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Tigecycline Material Safety Data Sheet (MSDS)

Identification

Product Name: Tigecycline
Chemical Name: (4S,4aS,5aR,12aS)-9-((2-tert-butylamino)acetylamino)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12-octahydrotetracene-2-carboxamide
CAS Number: 220620-09-7
Synonyms: GAR-936, Wy-435, Tygacil
Recommended Use: Pharmaceutical, antibiotic
Manufacturer/Supplier: [Name and contact details]
Emergency Phone Number: [Emergency contact phone]

Hazard Identification

Classification: GHS Classification in accordance with 29 CFR 1910 (OSHA HCS): Acute toxicity, Category 4
Label Elements: WARNING. Harmful if swallowed. May cause allergic skin reaction. Causes eye irritation. Avoid breathing dust.
Signal Word: Warning
Hazard Statements: H302: Harmful if swallowed. H317: May cause allergic skin reaction. H319: Causes serious eye irritation.
Precautionary Statements: P261: Avoid breathing dust. P264: Wash hands thoroughly after handling. P280: Wear protective gloves/eye protection.
Potential Health Effects: Eye irritation, skin sensitization, respiratory irritation, gastrointestinal discomfort if ingested.

Composition / Information on Ingredients

Chemical Name: Tigecycline
CAS Number: 220620-09-7
Concentration: 100% (pure substance)
Molecular Formula: C29H39N5O8
Molecular Weight: 585.65 g/mol
Impurities/Additives: Not significant

First Aid Measures

General Advice: Remove person from exposure area. Ensure own safety.
Eye Contact: Rinse with plenty of water for at least 15 minutes and seek medical advice if irritation persists.
Skin Contact: Wash off immediately with soap and plenty of water. Remove contaminated clothing. Seek medical attention if symptoms occur.
Inhalation: Move to fresh air. If breathing becomes difficult, give oxygen and call a physician.
Ingestion: Do not induce vomiting. Rinse mouth with water, and seek medical attention immediately.

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical, carbon dioxide.
Special Hazards: Thermal decomposition may release hazardous fumes, including oxides of carbon, nitrogen, and toxic smoke.
Protective Equipment: Wear self-contained breathing apparatus and full protective gear.
Specific Procedures: Keep containers cool with water spray. Prevent run-off from entering drains.

Accidental Release Measures

Personal Precautions: Avoid dust formation. Use personal protective equipment as stated.
Environmental Precautions: Do not let product enter drains. Prevent further leakage or spillage if safe.
Cleanup Methods: Sweep up and shovel with minimum dust generation. Place in suitable closed containers for disposal. Ventilate area.

Handling and Storage

Handling: Avoid contact with skin, eyes, and clothing. Avoid dust formation. Provide adequate ventilation.
Storage: Store in a tightly closed container in a cool, dry, well-ventilated place. Keep away from incompatible substances like strong oxidizers.
Special Requirements: Prevent static discharge. Protect from light and moisture.

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation to minimize dust exposure.
Eye Protection: Chemical safety goggles.
Skin Protection: Nitrile or latex gloves, lab coat, protective clothing.
Respiratory Protection: Use approved respirator if dust generated.
Hygiene Measures: Wash hands thoroughly after handling and before eating.

Physical and Chemical Properties

Appearance: Yellow-orange powder
Odor: Odorless
Odor Threshold: Not determined
pH: 2.3 – 2.7 (1 mg/mL in water)
Melting Point/Freezing Point: Decomposes prior to reaching melting point
Boiling Point: Not applicable (decomposes)
Flash Point: Not determined
Evaporation Rate: Not available
Flammability: Not considered flammable
Vapor Pressure: Negligible
Solubility: Water soluble
Partition coefficient (n-octanol/water): Not available
Auto-ignition Temperature: Not self-igniting
Decomposition Temperature: >210°C
Viscosity: Not applicable

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions.
Reactivity: No specific hazards known.
Conditions to Avoid: Moisture, strong light, excessive heat, strong oxidizing agents.
Incompatible Materials: Strong acids, bases, and oxidizers.
Hazardous Decomposition: May emit CO, CO2, nitrogen oxides, and toxic fumes.
Polymerization: Will not occur.

Toxicological Information

Routes of Exposure: Inhalation, skin and eye contact, ingestion.
Acute Toxicity: LD50 (oral, rat): 900 mg/kg. No significant acute inhalation toxicity observed in laboratory studies.
Skin Corrosion/Irritation: May cause allergic skin reactions, mild irritation possible.
Serious Eye Damage/Irritation: Causes moderate eye irritation.
Respiratory Sensitization: Not classified as a respiratory sensitizer.
Carcinogenicity: No components classified as carcinogenic in IARC, NTP, or OSHA.
Mutagenicity: Not shown to be mutagenic.
Reproductive Toxicity: Animal studies indicate effects on embryonic development at high exposure levels.
Other Effects: Long-term exposure may cause effects on liver and hematopoietic system.

Ecological Information

Ecotoxicity: Harmful to aquatic organisms. May cause long-term adverse effects in the aquatic environment.
Persistence and Degradability: Not readily biodegradable. Tends to persist in soil and water.
Bioaccumulation: Not expected to bioaccumulate significantly.
Mobility in Soil: Moderate mobility.
Other Adverse Effects: Avoid discharge into waterways; pharmaceutical residues in water can disturb aquatic life.

Disposal Considerations

Waste Treatment Methods: Dispose of material in accordance with all federal, state, and local regulations.
Contaminated Packaging: Empty containers should be rinsed and disposed of as pharmaceutical waste.
Special Precautions: Do not dispose of in household garbage or through wastewater systems.

Transport Information

UN Number: Not regulated for ground, air, or sea transport.
UN Proper Shipping Name: Not classified as hazardous
Transport Hazard Class: None
Packing Group: Not applicable
Special Precautions for User: Avoid spills and exposure during transportation. Ensure packaging is secure.
Transport in Bulk: Not applicable

Regulatory Information

OSHA Hazards: Harmful by ingestion, causes eye irritation, may cause skin sensitization
TSCA: Listed (for research and clinical use)
SARA 313: Not subject to reporting
California Proposition 65: Not listed
WHMIS (Canada): D2B (Toxic material causing other toxic effects)
EINECS/ELINCS: Listed
Other Regulations: Subject to pharmaceutical regulatory controls on use and distribution