Product Name: Vinorelbine ditartaric acid
Synonyms: Navelbine tartrate, Vinorelbine Tartrate
Formula: C45H54N4O8 • C4H6O6
CAS Number: 125317-39-7
Manufacturer: Pharmaceutical suppliers and oncology compounding facilities.
Recommended Uses: Chemotherapy agent for treatment of certain cancers, clinical research, specialty hospital settings.
Contact Information: Provided by the supplier—always review attached documentation.
GHS Classification: Acute toxicity (oral, dermal), Serious eye damage/eye irritation, Skin corrosion/irritation
Signal Word: Danger
Hazard Statements: Toxic if swallowed, harmful in contact with skin, causes serious eye damage, may cause genetic defects, suspected of causing cancer.
Pictograms: Skull and crossbones, health hazard, exclamation mark
Precautionary Statements: Wear protective clothing, goggles, gloves at all times; avoid all contact with skin and eyes; keep away from food and beverages.
Routes of Exposure: Inhalation, skin contact, ingestion, eye contact
Target Organs: Bone marrow, gastrointestinal tract, central nervous system
Potential Health Effects: Myelosuppression, gastrointestinal symptoms, neurotoxicity, tissue necrosis if extravasation occurs.
Chemical Name: Vinorelbine ditartaric acid
Concentration: 100% pure active ingredient in raw sample
Impurities/Additives: None stated for pure substance—formulations may contain stabilizers or other excipients, consult package insert for mixtures
EC Number: Not established
Molecular Weight: 1079.14 g/mol
Inhalation: Remove person immediately to fresh air; provide oxygen or artificial respiration if breathing becomes difficult; seek medical attention without delay.
Skin Contact: Remove contaminated clothing and rinse skin with copious amounts of water and mild soap for at least 15 minutes; prompt medical advice needed.
Eye Contact: Immediately flush eyes with plenty of clean water for a minimum of 15 minutes, holding eyelids open; medical evaluation as soon as possible.
Ingestion: Rinse mouth thoroughly; do not induce vomiting; administer water if victim is conscious; urgent medical care is necessary.
Important Symptoms: Nausea, vomiting, abdominal pain, skin redness, blistering, respiratory distress, symptoms of bone marrow suppression including fatigue and bleeding.
Indication for Immediate Medical Attention: Always; cytotoxic and hazardous, prompt medical personnel required.
Extinguishing Media: Use dry chemical, CO2, water spray, or alcohol-resistant foam.
Special Hazards: Combustion may produce toxic gases such as carbon monoxide, nitrogen oxides, hydrogen chloride.
Special Protective Equipment for Firefighters: Full protective clothing and self-contained breathing apparatus, goggles, and face shield.
Advice for Firefighters: Avoid inhalation of smoke; maintain upwind position; prevent runoff from fire control measures from entering waterways.
Personal Precautions: Evacuate unprotected personnel; ventilate area; avoid generating dust; use PPE including double gloves, gown, N95 respirator, eye protection.
Environmental Precautions: Prevent material from entering drains and water sources; restrict access to spillage area.
Methods for Cleaning Up: Moisten spill with a damp absorbent (not dry sweeping), collect using a spill kit for cytotoxic agents, clean area thoroughly with detergent and appropriate disinfectant, dispose of according to local guidelines.
Decontamination Tools: Commercial cytotoxic spill kits, absorbent pads, disposable towels.
Safe Handling: Use in certified cytotoxic drug safety cabinet or biological safety enclosure; restrict access to trained staff; handle away from incompatible substances such as strong oxidizers.
Hygiene Measures: No eating, drinking, or smoking in area; wash hands before breaks and after using the product; maintain strict inventory and accountability.
Conditions for Safe Storage: Cool, dry, well-ventilated area; store in original container tightly closed; segregate from food and incompatible materials.
Temperature Requirements: Keep refrigerated or as per label instructions; protect from light.
Special Storage Instructions: Secure pharmaceutical vault if available; restrict to authorized personnel.
Occupational Exposure Limits: No established exposure limit; minimize exposure as low as reasonably achievable.
Engineering Controls: Use laminar flow hoods, cytotoxic drug safety cabinets, local ventilation.
Respiratory Protection: NIOSH-approved respirator during powder handling or risk of aerosol formation.
Eye Protection: Chemical splash goggles or face shield.
Skin Protection: Double nitrile gloves, impermeable gown, closed shoes.
Hygiene Measures: Wash hands and exposed skin after handling, remove and wash contaminated clothing after use.
Appearance: White to off-white powder or crystalline substance
Odor: Odorless or faint chemical scent
pH: 4.5–6 (in aqueous solution)
Melting Point: ~210–215°C (decomposes)
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Soluble in water, sparingly soluble in methanol and ethanol
Relative Density: 1.3–1.4 g/cm³
Vapor Pressure: Not established for solid
Partition Coefficient: Not available
Evaporation Rate: Not applicable
Chemical Stability: Stable under recommended storage; avoid exposure to excessive heat, light, and moisture.
Possible Reactions: Decomposition at high temperatures produces hazardous gases.
Incompatible Materials: Strong acids, strong bases, oxidizing agents.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride on combustion or thermal decomposition.
Polymerization: Will not occur under normal conditions.
Acute Toxicity: Toxic if swallowed or absorbed through the skin; LD50 values (animal data) often cited as very low; serious risk at small doses.
Chronic Toxicity: Causes bone marrow suppression, can lead to neutropenia, anemia, thrombocytopenia; risk increases with repeated exposure.
Carcinogenicity: IARC lists vinorelbine as possibly carcinogenic to humans.
Mutagenicity: Evidence points to genotoxic effects in laboratory models.
Reproductive Toxicity: Fetal harm possible—avoid exposure during pregnancy.
Other Symptoms: May cause peripheral neuropathy, gastrointestinal toxicity, local tissue injury if extravasated.
Aquatic Toxicity: Highly toxic to aquatic life due to cytostatic property; studies confirm negative impacts at low concentrations.
Persistence and Degradability: Biodegrades slowly, persistence likely in environment.
Bioaccumulation Potential: Not likely to bioaccumulate, but chronic toxicity persists in aquatic settings.
Mobility in Soil: Can move through soil layers and contaminate ground water.
Other Environmental Hazards: Endocrine-disrupting effects on aquatic organisms suspected.
Disposal Methods: Treat as hazardous pharmaceutical waste; incinerate at high temperatures in licensed facility with pollution control.
Packaging Disposal: Use puncture-resistant, leak-proof, clearly labeled containers.
Contaminated Materials: Dispose of gloves, gowns, contaminated disposable items as cytotoxic waste.
Legal Requirements: Must conform with local, regional, and national procedures for cytotoxic substances.
UN Number: 2811 (toxic solid, organic, n.o.s.)
Hazard Class: 6.1 (toxic substances)
Packing Group: II or III (depending on concentration and packaging)
Labeling Requirements: Toxic substance labels clearly displayed on all outer packaging.
Special Precautions: Use sealed secondary containers, maintain detailed transport logs.
Additional Info: Custom declaration and documentation required for international transport—ensure chain of custody is clear.
OSHA: Not specifically listed, but treated as hazardous under the Hazard Communication Standard.
TSCA: Not listed for general public use.
EU Regulations: Listed as hazardous and subject to REACH requirements.
WHMIS: Classified as D1A (Very toxic material causing immediate and serious toxic effects); D2A (Very toxic material causing other toxic effects).
Other: All use, storage, and disposal must comply with national guidelines for handling cytotoxic and hazardous pharmaceuticals.
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