Product Name: Vinorelbine ditartrate salt hydrate
Chemical Formula: C45H54N4O8·2C4H6O6·xH2O
Synonyms: Navelbine tartrate, Vinorelbine tartrate hydrate
CAS Number: 125317-39-7
Intended Use: Pharmaceutical intermediate, research use only
Manufacturer: Contact supply/distributor for accurate address
Emergency Contact: Local poison control, or medical emergency number
Recommended Restrictions: Not for household use, not for food or feed
GHS Classification: Acute toxicity - Oral (Category 3), Skin irritation (Category 2), Eye irritation (Category 2A), Mutagenicity (Category 2), Carcinogenicity (Category 2), Reproductive toxicity (Category 1B)
Signal Word: Danger
Hazard Statements: Toxic if swallowed. Causes skin irritation. Causes serious eye irritation. Suspected of causing genetic defects. Suspected of causing cancer. May damage fertility or the unborn child.
Pictograms: Skull and crossbones, exclamation mark, health hazard
Route of Exposure: Inhalation, ingestion, skin contact, eye contact
Effects of Overexposure: Nausea, vomiting, neuropathy, fatigue, bone marrow suppression, tissue damage
Substance: Vinorelbine ditartrate salt hydrate
CAS Number: 125317-39-7
Percentage: 97-100% pure, balance water of hydration
Impurities: Trace levels of synthetic byproducts under GMP threshold
Additives: None incorporated during manufacture
Inhalation: Remove person to fresh air, keep at rest, seek immediate medical attention
Skin Contact: Remove contaminated clothes, wash affected area thoroughly with soap and water, medical help if irritation persists
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing, urgent medical evaluation required
Ingestion: Rinse mouth, do not induce vomiting, report immediately to medical provider
Most Important Symptoms: Nausea, vomiting, mucous membrane irritation, burning sensation to eyes or skin
Special Treatment Notes: Medical observation for signs of toxicity, supportive care, symptomatic therapy as instructed by toxicology expert
Suitable Extinguishing Media: Water spray, dry powder, CO2, or foam
Unsuitable Extinguishing Media: Do not use high-pressure water streams directly
Specific Hazards: Thermal decomposition releases toxic fumes of carbon oxides, nitrogen oxides, hydrogen chloride
Special Protective Equipment for Firefighters: Self-contained breathing apparatus (SCBA), full protective clothing
General Firefighting Instructions: Move containers from area if safe to do so, minimize runoff, control smoke spread, ventilate after fire
Personal Precautions: Ventilate area, clear unnecessary personnel, avoid inhalation and skin contact
Protective Equipment: Nitrile gloves, lab coat, chemical splash goggles, fitted respirator for dust
Spill Response: Avoid creating dust, scoop up with non-sparking tools, wipe with damp disposable cloth, place in labeled waste container
Waste Handling: Dispose via licensed hazardous waste handler
Environmental Precautions: Prevent spillage from entering drains, watercourses, or soil. Notify authorities in cases of large environmental release
Safe Handling Guidelines: Minimize dust, avoid direct contact, use only in approved ventilated areas, do not eat/drink/smoke near product
Hygiene Practices: Wash hands thoroughly after handling, change out of contaminated clothing promptly
Compatible Storage: Tight, clearly labeled containers, away from light and moisture, store below 8°C in cool dry place
Incompatible Materials: Strong oxidants, acids, alkalis
Specific Storage Requirements: Secure against unauthorized access, protect from physical damage, use secondary containment for bulk quantities
Occupational Exposure Limits: No exposure limits set, handle as a potent cytotoxic agent
Engineering Controls: Ventilated enclosure (Class II biological safety cabinet), general lab ventilation
Respiratory Protection: Fitted NIOSH-approved respirator if aerosol is generated
Eye Protection: Chemical splash goggles, face shield for large scale
Skin Protection: Nitrile or latex gloves, full-length lab coat or gown, long trousers, closed shoes
Environmental Controls: Prevent dust formation, HEPA-filtered exhaust for powder weighing
Additional Precautions: No open handling outside designated work area, use sealed processes where feasible
