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Product Name: Busulfan
Chemical Name: 1,4-Butanediol dimethanesulfonate
Synonyms: Myleran
CAS Number: 55-98-1
Molecular Formula: C6H14O6S2
Molecular Weight: 246.31 g/mol
Manufacturer/Supplier: Refer to product label
Recommended Use: Chemotherapy agent
Restrictions on Use: Not for household application; use only in controlled laboratory or medical environments
Emergency Telephone Number: Refer to institutional guidelines or SDS supplier contact
Classification: Acute Toxicity (Oral, Inhalation, Dermal) Category 2; Carcinogenicity Category 1B; Germ Cell Mutagenicity Category 2; Reproductive Toxicity Category 1B
Signal Word: Danger
Hazard Statements: Fatal if swallowed or inhaled; may cause cancer; suspected of causing genetic defects; may damage fertility or the unborn child
Pictograms: Skull and crossbones, Health hazard
Precautionary Statements: Avoid contact with eyes, skin, or clothing; use only in a well-ventilated area; wear appropriate protective gear; avoid release to the environment
Effects: Symptoms can include sore throat, coughing, dizziness, nausea, vomiting, bone marrow suppression, and increased cancer risk
Target Organs: Bone marrow, reproductive system, gastrointestinal tract
Chemical: Busulfan
Concentration: 100% (as supplied; for diluted forms, consult product label)
Impurities: May contain trace residual solvents based on supplier data
Ingredient Description: Pure active pharmaceutical ingredient or compounded as noted for clinical use
Inhalation: Move person to fresh air immediately; administer oxygen if breathing becomes difficult; seek prompt medical attention
Skin Contact: Remove contaminated clothing; wash affected area with soap and copious amounts of water for at least 15 minutes; get medical advice
Eye Contact: Hold eyelids open and rinse thoroughly with running water for at least 15 minutes; do not allow victim to rub eyes; immediate medical consultation is critical
Ingestion: Rinse mouth with water if person is conscious; do not induce vomiting; monitor for symptoms of toxicity; seek emergency treatment
Symptoms of Exposure: Gastrointestinal distress, respiratory complications, decreased blood counts, weakness, potential long-term complications such as secondary cancers
Advice to Physicians: Treat symptomatically; monitor hematological parameters and organ function; consult toxicolology resources for guidance on antidotes or intensive care interventions
Suitable Extinguishing Media: Water spray, dry chemical, foam, or carbon dioxide; choose agent appropriate for surrounding fire
Specific Hazards Arising from the Substance: Toxic and corrosive fumes may be released, including sulfur oxides and carbon oxides
Protective Equipment for Firefighters: Use self-contained breathing apparatus and full protective gear; avoid inhalation of decomposition products
Thermal Decomposition: At high temperatures, busulfan decomposes to produce highly toxic gases
Personal Precautions: Evacuate unnecessary personnel; wear fitted respirator, chemical-resistant gloves, goggles, and protective clothing
Environmental Precautions: Prevent drug from reaching sewage, surface water, or groundwater; reduce spread with absorbent material
Cleanup Methods: For small spills, absorb with inert material and collect in a closed container for disposal; use non-sparking tools
Decontamination: Wash area with mild detergent and large amounts of water; dispose wash solutions as hazardous waste
Reporting Requirements: Notify relevant authorities if a significant spill threatens environment or health; follow institution-specific protocols
Handling: Use only in chemical fume hood or designated areas; avoid producing dust; ground all equipment associated with handling to prevent static discharge; practice good hygiene and wash hands thoroughly after handling any amount
Storage Conditions: Keep container tightly closed in a cool, dry, and well-ventilated place; store locked up; segregate from incompatible substances such as strong oxidizers
Specific Requirements: Limit access to trained individuals; label storage area clearly; inspect storage regularly for leaks or deteriorating containers
Occupational Exposure Limits: No occupational exposure limit established in many regions; handle as hazardous drug with strict controls
