EC) No 1272/2008 (CLP), GHS-compliant labeling required
WHMIS Classification: Not controlled under Canadian WHMIS
REACH Registration: Exempt as pharmaceutical active ingredient used in finished drug products
Other Information: Subject to FDA and EMA regulations for finished pharmaceutical forms; local, state, and country-specific rules may apply