Appearance: White to pale-cream crystalline powder
Odor: Odorless
Molecular Weight: Approximately 1079.1 g/mol
Solubility: Freely soluble in water, sparingly soluble in methanol, insoluble in non-polar solvents
pH: 3.0-5.0 (1% solution in water)
Melting Point: Data not specified; decomposes before melting
Vapor Pressure: Not relevant for solids at ambient conditions
Density: About 1.1 g/cm³ (anhydrous). Hydrate varies
Auto-ignition Temperature: Not determined
Explosive Properties: Not classified as explosive
Partition Coefficient (Log Pow): Not established for salt hydrate form
Chemical Stability: Stable under specified storage conditions, sensitive to light and moisture
Conditions to Avoid: Exposure to heat, direct sunlight, humid environments
Incompatible Materials: Strong oxidizing agents, strong acids and bases, reactive metals
Hazardous Decomposition Products: Releases toxic fumes upon combustion: CO, CO2, oxides of nitrogen
Polymerization: No risk of hazardous polymerization reported
Reactivity: No dangerous reactions expected with normal use and storage
Acute Toxicity: LD50 (oral, rat) estimated below 10 mg/kg. Potent cytotoxic drug
Chronic Effects: Bone marrow suppression, peripheral neuropathy, reproductive toxicity, carcinogenic risk
Irritation Effects: Local irritation to skin, eyes, respiratory tract possible
Sensitization: No data on allergenic potential but handle as a known sensitizer
Mutagenicity: Positive in in vitro and in vivo tests
Carcinogenicity: IARC listing not established for this compound, but structurally-related alkaloids show cancer risk
Reproductive Toxicity: Teratogenicity and toxicity to fertility confirmed in laboratory studies
Routes of Exposure: Inhalation, dermal, oral, ocular
Symptoms of Exposure: Stomach pain, nausea, vomiting, weakness, nerve damage, lowered white blood cell count
Ecotoxicity: Expected to be highly toxic to aquatic life due to bioactivity
Persistence and Degradability: No data specific to compound. Expected to persist in the environment
Bioaccumulative Potential: Not studied. Structure suggests possible low bioaccumulation due to water solubility
Mobility in Soil: Likely mobile in aqueous phase owing to high solubility
Other Adverse Effects: Pharmaceutical effluents pose risks for aquatic organisms; avoid discharge to environment
Disposal Recommendations: Treat as hazardous chemical, use incineration by licensed operator
Waste Treatment Methods: Collect in tightly sealed, labeled cytotoxic drug waste containers
Recommended Disposal: Incineration with flue gas scrubbing in licensed facility
Prohibited Disposal: Do not discharge to sewer, storm drain, or natural water body
Contaminated Packaging: Rinse and treat packaging as chemical waste; do not reuse
Local Regulations: Follow regional and national requirements for cytotoxic pharmaceutical disposal
UN Number: UN2811 (Toxic solid, organic, n.o.s.)
Proper Shipping Name: Toxic solid, organic, n.o.s. (contains Vinorelbine ditartrate salt hydrate)
Transport Hazard Class: 6.1 (Toxic Substances)
Packing Group: II (medium danger)
Labels: Toxic (Skull and crossbones), handling cytotoxics label
Environmental Hazards: Marine pollutant (if shipped in large quantities)
Special Transport Precautions: Secure and label packages securely, keep away from food and feedstuffs, temperature control recommended
Transport Documentation: Include safety data, emergency response information with shipment
Safety, Health, Environmental Regulations: Subject to OSHA, REACH, and national cytotoxic control regulations
US TSCA Status: Not listed for pharmaceutical use
IARC, NTP, or OSHA Carcinogen status: Not evaluated by these agencies
EU Regulation: Regulation (EC) No 1907/2006 applies (REACH); controlled substance for research/clinical use
California Proposition 65: Not specifically listed; all antineoplastic drugs handled as reproductive toxin
Other Requirements: Laboratory and workplace safety plans must regulate training, handling, and disposal
Inventory Status: Check with local authorities for national registration; not a consumer product
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