Product Name: Navelbine Tartrate
Chemical Name: Vinorelbine tartrate
Synonyms: Navelbine, Vinorelbine,
CAS Number: 125317-39-7
Molecular Formula: C45H54N4O8•C4H6O6
Manufacturer: Pharmaceutical manufacturer or distributor
Contact Information: Refer to supplier documentation for phone numbers and addresses
Recommended Use: Cytotoxic medication for cancer therapy applications
Restrictions on Use: Medical professionals only; not intended for general consumer use
Hazard Class: Toxic if swallowed, inhaled, or absorbed through skin; classified as a Category 3 carcinogen
Signal Word: Danger
GHS Pictograms: Skull and crossbones, health hazard symbol
Potential Health Effects: Can cause you to feel nausea, vomiting, bone marrow suppression, neurological issues, and tissue irritation;
Routes of Exposure: Eyes, skin, ingestion, inhalation
Other Hazards: Substance is cytotoxic and presents teratogenic and mutagenic risks
Precautionary Statements: Avoid breathing dust, mist, or vapors; protect skin and eyes; handle in restricted access areas with trained personnel
Environmental Hazard: High risk to aquatic environments due to toxicity and persistence
Ingredient: Vinorelbine tartrate
Concentration: 100% (substance form) or as stated on specific product labeling
Impurities: May contain trace formulation agents or excipients such as mannitol in commercial vials
Exposure Limits: No established OSHA or ACGIH exposure limits;
Physical Form: Lyophilized powder or injectable solution based on product presentation
Eye Contact: Flush eyes with copious amounts of water for 15 minutes, keep eyelids apart, seek emergency medical care
Skin Contact: Remove contaminated clothing, wash exposed skin thoroughly with soap and water, obtain medical attention
Inhalation: Remove victim to fresh air immediately, provide oxygen if breathing is difficult, seek doctor quickly
Ingestion: Rinse mouth, do not induce vomiting, never give anything by mouth to an unconscious person, bring to emergency services
Medical Attention: Always consult a poison control center or an oncology/critical care specialist familiar with antineoplastic exposures
Suitable Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide
Specific Hazards from Fire: Emits toxic fumes of Nitrogen oxides, Carbon oxides
Protective Equipment for Firefighters: Full protective gear, including self-contained breathing apparatus
Special Precautions: Move containers from fire area if you can do it without risk; avoid runoff from extinguishing media entering waterways
Flammability: Product is not highly flammable, but dust, powder, or vapors may combust if fire is sustained around packaging
Personal Precautions: Evacuate non-essential personnel, equip responders with chemical splash goggles, protective gloves, disposable coveralls, and NIOSH-approved respirators
Environmental Precautions: Prevent release into drains, soil, or waterways
Containment: Cover spill with absorbent material such as spill pillows or inert granules, avoid creating dust
Clean-up: Collect material in plastic or glass containers for proper disposal; decontaminate surfaces with dilute bleach or strong detergent solution
Waste Disposal: Dispose of contaminated material at a licensed hazardous waste facility
Post-cleanup Decontamination: Clean all reusable PPE before taking off, dispose single-use items in cytotoxic waste containers
Handling: Work inside certified chemical fume hoods or biological safety cabinets; use dedicated tools and PPE that never leave the restricted area; avoid splashing or aerosol generation during preparation
Hygiene Measures: Wash hands and arms after handling, never eat, drink, or smoke in the work area
Storage Conditions: Store at 2°C–8°C (refrigerated), protect from light, moisture, and heat; keep in tightly sealed original packaging
Segregation: Store away from food and incompatible chemicals, limit access to trained personnel
Packaging: Maintain all labeling and safety warnings intact on primary and secondary containers
Engineering Controls: Use ventilated workstations, Class II biosafety cabinets, and closed-system transfer devices when possible
Personal Protective Equipment (PPE): Wear double nitrile or latex gloves, impermeable lab coats or disposable gowns, splash-resistant goggles, and NIOSH N95 or higher respirators as needed
