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Product Name: Nystatin
Chemical Name: Nystatin
Synonyms: Fungicidin
CAS Number: 1400-61-9
Recommended Uses: Pharmaceutical antifungal agent, topical and oral administration
Supplier: Contact information provided on packaging or by the manufacturer
Emergency Phone: Refer to the regulatory documents or supplier contact line for emergencies
GHS Classification: Eye irritation (Category 2A), Skin sensitization (Category 1), Acute oral toxicity (Category 4)
Signal Word: Warning
Hazard Statements: May cause eye irritation. May cause allergic skin reaction. Harmful if swallowed.
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust. Wash hands thoroughly after handling. Wear protective gloves and eye protection. Do not eat, drink, or smoke while using this product.
Other Hazards: May cause allergic reactions in sensitized individuals. Prolonged or repeated exposure may affect the liver or kidneys.
Chemical Identity: Nystatin
Concentration: >95%
Chemical Formula: C47H75NO17
Impurities: May contain trace amounts of related polyene antifungals
Additives: Typically none; supplied as pure active ingredient for pharmaceutical preparations
Inhalation: Remove person to fresh air, support breathing as needed, seek medical attention if symptoms develop
Skin Contact: Remove contaminated clothing. Wash exposed area with soap and water. If irritation or allergic reaction occurs, get medical advice
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present. Continue rinsing and seek medical attention if irritation persists
Ingestion: Rinse mouth. Never give anything by mouth to an unconscious person. Seek medical attention for persistent discomfort
Symptoms: Allergic reactions, irritation of eyes or skin, possible digestive upset if swallowed
Medical Attention: Treat symptomatically; monitor for allergic reactions, especially in individuals with known sensitivities
Suitable Extinguishing Media: Use water spray, dry chemical powder, foam, or carbon dioxide
Unsuitable Extinguishing Media: Do not use high-pressure water streams as powder may disperse
Specific Hazards: Combustion produces toxic fumes such as carbon monoxide, carbon dioxide, nitrogen oxides; product can generate dust in air, posing explosion risk
Protective Equipment: Firefighters should wear self-contained breathing apparatus (SCBA) and full protective clothing
Advice: Move undamaged containers from fire area, cool with water spray, avoid inhalation of fumes
Personal Precautions: Avoid creating dust, ventilate the area, use protective gloves, clothing, and eye protection
Environmental Precautions: Prevent product from entering waterways, drains, or soil
Spill Cleanup Methods: Sweep or scoop up material carefully to avoid dust generation; place in appropriate container for disposal
Decontamination: Wash spill area with water after removal of bulk material. Dispose of contaminated cleanup materials as hazardous waste
Reporting: Follow company guidelines and local regulations for reporting major spills or releases
Safe Handling: Use only in well-ventilated areas. Avoid contact with skin, eyes, and clothing. Do not breathe dust. Wash hands after handling
Storage Conditions: Store in a tightly sealed container, in a cool, dry, and well-ventilated area. Protect from moisture, heat, and light. Store away from incompatible substances such as strong oxidizers
Incompatible Materials: Strong bases, acids, oxidizing agents
Other Requirements: Keep out of reach of children and unauthorized personnel
Exposure Limits: No specific occupational limits established for nystatin. Handle using standard pharmaceutical laboratory precautions
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to minimize worker exposure
Personal Protective Equipment: Use chemical-resistant gloves (nitrile or latex), laboratory coat, safety goggles, and, if necessary, dust respirator
Additional Controls: Provide eyewash stations and safety showers in workplace. Keep containers tightly closed when not in use
Appearance: Pale yellow to light brown crystalline or powdery solid
Odor: Characteristic, weak odor
Odor Threshold: Not determined
pH: Slightly acidic aqueous solutions
Melting Point: 44–46°C (decomposes)
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not applicable
Flammability: Not highly flammable, but dust may form explosive mixture with air
Vapor Pressure: Negligible at room temperature
Solubility: Practically insoluble in water; slightly soluble in methanol, ethanol, and DMSO
Partition Coefficient (log Kow): Not available
Auto-Ignition Temperature: Not determined
Decomposition Temperature: Above 46°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions
Reactivity: Does not react vigorously with common substances under normal conditions
Conditions to Avoid: Excess moisture, sunlight, high temperatures, open flames, and sources of ignition
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition Products: Toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides
Hazardous Polymerization: Does not occur
Likely Routes of Exposure: Skin contact, eye contact, inhalation of dust, ingestion
Acute Toxicity: Oral LD50 (rat): >10,000 mg/kg
Skin Corrosion/Irritation: May cause irritation or allergic reaction in susceptible individuals
Eye Damage/Irritation: May cause irritation with redness and discomfort
Respiratory Sensitization: No reliable data; dust may cause mild irritation
Skin Sensitization: Known to cause allergic reactions in some individuals
Chronic Toxicity: High doses or long-term exposure may impact liver or kidney function
Mutagenicity: No evidence from standard tests
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Reproductive Toxicity: Evidence for teratogenic effects in animal studies at high doses
Other Effects: May exacerbate dermatitis or other pre-existing skin conditions
Ecotoxicity: Toxic to aquatic organisms at high concentrations; avoid environmental release
Persistence and Degradability: Slowly biodegradable; stable in environment for extended periods
Bioaccumulative Potential: Low potential, not expected to bioaccumulate significantly
Mobility in Soil: Tends to bind to soil particles, low mobility
Other Adverse Effects: Possible adverse effects on beneficial soil and water microorganisms
Disposal Methods: Dispose of contents or container in accordance with local, regional, or national regulations. Do not flush to sewer, surface water, or soil
Contaminated Packaging: Treat as hazardous waste; empty containers thoroughly before recycling or disposal
Special Precautions: Wear protective equipment during disposal. Notify authorities if spill causes environmental contamination
Waste Disposal Code: Confirm with authorized waste disposal agencies; generally managed as pharmaceutical waste
UN Number: Not classified as dangerous goods under transport regulations
Proper Shipping Name: Nystatin
Transport Hazard Class: Not regulated
Packing Group: Not regulated
Environmental Hazards: Not a marine pollutant
Transport Guidance: Protect containers from physical damage and keep sealed during transit
OSHA Status: Not specifically regulated
TSCA Inventory: Listed
DSL/NDSL (Canada): Listed
REACH Status (EU): Registered
Other Inventory Information: Check applicable country chemical inventories
Labeling Requirements: Follow GHS label elements and local regulations for occupational settings
Other Regulations: Pharmaceutical-grade product subject to drug regulations; suppliers and handlers follow federal and state pharmaceutical handling guidance
