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Material Safety Data Sheet: Tylvalosin Tartrate

Identification

Product Name: Tylvalosin Tartrate
Synonyms: 3-Acetyldeoxytylvaline tartrate, Macrolide antibacterial compound
CAS Number: 63428-13-7
Molecular Formula: C46H77NO17C4H6O6
Manufacturer: Listed pharmaceutical or veterinary medicine producers
Recommended Use: Veterinary antibiotic, feed additive
Restrictions: Restricted to professional use in animal health sectors
Contact Information: Manufacturer contact needed for emergencies or detailed chemical handling

Hazard Identification

Hazard Classification: Harmful if inhaled, skin contact, or swallowed; may cause serious eye irritation; possible respiratory allergen; classified as hazardous under chemical handling regulations
GHS Label Elements: Exclamation mark indicating acute toxicity and irritant properties
Potential Health Effects: Causes irritation to eyes, skin, respiratory tract; potential for allergic or asthmatic responses with repeated exposure; headache, dizziness, or gastrointestinal distress may occur
Environmental Hazards: Harmful to aquatic life, risk of lasting effects if released
Emergency Overview: Fine powders can create dust clouds; inhaled dust needs prompt attention; accidental spills on the skin or eyes demand immediate flushing

Composition / Information on Ingredients

Chemical Identity: Tylvalosin Tartrate
Common Name: Tylvalosin tartrate salt
Concentration: 99%+ pure active substance
Impurities: Residual solvents and byproducts from synthesis may be present in minor proportions
Other Ingredients: None typically present in formulated API

First Aid Measures

Inhalation: Remove person to fresh air, rest, monitor breathing; seek medical help if symptoms persist
Skin Exposure: Take off contaminated clothing, wash gently with water and soap for 15 minutes; seek medical attention for irritation or allergic reaction
Eye Contact: Flush with low-pressure water for 15 minutes while holding eyelids open; seek immediate medical care
Ingestion: Rinse mouth, do not induce vomiting, drink water if conscious; get prompt medical advice
Notes to Physicians: Treat based on patient’s symptoms, provide respiratory support and anti-allergic management where necessary

Fire-Fighting Measures

Suitable Extinguishing Media: Use foam, dry chemical powder, carbon dioxide, do not use high pressure water jets
Fire Hazards: Organic dust may form explosive mixtures with air; combustion creates hazardous decomposition products like CO, CO2, nitrogen oxides
Special Protective Equipment: Firefighters should wear full protective clothing, positive-pressure self-contained breathing apparatus
Precautions: Remove containers from fire area if safe, prevent run-off from entering water sources or drains, cool exposed containers with spray

Accidental Release Measures

Personal Precautions: Wear gloves, chemical goggles, apron, dust mask or respirator; avoid contact and inhalation of dust
Environmental Precautions: Block entry to drains, soil, surface waters; report any large release to authorities
Methods for Clean-up: Carefully sweep or vacuum without making dust clouds; shovel material into labeled waste containers for disposal; ventilate area; wash affected surface thoroughly

Handling and Storage

Precautions for Safe Handling: Avoid dust formation, wear protective gear, handle only in well-ventilated zones, keep away from food and drinks
Safe Storage Conditions: Store in tightly closed containers, cool, dry, ventilated place, protected from light, moisture, sources of ignition, segregate from incompatible substances such as oxidizers
Hygiene Measures: Wash hands after handling, do not eat, drink, or smoke near chemical, use dedicated equipment

Exposure Controls and Personal Protection

Engineering Controls: Operate under extracted air, fume hoods, or local exhaust; minimize airborne dust
Respiratory Protection: Use NIOSH-approved dust respirator where dust is present
Hand Protection: Wear nitrile or neoprene chemical-resistant gloves
Eye Protection: Protective safety goggles, face shields in bulk handling
Skin Protection: Wear lab coat or chemical-resistant apron, long sleeves
Exposure Limits: No established occupational exposure limits, but keep workplace air as free as possible from dust

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Mild or odorless
Boiling Point: Not available (decomposes before boiling)
Melting Point: 135–139°C approx.
Solubility: Freely soluble in water and methanol, slightly soluble in ethanol, practically insoluble in hexane
pH (1% solution): 5.5–7.0
Vapor Pressure: Not relevant
Flash Point: Not flammable under normal conditions
Density: Not applicable
Auto-ignition Temperature: Not determined

Stability and Reactivity

Chemical Stability: Stable under recommended handling and storage conditions
Reactivity: Doesn’t react with common materials under standard lab procedures
Incompatibilities: Strong oxidizers, acids, strong bases
Hazardous Decomposition: Burning releases carbon monoxide, carbon dioxide, nitrogen oxides
Hazardous Polymerization: Will not occur

Toxicological Information

Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Acute Toxicity: Reported oral LD50 in rats > 2000 mg/kg, low acute toxicity in mammals
Chronic Toxicity: Information is limited, but repeated or prolonged exposure has potential to cause allergic reactions or respiratory sensitization
Irritation: Causes eye and skin irritation on contact
Mutagenicity: No significant evidence from screening tests
Sensitization: Known potential skin and respiratory sensitizer for sensitive individuals

Ecological Information

Ecotoxicity: Harmful to aquatic organisms, may contribute to drug resistance in the environment if released
Degradability: Expected to have moderate persistence in water, limited biodegradability
Bioaccumulation: No significant bioaccumulation expected
Mobility: Moves through soil but binds moderately in organic-rich layers
Other Ecological Effects: Large amounts pose risk to water bodies and sensitive terrestrial species

Disposal Considerations

Method of Disposal: Treat as hazardous waste, incinerate or land-fill in accordance with local requirements
Container Disposal: Rinse and destroy packaging, dispose safely; avoid contamination of water sources
Precautions: Follow local, state, and federal regulations; avoid release to environment

Transport Information

UN Number: Not regulated for transport under UN criteria
Proper Shipping Name: Tylvalosin Tartrate, non-hazardous chemical, in bulk or packed powder form
Transport Hazard Class: No special class for road, sea, or air under regular conditions
Packing Group: Not assigned
Special Precautions: Avoid mechanical shock, secure against leaks or spillage during transport

Regulatory Information

Regulation Status: Approved for veterinary use under regulatory agencies in many countries, subject to prescription and administration controls
Occupational Regulations: Not assigned specific exposure limit values in most jurisdictions
Environmental Regulations: Disposal and use regulated under chemical waste, environmental protection, and pharmaceutical residue legislation
Additional Information: Controlled use in farm or veterinary practice; regular monitoring for residues in food-producing animals