Product Name: Vinorelbine Tartarate
Chemical Name: (Tartrate salt of Vinorelbine)
Synonyms: Navelbine tartrate, Vinorelbine ditartrate
CAS Number: 125317-39-7
Recommended Use: Antineoplastic agent for intravenous injection
Manufacturer: Listed by producer/wholesaler
Emergency Contact: Refer to local poison control center or medical authority
Form: Lyophilized powder or liquid concentrate (dependent on supplier)
Classification: Acute Toxicity (Oral, Dermal, Inhalation) Category 2, Carcinogenicity Category 2, Reproductive Toxicity Category 2, Specific Target Organ Toxicity
Signal Word: Danger
Hazard Statements: May be fatal if inhaled, swallowed, or absorbed through skin. Causes damage to organs. Suspected of causing cancer. Suspected of damaging fertility or the unborn child.
Pictograms: Skull and crossbones, Health hazard, Exclamation mark
Precautionary Statements: Only trained personnel handle this material. Use personal protective equipment.
Potential Health Effects: May cause hair loss, leukopenia, liver or kidney damage, gastrointestinal irritation, nervous system effects.
Environmental Hazard: Toxic to aquatic life with long lasting effects.
Chemical Name: Vinorelbine tartarate
Concentration: 100% (active pharmaceutical ingredient) or as specified on product label
Other Ingredients: None usually present in pure form; liquid preparation may contain saline or buffering agents as excipients
Impurities: Maximum limits as per product specifications
Molecular Formula: C45H54N4O8·C4H6O6 (tartrate)
Molecular Weight: 1079.10 g/mol
CAS Number: 125317-39-7 (ditartrate salt)
Inhalation: Move to fresh air. If breathing becomes difficult or stops, administer oxygen or perform artificial respiration. Seek immediate medical attention.
Skin Contact: Remove contaminated clothing. Wash skin thoroughly with soap and water for at least 15 minutes. Seek medical advice.
Eye Contact: Rinse eyes cautiously with water for at least 15 minutes. Remove contact lenses if present and easy to do. Seek medical attention.
Ingestion: Rinse mouth with water if person is conscious. Do not induce vomiting. Seek urgent medical assistance.
Most Important Symptoms/Effects: Nausea, vomiting, mucositis, neuropathy, bone marrow suppression, liver or kidney dysfunction.
Immediate Medical Attention: Antineoplastic agents require immediate intervention. Hospitalization recommended for accidental exposure.
Suitable Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide.
Unsuitable Media: Avoid high pressure water jet, which may disperse material.
Specific Hazards: May produce toxic fumes under fire conditions (carbon oxides, nitrogen oxides, hydrogen chloride).
Special Protective Equipment: Wear self-contained breathing apparatus and full protective gear.
Firefighting Procedures: Stay upwind, remove all persons from area, cool containers with flooding quantities of water, contain run-off.
Flash Point: Not applicable (non-combustible solid)
Personal Precautions: Use appropriate personal protective equipment such as impervious gloves, protective clothing, eye and face protection, and respirator if ventilation is inadequate.
Environmental Precautions: Do not let product enter drains or watercourses; inform environmental authorities if release occurs.
Methods for Cleanup: Evacuate area, ventilate. Absorb liquid spills with inert material (dry sand, earth, vermiculite). For powder form, apply gentle mist to limit dust formation before cleaning up. Collect material in a suitable container for disposal; decontaminate spill area with sodium hypochlorite solution if permissible.
Prevention of Secondary Hazards: Clean thoroughly to avoid residual contamination. Dispose as per local regulations.
Safe Handling: Only authorized, trained personnel wearing full protective equipment work with this material. Avoid inhaling dust, vapors, or aerosol. Prevent contact with skin, eyes, and clothing. Work in chemical fume hood or biologic safety cabinet.
Storage Conditions: Store in well-ventilated area, away from incompatible materials (acids, bases, oxidizers). Temperature maintained as specified by manufacturer (usually 2-8°C, avoid freezing unless otherwise directed).
Containment: Keep container tightly closed and properly labeled. Segregate from general storage.
Special Requirements: Protect from physical injury. Prevent unauthorized access.
Occupational Exposure Limits: Occupational exposure limits not established by regulatory agencies; exposure must be kept to a minimum.
Engineering Controls: Use chemical fume hood, biological safety cabinet, or glove box for all handling steps.
