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Product Name: Agomelatine, Mixed Polymorph 2
Chemical Name: N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide
CAS Number: 138112-76-2
Recommended Use: Active pharmaceutical ingredient for research and manufacturing
Manufacturer Details: Provided by authorized pharmaceutical supplier
Emergency Contact: Pharmaceutical safety office or relevant poison information service
Classification: Suspected to cause reproductive toxicity, skin irritation, and specific target organ toxicity
Hazard Symbols: Exclamation mark, health hazard
Risk Phrases: May cause skin and eye irritation, may damage fertility or the unborn child, may cause organ damage through prolonged exposure
Signal Word: Warning
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, use only outdoors or in well-ventilated area, wear personal protective equipment
Physical Hazards: None identified during typical handling
Chemical Identity: Agomelatine
Molecular Formula: C15H17NO2
Molecular Weight: 243.30 g/mol
Purity: >98% as active ingredient
Other Components: Non-detectable, no significant impurities exceeding regulatory thresholds
Inhalation: Move person to fresh air, keep at rest in comfortable position, get medical attention if symptoms persist
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, seek medical assistance for persistent irritation
Eye Contact: Rinse carefully with water for several minutes, remove contact lenses if present, continue rinsing, consult medical personnel
Ingestion: Rinse mouth, drink water, seek medical advice, do not induce vomiting unless recommended by medical personnel
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, alcohol-resistant foam
Extinguishing Methods to Avoid: Do not use high-pressure water streams directly on product
Specific Hazards: Combustion may produce carbon oxides, nitrogen oxides, and irritating fumes
Protective Equipment for Firefighters: Self-contained breathing apparatus and full protective clothing
Firefighting Actions: Move containers from fire area if safe, cool with water fog to prevent rupture
Personal Precautions: Avoid contact with skin, eyes, and clothing, avoid inhalation of dust
Protective Equipment: Gloves, eye protection, NIOSH-approved respirator for dust exposure
Environmental Precautions: Prevent further spillage, keep product out of drains and surface waters
Cleanup Methods: Sweep up without creating dust, transfer to compatible container for disposal, ventilate area
Safe Handling Advice: Handle in well-ventilated area, minimize dust generation, use personal protective equipment
Incompatible Materials: Strong oxidizing agents
Storage Conditions: Store in tightly closed original container, in cool, dry, and well-ventilated place, protect from light
Packaging: Use containers made from polyethylene, polypropylene, or glass
Occupational Exposure Limits: Not established for this compound
Engineering Controls: Local exhaust or general room ventilation
Personal Protective Equipment: Gloves (nitrile or latex), safety glasses or goggles, lab coat, NIOSH-certified particulate respirator for dust
Hygiene Measures: Wash hands after handling, avoid eating or drinking in work area
Appearance: White to pale yellow powder or crystalline solid
Odor: Odorless or faint chemical odor
Melting Point: 107 - 110 °C (approximate range)
Solubility: Slightly soluble in water, freely soluble in methanol and ethanol
pH (in solution): Neutral to slightly acidic
Partition Coefficient (log P): 2.86 - 3.6
Vapor Pressure: Not volatile
Boiling Point: Decomposes before boiling
Chemical Stability: Stable under recommended storage conditions
Reactivity: No dangerous reactions under normal conditions
Conditions to Avoid: Exposure to heat, moisture, light
Decomposition Products: Produces hazardous fumes including carbon oxides on thermal decomposition
Incompatible Substances: Strong acids, strong bases, oxidizing agents
Potential Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: LD50 oral (rat): >2000 mg/kg, may be harmful in large amounts
Skin Irritation: May cause mild irritation after prolonged exposure
Eye Irritation: Risk of redness and pain on contact
Chronic Effects: Evidence of reproductive toxicity in animal models, repeated exposure may affect liver
Mutagenicity: No evidence found in available studies
Aquatic Toxicity: Data limited, possible impact on aquatic organisms cannot be excluded
Persistence and Degradability: Not rapidly biodegradable, may persist in environment
Bioaccumulation Potential: Log Kow suggests low to moderate potential for bioaccumulation
Mobility in Soil: Limited water solubility indicates low mobility
Other Adverse Effects: Precaution necessary to avoid population-level exposure
Waste Disposal Methods: Dispose of contents and container through licensed hazardous waste contractor
Contaminated Packaging: Triple rinse and offer for recycling or controlled incineration
Regulatory Requirements: Follow local, national, and international regulations for pharmaceutical waste
UN Number: Not classified as dangerous for transport
Proper Shipping Name: Not regulated as hazardous material
Transport Hazard Class: Not assigned
Packing Group: Not applicable
Marine Pollutant: Not listed
Transport Precautions: Protect containers from physical damage and moisture during shipment
Labeling Requirements: Hazard and precautionary information to appear on container
Inventory Status: Registered or notified where required under chemical inventories (EU REACH, US TSCA, etc.)
Regulatory Restrictions: Active pharmaceutical ingredient status, restricted uses outside licensed facilities
Workplace Safety: Follow local occupational safety regulations for handling substances with reproductive effects
Other Relevant Legislation: Complies with applicable safe handling, transport, and disposal regulations
