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Substance Name: Levosimendan
Chemical Name: 4,5-dihydro-6-[4-(methylamino)phenyl]-3(2H)-pyridazinone
Synonyms: Simdax, Simdaxum, Levosimendanum
CAS Number: 141505-33-1
Recommended Use: Pharmaceutical active substance, typically used for treatment of acutely decompensated heart failure
Supplier/Manufacturer: Contact pharmaceutical provider or chemical supplier for detailed address and emergency contact numbers
Emergency Telephone: Refer to regional Poisons Information Center and local emergency services
Classification: Not classified as hazardous according to GHS for pharmaceutical use; irritation or respiratory sensitization risk increases for workers handling pure compound or large quantities
Acute Health Hazards: Exposure by inhalation, ingestion, or skin can cause irritation, with symptoms such as cough, headache, and dizziness
Chronic Health Hazards: No confirmed evidence of carcinogenicity or mutagenicity for this molecule in available studies, though data remains limited
Label Elements: None required for diluted or finished product; bulk chemical usually bears warnings for laboratory handling
Other Hazards: Environmental persistence potential not fully studied; standard lab hygiene necessary
Chemical Formula: C14H12N6O
Active Ingredient: Levosimendan (purity typically above 98%)
Impurities: Typical pharmaceutical formulations contain excipients such as mannitol, sodium chloride, but no relevant hazardous impurities for the pure substance
Concentration: Active pharmaceutical ingredient concentration ranges from 2.5 mg/mL to 5 mg/mL in infusion solutions
Inhalation: Move affected person to fresh air. Keep at rest and seek medical advice immediately if symptoms develop such as dizziness or respiratory discomfort
Skin Contact: Remove contaminated clothing. Wash affected skin thoroughly with soap and water. Seek medical attention if skin irritation develops
Eye Contact: Immediately rinse with plenty of water for at least 15 minutes, keeping eyelids open. Remove contact lenses if present and easy to do. Seek ophthalmological advice
Ingestion: Rinse mouth with water and seek immediate medical consultation. Never induce vomiting unless instructed by medical personnel
Suitable Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or CO2 for small-scale laboratory fires
Specific Hazards: Combustion may produce toxic gases, including carbon oxides, nitrogen oxides, and other hazardous decomposition products
Protective Equipment and Precautions: Firefighters should wear self-contained breathing apparatus and full protective clothing to limit exposure to toxic gases
Special Procedures: Contain runoff to prevent environmental contamination. Avoid direct contact with substance and contaminated extinguishing water
Personal Precautions: Evacuate area, ensure ventilation, wear approved respirator, gloves, and eye protection
Environmental Precautions: Prevent spillage from entering drains, soil, or watercourses
Cleanup Methods: Absorb spill with inert material such as sand or vermiculite. Place collected material in closed, labeled containers for proper disposal. Ventilate and clean spill site after material pickup
Safe Handling Reminders: Avoid raising dust, avoid inhalation and skin contact; use local exhaust where possible
Handling: Handle in accordance with good industrial hygiene and safety procedures. Minimize dust generation, wear appropriate PPE, wash hands before breaks and after handling
Storage: Store in tightly closed original container, in a cool, dry, ventilated area away from sources of moisture, heat, and direct sunlight
Incompatibilities: Strong acids, strong bases, strong oxidizers
Storage Recommendations: Temperature-controlled storage between 2°C to 8°C for bulk material; avoid freezing finished formulations unless specified by manufacturer
Exposure Limits: No established occupational exposure limit for Levosimendan, though all handling should follow strict laboratory safety recommendations
Engineering Controls: Use local exhaust or fume hood for open handling steps; maintain negative air pressure in handling areas where feasible
Personal Protective Equipment (PPE): Gloves made of nitrile, latex, or similar material; safety goggles or face shield; laboratory coat or coveralls
Respiratory Protection: Use NIOSH-certified respirator if risk of inhalation exists, especially during spill cleanup or powder handling
Hygiene Measures: Wash hands thoroughly after handling, no eating, drinking, or smoking in the working area
Appearance: Yellow crystalline powder
Odor: Odorless or faint organic odor
pH: Not directly applicable for solid; 2.5–4.5 for solution
Melting Point: 174–177°C
Boiling Point: Not available due to decomposition
Flash Point: Not flammable in standard pharmaceutical use; >150°C for pure powder
Solubility: Slightly soluble in water; more soluble in methanol and ethanol
Vapor Pressure: Negligible at room temperature
Relative Density: 1.33 g/cm³
Partition Coefficient (log Pow): Estimated 2.7–3.5 (moderate lipophilicity)
Other: Stable under normal storage and handling conditions
Chemical Stability: Stable under specified conditions (see above)
Reactivity: Inert under standard laboratory conditions, avoid mixing with strong acids or oxidizers
Conditions to Avoid: Prolonged exposure to heat, light, moisture
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides if heated to decomposition
Polymerization: Hazardous polymerization does not occur
Routes of Exposure: Oral, dermal, inhalation, ocular
Acute Toxicity: Levosimendan has relatively low acute toxicity in animal studies (oral LD50 in rats > 1000 mg/kg)
Skin and Eye Irritation: May cause mild irritation
Respiratory Sensitization: Possibility for individuals with pre-existing respiratory conditions
Chronic Toxicity: Limited evidence of organ toxicity with chronic occupational exposure; not mutagenic or carcinogenic in current studies
Other Effects: Pharmaceutical use at prescribed doses generally safe under medical supervision, serious toxicities may arise from excessive exposure
Ecotoxicity: Data limited; no large-scale studies published, treat as potentially hazardous to aquatic environments
Persistence and Degradability: Levosimendan may be slowly biodegradable in the environment; avoid uncontrolled discharges
Bioaccumulative Potential: Moderate based on structural properties
Mobility in Soil: Expected to bind moderately to soils due to moderate lipophilicity
Other Adverse Effects: No significant effects on data for terrestrial organisms, but prudent handling limits environmental exposure due to incomplete toxicity data
Waste Treatment Methods: Dispose of unused or waste material via incineration at a facility equipped to handle pharmaceutical compounds, or follow regional authority recommendations for hazardous waste
Contaminated Packaging: Dispose of containers as hazardous waste after complying with decontamination procedures
Precautions for Disposal: Prevent direct release into the environment, avoid flushing into drains, keep waste in closed, labelled containers until disposal
Regulatory Compliance: Follow local, state, and national waste disposal regulations to ensure safe management
UN Number: Not assigned under common transport regulations due to non-hazardous pharmaceutical classification
Proper Shipping Name: Levosimendan, bulk pharmaceutical chemical or formulated infusion, not regulated as dangerous goods
Class: Not classified as dangerous goods
Packing Group: Not assigned
Special Precautions: Transport in closed, robust packaging; maintain cool, dry conditions; prevent physical damage and theft
Transport Labeling: Apply standard labeling for identification; not subject to hazardous materials placarding
Workplace Safety: Levosimendan does not appear on main hazardous substance lists (OSHA, ACGIH, EU GHS), though lab-best practices and pharmaceutical handling guidelines apply
Environmental Regulations: Comply with general chemical control and waste minimization rules; avoid discharge into the environment
Other Regulations: Use subject to registration and authorization under pharmaceutical regulation, not controlled or scheduled as a chemical hazard outside large-scale manufacture
Labeling: Finished pharmaceutical products do not require chemical hazard labeling under standard medical supply regulations
