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Material Safety Data Sheet: Temozolomide

Identification

Product Name: Temozolomide
Chemical Name: 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide
CAS Number: 85622-93-1
Synonyms: Temodal, Temodar
Recommended Use: Pharmaceutical, antineoplastic agent for treatment of certain brain cancers
Manufacturer/Supplier: Pharmaceutical producers, oncology supply distributors
Contact Information: Refer to supplier or manufacturer for emergency phone numbers and address

Hazard Identification

Hazard Classification: Acute toxicity (oral, inhalation, dermal), Health hazard, Carcinogenicity
Signal Word: Danger
Hazard Statements: Toxic if swallowed, toxic if inhaled, risk of cancer, causes damage to organs through prolonged or repeated exposure
Pictograms: Skull and crossbones, Health hazard (exclamation mark), Carcinogen (silhouette with starburst)
Precautionary Statements: Avoid breathing dust, avoid skin contact, wear eye protection, use with appropriate containment

Composition / Information on Ingredients

Temozolomide: 100% active ingredient
Chemical Formula: C6H6N6O2
Impurities/Additives: No known additives at significant levels
Relevant Concentrations: Pure powder or pharmaceutical tablet/capsule formulations available

First Aid Measures

Inhalation: Move to fresh air, keep warm and at rest, seek immediate medical attention
Skin Contact: Rinse skin thoroughly with water, remove contaminated clothing, seek medical help if irritation or symptoms persist
Eye Contact: Flush eyes with water for several minutes, remove contact lenses if present, continue rinsing, get medical advice immediately
Ingestion: Rinse mouth, do not induce vomiting, seek medical attention without delay
Acute Symptoms: Nausea, vomiting, dizziness, respiratory distress, skin and eye irritation

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical, foam
Unsuitable Extinguishing Media: High-volume water jet
Hazardous Combustion Products: Carbon oxides, nitrogen oxides, toxic vapors
Special Protective Equipment: Wear self-contained breathing apparatus and full firefighting gear
Fire-Specific Hazards: Powder can become airborne and pose inhalation risk, pellets or tablets less volatile

Accidental Release Measures

Personal Precautions: Use personal protective equipment (gloves, mask, goggles), avoid dust formation, evacuate unnecessary personnel
Environmental Precautions: Prevent entry into sewers, drains or watercourses
Cleanup Methods: Carefully scoop spilled product into labeled waste container, use damp cloth or mop for powder, ventilate area
Decontamination: Wash area thoroughly with detergent and water, dispose of used cleaning materials safely
Disposal: Observe local regulations for cytotoxic waste

Handling and Storage

Handling: Work in a well-ventilated area, use containment devices (biosafety cabinet), avoid creating dust, never eat or drink near handling area, use dedicated utensils
Storage Conditions: Store at controlled room temperature (15–30°C), keep in original tightly-closed container, protect from moisture and light
Incompatibilities: Avoid strong acids, strong bases, oxidizing agents
Special Considerations: Secure storage area against unauthorized personnel, use warnings to highlight hazardous nature

Exposure Controls and Personal Protection

Exposure Limits: No established occupational exposure limit, handle as cytotoxic agent
Engineering Controls: Use local exhaust ventilation, laboratory fume hood, or biosafety cabinet
Personal Protection Equipment: Nitrile gloves, lab coat or gown, safety goggles, NIOSH-approved respirator if dust possible
Hygiene Measures: Wash hands before breaks and after handling, do not touch face, change contaminated clothing promptly
Environmental Controls: Prevent uncontrolled release to environment, use spill trays or containment mats

Physical and Chemical Properties

Physical State: Solid
Color: White to pale yellow
Odor: Odorless
Melting Point/Range: 212–214°C
Boiling Point: Decomposes before boiling
Solubility: Slightly soluble in water
Vapor Pressure: Not applicable at room temperature
Density: 1.67 g/cm³
Other Properties: Stable in solid form, sensitive to moisture, slowly degrades in water

Stability and Reactivity

Chemical Stability: Stable in dry conditions at room temperature
Conditions to Avoid: Heat, light, moisture, incompatible materials
Incompatible Materials: Strong oxidizing agents, acids, alkalis
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen compounds
Polymerization: No hazardous polymerization known
Reactivity Notes: Can break down rapidly if exposed to high humidity and light, loss of potency and potential for hazardous degradation products

Toxicological Information

Acute Toxicity: LD50 (oral, rat): approximately 93 mg/kg, toxic by ingestion
Routes of Exposure: Oral, inhalation, dermal, ocular
Symptoms: Nausea, vomiting, fatigue, respiratory distress, risk of myelosuppression in repeat/long-term exposure
Carcinogenicity: Classified as possibly carcinogenic to humans (IARC Group 2A)
Mutagenicity and Reproductive Effects: Causes genetic defects, risk of reproductive harm
Organ Toxicity: Bone marrow, gastrointestinal system, immune system
Medical Conditions Aggravated: Immunocompromised, pre-existing marrow disorders

Ecological Information

Aquatic Toxicity: Toxic to aquatic life (limited data, should not be released into environment)
Persistence and Degradability: Not readily biodegradable, persistent in soil and water
Bioaccumulative Potential: Not expected to bioaccumulate based on available data
Mobility in Soil: Moderate mobility, risk of leaching in moist conditions
Other Harmful Effects: Long-term hazard to aquatic organisms cannot be excluded with current data

Disposal Considerations

Waste Treatment Methods: Incinerate at approved facility with high-temperature combustion
Product Disposal: Treat as cytotoxic drug waste, label properly, consult local, regional, and national procedures
Packaging Disposal: Decontaminate if possible, dispose of in dedicated hazardous waste stream
Recommendations: Do not discharge to drains or environment, keep away from food or water sources during disposal

Transport Information

UN Number: Not assigned for transport in pharmaceutical form
Transport Hazard Class: Not classified for transport by ADR/RID/IMDG/IATA in finished pharmaceutical packaging
Packaging Requirements: Use leak-proof, sealed, clearly labeled containers
Special Precautions: Transport only by authorized firms, inform couriers of hazardous nature for bulk shipments
Regulatory Transport Status: Consult local authorities for bulk powder; finished dosage forms often exempt from hazardous material regulations, though labeling laws may change

Regulatory Information

OSHA Status: Not specifically listed, treat as hazardous under OSHA Hazard Communication Standard
EPA Status: Not listed as hazardous waste, though local regulations may require strict controls
IARC Status: Possibly carcinogenic to humans, Group 2A
SARA Title III: Not subject to specific reporting, but reporting for hazardous chemicals may apply
Other Regulations: Pharmaceutical handling guidelines enforce strict controls for cytotoxic agents, disposal and spill cleanup under safety and environmental regulations
Workplace Controls: Labs and pharmacies follow safe handling requirements, employee health surveillance recommended, training for hazardous drug exposure provided as part of compliance