Product Name: Liranaftate
Chemical Name: N-(5,6,7,8-Tetrahydronaphthalen-2-yl)-N-methyl-3-(pyridin-2-ylthio)propanamide
CAS Number: 88678-31-3
Molecular Formula: C20H23NOS
Intended Use: Antifungal ingredient for topical pharmaceutical preparations, researched and manufactured for use in over-the-counter or prescription medications.
Supplier Details: Contact details of supplier and manufacturer with address, emergency numbers, and relevant contact information for medical professionals and chemical handlers.
Classification: Not classified as hazardous under GHS criteria; skin and eye sensitization possible due to prolonged or repeated exposure.
Label Elements: Signal word: Warning; Hazard pictograms: None required; Hazard statements: May cause mild eye, skin, and respiratory tract irritation; Precautionary statements: Use personal protective equipment, avoid dust formation, wash affected skin thoroughly after handling.
Environmental Effects: Harmful to aquatic life with long lasting effects. Avoid release into natural waterways. Handle by minimizing spillage and waste.
Liranaftate: 98-100%
Impurities: May contain trace solvents or residual intermediates from synthesis, none classified as hazardous based on available data.
Other Components: No other hazardous components identified in typical finished raw material suitable for pharmaceutical compounding.
Eye Contact: Rinse immediately with plenty of water, keeping eyelids open, for at least 10–15 minutes; seek medical attention if irritation persists.
Skin Contact: Remove contaminated clothing and rinse off skin with water using soap if available. Seek medical attention for symptoms like redness, itching, or rash that persist.
Inhalation: Move to fresh air, keep at rest. Offer symptomatic support. If cough, shortness of breath, or other symptoms appear, contact a healthcare professional.
Ingestion: Rinse mouth with water. Do not induce vomiting without medical advice. Call poison center or doctor if large amounts swallowed or symptoms arise.
Suitable Extinguishing Media: Use dry powder, CO₂, or alcohol-resistant foam. Water spray can be used for larger fires.
Hazards from Combustion: Decomposes under heat to release hazardous gases such as carbon monoxide, sulfur oxides, nitrogen oxides, and unidentified organic compounds.
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and protective clothing to avoid exposure to fumes. Stay upwind to reduce inhalation risk.
Personal Precautions: Wear chemical-resistant gloves, safety glasses, and dust mask or respirator as needed.
Environmental Precautions: Prevent further leakage or spillage. Avoid discharge into drains, soil, or water bodies.
Containment and Cleaning: Sweep up and collect solid product without creating dust. Place in tightly closed containers for disposal. Ventilate area and wash spill site after material pickup is complete.
Safe Handling: Use in a well-ventilated area or fume hood. Avoid breathing dust, vapors, or aerosols. Use suitable personal protective equipment at all times.
Storage Conditions: Store in tightly sealed containers, kept in a cool, dry, well-ventilated place away from direct sunlight and moisture. Maintain segregation from incompatible materials such as oxidizing agents.
Technical Measures: Keep away from sources of ignition and heat. Use only non-sparking tools where powder dust may accumulate.
Occupational Exposure Limits: No established occupational exposure limits for Liranaftate; treat as a nuisance dust where handling bulk powders.
Engineering Controls: Use local exhaust ventilation or process enclosure to minimize exposure.
Personal Protection: Wear disposable gloves (nitrile or similar), safety goggles or face shield, dust mask or respirator (N95 or higher standard) during bulk handling. Work clothing should protect arms and legs. Wash hands after use and before eating, drinking, or smoking.
Appearance: White to off-white crystalline powder
Odor: Odorless or faint organic odor
Melting Point: 133–137°C
Boiling Point: Decomposes before boiling
Solubility: Practically insoluble in water; soluble in organic solvents such as ethanol, acetone, dimethyl sulfoxide
Vapor Pressure: Not significant under normal conditions
Partition Coefficient: logP (octanol/water): estimated 4.5–5.2
Stability: Stable under standard conditions. Avoid strong acids and alkalis.
Reactivity: No hazardous reactions expected under normal conditions.
Chemical Stability: Stable at ambient temperature and pressure, may decompose under strong heat or sunlight.
Incompatible Materials: Strong oxidizers, strong acids and alkalis.
Hazardous Decomposition Products: Combustion or extreme heat produces carbon oxides, sulfur dioxide, and nitrogen oxides.
Acute Toxicity: Oral LD50 (rat): >2000 mg/kg; low acute toxicity based on animal data
Skin Irritation: May cause mild, transient irritation
Eye Irritation: May cause mild, transient irritation
Respiratory Sensitization: Not expected with proper handling; dust may cause upper respiratory tract irritation
Carcinogenicity: No data suggest carcinogenic potential in humans
Mutagenicity: Not mutagenic in standard bacterial or mammalian cell assays
Reproductive Toxicity: No adverse reproductive effects reported in animal studies at therapeutic exposure levels
Chronic Effects: Long-term exposure data lacking for humans, good lab practice reduces possible risks.
Toxicity to Aquatic Organisms: Harmful to aquatic invertebrates and fish at moderate concentrations; long-lasting environmental persistence possible.
Persistence and Degradability: Degrades slowly; not readily biodegradable.
Bioaccumulative Potential: High logP indicates potential for bioaccumulation in aquatic organisms.
Mobility in Soil: Low water solubility and high partition coefficient reduce mobility.
Other Adverse Effects: Do not allow residues to enter streams or groundwater.
Waste Disposal Methods: Incinerate in authorized facility or dispose of according to local, regional, and national regulations. Do not flush to drains or place in household waste.
Container Disposal: Rinse and render inert before recycling or disposal. Follow procedures for handling chemical residues.
Special Precautions: Avoid contact with skin and eyes during disposal tasks. Use personal protective equipment, and document disposal in compliance with governing regulations.
UN Number: Not regulated as dangerous goods for land, air, or sea transport
Transport Hazard Class: None assigned
Packing Group: None assigned
Special Precautions: Protect containers from physical damage and moisture during shipping. Keep separate from incompatible substances.
EU Regulations: Not listed as a hazardous material under current REACH or CLP regulations
US Regulations: Not listed under OSHA, TSCA, CERCLA or SARA Title III for special hazard; pharmaceutical use subject to FDA oversight
International Inventories: Registered for pharmaceutical manufacture and distribution in accordance with local and national regulations
Workplace Safety: Employers provide appropriate labeling, training, and documentation as required.
Labeling Requirements: Ensure workplace containers bear correct labeling for identity and warning statements.