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MSDS for Doxorubicin Hydrochloride

Identification

Product Name: Doxorubicin Hydrochloride
Synonyms: Adriamycin, Hydroxydaunorubicin Hydrochloride
CAS Number: 25316-40-9
Product Use: Pharmaceutical active, anticancer agent
Supplier Name: Manufacturer and distributor information required by user
Emergency Phone Number: Local/national poison centers or emergency medical response hotline
Recommended Restrictions: For professional use in clinical and research settings only

Hazard Identification

GHS Classification: Acute toxicity, Category 2 (oral), Category 4 (dermal), Germ cell mutagenicity, Carcinogenicity, Reproductive toxicity, Specific target organ toxicity
Signal Word: Danger
Hazard Statements: Toxic if swallowed; causes serious eye irritation; suspected of causing genetic defects; may cause cancer by inhalation, ingestion, or skin absorption; suspected to impair fertility or harm the unborn child
Pictograms: Skull and crossbones, health hazard
Precautionary Statements: Avoid all routes of exposure, handle with dedicated PPE, use in fume hood or biosafety cabinet, do not eat or drink around powder or solution
Other Hazards: Potential for hazardous dust, may cause delayed health effects in healthcare workers over long exposure periods

Composition / Information on Ingredients

Substance: Single substance
Chemical Name: Doxorubicin Hydrochloride
CAS Number: 25316-40-9
Concentration: Greater than 98% for pharmaceutical formulations
Impurities: Trace byproducts from manufacturing, not routinely present above threshold levels
Molecular Formula: C27H29NO11•HCl
Molecular Weight: 579.98 g/mol

First Aid Measures

General Advice: Remove contaminated clothing and isolate patient
Inhalation: Move person to fresh air promptly, consult physician, monitor for respiratory symptoms; oxygen as required
Skin Contact: Wash exposed area with soap and running water for at least 15 minutes, seek medical attention if irritation develops, do not delay for minor symptoms
Eye Contact: Flush with copious amounts of water for 15 minutes, eyelids held open, immediate medical evaluation by ophthalmologist
Ingestion: Rinse mouth thoroughly, do not induce vomiting, provide supportive care, transport to hospital without delay
Most Important Symptoms: Nausea, vomiting, mucosal irritation, bone marrow suppression, tissue necrosis in accidental exposure
Immediate Medical Attention Needed: Yes—potential for life-threatening events via all routes, especially if exposure significant or unknown

Fire-Fighting Measures

Flammability: Non-flammable solid, but organic content may combust under extreme heat
Extinguishing Media: Use water fog, foam, CO2 or dry powder
Do Not Use: Strong water jets that may spread contaminated material
Special Hazards: Decomposition releases toxic fumes including nitrogen, carbon oxides, and hydrogen chloride
Protective Equipment: Wear full protective gear, self-contained breathing apparatus, avoid direct contact with concentrated drug or combustion residues
Firefighting Precautions: Dike runoff to contain drug and prevent entry into sewers or watercourses

Accidental Release Measures

Personal Precautions: Restrict access to area, use proper PPE (double gloves, disposable gown, eye/face shield, respiratory protection if dust risk), avoid contact with skin and eyes
Environmental Precautions: Prevent entry into drains, sewers, and natural waterways, isolate spill
Cleanup Methods: Absorb spill with inert, non-combustible material (such as sand or vermiculite), sweep up and collect in clearly labeled hazardous waste container
Decontamination: Area and tools cleaned with copious water and approved detergent, trace residues traced with UV light if available
Disposal: All cleanup material treated as cytotoxic hazardous waste, follow institutional protocols and regulatory guidelines
Prevention of Secondary Hazards: Address any airborne dust generation immediately, ventilate area, monitor for delayed onset symptoms in cleanup personnel

Handling and Storage

Safe Handling: Use in certified chemical fume hood or biosafety cabinet, avoid generating dust, minimize direct handling, employ closed system transfer where possible
Hygiene Practices: No eating, drinking or smoking around material, wash hands and exposed skin post-handling, change gloves regularly, dedicated work clothes if at risk of splash
Storage Conditions: Store in tightly-closed original container in cool, dry, dark, well-ventilated, clearly labeled area
Temperature: 2–8°C, avoid freezing
Incompatibilities: Strong oxidizing agents, strong acids and bases, reactive metals
Packing Materials: Shatterproof, leakproof containers required, secondary containment advised in storage rooms
Specific End Use: Pharmaceutical application by trained professionals, do not repurpose container, prevent unauthorized access

