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Product Name: Mitomycin C
Chemical Name: Mitomycin C
Synonyms: Mutamycin, Mitozantrone
CAS Number: 50-07-7
Recommended Use: Pharmaceutical agent, chemotherapy drug
Manufacturer/Supplier Details: Institutional compounding pharmacies and pharmaceutical suppliers
Emergency Contact: Available on manufacturer’s label or local poison control center
Classification: Acute toxicity (oral, inhalation, dermal); Carcinogen; Mutagen; Reproductive toxin
Signal Word: Danger
Hazard Statements: Causes severe eye damage; causes skin irritation; toxic if inhaled or swallowed; suspected of causing genetic defects; may cause cancer by inhalation, ingestion or skin absorption
Pictograms: Skull and crossbones, health hazard, exclamation mark
Precautionary Statements: Avoid breathing dust/fume; wash skin thoroughly after handling; use only in a chemical fume hood; wear protective gloves/eye protection/face protection; handle in a well-ventilated space
Chemical Identity: Mitomycin C
Concentration: Pure compound or in pharmaceutical dilution
Chemical Formula: C15H18N4O5
Molecular Weight: 334.33 g/mol
Ingredient Description: Alkylating antibiotic derived from Streptomyces caespitosus, commonly used for its antineoplastic effects
Impurities/Additives: No known significant impurities in properly manufactured lots intended for pharmaceutical use
Inhalation: Seek fresh air; keep victim warm and at rest; provide oxygen if breathing is difficult; seek medical advice immediately
Skin Contact: Remove contaminated clothing; rinse skin with soap and water for at least 15 minutes; seek medical attention
Eye Contact: Hold eyelids apart and flush thoroughly with copious amounts of water for at least 15 minutes; remove contact lenses; obtain medical help
Ingestion: Rinse mouth with water, never give anything by mouth if person is unconscious; do not induce vomiting; get immediate medical assistance
Most Important Symptoms/Effects: Headache, nausea, vomiting, bone marrow suppression, respiratory distress, possible allergic reaction
Suitable Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical, carbon dioxide
Unsuitable Extinguishing Media: High volume water jet
Hazardous Combustion Products: Carbon oxides, nitrogen oxides, toxic fumes
Protective Equipment: Wear self-contained breathing apparatus, use chemical protective clothing
Special Procedures: Move containers from fire area if without risk; avoid inhalation of vapor, smoke, or gases; keep personnel far from the area; stay upwind
Personal Precautions: Evacuate unnecessary personnel; avoid contact with skin, eyes and clothing; avoid creating dust
Protective Equipment: Appropriate lab coat, gloves, safety goggles, NIOSH/MSHA approved respirator
Emergency Procedures: Ventilate area, prevent dust formation, follow chemical spill clean-up protocol
Containment: Dike and contain spillage; use absorbent material to collect spills
Cleanup Methods: Sweep up and place in suitable, closed container for disposal; decontaminate area with detergent solution
Handling: Use containment such as glove boxes or fume hoods; prevent inhalation, ingestion, or skin contact; prohibit eating, drinking, or smoking in work area
Storage: Keep in tightly closed, light-protected containers; store at controlled room temperature (2-8°C if not already diluted); keep away from incompatible substances; secure area against unauthorized access
Other Precautions: Maintain strict hygiene standards; keep away from children and animals; use signage where handled
Exposure Limits: No established OSHA or NIOSH limits; use recommended pharmaceutical exposure guidelines (as low as reasonably achievable, ALARA principle)
Engineering Controls: Chemical fume hood, local exhaust ventilation, closed systems
Personal Protection: Nitrile or neoprene gloves, lab coat, eye/face protection, approved respirator where necessary
Hygiene Measures: Wash hands and face thoroughly after use; discard contaminated protective equipment properly
Other Controls: Use disposable working surfaces and spill mats where appropriate
Appearance: Blue-violet crystalline powder
Odor: Odorless
Odor Threshold: No data
pH: 6.5–7.5 (in solution)
Melting Point/Freezing Point: 133–136°C
Boiling Point: Decomposition occurs before boiling
Flash Point: Not applicable
Evaporation Rate: Not measured
Flammability: Not flammable
Vapor Pressure: Negligible under standard conditions
Solubility: Soluble in water, methanol, ethanol
Partition Coefficient (n-octanol/water): Approx. 0.28
Vapor Density: Not applicable
Relative Density: ~1.5
Decomposition Temperature: Above 200°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions; light sensitive
Reactivity: No data on reactivity hazards; does not react with common materials under normal conditions
Conditions to Avoid: Heat, light, moisture
Incompatible Materials: Strong bases, strong acids, oxidizing agents
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, unknown toxic fumes
Polymerization: Will not occur under normal handling and storage
Routes of Exposure: Inhalation, skin/eye contact, ingestion
Effects of Short-Term Exposure: Serious irritation to eyes, skin, respiratory tract; nausea, vomiting, diarrhea
Chronic Effects: Bone marrow suppression, nephrotoxicity, pulmonary toxicity, possible mutagenicity and carcinogenicity
LD50 (oral, mouse): Approx. 2 mg/kg
LD50 (intravenous, rat): Approx. 1 mg/kg
Other Acute Data: Potential to cause fetal damage; highly toxic even at low doses
Symptoms: Fatigue, infection, bruising, bleeding, skin rashes, vision impairment
Target Organs: Bone marrow, kidneys, lungs
Ecotoxicity: Highly toxic to aquatic life with long lasting effects; persistence in the environment can cause disruption in aquatic organisms
Persistence/Degradability: Not readily biodegradable; may remain in the environment for long periods
Bioaccumulative Potential: Low bioaccumulation expected due to molecular structure
Mobility in Soil: May leach to groundwater but binds moderately to organic matter in soil
Other Adverse Effects: Potential to harm sewage microbial flora; avoid discharge into drains or surface waters
Waste Treatment Methods: Dispose of as hazardous pharmaceutical waste; incinerate at approved facility
Contaminated Packaging: Handle as hazardous waste; dispose of containers in accordance with regulations
Disposal Precautions: Do not discharge into drains, surface water, or soil; communal waste disposal not allowed; contact licensed waste disposal contractor
Special Considerations: Decontaminate surfaces with bleach-based solutions prior to disposal, ensure all biohazard markings are removed after decontamination
UN Number: 2811
UN Proper Shipping Name: Toxic solid, organic, n.o.s. (Mitomycin C)
Transport Hazard Class: 6.1 (Toxic substances)
Packing Group: II (medium danger)
Marine Pollutant: Yes
Land Transport (ADR/RID): Controlled transport; handle in compliance with regulations
Air Transport (ICAO/IATA): Regulated as toxic substance; specific packing instructions required
Special Precautions for User: Never transport with food products; keep secured and labeled
U.S. Regulatory Status: Prescription drug for human use; listed on TSCA for research; OSHA hazardous chemical; CERCLA hazardous substance in bulk amounts
EU Regulation: Major hazard per CLP regulation; classified as Category 1B carcinogen; REACH restrictions apply
Other Standards: Listed in IARC Group 2B (possibly carcinogenic); included in NIOSH hazardous drug list; covered under USP<800> for hazardous drugs
Labeling Requirements: Signal word Danger; appropriate hazard pictograms; hazard and precautionary statements clearly printed
Workplace Classification: Use requires controlled procedures under local occupational health and safety legislation; safety training essential for all personnel
