Product Name: Levetiracetam
Chemical Name: (S)-α-ethyl-2-oxo-1-pyrrolidine acetamide
CAS Number: 102767-28-2
Molecular Formula: C8H14N2O2
Molecular Weight: 170.21 g/mol
Synonyms: UCB L059, Keppra
Recommended Use: Pharmaceutical ingredient, antiepileptic drug
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Classification: Not classified as hazardous according to OSHA Hazard Communication Standard
Physical Hazards: No significant physical hazard under normal conditions
Health Hazards: May cause mild irritation upon direct contact with skin or eyes; may cause mild respiratory discomfort if dust inhaled, limited toxicity if ingested
Signal Word: None required for this compound
Pictograms: Not applicable
Precautionary Statements: Avoid inhaling dust, keep out of reach of children, wash hands thoroughly after handling
Potential Health Effects: Prolonged exposure by ingestion at high doses linked to nervous system disturbances due to pharmacological action
Chemical: Levetiracetam
Concentration: 98–100% by weight
CAS Number: 102767-28-2
Impurities: Not classified as hazardous, levels typically below pharmacopoeial limits
Other Components: None present at reportable levels
Inhalation: Remove to fresh air, seek medical attention if symptoms develop
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing
Eye Contact: Rinse gently with plenty of water for at least 15 minutes, contact physician if irritation persists
Ingestion: Rinse mouth, get medical help if large quantities swallowed or if symptoms develop
Most Important Symptoms: Mild irritation, central nervous system effects if ingested in large amounts
Medical Attention: Symptomatic and supportive treatment recommended
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, or foam
Unsuitable Extinguishing Media: None known, avoid high-pressure water jets which may spread powder
Hazardous Combustion Products: Emits oxides of carbon and nitrogen, possibly other unidentified toxic gases
Fire-Fighter Protection: Use self-contained breathing apparatus and full protective gear to avoid exposure to decomposition products
Special Fire-Fighting Procedures: Avoid inhalation of smoke, cool exposed storage containers with water spray
Personal Precautions: Wear appropriate protective equipment, avoid generating dust, ventilate area
Environmental Precautions: Prevent entry to waterways, sewers, and soil; minimize environmental exposure
Methods for Cleanup: Sweep up carefully, place in sealed containers for disposal, vacuum with HEPA filter if possible, wash spill area with plenty of water to remove residues
Other Actions: Avoid raising dust, dispose of according to local, state, and federal regulations
Handling: Handle in accordance with good industrial hygiene and safety practices, minimize generation of airborne dust
Storage Conditions: Store at room temperature, keep in tightly closed original container, store away from heat, moisture, and incompatible materials
Incompatible Materials: Strong oxidizing agents
Hygiene Practices: Wash hands thoroughly after handling, do not eat, drink, or smoke in work area
Other Recommendations: Use only with adequate ventilation, maintain clear labeling
Occupational Exposure Limits: No established OSHA or ACGIH exposure limits
Engineering Controls: Local exhaust ventilation or process enclosure to control dust levels
Personal Protective Equipment: Safety glasses or chemical goggles, disposable gloves, laboratory coat, NIOSH-approved respirator if dust likely
Specific Controls: Emergency eyewash and safety shower in area of use
Environmental Controls: Prevent release to environment, use proper containment
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH (1% solution): Approx. 6.0–8.0
Melting Point: 109–111°C
Boiling Point: Decomposes before boiling
Flash Point: Not available
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Vapor Pressure: Negligible
Vapor Density: Not applicable
Solubility: Easily soluble in water; sparingly soluble in methanol and ethanol
Partition Coefficient (log P): -0.6
Auto-Ignition Temperature: Not determined
Decomposition Temperature: Above 200°C
Viscosity: Not applicable
Density: 1.52 g/cm³
Chemical Stability: Stable under normal storage and handling conditions
Reactivity: Inert under normal usage
Conditions to Avoid: Exposure to high heat, strong sunlight, moisture
Incompatible Materials: Strong oxidizing agents, strong acids
Hazardous Decomposition Products: Oxides of carbon and nitrogen
Hazardous Polymerization: Will not occur
Likely Routes of Exposure: Inhalation, skin and eye contact, ingestion
Acute Toxicity: Low acute oral toxicity (LD50 rat: >5000 mg/kg), low dermal toxicity
Chronic Effects: No evidence of carcinogenicity or mutagenicity, reproductive studies in animals show no significant risk at moderate doses
Irritation/Corrosion: Slight irritation possible on skin or eyes
Sensitization: Not known to cause skin sensitization
Other Health Effects: Central nervous system effects (sedation, dizziness, ataxia) linked to high single doses
Target Organs: Primarily central nervous system at excessive exposure
Medical Conditions Aggravated: Seizure disorders managed under medical supervision; otherwise none known
Carcinogenicity: Not listed by IARC, NTP, OSHA as carcinogenic
Ecotoxicity: Expected to have low toxicity to aquatic Life based on available data; not bioaccumulative
Persistence/Degradability: Readily biodegradable in standard test systems
Bioaccumulative Potential: Low, log P value below 1
Mobility in Soil: Significant solubility in water suggests potential to migrate in soil, though limited environmental exposure expected
Other Adverse Effects: No known significant effects or hazards
Aquatic Toxicity (fish): LC50 (96h, rainbow trout) >100 mg/L
Waste Disposal: Dispose of in accordance with federal, state, and local environmental control regulations
Method: Incineration preferred for large quantities, small quantities may be landfilled after solidification if local regulations allow
Container Disposal: Rinse empty containers with water, avoid re-use, dispose via approved waste handler
Precautions: Prevent release to the environment, do not flush into drains or waterways
UN Number: Not regulated
UN Proper Shipping Name: Not classified as dangerous goods
Transport Hazard Classes: Not applicable
Packing Group: Not applicable
Marine Pollutant: No
Special Transport Precautions: Avoid extremes of temperature and moisture during transport, maintain container integrity
U.S. Regulations: Not a hazardous substance under OSHA, CERCLA, SARA Title III; not on the California Prop 65 list
EU Regulations: No classification under Regulation (EC) No. 1272/2008 (CLP)
WHMIS (Canada): Not controlled
Inventory Status: Listed on TSCA, EINECS, other national inventories
Other Regulatory Data: Pharmaceutical substance governed by FDA or national equivalents for usage; worker protection regulations apply for bulk handling