Environmental Controls: Employ local exhaust ventilation; monitor for airborne material during handling
Special Advice: Use automated equipment for reconstitution and administration when feasible to reduce human contact
Hygiene Practices: Remove gloves and gowns before leaving the handling area, and thoroughly wash exposed skin
Occupational Exposure Monitoring: Implement routine wipe testing and air sampling in oncology pharmacy areas
Appearance: White to off-white crystalline powder or clear, colorless solution
Odor: Odorless
Odor Threshold: Not determined due to low volatility
pH: Typically 3–4 in solution
Melting Point/Freezing Point: 115–120°C (decomposes)
Initial Boiling Point/Boiling Range: Not available as product decomposes before boiling
Flash Point: Not applicable
Evaporation Rate: Negligible for powder
Flammability: Not classified as flammable
Vapor Pressure: Very low; essentially non-volatile
Vapor Density: Not available
Solubility in Water: Freely soluble in water
Partition Coefficient (log Kow): Not determined
Auto-ignition Temperature: Not applicable
Decomposition Temperature: Above 120°C
Viscosity: Not relevant (solid material)
Chemical Stability: Stable when stored as indicated
Conditions to Avoid: Excess heat, moisture, exposure to light
Incompatible Materials: Oxidizing agents, strong acids or bases, reactive chemicals
Hazardous Decomposition Products: Can form toxic nitrogen oxides and carbon oxides on decomposition
Polymerization: Does not undergo hazardous polymerization
Reactivity: No reactive hazards under normal storage/handling
Acute Toxicity: Highly toxic and cytotoxic; LD50 values (animal studies) available in literature but effects in humans based extensively on clinical data
Chronic Effects: Expected to cause suppression of bone marrow, immune dysfunction, peripheral neuropathy with repeated occupational exposure
Irritation: May irritate skin, eyes, respiratory system
Mutagenicity: Demonstrated potential in cell and animal studies
Carcinogenicity: Listed by IARC as a possible human carcinogen; healthcare workers have reported increased risk with occupational exposure to cytotoxic drugs
Teratogenicity: Demonstrated fetal toxicity in animal models
Target Organs: Blood, bone marrow, peripheral nervous system, gastrointestinal system
Ecotoxicity: Demonstrated toxicity to aquatic invertebrates, algae, and fish based on studies of cytotoxic pharmaceuticals in water
Persistence: Not readily biodegradable in environmental media
Bioaccumulation: Potential exists due to slow breakdown
Mobility in Soil: Moderate mobility; may migrate into groundwater if spilled in large quantities
Other Adverse Effects: Pharmaceuticals in aquatic ecosystems present long-term risks to reproductive health and ecological diversity
Safe Disposal Methods: Incinerate at licensed site equipped to handle cytotoxic and pharmaceutical waste
Packaging Disposal: Use designated cytotoxic waste containers for all contaminated packaging, gloves, PPE, and unused product
Environmental Precautions: Do not flush into wastewater or discard in general trash
Waste Code: As directed by national or local hazardous waste regulations (typically classified as hazardous waste due to toxicity)
UN Number: UN 2811 (if applicable, based on local law for toxic solid, organic)
Proper Shipping Name: Toxic solid, organic, n.o.s. (contains vinorelbine tartrate)
Hazard Class: 6.1 (toxic substances)
Packing Group: II
Labels Required: Toxic, cytotoxic
Special Handling: Only trained personnel should conduct shipping, use secure sealed containers, keep away from food or feed
Transport Regulations: Check applicable ADR, IATA, and IMDG codes for national/international requirements
US Regulations: Not listed under US TSCA; classified as hazardous under OSHA Hazard Communication Standard
EU Regulations: Covered under REACH and CLP for cytotoxic pharmaceuticals; labeled as hazardous to health and environment
IARC: Group 2A carcinogen (probable cancer risk)
Other International Regulations: Professional use only, prescription-mandated, subject to strict handling, occupational safety, and environmental controls in most countries
Workplace Regulation: Routine use and handling require written policies, designated safe work procedures, and regular staff training
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