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Product name: Venetoclax
Synonyms: ABT-199
CAS number: 1257044-40-8
Recommended use: BCL-2 inhibitor, pharmaceutical agent
Manufacturer: AbbVie Inc.
Contact information: AbbVie Inc., North Chicago, Illinois, USA
Emergency phone: CHEMTREC: +1-800-424-9300
Hazard classification: Reproductive toxicity, Category 1B; Specific Target Organ Toxicity; May damage fertility or the unborn child
Signal word: Danger
Hazard statements: May damage fertility or the unborn child. Harmful if swallowed. Causes serious eye irritation. May cause respiratory irritation. May cause allergy or asthma symptoms if inhaled.
Precautionary statements: Avoid breathing dust, fumes. Wear protective clothing. Wash hands thoroughly after handling. Use only outdoors or in well-ventilated areas.
Label elements: GHS07, GHS08
Ingredient: Venetoclax (ABT-199)
Chemical formula: C45H50ClN7O7S
Purity: ≥98% (pharmaceutical grade)
Impurities: None above regulatory thresholds
Other components: Formulation excipients for dosage forms, not classified as hazardous
Inhalation: Remove to fresh air immediately. Provide oxygen if breathing is difficult. Get medical attention.
Ingestion: Rinse mouth with water. Do not induce vomiting. Seek medical attention without delay.
Skin contact: Remove contaminated clothing. Wash skin with soap and plenty of water. Get medical attention if irritation develops.
Eye contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do so. Continue rinsing. Obtain medical help.
Most important symptoms: Eye and respiratory irritation, gastrointestinal discomfort, potential reproductive effects.
Advice to physician: Symptomatic and supportive care, no specific antidote.
Suitable extinguishing media: Water spray, dry chemical, foam, carbon dioxide.
Unsuitable extinguishing media: High volume water jet.
Hazardous combustion products: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides, hydrogen chloride.
Protective equipment: Wear self-contained breathing apparatus and full protective suit.
Fire/explosion hazards: Dust in sufficient concentrations can form explosive mixtures with air.
Special procedures: Prevent fire-fighting water from entering watercourses or drainage systems.
Personal precautions: Avoid breathing dust. Wear appropriate personal protective equipment. Ensure adequate ventilation.
Environmental precautions: Prevent further leakage or spillage if safe to do so. Prevent entry into waterways, sewers, and soil.
Methods for cleanup: Dampen spilled material to prevent dust, sweep up, and collect in marked containers for disposal. Wash spill area with detergent and water.
Decontamination: Dispose of rags and materials used for cleaning as hazardous waste.
Safe handling: Avoid inhalation, ingestion, and contact with skin and eyes. Use tools and practices to limit dust, keep containers tightly closed. Wash hands after handling.
Storage requirements: Store at controlled room temperature, preferably between 20-25°C. Protect from moisture, light, and incompatible substances. Keep away from food and beverages.
Incompatibilities: Strong acids and bases, strong oxidizers, reducing agents.
Safe transfer: Use grounded equipment to transfer powder to prevent static discharge.
Engineering controls: Work in a chemical fume hood or with local exhaust. Enclose operations and use equipment to contain dust.
Exposure limits: No established occupational exposure limits for Venetoclax. Handle as an active pharmaceutical ingredient (API).
Personal protective equipment: Wear safety goggles, chemical-resistant gloves, protective laboratory clothing. Use a particulate respirator if ventilation is insufficient.
Hygiene measures: Remove and wash contaminated clothing before reuse. Wash hands and skin thoroughly after handling.
Environmental controls: Use spill trays and prevent release to the environment.
Appearance: Off-white to light yellow powder
Odor: Odorless or faint odor
Melting point: Approximately 138–143°C
pH: Not applicable (insoluble in water)
Solubility: Practically insoluble in water; soluble in dimethyl sulfoxide (DMSO) and ethanol
Vapor pressure: Not determined
Relative density: Not determined
Partition coefficient (Log Kow): >3 (estimated, lipophilic)
Boiling point: Not applicable (decomposes before boiling)
Flash point: Not determined
Explosive properties: No data available
Chemical stability: Stable under recommended storage conditions
Conditions to avoid: High temperatures, direct sunlight, moisture
Incompatible materials: Strong oxidizing agents, strong acids, strong bases
Hazardous decomposition products: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides, hydrogen chloride
Reactivity: No known hazardous reactivity under normal use
Likely routes of exposure: Inhalation, ingestion, skin contact, eye contact
Acute toxicity: Harmful if swallowed; possible irritation on contact with eyes and skin
Chronic effects: Animal studies show risk of reproductive toxicity, possible liver and hematological effects
Carcinogenicity: No data available in humans; not listed by IARC, NTP, OSHA
Mutagenicity: Not found to be mutagenic in standard tests
Reproductive toxicity: Positive evidence from animal studies; may harm fertility and unborn children
Sensitization: May cause respiratory or skin sensitization in susceptible individuals
Target organs: Liver, hematopoietic system, reproductive system
Toxicity to aquatic life: No comprehensive data, but high log Kow indicates potential risk to aquatic organisms
Persistence and degradability: Venetoclax is likely to be persistent due to low aqueous solubility and slow biodegradation
Bioaccumulative potential: High, based on estimated partition coefficient
Mobility in soil: Low, expected to bind strongly to organic material in soil
Other adverse effects: May have long-term effects in the aquatic environment
Waste disposal methods: Treat as hazardous pharmaceutical waste. Dispose in accordance with local, regional, national, and international regulations. Incinerate in a licensed facility. Do not dispose of in household garbage or drains.
Unused product: Return to manufacturer or supplier for safe disposal if possible.
Contaminated packaging: Dispose of as hazardous chemical waste. Decontaminate before recycling or discarding if required.
UN number: Not assigned
UN proper shipping name: Not regulated for transport under current UN, IMO, IATA, DOT rules
Hazard class: Not classified
Packing group: Not assigned
Transport precautions: Keep containers tightly closed. Protect from physical damage. Comply with all applicable transport regulations.
Special provisions: Handle as a pharmaceutical material with potential toxicity if bulk quantities are shipped.
TSCA status: Not listed for commercial use
SARA 313 (USA): Not listed
OSHA status: Hazardous substance under OSHA Hazard Communication Standard
EU REACH: Exempt as medicinal product
WHMIS (Canada): Controlled product – consult provincial requirements
Other regulations: Subject to DEA and FDA regulations for controlled pharmaceuticals. Handle under cGMP and laboratory biosafety guidelines. Medical professionals should consult national or regional health and environmental authorities for compliance.