Engineering Controls: Utilize local exhaust ventilation or chemical fume hood; maintain negative pressure in work area
Personal Protection: Wear chemical splash goggles, face shield, lab coat, chemical-resistant gloves, and suitable respiratory protection if airborne exposure risk exists
Hygiene Measures: No eating, drinking, or smoking in work area; change gloves regularly and after contact; dispose single-use protective equipment as hazardous waste
Appearance: White to off-white crystalline powder
Odor: No significant odor
Odor Threshold: Not established
pH: Not available
Melting Point: 103-105°C
Boiling Point: Decomposes before boiling
Flash Point: Not determined
Evaporation Rate: Not applicable
Flammability: Not classified as flammable under normal conditions
Vapor Pressure: Negligible at room temperature
Solubility: Moderately soluble in water; more soluble in organic solvents such as acetone, ethanol, dimethyl sulfoxide
Density: Approximately 1.4 g/cm³
Partition Coefficient (log Kow): Data not available
Viscosity: Not applicable
Explosive Properties: None identified
Oxidizing Properties: Does not possess oxidizing properties
Chemical Stability: Stable under recommended storage and handling conditions
Conditions to Avoid: Elevated temperatures, exposure to moisture, light, and air; avoid strong shaking or mechanical impact
Incompatible Materials: Strong oxidizing agents, strong bases, strong reducing agents
Hazardous Decomposition Products: Emits toxic gases including carbon monoxide, carbon dioxide, sulfur oxides upon decomposition
Hazardous Reactions: No known hazardous polymerization
Routes of Exposure: Inhalation, ingestion, dermal, ocular
Acute Toxicity: Oral LD50 (rat): approximately 15 mg/kg; inhalation and dermal toxicity data limited but assumed hazardous
Chronic Effects: Bone marrow suppression; secondary malignancies; reproductive and developmental toxicity observed in animal studies
Carcinogenicity: Classified as carcinogenic to humans by IARC (Group 1); NTP includes busulfan in list of known human carcinogens
Mutagenicity: Mutagenic in in vitro and in vivo assays
Reproductive Effects: Teratogenicity, reduced fertility documented in lab animals and clinical settings
Other Effects: Potential for severe aplastic anemia, pulmonary fibrosis, hepatotoxicity
Target Organs: Bone marrow, reproductive system, lungs, liver
Ecotoxicity: Toxic to aquatic organisms; may cause long-term adverse effects in the aquatic environment
Persistence and Degradability: Not rapidly biodegradable; specific degradation pathways not fully characterized
Bioaccumulative Potential: Data not available, but unlikely to bioaccumulate significantly due to chemical properties
Mobility in Soil: Moderate water solubility may allow movement through soil; potential risk of groundwater contamination
Other Adverse Effects: Potential toxicity to microorganisms and invertebrates; large releases threaten ecosystem health
Disposal Methods: Manage as hazardous pharmaceutical waste; incinerate at licensed waste facility equipped to handle cytotoxic substances; do not flush or release into the environment
Container Handling: Triple-rinse and destroy empty containers via appropriate hazardous waste protocols
Waste Legislation: Comply with local, regional, and national hazardous waste disposal regulations
UN Number: UN 2811
UN Proper Shipping Name: Toxic solid, organic, n.o.s. (contains Busulfan)
Transport Hazard Class: 6.1 (Toxic substances)
Packing Group: II
Marine Pollutant: Not classified as marine pollutant, but prevent release to aquatic networks during transit
Special Precautions for User: Use secure, labeled containers; restrict transport to authorized personnel; follow emergency procedures for accidental release during shipment
Labeling Requirements: Comply with OSHA, WHMIS, and regional requirements for cytotoxic drugs
Chemical Inventory Status: Registered under TSCA (United States), EINECS (European Union), and other jurisdictional lists
Specific Regulations: Busulfan falls under hazardous drug guidelines in medical and laboratory settings (e.g., U.S. NIOSH Hazardous Drugs List, EU Carcinogens Directive)
Worker Protection: Training, engineering controls, and personal protective equipment required by law in most settings
Community Right-to-Know: Disclosure for emergency response teams and environmental health authorities required in many regions
