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Product Name: Tobramycin Base
Synonyms: Tobramycin, Nebramycin Factor 6
CAS Number: 32986-56-4
Manufacturer: Major pharmaceutical suppliers, generic production facilities
Contact Information: Reach out to supplier or relevant local authority for the latest details
Recommended Use: Antibacterial agent, clinical and laboratory research
Restrictions: Prescription only, human pharmaceutical ingredient
GHS Classification: Eye irritation, Category 2A; Respiratory sensitizer, Category 1; Skin sensitizer, Category 1
Hazard Statements: Causes serious eye irritation, May cause allergy or asthma symptoms if inhaled, May cause allergic skin reaction
Signal Word: Warning
Pictograms: Exclamation Mark, Health Hazard
Precautionary Statements: Wear protective gloves and eye protection, Avoid breathing dust, Wash thoroughly after handling, In case of inadequate ventilation wear respiratory protection
Emergency Overview: White to off-white powder, poses risk by inhalation, ingestion, or dermal exposure
Component: Tobramycin Base
Chemical Formula: C18H37N5O9
Purity: Typically 98% or higher
Impurities: Residual solvents, related aminoglycoside compounds
Concentration: 100% active ingredient unless diluted with inert fillers
Eye Contact: Immediately flush eyes with large amounts of water for at least 15 minutes, remove contact lenses if present, seek medical attention
Skin Contact: Remove contaminated clothing, wash affected area with soap and water, if irritation persists seek medical advice
Inhalation: Move person to fresh air, keep comfortable for breathing, seek medical assistance if symptoms develop
Ingestion: Rinse mouth with water, do not induce vomiting, seek immediate medical attention
Note to Physician: Symptomatic treatment, monitor for allergic reactions, supportive care as needed
Suitable Extinguishing Media: Dry chemical, carbon dioxide, foam, water spray
Unsuitable Media: Water jet in direct application
Hazards from Combustion: May produce nitrogen oxides, carbon monoxide, and other toxic fumes
Protective Equipment: Full protective gear and self-contained breathing apparatus for fire-fighting
Special Procedures: Evacuate area, avoid inhalation of combustion products, cool containers with water spray if exposed to fire
Personal Precautions: Wear gloves, protective clothing, eye protection, and respiratory protection in case of dust formation
Environmental Precautions: Prevent entry to sewers or natural water systems
Cleanup Methods: Sweep up or vacuum without creating dust, collect in suitable container for disposal, wash area with water and detergent
Reporting: Report large spills to environmental authorities as required
Handling: Avoid contact with skin, eyes, and clothing, minimize dust generation, use engineering controls if available
Hygiene Measures: Do not eat, drink, or smoke during handling, wash hands thoroughly after use
Storage: Store tightly closed in a cool, dry, well-ventilated area away from incompatible substances
Incompatibilities: Strong oxidizing agents, strong acids
Specific Storage Recommendations: Keep container tightly sealed, protect from moisture, store below 25°C if possible
Engineering Controls: Use local exhaust ventilation, process enclosures, or other engineering controls to reduce exposure
Exposure Limits: No established occupational exposure limits for tobramycin base; use pharmaceutical industry best practices
Eye Protection: Chemical safety goggles or face shield
Skin Protection: Impervious gloves, lab coat or protective suit
Respiratory Protection: Suitable respirator if airborne dust is generated or expected
Other: Safety shower and eyewash station in the work area
Appearance: White to off-white crystalline powder
Odor: Odorless or faint
Melting Point: 160-165°C (decomposes)
Solubility: Freely soluble in water, slightly soluble in alcohols
pH (5% solution): 6.5-8.5
Molecular Weight: 467.52 g/mol
Partition Coefficient (Log Kow): Less than 0, highly hydrophilic
Vapor Pressure: Not volatile
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not flammable under typical conditions
Chemical Stability: Stable under recommended conditions of use and storage
Reactivity: May react with strong oxidants, avoid mixing with strong acids or bases
Conditions to Avoid: Heat, moisture, strong oxidizers
Hazardous Decomposition: Carbon oxides, nitrogen oxides, other toxic fumes on combustion
Polymerization: Not known to occur
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Acute Effects: May cause irritation to skin, eyes, respiratory tract; inhalation can trigger allergic reactions in sensitized people
Chronic Effects: Occupational exposure may lead to sensitization, risk of ototoxicity and nephrotoxicity upon repeated significant exposure
Animal Toxicity: LD50 (oral, rat) >5000 mg/kg; LD50 (intraperitoneal, mouse) 367 mg/kg
Mutagenicity: Not classified as genotoxic
Other Data: Prolonged or repeated exposure leads to risk of allergic reaction or organ toxicity
Environmental Fate: Not readily biodegradable, water soluble, may persist in aquatic environments
Ecotoxicity: Harmful to aquatic organisms at high concentrations, potential risk for bioaccumulation is low
Mobility in Soil: Moves easily through soil due to high water solubility
Aquatic Toxicity Data: LC50 (zebrafish, 96 h) >100 mg/L
Other Ecological Concerns: Antibacterial properties could disrupt microbial communities in wastewater systems
Disposal in Wastewater: Avoid direct release to environment, consult local regulations and treatment capacities
Product Disposal: Incinerate in a chemical incinerator equipped with afterburner and scrubber, otherwise dispose of in accordance with local, regional, and national regulations
Container Disposal: Empty containers should be rinsed and disposed of as hazardous waste
Special Precautions: Do not allow material to enter surface water or groundwater systems, follow all pharmaceutical disposal protocols
Regulatory Considerations: Consult specialized waste disposal companies for guidance on pharmaceutical ingredients
UN Number: Not classified for transportation as a hazardous material at the pharmaceutical ingredient level
Proper Shipping Name: Tobramycin Base (non-hazardous for transport under standard handling conditions)
Transport Hazard Class: Not applicable
Packing Group: Not regulated
Labels Required: None for normal transport; bulk packaging may require additional labeling in some regions
Special Transport Precautions: Protect package from moisture and rough handling, transport within temperature-controlled environment if required
US Regulations: Not listed under CERCLA, SARA Title III, or TSCA; FDA regulated substance as an active pharmaceutical ingredient
EU Regulations: Listed under ECHA REACH for pharmaceutical use; require SDS for workplace handling
Canadian Regulations: DSL/NDSL not applicable, medical substance under Food and Drugs Act
International Inventories: Registered as a drug substance in multiple jurisdictions
Other Guidance: Ensure compliance with local, regional, and international statutes governing pharmaceuticals and chemicals in the workplace