Personal Protection: Wear chemically resistant gloves (nitrile, butyl rubber), full body gown, safety goggles or face shield, and NIOSH-approved respirator if risk of aerosol formation exists.
Hygiene Measures: Wash hands thoroughly after handling. Do not eat, drink, or smoke near product.
Environmental Controls: Use closed systems and local exhaust ventilation to reduce risk of environmental exposure.
Appearance: White or almost white powder (lyophilized), or colorless to yellow liquid concentrate
Odor: Odorless or slight
Odor Threshold: Not applicable
pH: 3.0 to 4.0 (aqueous solution)
Melting Point: Not available
Boiling Point: Not available
Flash Point: Not applicable
Solubility: Soluble in water, partially soluble in methanol, insoluble in most organic solvents
Partition Coefficient (n-octanol/water): Not available
Vapor Pressure: Not available
Density: Not available
Evaporation Rate: Not available
Explosive Properties: No data
Oxidizing Properties: Not classified as oxidizing
Chemical Stability: Stable under recommended conditions of storage and handling.
Reactivity: No dangerous reactions known under normal conditions.
Conditions to Avoid: Extreme temperatures, incompatibility with strong acids, strong bases, and oxidizers.
Incompatible Materials: Strong oxidizing agents, strong acids and bases.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride.
Polymerization: No hazardous polymerization anticipated.
Acute Toxicity: Highly toxic; LD50 (oral, rat): data suggest less than 10 mg/kg. Intravenous administration causes severe toxicity at low doses in animal models.
Routes of Exposure: Inhalation, ingestion, skin and eye contact.
Symptoms of Exposure: Bone marrow suppression, gastrointestinal disturbances (nausea, vomiting, diarrhea), peripheral neuropathy, fatigue, mucositis, hepatotoxicity.
Chronic Toxicity: Risk of cumulative toxicity. Reproductive toxicity suspected. Possible carcinogenicity.
Mutagenicity: Positive findings in some in vitro tests.
Carcinogenicity: Not classified by IARC, but listed as hazardous due to possible carcinogenic effects.
Reproductive Toxicity: Suspected of damaging fertility or causing harm to unborn child.
Medical Conditions Aggravated by Exposure: Pre-existing liver, kidney, blood, or nervous system disorders.
Ecotoxicity: Toxic to aquatic organisms; expected to cause long-lasting adverse effects in aquatic environments.
Persistence and Degradability: Limited data; pharmaceutical agents often display poor biodegradability.
Bioaccumulative Potential: Bioaccumulation potential not fully studied; remains a concern for persistent use.
Mobility in Soil: Not known; water soluble, may migrate through soil and contaminate groundwater.
Other Adverse Effects: Harmful impact on local aquatic and soil organisms by altering physiological processes.
Waste Treatment Methods: Incinerate at high temperature in facility with controls for halogenated organics. Do not discharge to sewer or environment.
Contaminated Packaging: Dispose of as hazardous pharmaceutical waste through licensed waste contractor.
Special Precautions: Avoid contact with skin and inhalation during disposal, ensure complete destruction.
Refer to Local Regulations: Follow procedures in accordance with government hazardous waste disposal guidelines.
UN Number: UN 2811 (Toxic solids, organic, n.o.s. [contains Vinorelbine tartarate])
UN Proper Shipping Name: Toxic solid, organic, n.o.s.
Transport Hazard Class: 6.1 (Toxic substances)
Packing Group: II
Marine Pollutant: Yes
Special Precautions: Secure packaging to prevent spillage, ensure trained personnel only handle during transport, mark outer container with hazard labels and UN number.
Transport in Bulk: Not applicable for pharmaceuticals; ship in approved containers only
US Regulations: TSCA Exemption; Listed as hazardous under OSHA Hazard Communication Standard; regulated under Clean Water Act for discharge; listed hazardous waste under RCRA if discarded as unused product.
EU Regulations: Classified as toxic under Regulation (EC) No 1272/2008 (CLP); requires safety data sheet as per REACH Annex II; subject to Prior Informed Consent (PIC) Regulation for export outside EU.
International Regulations: Listed in some jurisdictions as controlled drug and hazardous chemical; transport regulated by IATA, IMDG, and ADR codes.
Label Elements: Pictograms, hazard, and precautionary statements must appear on primary and shipping containers.
Other Regulations: Store, handle, dispose following local, state, federal, and international laws for cytotoxic pharmaceuticals; training required for personnel.
Providing high-quality chemical products and logistics solutions for global trade partners.
