Product Name: Vinorelbine Ditartrate
Chemical Formula: C45H54N4O8 · 2C4H6O6
CAS Number: 125317-39-7
Recommended Use: Used in chemotherapy treatment, research and laboratory environments
Supplier Details: Name, address, emergency contact number, and technical advice contact noted on bottle label or procurement sheet
Synonyms: Navelbine, Vinorelbine ditartrate salt
GHS Classification: Acute Toxicity (oral, dermal, inhalation), Carcinogenicity (Category 2), Mutagenicity (Category 2), Reproductive Toxicity (Category 2)
Signal Word: Danger
Hazard Statements: Harmful if swallowed, toxic in contact with skin or if inhaled, suspected of causing genetic defects, suspected of causing cancer or fertility damage
Pictograms: Skull and crossbones, health hazard
Other Hazards: May cause irritation to eyes, skin, and respiratory system, environmental toxicity suspected in aquatic settings
Chemical Name: Vinorelbine Ditartrate
Percentage: Greater than 95% active ingredient
CAS Number: 125317-39-7
Impurities/Additives: Trace water and tartaric acid
Molecular Structure: Vinca alkaloid derivative carrying two tartaric acid moieties
Inhalation: Move to fresh air, monitor for respiratory symptoms, seek immediate medical attention for signs of difficulty breathing
Skin Contact: Remove contaminated clothing, rinse skin with water and soap for at least 20 minutes, consult a physician if redness or irritation develops
Eye Contact: Flush eyes with water for minimum 20 minutes, lift eyelids occasionally, obtain medical attention
Ingestion: Rinse mouth, never induce vomiting unless directed by a medical professional, seek medical attention without delay
Note to Physicians: Supportive care with symptomatic treatment, monitor blood counts, respiratory, hepatic, and renal function
Suitable Extinguishing Media: Water mist, carbon dioxide, dry chemical powder, foam
Specific Hazards Arising: Toxic and irritating fumes like nitrogen oxides, carbon oxides, possibly hydrogen chloride
Protective Equipment: Wear self-contained breathing apparatus and full protective suit
Special Procedures: Avoid chemical runoff into drains, cool containers exposed to fire with water spray, isolate the fire area from unnecessary personnel
Personal Precautions: Use chemical-resistant gloves, safety goggles, and lab coat; limit personnel in spill area
Environmental Protection: Prevent entry into waterways, drains, or soil
Spill Cleanup: Use absorbent materials like sand or vermiculite, gently sweep and transfer to a tightly sealed container for disposal, wash affected zone with water and detergent
Decontamination: Clean tools and surfaces with copious water, avoid generating dust or aerosols
Handling: Operate in well-ventilated or fume hood space, avoid direct physical contact, minimize aerosol and dust generation, use closed handling systems if possible
Storage: Store in cool, dry, ventilated area, keep container tightly closed in light-resistant packaging, avoid incompatible substances such as strong acids or bases, check for temperature stability per label, restrict access to trained personnel only
Engineering Controls: Use local exhaust ventilation, biological safety cabinet, or other containment measures
Eye/Face Protection: Safety goggles or face shield for splash risk
Skin Protection: Chemical-resistant gloves (nitrile recommended), lab coat, impermeable apron
Respiratory Protection: Use NIOSH/MSHA-approved respirators if dust, mist, or aerosol forms
Hygiene: Wash hands thoroughly after handling, require removal of contaminated clothing and cleaning before reuse, prohibit food and drink in work areas
Appearance: White or off-white powder
Odor: Odorless or faint chemical odor
Odor Threshold: Not determined
pH: Typically acidic in solution
Melting Point: Decomposition begins around 200°C
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Soluble in water, slightly soluble in organic solvents like methanol and ethanol
Partition Coefficient: No official values available
Vapor Pressure: Not measurable under normal conditions
Bulk Density: Information varies by manufacturer
Chemical Stability: Stable under ambient laboratory conditions and sealed container
Possibility of Hazardous Reactions: None expected under recommended handling
Incompatible Materials: Strong oxidizing agents, strong acids, and strong bases
Decomposition Products: May yield toxic gases such as carbon monoxide, carbon dioxide, and nitrogen oxides on thermal breakdown
Hazardous Polymerization: Does not occur under standard conditions
Routes of Exposure: Inhalation, skin absorption, ingestion, and eye contact
Acute Toxicity: Oral LD50 in rodents ranges from 12-30 mg/kg, dermal and inhalation thresholds much lower than non-cytotoxic drugs
Chronic Effects: Blood dyscrasias, immunosuppression, reproductive impact, teratogenicity, carcinogenic potential increases with prolonged or repeated exposure
Irritation: Causes skin and mucous membrane irritation
Sensitization: Possible allergic responses after repeated contact
Ecotoxicity: Toxic to aquatic life at concentrations as low as single-digit mg/L in laboratory studies
Persistence and Degradability: Degrades slowly in the environment, risk of bioaccumulation possible in some species
Mobility in Soil: Binds moderately to soil; leaching to groundwater can occur depending on soil type
Bioaccumulation: Species-dependent bioaccumulation not well understood
Other Environmental Hazards: Releases should be minimized, and contaminated packaging managed as hazardous waste
Waste Disposal: Incinerate using approved hazardous pharmaceutical waste facility, avoid entry into local waste streams
Container Handling: Rinse all contaminated containers and provide triple washing before disposal or recycling
Special Precautions: Follow institutional, local, and national disposal standards for cytotoxic drug waste materials and sharps
UN Number: 2811
Proper Shipping Name: Toxic Solid, Organic, N.O.S. (Vinorelbine Ditartrate)
Transport Hazard Class: 6.1 (Toxic substances)
Packing Group: II
Special Precautions: Ship in tightly closed and labeled containers, restrict temperature extremes, ensure spill kits are available during transit
Regulations: Classified and handled as hazardous material under IATA, ADR, IMDG, and DOT codes
OSHA: Regulated as cytotoxic agent under hazardous chemicals rules
TSCA: Not listed for commercial use in the United States
REACH: Notified substance within the European Union for specific industrial medical use
WHMIS: Controlled product, cytotoxic hazard, Class D2A
Other Regulatory Notes: Professional handling only, reporting requirements in case of large-scale release apply in most countries, comply with institutional biosafety and chemotherapy drug management policies
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