Material Safety Data Sheet (MSDS) for Vinorelbine Tartrate

Identification

Product Name: Vinorelbine tartrate
Chemical Family: Vinca alkaloid; antineoplastic agent
CAS Number: 125317-39-7
Synonyms: Navelbine tartrate; 5'-noranhydrovinblastine tartrate
Recommended Use: Chemotherapeutic drug for cancer treatment
Manufacturer: Pharmaceutical suppliers or drug manufacturers
Emergency Contact Number: Local Poison Control Center

Hazard Identification

Health Hazards: May cause severe irritation to skin, eyes, and respiratory tract. Toxic by ingestion, inhalation, and dermal exposure. Can cause bone marrow suppression and neurotoxic effects.
Signal Word: Danger
GHS Classification: Acute toxicity (oral, dermal, inhalation) - Category 2; carcinogenicity - Category 2; reproductive toxicity - Category 2; specific target organ toxicity - repeated exposure - Category 2
Label Elements: Toxic, hazardous to health, environmental toxicity
Hazard Statements: Fatal in contact with skin or if swallowed. Causes damage to organs through prolonged or repeated exposure. Suspected of causing cancer.

Composition / Information on Ingredients

Chemical Name: Vinorelbine tartrate
CAS Number: 125317-39-7
Concentration: 100% (pure substance) or as supplied in pharmaceutical formulations
Molecular Formula: C45H54N4O8·C4H6O6
Impurities and Stabilizing Additives: No known significant impurities affecting classification under current regulations

First Aid Measures

Inhalation: Move to fresh air at once. Give oxygen or artificial respiration if needed. Seek medical attention without delay. Avoid direct contact with patient if possible.
Skin Contact: Remove contaminated clothing. Wash affected area with soap and plenty of water for at least 15 minutes. Seek immediate medical attention.
Eye Contact: Rinse eyes with flowing water for at least 15 minutes, lifting eyelids. Get immediate medical attention.
Ingestion: Seek medical help right away. Do not induce vomiting unless advised by a poison center or physician. Rinse mouth thoroughly with water.

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, carbon dioxide, water spray, foam
Unsuitable Extinguishing Media: Avoid strong water jets as they may spread the substance
Specific Hazards: Produces toxic fumes including nitrogen oxides and carbon monoxide under fire conditions
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective gear. Avoid inhaling combustion products.
Special Precautions: Runoff from fire control may cause pollution and toxicity to aquatic life. Contain and do not let water sources become contaminated.

Accidental Release Measures

Personal Precautions: Use personal protective equipment including gloves, gown, and respiratory protection. Avoid breathing dust or mist.
Environmental Precautions: Do not allow release into sewers, surface water or soil. Prevent spillage from spreading.
Methods for Cleaning Up: Collect spilled material with absorbent designed for hazardous drugs. Sweep up and place in a clearly labeled hazardous waste container. Ventilate area and wash spill site with water and detergent after material pick-up.

Handling and Storage

Handling: Handle in a certified chemical fume hood or biological cabinet. Use only with trained personnel. Avoid all contact with skin, eyes, and clothing. Strictly avoid inhalation or ingestion.
Storage: Store in a cool, dry place. Keep container tightly closed and marked as cytotoxic. Protect from light and moisture. Isolate from incompatible substances including strong oxidizers and acids.

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation and chemical safety cabinets.
Eye/Face Protection: Wear chemical safety goggles and a face shield as needed.
Skin Protection: Wear impervious gloves (nitrile or neoprene) and a protective lab coat or gown design for chemotherapy agents.
Respiratory Protection: Use NIOSH-approved particulate respirator if dust or aerosols are generated.
Hygiene Measures: Wash hands and face thoroughly after handling. Do not eat, drink, or smoke in storage or work area.
Exposure Limit Values: No occupational exposure limits established, follow safe-handling guidelines for cytotoxic drugs.

Physical and Chemical Properties

Appearance: White or pale yellow powder
Odor: Odorless or faint odor
pH: Not available
Melting Point: Not established
Boiling Point: Not established
Solubility: Slightly soluble in water, soluble in methanol and ethanol
Vapor Pressure: Not available
Density: Not available
Partition Coefficient (n-octanol/water): Not available
Flash Point: Not applicable
Explosive Properties: Not considered explosive
Other Data: Decomposes at high temperatures with toxic vapors.

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Possible Hazardous Reactions: No dangerous reactions identified under normal use.
Conditions to Avoid: Exposure to light, moisture, and high temperatures
Incompatible Materials: Strong oxidizing agents, acids, bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, other toxic vapors

Toxicological Information

Acute Toxicity: Extremely toxic substance; LD50 (oral, rat) data not publicly established; reports show significant toxicity at low doses
Chronic Toxicity: Prolonged exposure leads to severe bone marrow suppression, neurotoxicity, and possible reproductive toxicity
Carcinogenicity: Suspected human carcinogen
Mutagenicity: Shown mutagenic in some in vitro studies
Routes of Exposure: Inhalation, ingestion, dermal contact, injection
Target Organs: Bone marrow, nervous system, gastrointestinal tract
Symptoms of Exposure: Nausea, vomiting, constipation, muscle weakness, numbness, immune suppression, infection risk

Ecological Information

Ecotoxicity: Highly toxic to aquatic organisms, may cause long-term damage in aquatic environments
Persistence and Degradability: Not readily biodegradable
Bioaccumulation Potential: Not expected to accumulate, but data is lacking
Mobility in Soil: Data not available
Other Adverse Effects: One cytostatic drug molecule may negatively affect water-treatment environments and non-target species

Disposal Considerations

Waste Treatment Methods: Incinerate in a chemical incinerator equipped with afterburner and scrubber.
Product Disposal: Treat as hazardous chemical waste. Place in closed, labeled containers.
Contaminated Packaging: Dispose of as hazardous waste according to local regulations.
Sewage Disposal: Do not generate waste streams containing cytotoxic drugs into drains or sewers.
Precautions: Professional waste handlers should use proper personal protective equipment and procedures.

Transport Information

UN Number: Not classified for transport under UN regulations, but treat as hazardous medicament.
Transport Hazard Class: Not specifically assigned; typically shipped as a regulated pharmaceutical product
Packing Group: Not assigned
Special Precautions for User: Secure container, avoid spillage or breakage. Inform carriers about hazardous properties.
Marine Pollutant: Not classified, but poses risk to aquatic life if released.

Regulatory Information

Safety, Health and Environmental Regulations: Subject to specific workplace cytotoxic drug handling guidelines. OSHA, NIOSH, and ASHP provide relevant best-practices for antineoplastic drugs.
Inventory Status: Not listed specifically by TSCA or REACH; treat as a prescription hazardous medicine.
Labeling: Follow cytotoxic hazard labeling requirements as per national or local law.
Other Regulations: Handle with care in accordance with federal, state, and local workplace safety laws. Medical surveillance of workers handling this drug is strongly advised.