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Product Name: Tobramycin Sulfate
Chemical Family: Aminoglycoside antibiotic
SYNONYMS: Tobramycin, sulfate; Nebcin
CAS Number: 49842-07-1
Formula: C18H37N5O9 • H2SO4
Intended Use: Pharmaceutical manufacturing, research, antibiotic for bacterial infections
Manufacturer Details: Refer to packaging or supplier’s information.
Emergency Contact: Local Poison Center or Chemtrec: 1-800-424-9300
Classification: Not classified as hazardous under OSHA Hazard Communication Standard
Health Hazards: Eye, skin, and respiratory tract irritant; potential for allergic reactions with repeated contact
Environmental Hazards: May be harmful to aquatic organisms
Signal Words: Caution
Hazard Statements: May cause sensitization, risk of adverse effects if swallowed or upon repeated exposure
Pictograms: No standard GHS pictogram assigned, as chemical presents low inherent hazard profiles
Precautionary Statements: Use personal protective gear, avoid breathing dust, avoid contact with eyes and skin
Chemical Name: Tobramycin sulfate
Concentration: 95-100%
Identifiers: CAS No: 49842-07-1
Impurities/Additives: Trace amounts of related aminoglycoside compounds as by-products
Formula Weight: Approx. 635.65 g/mol with sulfate group
Other Components: Inactive excipients in formulated product forms may include buffering agents or bulking agents
Eye Contact: Rinse immediately with plenty of tepid water for 15 minutes, lift upper and lower eyelids regularly, seek medical evaluation
Skin Contact: Wash affected skin thoroughly with soap and water, remove contaminated clothing, consult a doctor if irritation or allergic reaction occurs
Inhalation: Relocate person to area with fresh air, supply oxygen if needed, get medical attention for symptoms such as coughing or shortness of breath
Ingestion: Rinse mouth with water only if victim is conscious, do not induce vomiting, seek medical help
Symptoms: Potential irritation; risk of allergic skin reaction; nausea, headache, respiratory distress with large exposures
Suitable Extinguishing Media: Water spray, foam, dry chemical, carbon dioxide
Unsuitable Media: Avoid strong water jets directly at product
Specific Hazards: Dust formation can cause air-dust explosive mixtures; heat exposure can release toxic/irritating fumes including nitrogen oxides, sulfur oxides
Protective Equipment: Firefighters require self-contained breathing apparatus and full protective gear
Special Procedures: Use water spray to cool unopened containers, prevent runoff into drains
Personal Precautions: Wear protective gloves and goggles, use NIOSH-approved respirator for significant dust levels
Environmental Precautions: Prevent material from entering drains, water sources, or soil
Cleanup Procedures: Scooping up material with non-sparking tools, avoid dust generation, place into sealed waste container for approved disposal; wash spill locations thoroughly
Decontamination: Use suitable detergent and copious water to clean surfaces, ventilate area after cleanup
Safe Handling: Avoid direct contact; minimize dust formation; handle in a well-ventilated area; never eat, drink, or smoke during handling
Storage Conditions: Keep container tightly sealed; store away from incompatible materials (acids, oxidizers); maintain storage at 2-8°C for pharmaceutical-grade material; protect from moisture and light
Measures Against Static: Ground equipment, avoid generating dust clouds
General Hygiene: Wash hands after handling; remove contaminated clothing and wash before reuse
Exposure Limits: No established ACGIH or OSHA exposure limits; minimize occupational exposure; consider internal company guidelines
Ventilation: Use downflow booths, fume hoods, or local exhaust ventilation
Eye Protection: Safety glasses with side shields; use goggles if risk of splashing or dust formation
Skin Protection: Chemical-resistant gloves (nitrile or latex); long-sleeved protective clothing
Respiratory Protection: Dust mask or NIOSH-approved respirator for airborne particulates
Protective Measures: Emergency eye wash stations and safety showers in work area
Appearance: White to off-white crystalline powder
Odor: Odorless or almost odorless
Odor Threshold: Not applicable
pH: Approximately 6.5-7.5 for a 1% aqueous solution
Boiling Point: Not available (decomposes)
Melting Point: Decomposes before melting
Flash Point: Not applicable
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Vapor Pressure: Negligible
Solubility: Freely soluble in water, practically insoluble in organic solvents
Molecular Weight: 635.65 g/mol (as sulfate)
Partition Coefficient: Not determined
Decomposition Temperature: Data not available
Density: Data not available
Chemical Stability: Stable under recommended storage conditions
Reactivity: Non-reactive under normal lab and industrial conditions
Incompatible Materials: Strong oxidizing agents, strong acids
Hazardous Reactions: No dangerous reactions known under normal use
Hazardous Decomposition Products: Burning can generate toxic gases including nitrogen oxides, sulfur oxides
Polymerization: Will not occur
Acute Toxicity: Oral LD50 (rat): >5000 mg/kg; low acute toxicity by oral or dermal routes
Skin Irritation: May cause irritation on prolonged or repeated contact
Eye Irritation: May irritate eyes
Sensitization: Possible skin sensitizer; rare risk of allergic reactions
Chronic Toxicity: Repeated exposure may lead to adverse effects on kidneys and hearing (ototoxicity and nephrotoxicity documented with systemic exposure)
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Target Organs: Kidneys, auditory system
Carcinogenicity: Not identified as carcinogenic by NTP, IARC, or OSHA
Mutagenicity: Negative in standard tests; not mutagenic in Ames assay
Reproductive Toxicity: Studies show no evidence of teratogenicity at therapeutic levels
Toxicity to Aquatic Organisms: Data is limited, but potential risk to bacteria and aquatic microorganisms
Persistence and Degradability: Biodegradable to some extent; persistence in surface waters possible due to low volatility and high solubility
Bioaccumulation Potential: Bioaccumulation unlikely due to low Log Kow
Mobility in Soil: Very mobile in aquatic environments; low tendency to bind to soils
Other Effects: May disrupt sewage and wastewater microbial flora on significant release
Waste Disposal Methods: Dispose of content and container according to local, regional, or national regulations for pharmaceutical waste
Incineration: Preferred treatment for bulk quantities; avoid release into waterways
Packaging: Use sealed, labeled containers; avoid reuse of packaging for other purposes
Contaminated Materials: Dispose of gloves, tools, and cleaning rags as hazardous waste
UN Number: Not regulated for transport
Transport Hazard Class: Not classified as hazardous
Packing Group: Not assigned
Sea Transport (IMDG): Not regulated
Air Transport (IATA/ICAO): Not regulated
Special Transport Precautions: Keep container sealed and upright; avoid damage
US Regulations (TSCA): Not listed for industrial use
FDA: Approved for specific pharmaceutical use
OSHA: Not classified as hazardous
SARA Section 313: Not listed as a toxic chemical
California Proposition 65: Not listed
WHMIS (Canada): Not controlled
EU Classification: Not classified as dangerous
Labeling: Comply with pharmaceutical labeling standards; include manufacturer address and lot information
