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Product Name: Ketoconazole
Chemical Name: 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
CAS Number: 65277-42-1
Recommended Use: Antifungal agent for topical and systemic treatment
Manufacturer: Various pharmaceutical manufacturers produce ketoconazole for prescription and over-the-counter use in human and veterinary health
Contact Details: Provided by the supplier on request or product label
Emergency Phone: Refer to local poison control center
Synonyms: Nizoral, Fungarest, Ketozol
Formula: C26H28Cl2N4O4
Classification: Classified as hazardous under OSHA Hazard Communication Standard (29 CFR 1910.1200)
Hazard Statements: Harmful if swallowed, may cause skin and eye irritation, possible respiratory irritation
Signal Word: Warning
Pictograms: Health hazard, exclamation mark
Routes of Exposure: Inhalation, ingestion, dermal, ocular
Symptoms: Nausea, headache, abdominal pain, rash, irritation to eyes/skin/respiratory tract
Potential Health Effects: Prolonged exposure could affect liver function, rare severe allergic reactions reported
Chronic Effects: Hepatotoxicity documented in some medical literature
Target Organ Effects: Liver, skin, nervous system
Chemical Component: Ketoconazole
CAS Number: 65277-42-1
Concentration: 98%–100% (pure substance); 1–2% (cream/shampoo formulations)
Other Ingredients: Topical creams and shampoos contain propylene glycol, cetostearyl alcohol, polysorbate, sodium sulfite, water, and preservatives depending on manufacturer
Impurities: No significant impurities hazardous to health at standard concentrations
Inhalation: Move to fresh air, keep person at rest, seek medical attention if symptoms develop
Skin Contact: Remove contaminated clothing, wash skin with plenty of soap and water, seek care if irritation persists
Eye Contact: Rinse thoroughly with plenty of water for at least 15 minutes, remove contact lenses if present and easy to do, get medical advice if irritation continues
Ingestion: Rinse mouth with water, seek immediate medical advice, do not induce vomiting unless directed by medical personnel
Symptoms Requiring Immediate Action: Difficulty breathing, swelling of face/lips/throat, severe rash
Suitable Extinguishing Media: Dry chemical, CO2, foam, water spray
Specific Hazards: May emit toxic fumes of carbon monoxide, carbon dioxide, hydrochloric acid, and nitrogen oxides
Protective Equipment for Firefighters: Full protective gear and self-contained breathing apparatus
Special Precautions: Move containers from fire area if safe to do, cool surrounding equipment with water mist, avoid inhaling smoke/fumes
Personal Precautions: Wear gloves, goggles, appropriate shoes, avoid breathing dust
Environmental Precautions: Prevent spillage from entering drains, water sources, or soil
Containment: Sweep up with minimal dust generation, place in suitable closed container for disposal
Clean Up: Wash site with plenty of water to remove residues, ventilate area
Handling: Handle in well-ventilated space, avoid contact with skin, eyes, clothing, and do not inhale dust or mist
Hygiene Practices: Wash hands after handling, remove contaminated clothing and wash before reuse
Storage: Store tightly closed at room temperature (15–30°C), in dry, dark area away from incompatible substances (strong oxidizing agents, acids, bases)
Segregation: Keep away from food and beverages, locked cabinet recommended in clinical or laboratory settings
Occupational Exposure Limits: No specific OSHA or ACGIH exposure limits established; minimize exposure by use of controls
Engineering Controls: Local exhaust ventilation, laminar flow hood for bulk handling
Personal Protection: Gloves, safety goggles, lab coat or apron, dust respirator if handling powder in bulk
General: No eating, drinking, or smoking in handling area, wash hands thoroughly after use
Appearance: White-to-off-white crystalline powder
Odor: Odorless
pH: 4–5 (1% in water)
Melting Point: 146–150°C
Boiling Point: Decomposes before boiling
Flash Point: Not applicable
Solubility: Practically insoluble in water, soluble in methanol, chloroform, ethanol
Density: 1.4 g/cm3
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log P): 4.3 (octanol/water)
Evaporation Rate: Not applicable
Chemical Stability: Stable under normal conditions of use and storage
Reactivity: Not expected to react dangerously with air or water
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Decomposition Products: Emits hazardous fumes (CO, CO2, HCl, nitrogen oxides) on combustion
Hazardous Polymerization: Will not occur
Acute Toxicity – Oral (rat LD50): Approximately 1700 mg/kg
Skin Irritation: Can cause skin irritation on repeated or prolonged contact, especially in sensitive individuals
Eye Irritation: May cause irritation and redness
Respiratory Sensitization: Dust may irritate airway passages in high concentrations
Carcinogenicity: Not classified as carcinogenic to humans by IARC or NTP
Mutagenicity: No known mutagenic effects at therapeutic concentrations
Reproductive Toxicity: High doses in animal studies affected fetal development
Target Organs: Liver most notably, skin, possibly central nervous system
Potential for Allergic Reactions: Rash, angioedema, rarely anaphylactic reactions reported
Environmental Toxicity: Moderately toxic to aquatic organisms, can affect fish and invertebrates if released into water systems
Persistence and Degradability: Poorly biodegradable, may persist in environment
Bioaccumulative Potential: Potential to bioaccumulate in aquatic and terrestrial organisms
Mobility in Soil: Low water solubility limits mobility, likely to bind to soil particles
Other Adverse Effects: Improper disposal or spillage may disrupt wastewater treatment or aquatic habitats
Handling Waste: Collect in sealed, appropriately labeled containers
Disposal Method: Dispose by incineration or in accordance with local, state, and federal guidelines for hazardous waste
Precautions: Do not pour product or rinsates into sewers, soil, or water bodies
Contaminated Packaging: Clean or incinerate as hazardous waste
Regulatory Considerations: Waste codes may apply, consult local authorities for classification
UN Number: Not regulated as a hazardous material for road, air, or sea transport in standard finished pharmaceutical form
Proper Shipping Name: Ketoconazole or medicinal product, not otherwise specified
Hazard Class: None assigned under UN transport regulations
Packing Group: Not applicable
Special Precautions: Avoid contact with incompatible substances during transport, label shipping containers as required by local law
Marine Pollutant: Not regulated, but avoid release to environment
OSHA: Requires hazard communication for workplace use, falls under hazardous chemical category
FDA: Approved veterinary and human use for indicated conditions, subject to prescription controls
TSCA (Toxic Substances Control Act): Listed
SARA Title III: Not subject to reporting under Sections 302, 304, or 313
REACH: Registration required for manufacturing or importation in the European Economic Area
California Prop 65: Not listed
Other Regulatory Listings: Product subject to pharmaceutical controls, labeling requirements, and environmental protection laws in most regions
