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Material Safety Data Sheet: Sultamicillin Tosylate

1. Identification

Product Name: Sultamicillin Tosylate
Chemical Formula: C26H29N7O9S2·C7H7O3S
Synonyms: Sultamicillin tosilate, Sultamicillin tosylate hydrate
Manufacturer: Pharmaceutical manufacturers and distributors supplying active pharmaceutical ingredients
Recommended Use: Semi-synthetic antibiotic for use in manufacture of anti-infective medications
Emergency Contact: Refer to facility EHS coordinator or poison control center
CAS Number: 957-20-2 (parent compound)

2. Hazard Identification

GHS Classification: Eye irritation (Category 2), Skin sensitization (Category 1), Respiratory sensitization (Category 1), Specific target organ toxicity (repeated exposure) (Category 2)
Signal Word: Warning
Hazard Statements: Causes serious eye irritation, may cause allergy or asthma symptoms or breathing difficulties if inhaled, may cause an allergic skin reaction, may cause damage to organs through prolonged or repeated exposure
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, use only outdoors or in a well-ventilated area, wear protective gloves and eye/face protection
Symptoms of Exposure: Eye redness or watering, skin rashes, sneezing, difficulty in breathing, coughing, possible gastrointestinal upset
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion

3. Composition / Information on Ingredients

Chemical Identity: Sultamicillin Tosylate
Concentration: Active ingredient, typically >90% by weight
Additional Components: Water (hydrate), tosylate salt
Impurities: Minor byproducts and residual solvents below regulatory limits
Chemical Family: Beta-lactam antibiotics

4. First Aid Measures

Inhalation: Move affected person to fresh air without delay; seek medical attention if symptoms like coughing or difficulty breathing occur
Skin Contact: Immediately rinse exposed skin area with plenty of water and soap; remove contaminated clothing; consult a healthcare provider if irritation persists
Eye Contact: Flush eyes thoroughly with water for at least 15 minutes, keeping eyelids apart; obtain medical advice if discomfort continues
Ingestion: Rinse mouth with water, never induce vomiting, seek prompt medical help, provide product label or MSDS if possible
Advice for Physician: Treat symptomatically and supportively; monitor for allergic reactions

5. Fire-Fighting Measures

Suitable Extinguishing Media: Use water mist, dry chemical, carbon dioxide, or foam extinguishers
Unsuitable Media: Direct water spray on product dusts can cause spreading
Hazardous Combustion Products: Irritating or toxic fumes of nitrogen oxides, sulfur oxides, and carbon oxides can develop during combustion
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Special Procedures: Cool affected containers with water spray from safe distance, avoid inhaling fumes

6. Accidental Release Measures

Spill Response: Evacuate unnecessary personnel, ventilate area, wear respiratory protection, gloves, laboratory coat, and safety goggles
Spill Containment: Avoid generating dust, use non-sparking tools to collect material for proper disposal
Cleanup Methods: Sweep up gently and transfer to a closed container for disposal, wipe residual traces with damp cloth and detergent
Environmental Precautions: Prevent product from entering drains, surface water, and ground water

7. Handling and Storage

Handling Advice: Operate in a well-ventilated area, use appropriate local exhaust, avoid formation and inhalation of dust; wash hands after handling
Storage Requirements: Store in original airtight container, away from incompatible substances, protect from moisture and light
Temperature Sensitivity: Maintain storage at controlled room temperature (15-25°C), avoid temperature extremes
Incompatibilities: Strong oxidizing agents, acids, bases

8. Exposure Controls and Personal Protection

Exposure Limits: No specific occupational exposure limits established, handle as a sensitizing pharmaceutical product
Engineering Controls: Laboratory fume hoods, local exhaust, closed handling systems
Personal Protective Equipment: Protective gloves (nitrile or latex), laboratory coat or gown, splash-proof goggles or face shield, NIOSH-approved respirator for dust
Hygiene Measures: Do not eat, drink, or smoke during handling, wash hands thoroughly after exposure, launder work clothing regularly
Environmental Controls: Avoid release to environment and minimize dust formation

9. Physical and Chemical Properties

Appearance: White to off-white powder
Odor: Mild, characteristic
Odor Threshold: Not established
pH: Slightly acidic in aqueous solution
Melting Point: 170–195°C (decomposes)
Boiling Point: Not applicable for solid
Flash Point: Not determined (non-flammable solid)
Solubility: Freely soluble in water, sparingly soluble in organic solvents
Partition Coefficient: Not defined
Vapor Pressure: Negligible at room temperature
Bulk Density: Approximately 0.3–0.5 g/cm³
Stability: Stable under recommended conditions, sensitive to moisture and excessive heat

10. Stability and Reactivity

Chemical Stability: Stable under normal storage and handling; may degrade under elevated temperature and humidity
Reactivity: No hazardous polymerization expected
Conditions to Avoid: Heat, moisture, sunlight, strong oxidizing agents
Hazardous Decomposition Products: Toxic gases during combustion such as SOx, NOx, carbon monoxide
Incompatibility: Avoid contact with strong oxidizers, acids, or bases

11. Toxicological Information

Likely Routes of Exposure: Inhalation, skin and eye contact, ingestion
Acute Effects: Moderate to severe irritation to eyes, skin, respiratory tract; potential allergic reactions
Chronic Effects: Prolonged exposure may result in skin or respiratory sensitization and organ effects with repetitive exposure
Toxicity Data: Oral LD50 (rat): Not fully determined, low acute toxicity expected based on pharmacological knowledge
Carcinogenicity: Not classified as carcinogen by IARC, NTP, or OSHA
Mutagenicity / Teratogenicity: Negative in standard tests; no evidence of reproductive hazard reported in therapeutic contexts

12. Ecological Information

Ecotoxicity: May be harmful to aquatic life at high concentrations, persistent antibiotic residues can affect microbial communities
Degradability: Not readily biodegradable, stable in environment under typical conditions
Mobility in Soil: Moderate mobility expected due to water solubility; risk of contamination to surface and groundwater
Bioaccumulation: Bioaccumulation potential limited by molecular structure
Other Effects: May contribute to development of antimicrobial resistance in environmental bacteria when released in significant amounts

13. Disposal Considerations

Waste Treatment Methods: Dispose in accordance with local, regional, and national regulations; incineration recommended for large amounts; do not recycle or use down drain
Empty Container Handling: Triple rinse and render unusable before disposal
Special Considerations: Products containing residual amounts should be managed as pharmaceutical waste

14. Transport Information

Regulatory Status: Not classified as dangerous good under ADR, DOT, IMDG, or IATA regulations for transport
Proper Shipping Name: Sultamicillin Tosylate or Pharmaceutical Product, n.o.s.
UN Number: Not assigned
Packing Group: Not assigned
Transport Precautions: Protect against physical damage, moisture, and extreme temperatures during transit
Emergency Response Guide: Use standard precautions for non-hazardous pharmaceuticals if accidental release occurs during shipping

15. Regulatory Information

International Inventories: Check local country chemical inventories
Labeling Requirements: Hazard and precautionary statements as per GHS
OSHA Status: Considered hazardous by OSHA Hazard Communication Standard
EPA, SARA Title III: Not listed as hazardous substance
Right-to-Know Information: State-specific regulations may apply (US: California Proposition 65 not listed)
Other Regulations: Subject to pharmaceutical handling standards in healthcare and manufacturing