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Product Name: Flumazenil
Chemical Name: Ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate
Synonyms: Anexate, Romazicon, Lanexat
CAS Number: 78755-81-4
Manufacturer: Major pharmaceutical suppliers
Recommended Use: Benzodiazepine antagonist for medical settings
Restrictions on Use: Strictly for healthcare, not for general consumer or veterinary use
GHS Classification: Acute toxicity (oral, dermal, inhalation); Eye irritation; Specific target organ toxicity
Label Elements: GHS skull and crossbones, exclamation mark
Hazard Statements: Harmful if swallowed, may cause respiratory irritation, may cause drowsiness or dizziness
Precautionary Statements: Avoid breathing dust or vapors, use only outdoors or in ventilated areas, wash hands thoroughly after handling
Signal Word: Warning
Pictograms: Health hazard, exclamation mark
Main Ingredient: Flumazenil (CAS No: 78755-81-4) 99%+
Impurities: Possible residual solvents under controlled limits
Other Additives: None intentionally added
Inhalation: Remove person to fresh air; seek medical help if symptoms develop
Skin Contact: Rinse with plenty of water and soap; remove contaminated clothing
Eye Contact: Rinse cautiously with water for at least 15 minutes; seek medical attention if irritation persists
Ingestion: Rinse mouth with water; seek immediate medical advice
Most Important Symptoms: Drowsiness, confusion, agitation, seizures in severe overdose
Suitable Extinguishing Media: Water spray, dry powder, carbon dioxide, alcohol-resistant foam
Special Hazards: Toxic fumes of carbon oxides, nitrogen oxides, hydrogen fluoride under fire conditions
Protective Equipment: Wear self-contained breathing apparatus and full protective gear
Special Procedures: Evacuate area, control run-off to prevent environmental contamination
Personal Precautions: Use personal protective equipment, avoid breathing dust or vapors
Environmental Precautions: Prevent entry into drains, surface waters, or soil
Containment: Sweep up and shovel spill, keep in closed container for proper disposal
Cleaning Method: Dampen with water to avoid dust formation, ventilate area well
Precautions for Safe Handling: Use in chemical fume hood, avoid dust and aerosol generation, handle with care
Hygiene Measures: Wash hands and exposed skin after use, remove contaminated clothing
Storage Conditions: Store in a tightly closed container, keep in a cool, dry, well-ventilated area away from light and incompatible substances
Incompatibilities: Strong oxidizers, acids, bases
Engineering Controls: Work under local exhaust ventilation, use safety cabinets for weighing and sampling
Personal Protective Equipment: Safety goggles, chemical-resistant gloves (nitrile recommended), laboratory coat, suitable respiratory protection in case of inadequate ventilation
Exposure Limits: No specific occupational exposure limits established for flumazenil; avoid unnecessary contact
Environmental Controls: Procedures to prevent environmental release and exposure
Appearance: White to off-white crystalline powder
Odor: Faint, characteristic
Melting Point: 198–204°C
Boiling Point: Not available
Solubility: Sparingly soluble in water, soluble in ethanol, DMSO
pH: Not determined
Vapor Pressure: Not notable under normal conditions
Partition Coefficient: logP (octanol/water) estimated at 0.7
Flash Point: Not applicable
Stability: Stable under recommended storage conditions
Chemical Stability: Stable under suggested storage, can degrade in strong sunlight or high heat
Reactivity: No hazardous reactions with common materials, avoid exposure to strong oxidizing agents
Hazardous Decomposition: Emits toxic fumes on combustion—carbon and nitrogen oxides, hydrogen fluoride
Polymerization: No risk of hazardous polymerization
Acute Toxicity: Limited data in humans; LD50 in animals (oral, rat) above 500 mg/kg
Chronic Toxicity: No long-term studies but known CNS effects from clinical use
Routes of Exposure: Inhalation, skin, eye, ingestion
Symptoms: Drowsiness, headache, agitation, sometimes seizures at high doses
Carcinogenicity: Not classified as carcinogenic to humans
Mutagenicity: No conclusive evidence for mutagenic effects
Reproductive Toxicity: Risk unclear; avoid use in pregnant and breastfeeding people unless essential
Ecotoxicity: Expected low aquatic toxicity, not persistent in the environment, but use care to prevent larger releases
Persistence and Degradability: Likely biodegradable under environmental conditions
Bioaccumulation: Low potential based on logP
Mobility in Soil: Moderate; not highly mobile but prevent from leaching to water systems
Other Effects: No expected effect on aquatic or terrestrial organisms from usual lab use
Waste Treatment Methods: Dispose through licensed chemical waste disposal contractors
Contaminated Packaging: Treat as hazardous waste—triple-rinse and follow local disposal regulations
Precautions: Avoid landfill, incinerate under controlled conditions
Regulations: Comply with state, local, and federal chemical disposal laws
UN Number: Not regulated under most international transport rules
Shipping Name: Flumazenil, not classified as hazardous for transport
Transport Hazard Class: None assigned
Packing Group: None
Environmental Hazards During Transport: Not classified as marine pollutant
Special Recommendations: Use leak-proof, properly labeled packaging; ship with documentation indicating nonhazardous class
TSCA Status: Dental, pharmaceutical agents like flumazenil are under regulatory oversight, not listed as a bulk industrial chemical
OSHA Status: No specific occupational limit, handle as potentially hazardous substance in medical and research labs
WHMIS (Canada): Class D2B—Toxic Material causing other toxic effects
REACH (EU): Not specifically registered but subject to control under pharmaceutical directives
Other Regulations: Drug regulatory agencies hold legal control over access, prescribing, and use—medical professionals must comply with local pharmaceutical laws
