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Product Name: Irinotecan Hydrochloride Trihydrate
Chemical Name: (4S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate monohydrochloride trihydrate
Synonyms: Camptosar, CPT-11
CAS Number: 136572-09-3
Recommended Use: Chemotherapy agent for cancer treatment
Manufacturer Information: Pharmaceutical company details with emergency contact phone
Supplier Address: Manufacturer’s or distributor’s physical address and phone
Hazard Classification: Acute toxicity (oral and inhalation, category 3), Irritant, Health hazard for repeated exposure
Signal Word: Danger
Hazard Statements: Causes damage to organs through prolonged or repeated exposure; causes serious eye irritation, may cause respiratory irritation, may cause allergic skin reaction, suspected of causing genetic defects
Pictograms: Health hazard, exclamation mark
Precautionary Statements: Obtain special instructions before use, do not breathe dust/fume/gas/mist/vapors/spray, wash thoroughly after handling, use only outdoors or in a well-ventilated area, wear protective gloves and eye/face protection
Chemical Name: Irinotecan Hydrochloride Trihydrate
Percentage: 98–100%
Impurities: Related substances in trace amounts, residual solvents below ICH guidelines
Molecular Formula: C33H38N4O6·HCl·3H2O
Molecular Weight: 677.2 g/mol
Other Components: Possible excipients in formulations may include acids or buffers like sorbitol, lactic acid, or sodium chloride
Inhalation: Move affected individual to fresh air immediately, keep at rest while maintaining a clear airway, seek medical attention if symptoms develop or persist
Skin Contact: Wash exposed skin with soap and plenty of water, remove contaminated clothing and shoes, seek medical advice if irritation or redness appears
Eye Contact: Immediately flush eyes with copious amounts of water for at least 15 minutes separating eyelids, obtain medical attention if discomfort or pain continues
Ingestion: Rinse mouth with water, do not induce vomiting unless directed by medical personnel, never give anything by mouth to an unconscious person, seek medical attention promptly
Most Important Symptoms: Nausea, vomiting, diarrhea, contact dermatitis, respiratory difficulties, sore throat
Suitable Extinguishing Media: Dry chemical, carbon dioxide, water spray, alcohol-resistant foam
Unsuitable Extinguishing Media: Direct water jet, as it may scatter powder
Specific Hazards Arising: Emits toxic fumes of carbon oxides, nitrogen oxides, hydrogen chloride when heated to decomposition
Protective Equipment: Wear self-contained breathing apparatus and protective gear to avoid inhalation and skin contact
Special Procedures: Move container from fire area if it can be done safely, prevent runoff from entering drains or waterways
Personal Precautions: Restrict access to area, wear protective equipment including gloves, mask, goggles, and impermeable clothing
Environmental Precautions: Prevent further leakage or spillage by containing the release, minimize entry into sewers, surface water or confined areas
Clean-up Methods: Scoop up material without creating dust, place in suitable containers for disposal, wash spill area thoroughly with soap and water, ventilate the area
Decontamination: Use damp cloths for cleaning, place all contaminated materials in sealed, marked containers for disposal
Handling: Handle with care using appropriate containment, avoid prolonged or repeated exposure, do not breathe dust, vapors, or spray, wash hands thoroughly after handling, avoid contact with skin and eyes, use in closed system or laboratory fume hood
Storage Conditions: Store in original packaging tightly closed, at 2–8°C (refrigerated), protect from light and moisture, keep away from incompatible substances such as oxidizers and strong acids
Specific Use: Only qualified personnel experienced in cytotoxic or hazardous drug handling should work with this product, special procedures for cleaning and disposal recommended
Exposure Limits: No specific occupational exposure limits established; treat as hazardous
Engineering Controls: Use local exhaust ventilation, safety cabinets, or fume hoods when handling powder or making solutions
Personal Protective Equipment: Nitrile or latex gloves, long-sleeved laboratory coat, impervious boots, chemical splash goggles, face shield in high-risk scenarios
