Material Safety Data Sheet for Tylosin Tartrate Salt

Identification

Product Name: Tylosin Tartrate Salt
Chemical Family: Macrolide Antibiotic
Synonyms: Tylan Tartrate, Tylosin Ditartrate
CAS Number: 74610-55-2
Intended Use: Veterinary antibiotic; controls and treats certain infections in livestock
Supplier Contact: Pharmaceutical supplier or manufacturer.
Emergency Phone Number: Local poison control or emergency helpline; refer to manufacturer for direct support

Hazard Identification

Classification: Eye Irritant, Sensitizer (Respiratory, Skin)
Signal Word: Warning
Hazard Statements: Causes moderate eye irritation. Dust may provoke allergic reactions in sensitized individuals. Animal studies reveal potential for antibiotic resistance.
Precautionary Statements: Prevent dust formation. Avoid inhalation and contact with eyes or skin. Use only outdoors or in well-ventilated area.
Potential Health Effects: Short-term exposure may irritate eyes, nose, respiratory tract; long-term occupational exposure may increase risk for skin sensitization and respiratory issues.

Composition / Information on Ingredients

Tylosin Tartrate: 80–100%
Other Components: Trace impurities (<1%, trade secret)
Molecular Formula: C46H77NO17 · C4H6O6
Chemical Structure: Polyol lactone with tartrate counterion

First Aid Measures

Inhalation: Remove the individual to fresh air. Seek medical attention if breathing becomes difficult.
Skin Contact: Remove contaminated clothing. Wash skin thoroughly with soap and water. Seek medical advice if redness or swelling develops.
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes, holding eyelids open. Remove contact lenses if present and easy to do. Get prompt medical attention.
Ingestion: Rinse mouth with water. Drink plenty of water if conscious, but do not induce vomiting. Get medical help if symptoms develop.
General Advice: Show this sheet to healthcare provider.

Fire-Fighting Measures

Suitable Extinguishing Media: Use foam, dry chemical, or carbon dioxide. Water spray can cool fire-exposed containers.
Hazards from Combustion: Decomposes above 200°C, producing carbon oxides, nitrogen oxides, sulfur oxides, and irritant fumes.
Personal Protection: Wear self-contained breathing apparatus and full protective clothing. Avoid inhalation of combustion products.
Special Instructions: Move containers from fire area if you can do so safely, spray exposed containers to keep cool.

Accidental Release Measures

Personal Precautions: Evacuate personnel not directly involved. Avoid breathing dust. Ventilate area. Wear NIOSH-approved respirator, gloves, protective clothing.
Environmental Precautions: Prevent spilled material from entering drains, surface water, or soil.
Clean Up Methods: Scoop up or vacuum dry spill using HEPA-filtered device. Wipe area with damp cloth. Place contaminated material in sealed container for disposal. Wash area thoroughly with detergent and water.

Handling and Storage

Handling: Minimize dust generation. Do not eat, drink, or smoke when handling. Wash hands after use. Wear appropriate PPE as recommended.
Storage: Store in a tightly closed container in a cool, dry, well-ventilated place. Keep away from incompatible substances (strong oxidizers, acids). Store at temperatures below 30°C. Protect from moisture.

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation to maintain dust concentration below occupational exposure limits. Enclosed transfer systems recommended.
Personal Protection: Wear NIOSH-approved dust mask/respirator, chemical safety goggles, gloves (nitrile or latex), lab coat or industrial protective clothing, and safety shoes.
Hygiene Measures: No food, drink, or tobacco permitted in process areas. Wash after handling.

Physical and Chemical Properties

Appearance: Yellow to light brown crystalline powder
Odor: Slight, medicinal
Odor Threshold: Not established
pH (1% solution): Approximately 5.0
Melting Point: Decomposes before melting
Boiling Point: Not applicable (decomposes)
Flash Point: Not available
Solubility: Soluble in water
Vapor Pressure: Not available
Relative Density: About 1.3 g/cm³
Partition Coefficient (octanol/water): Not established

Stability and Reactivity

Chemical Stability: Stable under normal temperatures and pressures.
Hazardous Polymerization: Will not occur.
Conditions to Avoid: Excessive heat, moisture, incompatible materials.
Incompatible Materials: Strong oxidizing agents, acids, alkalis.
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, sulfur oxides, irritating fumes.

Toxicological Information

Routes of Exposure: Inhalation, skin and eye contact, ingestion
Acute Effects: Irritation to eyes, skin, respiratory tract. Allergic reactions in sensitized people (rash, asthma-like symptoms).
Chronic Effects: May cause skin or respiratory sensitization through repeated or prolonged exposure. Long-term or repeated exposures may increase the risk for antibiotic resistance.
Toxicity Data: Oral LD50 (rat): >5,000 mg/kg
Carcinogenicity: Not classified as carcinogen by IARC, NTP, OSHA.
Mutagenicity: No evidence available.
Reproductive Effects: No specific studies documenting reproductive toxicity, but wide veterinary use suggests low systemic toxicity.
Other Information: Contact with antibiotic may perturb gut flora and potentially promote antimicrobial resistance.

Ecological Information

Ecotoxicity: Potentially toxic to aquatic organisms, especially algae and protozoa.
Aquatic Toxicity: Limited data indicate high chronic toxicity to some invertebrate species.
Persistence and Degradability: Moderately persistent in soil and water; not readily biodegradable.
Bioaccumulation: Low potential for bioaccumulation.
Mobility in Soil: May leach to groundwater under certain conditions, especially if used in large quantities near water sources.
Other Adverse Effects: Promotes resistance in environmental microbial populations; release should be minimized.

Disposal Considerations

Waste Treatment Methods: Do not discharge to surface water or soil. Collect and place in suitable, labeled containers for disposal. Avoid dust generation.
Disposal of Product: Dispose according to local, regional, national, and international regulations for pharmaceuticals and antibiotics.
Disposal of Contaminated Packaging: Triple rinse container; puncture and dispose as hazardous waste.
Precautions: Avoid contaminating watercourses or animal feed.

Transport Information

UN Number: Not regulated as a hazardous material for transport.
Proper Shipping Name: Not classified as dangerous cargo.
Transport Hazard Class: Not applicable.
Packing Group: Not assigned.
Special Precautions: Keep container tightly sealed and protected from physical damage during transit. Follow applicable guidelines for pharmaceutical products.

Regulatory Information

OSHA: Not listed as a hazardous chemical under OSHA regulations.
TSCA: Not listed on the United States TSCA inventory; veterinary medicine — FDA regulated.
REACH (EU): Pre-registered for veterinary use.
SARA Title III: Not listed as a reportable material.
California Proposition 65: Not listed.
Other Regulations: Observe all national and local environmental protection requirements. Comply with public health and antimicrobial stewardship policies.