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Product Name: Levobupivacaine
Chemical Formula: C18H28N2O
Synonyms: S(-)-bupivacaine, Chirocaine
CAS Number: 27262-47-1
Recommended Use: Local anesthetic for medical and dental procedures
Manufacturer Information: Find details on the package insert or supplier’s website, as suppliers may change
Emergency Contact: Refer to country-specific Poison Control Centers or direct manufacturer support
Classification: Acute toxicity (oral, dermal, inhalation), Specific target organ toxicity (central nervous system, cardiovascular system)
GHS Signal Word: Danger
Hazard Statements: May be harmful if swallowed. Can cause irritation to skin, eyes, and respiratory tract. Exposure may result in central nervous system effects such as dizziness, drowsiness, convulsions, or cardiac complications like bradycardia and hypotension.
Precautionary Statements: Avoid inhalation, skin contact, and ingestion. Use only with adequate ventilation or local exhaust. Wear suitable personal protective equipment. Wash thoroughly after handling. Store locked up and away from unauthorized access.
Pictograms: GHS07 (exclamation mark), GHS08 (health hazard)
Main Ingredient: Levobupivacaine hydrochloride
Concentration: Up to 100% (depending on formulated product strength)
Other Ingredients: May include sodium chloride, water for injection, buffering agents depending on formulation
Impurities: Process impurities may be present at very low concentrations based on manufacturer’s specifications. Non-hazardous excipients present for isotonicity or pH adjustment are generally pharmacologically inactive.
Inhalation: Remove victim from exposure area to fresh air. Provide oxygen if breathing is labored or shortness of breath develops. Get medical attention right away.
Skin Contact: Remove contaminated clothing promptly. Rinse affected area thoroughly with soap and water for at least 15 minutes. Seek medical advice if irritation continues.
Eye Contact: Rinse eyes immediately with plenty of running water, holding eyelids apart. Continue rinsing for at least 15 minutes. Seek ophthalmologic advice.
Ingestion: Rinse mouth with water cautiously. Do not induce vomiting unless specifically advised. Seek immediate medical attention. Monitor and support airway, breathing, circulation as clinical signs dictate.
Most Important Symptoms: Central nervous system effects such as confusion, muscle twitching, respiratory depression, cardiac rhythm disturbances, coma in severe cases.
Immediate Medical Attention: Monitor closely for respiratory or cardiac depression. Provide advanced supportive care as indicated.
Suitable Extinguishing Media: Dry chemical, water spray, foam, or carbon dioxide. Avoid direct water jets.
Special Hazards: Can produce toxic fumes such as nitrogen oxides, carbon monoxide, carbon dioxide when burned.
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and chemical protective clothing.
Explosion Data: No evidence of explosive properties noted from available chemical data.
Personal Precautions: Prevent skin and eye contact. Wear gloves, goggles, and lab coat. Use respirator in poorly ventilated areas.
Environmental Precautions: Do not let product enter drains or watercourses. Notify authorities if a significant environmental exposure occurs.
Containment: Absorb with inert material (sand or earth). Gather residue in tightly closed, labeled containers.
Cleanup: Wash spill area with plenty of water after collecting bulk material. Ventilate the area.
Handling: Work in well-ventilated areas. Avoid contact with skin, eyes, and clothing. Do not eat, drink, or smoke in work areas. Keep containers tightly closed when not in use. Wear appropriate personal protective equipment.
Storage: Keep in original, labeled containers. Store in a cool, dry, well-ventilated area away from incompatible substances such as oxidizers and acids. Avoid light and freeze conditions. Secure against unauthorized access. Observe shelf-life and stability limits specified by the manufacturer.
Occupational Exposure Limits: No specific occupational limits established by OSHA, ACGIH, NIOSH, or EU guidelines
Engineering Controls: Use fume hoods, local exhaust, or well-ventilated environments in medical or laboratory settings.
Personal Protective Equipment: Chemical-resistant gloves, safety glasses or goggles, lab coat or apron, and respiratory protection if airborne levels may exceed safe concentrations.
Hygiene Measures: Always wash hands after handling material, before breaks, and at the end of the workday. Avoid contaminated clothing and wash before reuse.
Appearance: White to off-white crystalline powder
Odor: Odorless
pH: Around 4 to 6.5 (in solution)
Melting Point: 236-240°C (approximate)
Boiling Point: Not applicable under normal conditions; degrades before boiling
Solubility: Freely soluble in water and alcohol
Partition Coefficient (Log Pow): Around 2.6
Vapor Pressure: Not available or negligible
Relative Density: About 1.0 g/cm³
Other Properties: Stable under proper storage conditions
Chemical Stability: Stable under recommended storage and handling conditions
Incompatibilities: Strong oxidizing agents, acids
Decomposition Products: Burning yields carbon monoxide, carbon dioxide, nitrogen oxides, and other toxic gases.
Reactivity: No hazardous polymerization anticipated. Reacts with strong acids or oxidizers under improper conditions.
Conditions to Avoid: Excess heat, open flame, prolonged exposure to light, incompatible chemicals
Routes of Exposure: Inhalation, skin and eye contact, ingestion
Acute Toxicity: CNS symptoms like dizziness, seizures, respiratory depression; cardiovascular effects include arrhythmia, hypotension, cardiac arrest at high exposure
Chronic Effects: Can contribute to liver or kidney effects after long-term, repeated exposure although no robust epidemiological data exist.
Skin and Eye Effects: May cause redness, itching, swelling; Contact can result in absorption and systemic toxicity.
Carcinogenicity: Not classified by EPA, IARC, or NTP as carcinogenic.
Reproductive Toxicity: No clear evidence in humans, but some effects found in animal studies at high doses.
Mutagenicity: Not considered a significant genotoxic risk based on available data.
Ecotoxicity: Harmful to aquatic organisms at high concentrations; concrete ecological impact has not undergone widespread, long-term study
Persistence and Degradability: Expected to biodegrade but persistence not completely known
Bioaccumulative Potential: Low to moderate based on Log Pow value
Mobility in Soil: May adsorb to some soil components, can migrate to water sources in presence of spills
Other Harmful Effects: Avoid discharge or uncontrolled release into the environment
Waste Disposal Methods: Treat as hazardous pharmaceutical waste. Incinerate in accordance with local, regional, and national regulations. Do not discharge to surface water, sewer, or public drains.
Container Disposal: Use only authorized biomedical or hazardous-waste disposal services. Triple-rinse containers before disposal, remove identifying label, and puncture before final disposal.
UN Number: May not be classified as dangerous for transport in many jurisdictions when shipped in medically prepared form but confirm with local regulations
Transport Hazard Class: Not generally classified as hazardous
Packing Group: Not classified
Proper Shipping Name: Levobupivacaine hydrochloride (pharmaceutical preparation)
Special Precautions: Pack securely with cushioning to prevent physical damage or leakage
Labeling: Labeled according to requirements for prescription pharmaceuticals
Workplace Classification: May be handled as a hazardous chemical under OSHA (USA), WHMIS (Canada), or equivalent laws.
Safety, Health, Environmental Regulations: Subject to review by FDA, EMA, and other global regulatory authorities for manufacturing and distribution. Safety guidelines specified under Occupational Safety and Health rules. Consult local, state, and international transport and disposal regulations.
