Product Name: Vinorelbine Tartrate
Chemical Name: 3',4'-Didehydro-4'-deoxy-C'-norvincaleukoblastine ditartrate
CAS Number: 125317-39-7
Molecular Formula: C45H54N4O8 · C4H6O6
Recommended Use: Pharmaceutical agent, antineoplastic therapy
Manufacturer Information: Provided by respective licensed pharmaceutical companies with address and emergency contact information available on request
Emergency Telephone: Refer to local guidelines for poison regulation contacts
GHS Classification: Acute toxicity (oral), Category 3; Skin corrosion/irritation, Category 2; Serious eye damage/eye irritation, Category 2A; Specific target organ toxicity—single exposure, Category 2; Carcinogen, Category 2
Hazard Pictograms: Skull and crossbones, exclamation mark, health hazard
Signal Word: Danger
Hazard Statements: Harmful if swallowed; May cause skin and eye irritation; Suspected of causing cancer; May cause damage to organs
Precautionary Statements: Avoid breathing dust/mist; Wash thoroughly after handling; Wear protective gloves/protective clothing/eye protection/face protection; Do not eat, drink, or smoke during use
Chemical Composition: Vinorelbine tartrate (active ingredient), excipients and fillers (for formulated products only)
Content: Pure compound or present as diluted pharmaceutical formulation, concentration varies by final product
CAS Number: 125317-39-7 (Vinorelbine Tartrate)
Impurities: Trace amounts of synthetic precursors and related alkaloids may be present in raw material but strictly controlled by pharmacopeial specifications
Stabilizing Agents: Sometimes formulated with citric acid or sodium chloride in intravenous solutions
Inhalation: Remove to fresh air, keep at rest – seek medical attention if symptoms develop such as coughing, headache or dizziness
Skin Contact: Remove contaminated clothing, wash affected area with plenty of water and soap – early treatment lowers risk of sensitization
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing and obtain medical advice
Ingestion: Rinse mouth with water – never induce vomiting, immediately consult poison control center or seek emergency medical care
Most Important Symptoms and Effects: Irritation, nausea, headache, dizziness, bone marrow suppression, or local necrosis following injection
Advice for Immediate Medical Care: Supportive measures and symptomatic treatment prioritized; monitor cardiac and liver function in exposed persons
Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam depending on surrounding fire
Unsuitable Extinguishing Media: Direct water jet may scatter spilled material
Hazardous Combustion Products: Carbon oxides, nitrogen oxides, acidic gases
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective gear
Firefighting Instructions: Move containers from fire area if safe, use water spray to cool unopened containers, avoid inhaling gases or fumes generated by fire
Personal Precautions: Prevent skin or eye contact, use personal protective equipment including gloves, lab coat, safety goggles, and, if airborne, a respirator
Environmental Precautions: Prevent release into drains, surface water, and soil – use appropriate containment methods
Spill Handling: Avoid dust formation, ventilate area, collect spillage with absorbent, non-combustible material (e.g., sand, vermiculite), place in tightly closed containers for hazardous waste disposal
Decontamination: Wash contaminated surfaces with detergent and a large amount of water; dispose of washings as hazardous waste
Safe Handling: Use in a fume hood or biologically protected area if possible, keep away from incompatible materials such as oxidizers, avoid ingestion or inhalation, prevent contact with skin, eyes, and clothes
Storage Conditions: Store tightly closed in a cool, dry, and well-ventilated area away from direct sunlight and heat sources, maintain temperature per label (often 2-8°C for injectables), segregate from food and drink
Special Considerations: Label storage area clearly, limit access to trained personnel, keep original packaging whenever possible, ensure emergency eyewash and safety shower nearby
Exposure Limits: No established occupational exposure limit in many jurisdictions; hazardous drug handling programs recommend minimizing all exposure
Engineering Controls: Work in a certified chemical fume hood or Class II biosafety cabinet, ensure adequate ventilation
