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Product Name: Bifonazole
Chemical Name: 1-(4-Phenoxyphenyl)-1H-imidazole
Synonyms: 1H-Imidazole, 1-[4-(phenoxy)phenyl]-
CAS Number: 60628-96-8
Molecular Formula: C22H18N2O
Molecular Weight: 326.39 g/mol
Recommended Use: Antifungal agent for topical pharmaceutical applications
Manufacturer or Supplier: Pharmaceutical supplier information required by user
Emergency Telephone: Local Poison Control or safety specialist contact
Classification: Classified as potentially hazardous based on laboratory animal studies and handling dusts
GHS Label Elements: Exclamation mark (Irritant)
Signal Word: Warning
Hazard Statements: May cause skin irritation, eye irritation, or respiratory tract irritation if inhaled in dust form
Precautionary Statements: Avoid breathing dust, wash hands after handling, use personal protective equipment as required
Routes of Exposure: Skin, eyes, inhalation, ingestion
Target Organs: Skin, eyes, respiratory system
Chemical Identity: Bifonazole
Concentration: Typically pure (<99%) for raw material
Impurities: Trace synthetic intermediates below reporting levels
Other Components: None significant for safety reporting purposes
Eye Contact: Flush eyes gently with large amounts of water for at least 15 minutes, remove contact lenses if present, seek medical advice if irritation persists
Skin Contact: Remove contaminated clothing, wash exposed skin thoroughly with soap and water, consult physician for persistent symptoms
Inhalation: Move person to fresh air, monitor for respiratory symptoms, seek medical attention if cough or irritation develops
Ingestion: Rinse mouth with water if conscious, do not induce vomiting, seek medical attention for large exposures or symptoms
Suitable Extinguishing Media: Water spray, foam, carbon dioxide, dry chemical
Specific Hazards: Product may decompose under high heat releasing toxic fumes such as carbon oxides and nitrogen oxides
Protective Equipment for Firefighters: Self-contained breathing apparatus and full protective gear required
Firefighting Instructions: Prevent contaminated runoff, use water spray to cool adjacent containers, evacuate area if large quantities involved
Personal Precautions: Avoid dust formation, wear suitable protective clothing and respiratory protection
Environmental Precautions: Prevent product from entering drains, sewers, or watercourses
Methods for Clean-Up: Collect spilled product with suitable inert absorbent, clean up with wet methods to limit dust, place in closed containers for disposal, ventilate area and wash surfaces after removal
Precautions for Safe Handling: Minimize dust generation, use only in well-ventilated areas, avoid contact with skin and eyes
Hygiene Measures: Wash thoroughly after handling, remove contaminated clothing before eating or drinking
Storage Conditions: Store in tightly closed original container, keep in a cool, dry, well-ventilated place, protect from light and incompatible substances
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Occupational Exposure Limits: No established exposure limits for Bifonazole; use workplace dust limits as a guide
Engineering Controls: General exhaust ventilation or local exhaust to control dust levels
Eye Protection: Safety goggles or glasses
Skin Protection: Lab coat, gloves made of nitrile or other appropriate material
Respiratory Protection: Dust mask or respirator if dust generation is likely
General Hygiene: Avoid eating, drinking or smoking during use, wash thoroughly before breaks and at shift end
Appearance: White to off-white crystalline powder
Odor: Odorless
Melting Point: 142-147°C
Boiling Point: Not available
Solubility in Water: Practically insoluble
Solubility in Organic Solvents: Soluble in ethanol, methanol, chloroform, dimethyl sulfoxide
pH: Not applicable
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log Pow): Approximately 4.0-4.5
Flash Point: Data not available, expected to be high
Stability: Stable under recommended handling and storage
Chemical stability: Stable under normal temperatures and pressures
Reactivity: Not reactive under normal conditions
Conditions to Avoid: Exposure to strong heat, sunlight, humid environment, incompatible chemicals
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, traces of other toxic gases on combustion
Polymerization: No known hazard of polymerization under normal storage
Incompatibility: Avoid contact with strong acids, strong bases, and oxidizers
Acute Toxicity: Oral LD50 in rats exceeds 5000 mg/kg; low acute toxicity
Skin Sensitization: Occasional reports of local skin or eye irritation
Chronic Effects: No evidence of carcinogenicity or mutagenicity in animal studies at typical exposure levels
Target Organ Effects: Possible effects on skin and eyes through irritation, respiratory tract with dust exposure
Symptoms of Exposure: Itching, redness, dry skin, coughing
Additional Information: Not classified as a human carcinogen or reproductive toxin by major regulatory agencies
Ecotoxicity: Not expected to be hazardous to aquatic organisms at predicted environmental concentrations, though high doses may affect algae and invertebrates
Persistence and Degradability: Slowly biodegradable
Bioaccumulation: Moderate potential for bioaccumulation based on log Pow
Mobility in Soil: Limited mobility due to low water solubility
Other Adverse Effects: None expected at normal environmental release levels
Waste Treatment Methods: Dispose of with pharmaceutical or chemical waste in accordance with local, national, and international regulations
Incineration: Suitable for high-temperature incineration under controlled conditions
Container Handling: Empty containers may contain residues; handle as hazardous waste
Disposal Advice: Do not discharge into drains or waterways
UN Number: Not assigned
UN Proper Shipping Name: Not regulated for transport
Transport Hazard Class: Not a dangerous good under ADR, IMDG, or IATA rules
Packing Group: Not assigned
Environmental Hazards: Not a marine pollutant
Special Precautions for User: Avoid formation and spread of dust during handling and transport
US TSCA: Substance is subject to FDA regulations, not typically listed on TSCA
EU Reach Registration: Substance exempt as active pharmaceutical ingredient
OSHA Hazard Communication: Substance qualifies for hazard communication as irritant
WHMIS Classification (Canada): Not controlled
Other Regulations: Not listed as a controlled or regulated chemical by major international agencies at recommended use levels
Inventory Listings: May appear on regulated pharmaceutical ingredient lists as approved antifungal