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established OSHA/NIOSH limits for doxorubicin hydrochloride; institutional and professional recommendations prioritize minimal exposure
Engineering Controls: Use ventilated enclosure or high-efficiency particulate air (HEPA) filtration in pharmacy and lab settings, access restricted to trained personnel
Personal Protective Equipment (PPE): Lab coat or protective gown, double-gloving with disposable nitrile or latex gloves, eye protection (goggles/face shield), respirator (P100 or better) if risk of aerosol
Additional Protection: Shoe covers, head cover, splash-resistant apron for large volumes, emergency eyewash and safety shower facilities nearby
Exposure Monitoring: Periodic review and monitoring for signs of contamination, surface sampling encouraged in compounding or high-use areas
Medical Surveillance: Regular health checks for workers routinely handling cytotoxic drugs, documentation of accidental exposures, prompt reporting and follow-up

Physical and Chemical Properties

Physical State: Crystalline powder
Color: Orange-red
Odor: Odorless
Melting Point: Decomposes at approximately 200°C
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Readily soluble in water; slightly soluble in methanol; practically insoluble in chloroform and ether
pH: 4.0–6.0 (1% solution in water)
Density: 1.67–1.75 g/cm³
Partition Coefficient (Log Pow): < 0
Vapor Pressure: Not volatile
Flash Point: Not applicable
Evaporation Rate: Not applicable

Stability and Reactivity

Chemical Stability: Stable under standard storage conditions (2–8°C, protected from light and moisture), decomposes at elevated temperatures
Reactivity: Unreactive under normal handling conditions
Hazardous Reactions: May react violently with strong oxidizers, acids, and bases
Hazardous Decomposition: Emits toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride if burned or decomposed
Conditions to Avoid: Excessive heat, sunlight, contact with incompatible materials
Polymerization: Will not occur

Toxicological Information

Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Acute Toxicity: LD50 oral (rat) ~21 mg/kg, highly toxic by all routes, causes gastrointestinal, hematopoietic, and cardiac effects
Chronic Effects: Linked with genotoxicity, teratogenicity, reproductive toxicity, delayed cardiomyopathy with repeated exposure
Target Organs: Bone marrow, heart, liver, kidneys
Symptoms of Exposure: Nausea, vomiting, rash, hair loss, local necrosis on contact, possible allergic reactions in some workers
Carcinogenicity: Classified as 2A by IARC (“probably carcinogenic to humans”)
Mutagenicity: Positive in a range of in vitro and in vivo test systems
Sensitization: Reports of allergic or hypersensitivity among exposed healthcare staff
Other Information: Occupational studies suggest increased risk from long-term, low-level workplace exposures

Ecological Information

Aquatic Toxicity: Harmful to aquatic organisms even at low concentrations; bioaccumulation unlikely, but effect on aquatic invertebrates and algae documented
Persistence and Degradability: Not quickly biodegradable, risk for persistence in controlled settings such as hospital wastewater
Bioaccumulative Potential: Low
Mobility in Soil: High solubility and mobility in water, but binds weakly to soil particles
Other Adverse Effects: Presence detected in hospital effluents, potential for long-term effects on microbial communities and aquatic food web
Precautions: Prevent uncontrolled release to environment, as standard wastewater treatment does not fully remove

Disposal Considerations

Waste Disposal Methods: Treat as hazardous cytotoxic chemical waste, incinerate using licensed high-temperature facility capable of destroying chemotherapeutics
Container Disposal: Decontaminate or triple-rinse, then destroy or dispose with hazardous waste
Regulatory Waste Codes: U123 (US EPA), specific state or national hazardous codes also apply
Precautions: Never discharge into sewer, water systems, or regular landfill; maintain document trail for cradle-to-grave disposal
Worker Protection: PPE required for waste handlers, restrict access to waste storage, immediate spill response if container breach suspected
Best Practice: Follow local, institutional, and national protocols for all unused, broken, or expired products

Transport Information

UN Number: UN 3249 (Medicines, solid, toxic, n.o.s.)
UN Proper Shipping Name: Medicinal substances, toxic, solid
Transport Hazard Class: 6.1 (Toxic substances)
Packing Group: II
Environmental Hazards: Marine pollutant, avoid transport with foodstuffs or animal feed
Special Precautions: Use tight secondary containment, absorbent packing, label package “Cytotoxic,” supply full MSDS on shipment
Transport Requirements: Trained personnel, documentation of chain of custody, strict adherence to national/international regulations (ADR/RID, IATA, IMDG)

Regulatory Information

Workplace Classification: Cytotoxic drug, subject to occupational health surveillance
Labelling Requirements: At minimum, hazard pictograms and signal words per GHS, assign handling restrictions in healthcare and laboratory setting
Key Regulations: OSHA Hazard Communication Standard, US EPA RCRA (hazardous waste), EU CLP Regulation (EC 1272/2008), IARC Monograph, local and state occupational safety laws
Medical Surveillance: Recommended for all staff with routine exposure
Training: Mandatory initial and annual retraining for workers
Other Requirements: Secure storage, procurement logs, universal precautions in handling, incident and exposure reporting, environmental discharge prevention