Personal Protective Equipment: Use chemical-resistant gloves (e.g., nitrile), lab coat or protective suit, goggles or face shield, and appropriate respiratory protection for dust or aerosol
Hygiene Measures: Wash hands before breaks and after work, remove contaminated clothing promptly, avoid eating, drinking, or smoking in work area
Environmental Controls: Install spill kits and hazardous waste containers in preparation and administration areas
Appearance: White to off-white powder or lyophilized cake
Odor: Odorless
pH: 3-4 (for injectable solution)
Melting Point: 210–215°C (decomposes)
Boiling Point: Not applicable to powder, decomposes before boiling
Solubility: Soluble in water, slightly soluble in methanol, practically insoluble in acetone, ether, and chloroform
Vapor Pressure: Not measurable at room temperature
Partition Coefficient: LogP < 0.5 (very low lipophilicity)
Other Properties: Forms colorless solutions, stable under recommended storage conditions
Chemical Stability: Stable under recommended storage conditions; solutions may degrade on exposure to light or extremes of pH
Reactivity: Not reactive under normal uses
Hazardous Reactions: Avoid contact with strong oxidizers, acids, and bases, which can promote decomposition
Decomposition Products: Toxic and corrosive fumes including nitrogen oxides and carbon oxides
Conditions to Avoid: Heat, moisture, direct sunlight, exposure to air for extended periods
Acute Toxicity: Highly toxic by oral, inhalation, or injection routes – LD50 (rat, oral) approximately 10 mg/kg
Routes of Exposure: Skin, eyes, inhalation, ingestion
Symptoms: Nausea, vomiting, diarrhea, cytopenias, peripheral neuropathy, mucositis, local tissue necrosis if extravasated
Chronic Toxicity: Prolonged or repeated exposure affects bone marrow, immune function, and peripheral nerves; teratogenicity and carcinogenicity reported in animal studies
Mutagenicity: Positive results in standard in vitro assays
Carcinogenic Potential: Classified as possible human carcinogen by some agencies
Target Organs: Blood, bone marrow, nervous system, gastrointestinal tract
Ecotoxicity: Aquatic organisms may be harmed by release, even at low concentrations; cytotoxic compounds accumulate in wastewater
Persistence and Degradability: Not readily biodegradable, persistent especially in low-temperature environments
Bioaccumulation Potential: Low bioaccumulation expected because of low partition coefficient
Mobility in Soil: Moderate to high, especially if released in aqueous solution
Other Adverse Effects: Pharmaceutical antineoplastics like vinorelbine have measurable impact in waterways, showing cytotoxicity to aquatic organisms and microbial communities
Waste Treatment Methods: Collect residues and all contaminated material for incineration at an approved facility specializing in cytotoxic or hazardous pharmaceutical waste
Disposal of Product: Dispose of unused product as hazardous waste via licensed waste disposal contractor
Disposal of Packaging: Rinse triple-contaminated containers and treat wash liquids as hazardous; keep records as required by local regulations
Environmental Precautions: Prevent leaks into public water supply, landfill, or sewage systems
Regulatory Waste Designation: Often regulated as hazardous waste due to toxicity and cytotoxicity
UN Number: UN 2811 (Toxic solid, organic, n.o.s.)
Proper Shipping Name: Toxic solid, organic, n.o.s. (contains Vinorelbine tartrate)
Transport Hazard Class: 6.1 (Toxic substances)
Packing Group: III
Labels Required: Poison
Transport Category: Keep away from foodstuffs, animals, and animal feed during transport; secure tightly and label container
Special Transport Conditions: Ship in accordance with regulations for dangerous goods in transit (IATA/ICAO, ADR/RID, IMDG)
US OSHA: Listed as hazardous under Hazard Communication Standard
TSCA: Not listed for chemical inventory
EU Regulations: Subject to REACH regulation, requires handling as a cytostatic agent with workplace exposure prevention
WHMIS (Canada): D1A (Very Toxic material), D2A (Carcinogenic/mutagenic)
RoHS / WEEE Compliance: Not applicable to finished pharmaceutical products
Other: Covered by regulations for hazardous pharmaceuticals and antineoplastic agents worldwide; labs, pharmacies, and hospitals must comply with specific worker safety and environmental standards
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