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Product Name: Ketoconazole
Chemical Name: 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
CAS Number: 65277-42-1
Synonyms: Nizoral; Fungoral
Recommended Use: Pharmaceutical antifungal
Supplier Information: Manufacturer or distributor contact details found on product packaging
Emergency Contact: Listed on product label or local poison control center
Classification: Eye irritation, Skin sensitization, Specific target organ toxicity, Acute toxicity (oral, inhalation, dermal)
GHS Label Elements: Danger—Harmful if swallowed, Harmful in contact with skin, May cause allergic skin reaction, Causes serious eye irritation
Pictograms: Exclamation mark, Health hazard
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Potential Health Effects: Burning or irritation to eyes and skin, dizziness, headache, allergic reactions, gastrointestinal discomfort
Chronic Effects: Prolonged or repeated contact may cause liver toxicity, endocrine disruption, or sensitization
Main Ingredient: Ketoconazole 99.5%
Impurities: Trace solvents and crystalline byproducts
Formulation Components: Small amounts of silica, excipients depending on product
Eye Contact: Rinse cautiously with water for several minutes—remove contact lenses if present; keep rinsing and seek medical advice
Skin Contact: Remove contaminated clothing; rinse skin with plenty of water—seek medical attention if irritation develops
Inhalation: Move to fresh air, support breathing, get medical help
Ingestion: Rinse mouth with water; do not induce vomiting; consult poison control or medical professionals
Most Important Symptoms: Eye burning, skin rash, headache, dizziness, nausea
Medical Attention: Immediate for severe reactions or persistent symptoms
Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, water spray
Unsuitable Media: Direct water jet may spread material
Hazards from Combustion: Toxic gases released such as nitrogen oxides, hydrogen chloride, carbon monoxide, carbon dioxide
Protective Equipment: Self-contained breathing apparatus, chemical resistant gear
Special Fire Procedures: Avoid inhaling fumes, contain runoff
Personal Precautions: Wear gloves, safety goggles, and dust mask
Environmental Precautions: Prevent spill from entering waterways or soil
Cleanup Methods: Sweep up dry spill for disposal, wash area with water, ventilate area
Disposal: Collect in sealed containers labeled for hazardous pharmaceutical waste
Decontamination: Wash hands and exposed skin after handling
Handling: Use only in well-ventilated areas, avoid breathing dust, wear PPE
Storage: Keep container tightly closed, store in cool, dry place, away from sunlight, incompatible materials such as strong bases and oxidizers
Incompatible Materials: Strong oxidizing agents, bases, acids
Storage Conditions: Maintain below 25°C, keep away from moisture and heat sources
Occupational Exposure Limits: No established limits for ketoconazole, minimize exposure as best practice
Engineering Controls: Local exhaust ventilation, closed systems
Personal Protective Equipment: Chemical-resistant gloves, goggles, protective clothing, dust mask or respirator if airborne dust is present
Hygiene Measures: Wash hands after use, do not eat or smoke near product, remove contaminated clothing
Appearance: White to off-white crystalline powder
Odor: Slight, characteristic
Odor Threshold: Not available
pH: Insoluble in water—reagents vary
Melting Point: 146-150°C
Boiling Point: Not applicable
Flash Point: Not applicable
Evaporation Rate: Not relevant
Flammability: Not flammable as solid, may evolve toxic fumes if burned
Vapor Pressure: Negligible at room temperature
Vapor Density: Not available
Solubility: Insoluble in water, soluble in methanol, chloroform, ethanol
Partition Coefficient (log Kow): 4.3
Decomposition Temperature: >200°C
Viscosity: Not applicable
Chemical Stability: Stable under normal storage conditions
Reactivity: Avoid contact with strong oxidizers, bases
Hazardous Polymerization: Not expected
Decomposition Products: Toxic fumes, nitrogen oxides, HCl, COx
Conditions to Avoid: High heat, humidity, sunlight
Acute Toxicity—Oral (LD50): 960 mg/kg (rat)
Acute Toxicity—Dermal (LD50): >2000 mg/kg (rat)
Acute Toxicity—Inhalation: Data not available; avoid dust
Skin Corrosion/Irritation: Moderate irritant
Serious Eye Damage/Irritation: Causes irritation
Respiratory Sensitization: May cause allergic reactions on repeated exposure
Germ Cell Mutagenicity: Not mutagenic in standard tests
Carcinogenicity: Not listed by IARC, NTP, OSHA
Reproductive Toxicity: Animal studies indicate possible risk of reduced fertility with high repeated doses
Target Organ Effects: Liver, endocrine system
Ecotoxicity—Aquatic: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment
Degradation: Not readily biodegradable
Bioaccumulation: Potential for bioaccumulation due to log Kow above 4
Mobility in Soil: Low solubility, tends to bind to soil particles
Other Adverse Effects: Avoid uncontrolled release to environment
Waste Disposal Methods: Incinerate in approved facility, follow local, regional, national laws for hazardous waste
Contaminated Packaging: Dispose as hazardous material; containers should not be reused
Sewage Disposal: Avoid entry into drains and watercourses
Special Cautions: Trained personnel should handle unwanted material
UN Number: Not regulated in most formulations
UN Proper Shipping Name: Not applicable
Transport Hazard Class: Not applicable
Packing Group: Not assigned
Environmental Hazard: Not classified for transport as marine pollutant
Special Precautions: Prevent spillage; avoid generating dust during transport
Safety, Health, and Environmental Regulations: Not listed as a controlled substance, falls under general chemical safety laws
OSHA Status: Not hazardous under OSHA definitions, but handle per best industrial hygiene practices
SARA 302/304: Not a listed substance
SARA 313: Not subject to reporting
TSCA Inventory Status: Listed
REACH Status (EU): Substance registered; requires workplace safety controls
Other International Regulations: Subject to pharmaceutical guidelines; national environmental disposal rules apply
