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Material Safety Data Sheet (MSDS) – Olaparib

Identification

Product Name: Olaparib
Chemical Name: 4-[(3-{[4-(Cyclopropanecarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2H)-one
Product Code: As assigned by manufacturer
Synonyms: AZD2281, Lynparza
Manufacturer: Reference on packaging or SDS source
Recommended Use: Pharmaceutical, anticancer agent
Contact Information: Refer to manufacturer's regulatory department for emergencies involving spills, exposures, or accidental releases

Hazard Identification

GHS Classification: Specific Target Organ Toxicity (Repeated Exposure), Category 2; Acute Toxicity, Category 4; Reproductive Toxicity, Category 2
Signal Word: Warning
Hazard Statements: Causes damage to organs through prolonged or repeated exposure. Harmful if swallowed or inhaled. Suspected of damaging fertility or the unborn child.
Pictograms: Health hazard, Exclamation mark
Precautionary Statements: Do not breathe dust; wash hands thoroughly after handling; use only outdoors or in a well-ventilated area; do not eat, drink, or smoke when using this product; avoid release to the environment

Composition / Information on Ingredients

Chemical Formula: C24H23FN4O3
CAS Number: 763113-22-0
Concentration: 100% (pure substance) or quoted as provided in the formulation
Impurities/Additives: None reported for pharmaceutical grade olaparib
Ingredient Name: Olaparib (active pharmaceutical ingredient)

First Aid Measures

Inhalation: Move to fresh air, seek medical attention if symptoms appear. Give oxygen if breathing is difficult.
Skin Contact: Remove contaminated clothing. Wash skin with soap and water for at least 15 minutes. Seek medical help for rash, irritation, or severe reaction.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing and seek medical advice.
Ingestion: Rinse mouth with water. Do not induce vomiting unless directed by medical personnel. Seek immediate medical attention.

Fire-Fighting Measures

Suitable Extinguishing Media: Carbon dioxide, dry chemical powder, foam, or water spray
Unsuitable Extinguishing Media: Direct water jet
Special Protective Equipment: Self-contained breathing apparatus and full protective gear against potential toxic fumes
Hazardous Combustion Products: Carbon oxides, nitrogen oxides, fluorinated organic compounds
Specific Hazards: May form toxic gases in a fire situation; vapors may be irritating

Accidental Release Measures

Personal Precautions: Use personal protective equipment recommended for lab pharmaceuticals. Avoid dust generation. Remove ignition sources.
Environmental Precautions: Prevent further leakage or spillage. Avoid contamination of soil, water, and drains.
Methods for Cleaning Up: Sweep up without creating dust and collect in suitable container for disposal. Ventilate area, wash spill area with water after pick-up.

Handling and Storage

Precautions for Safe Handling: Use in well-ventilated areas. Minimize dust formation. Wear appropriate protective equipment. Handle in accordance with proper pharmaceutical hygiene.
Conditions for Safe Storage: Store away from incompatible materials such as strong oxidizers. Keep container tightly closed in a cool, dry, well-ventilated location. Store at temperatures specified by manufacturer (commonly 2°C to 8°C).

Exposure Controls and Personal Protection

Occupational Exposure Limits: Not established by OSHA, NIOSH, or ACGIH for Olaparib; follow internal company OELs if specified
Engineering Controls: Local exhaust ventilation or laboratory fume hood
Eye/Face Protection: ANSI-approved safety glasses or chemical goggles
Skin Protection: Chemical-resistant gloves (nitrile recommended), laboratory coat
Respiratory Protection: Dust mask or respirator in case airborne dust concentration exceeds limits

Physical and Chemical Properties

Appearance: White to off-white solid powder
Odor: Odorless
Odor Threshold: Not determined
pH: Not applicable
Melting Point: 223-225°C (literature may vary slightly)
Boiling Point: Not determined
Flash Point: Not applicable
Evaporation Rate: Not determined
Flammability: Not flammable in normal use
Vapor Pressure: Negligible (solid at room temperature)
Solubility: Slightly soluble in water, more soluble in DMSO, methanol
Partition Coefficient (log Pow): 0.7 (reported values vary)
Vapor Density: Not applicable
Relative Density: Not determined
Decomposition Temperature: Not determined

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Reactivity: No known hazardous reactions with standard pharmaceutical materials
Conditions to Avoid: Excessive temperature, contact with strong oxidizers
Incompatible Materials: Strong acids, bases, oxidizing agents
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, fluoride-containing compounds

Toxicological Information

Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: Data in rodents: LD50 oral (rat): >1000 mg/kg; may be harmful if swallowed
Chronic Toxicity: Evidence from animal studies links repeated exposures to organ effects, especially bone marrow suppression
Carcinogenicity: No classification by IARC, NTP, OSHA
Mutagenicity: Not considered mutagenic by standard assays
Reproductive Toxicity: Suspected risk to fetal development and fertility based on preclinical study findings
Common Health Effects: Nausea, vomiting, fatigue, anemia, neutropenia, possible skin or eye irritation

Ecological Information

Ecotoxicity: Limited data; expected harmful effects in aquatic organisms at high concentrations
Persistence and Degradability: May not readily degrade in environment; detailed fate unknown
Bioaccumulative Potential: Low to moderate potential for bioaccumulation
Mobility in Soil: Low mobility due to insolubility in water
Other Adverse Effects: Avoid release into environment and watercourses

Disposal Considerations

Waste Treatment Methods: Dispose of contents/container through licensed disposal contractor
Unused Product: Follow pharmaceutical waste protocols
Contaminated Packaging: Triple rinse and dispose according to local, regional, or national regulations
Precautions: Avoid release to the environment, incineration recommended under controlled conditions

Transport Information

UN Number: Not regulated as dangerous goods under UN, IATA, IMDG, DOT rules for most quantities but verify with local adviser
Proper Shipping Name: Pharmaceutical product (not otherwise specified)
Transport Hazard Class: Not classified
Packing Group: Not assigned
Environmental Hazards: Not classified as hazardous for transportation
Special Precautions for User: Secure packaging to prevent breakage or spillage during transit

Regulatory Information

TSCA Status: Not listed for commercial use in US
EPA SARA Title III: Not listed as a hazardous substance
REACH Status (EU): Exempt as a medicinal product
OSHA Status: Not specifically regulated
WHMIS (Canada): Not classified as a controlled product
FDA/EMA: Approved for human therapeutic use under specified prescription conditions
Other Regulations: Handle according to local, national, and international pharmaceutical safety standards