Respiratory Protection: Use NIOSH-approved particulate respirator or medical mask during potential aerosol or powder exposure
Hygiene Measures: Remove contaminated clothing after use, avoid eating, drinking, or smoking in handling area, wash hands thoroughly before breaks and after shift
Appearance: White to pale yellow crystalline powder
Odor: Odorless or very faint chemical odor
pH (solution): 3.0–3.8 (20 mg/mL aqueous solution)
Melting Point: 238–240°C (decomposes)
Solubility: Soluble in water, slightly soluble in methanol and ethanol, practically insoluble in ether
Partition Coefficient (log P): Less than 0.1 at pH 7
Vapor Pressure: Negligible at room temperature
Density: Approximately 1.3 g/cm³
Flash Point: Not applicable due to negligible volatility and water content
Boiling Point: Decomposes before boiling
Chemical Stability: Remains stable under recommended storage conditions, sensitive to light and hydrolysis under alkaline or acidic conditions
Conditions to Avoid: Heat, light, moisture, strongly acidic or alkaline environments
Incompatible Materials: Strong oxidizers, acids, bases, metal salts
Hazardous Decomposition: Produces nitrogen oxides, carbon monoxide, carbon dioxide, hydrogen chloride gas on decomposition
Polymerization: Hazardous polymerization not expected under normal conditions
Acute Toxicity: Oral LD50 (rat) approximately 25–50 mg/kg, intraperitoneal LD50 (rat) around 40 mg/kg, can be fatal if swallowed
Chronic Exposure: Can cause organ damage through repeated or prolonged use, target organs include gastrointestinal tract, bone marrow, and liver
Routes of Exposure: Inhalation, ingestion, skin, and eye contact
Symptoms: Diarrhea, vomiting, bone marrow suppression with leukopenia/neutropenia, dehydration, respiratory distress, mucositis, skin rash
Carcinogenicity: Not listed as carcinogenic by IARC, NTP, or OSHA at this time, but based on pharmacologic properties, considered potentially mutagenic
Reproductive Toxicity: Animal studies reveal teratogenic and embryotoxic effects
Additional Information: Healthcare workers repeatedly handling may face increased risk of adverse effects if personal protection is not used properly
Ecotoxicity: Toxic to aquatic life with long lasting effects, causes adverse outcomes to fish and invertebrates in laboratory studies
Persistence and Degradability: Not readily biodegradable, can persist in environmental waters for weeks, slow breakdown under sunlight
Bioaccumulation Potential: Low due to low octanol-water partition coefficient
Mobility in Soil: Moderate to high mobility in water, loses integrity by hydrolysis but only under highly basic or acidic conditions
Other Adverse Effects: Pharmaceutical residues can disrupt natural microbial populations in aquatic systems once excreted in hospital and domestic waste
Waste Disposal: Dispose of as hazardous waste according to federal, state, and local environmental regulations, do not discharge into drains or the environment
Contaminated Packaging: Triple-rinse bottles and vials, dispose through approved hazardous waste facility
Recommended Disposal Methods: Incineration by licensed chemical incinerator, segregation from municipal or general waste
Special Instructions: Healthcare or laboratory-generated cytotoxic waste should be handled as per institutional protocols; documentation and chain of custody for hazardous substances required
UN Number: UN2811 (Toxic solid, organic, n.o.s., if shipping bulk) or similar
Proper Shipping Name: Irinotecan Hydrochloride Trihydrate or Toxic Solid, Organic, n.o.s.
Transport Hazard Class: 6.1 (Toxic substances)
Packing Group: II or III (depending on concentration/formulation)
Label: Toxic
Special Transport Precautions: Secure packaging to prevent breaks or spills, maintain temperature as per storage guidelines, notify carrier of hazardous content
TSCA Inventory: Not listed
RCRA Status: Listed as hazardous waste due to cytotoxicity
OSHA Hazard Communication: Covered under OSHA hazardous chemical standard as a cytotoxic drug
SARA Title III: Subject to reporting under certain circumstances – consult applicable sections
WHMIS Classification: D2A - Very toxic material (Canada)
EU Regulations: Carcinogen, Mutagen, Reproductive Toxicant (CMR category 2); hazardous to aquatic environment under Regulation (EC) No 1272/2008 (CLP/GHS)
Other International Regulations: Monitoring and handling guidance published by OSHA, NIOSH, and similar workplace safety agencies in multiple countries
