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Product Name: Tylvalosin Tartrate
Chemical Formula: C46H77NO17·C4H6O6
SYNONYMS: Aivlosin, Tylvalosin hydrogen tartrate
Intended Use: Veterinary antibiotic for treatment of swine and poultry diseases
Manufacturer Details: Refer to label for local supplier details
Emergency Contact: Local poison control center or medical services
CAS Number: 63428-13-7 (Tylvalosin base), 63428-13-7 / 87618-50-0 (as tartrate)
UN Number: Not classified as dangerous for transport
Molecular Weight: 1079.2 g/mol (tartrate form)
Recommended Restrictions: For veterinary use only; not for human consumption or unauthorized application
Label Elements: May include hazard pictograms and signal word 'Warning'
GHS Classification: Acute toxicity, Skin irritant, Respiratory sensitizer, Eye irritation
Signal Word: Warning
Hazard Statements: Harmful if swallowed or inhaled, causes skin and serious eye irritation, may cause an allergic respiratory reaction in sensitive individuals
Precautionary Statements: Avoid breathing dust, wash thoroughly after handling, wear protective gloves and eye/face protection
Symptoms of Exposure: Irritation to mucous membranes, skin redness or rash, respiratory discomfort, possible shortness of breath
Target Organs: Respiratory system, skin, eyes
Environmental Hazards: Harmful to aquatic organisms; avoid uncontrolled release
Main Active Ingredient: Tylvalosin tartrate
Concentration: Purity typically greater than 95% for bulk active ingredient; formulation strengths dilute accordingly
Other Ingredients: Minor excipients or stabilizers such as starch, lactose, microcrystalline cellulose depending on final product.
Impurities: Residual solvents and trace manufacturing byproducts below regulated thresholds
Inhalation: Remove person to fresh air. If breathing difficulties occur, seek immediate medical attention.
Skin Contact: Rinse with copious amounts of flowing water and mild soap; remove contaminated clothing.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present. Continue rinsing. Seek prompt medical evaluation if irritation persists.
Ingestion: Rinse mouth thoroughly with water. Do not induce vomiting. Seek medical advice or call poison control.
Most Important Symptoms/Effects: Respiratory irritation, aggravated asthma, possible allergic reaction, eye or skin discomfort. Medical staff should monitor for delayed effects after significant exposure.
Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam. Avoid using water jets.
Specific Hazards from Fire: Burning may produce toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides, and sulfur oxides
Precautions for Firefighters: Wear self-contained breathing apparatus and full protective gear. Isolate area and avoid inhaling smoke or fumes.
Special Procedures: Cool containers exposed to fire using water spray. Prevent fire-fighting runoff from entering drains or water courses.
Personal Precautions: Use recommended personal protective equipment such as gloves, goggles, and dust mask. Avoid generating dust or breathing airborne particles.
Environmental Precautions: Prevent spillage from entering drains, sewers, or open water sources. Notify authorities if release causes environmental contamination.
Containment and Clean-up: Sweep up spillage carefully, collect in closed container for disposal. Wash area with water and detergent to remove residues. Decontaminate surrounding area.
Safe Handling: Avoid ingestion, inhalation, or contact with skin or eyes. Use only in well-ventilated areas, ideally under engineering controls such as local exhaust. Do not eat, drink, or smoke during use. Use hygiene practices.
Storage Conditions: Store in tightly closed container. Keep in a cool, dry, well-ventilated area, away from incompatible materials such as oxidizing agents
Temperature Requirements: Room temperature preferred, avoid heat and humidity
Incompatibilities: Strong oxidizers, acids, bases
Storage Life: Refer to expiration date on packaging or container
Occupational Exposure Limit: No established OEL for Tylvalosin tartrate; minimize exposure as low as reasonably achievable
Engineering Controls: Use effective process enclosure, local exhaust ventilation, and natural or forced draft where needed
Personal Protective Equipment: Disposable lab gloves, long-sleeved laboratory coats, approved safety goggles. In poorly ventilated spaces or dusty conditions, use NIOSH-certified particulate respirator
Environmental Controls: Avoid airborne aerosolization or significant spills; maintain spill response supplies at work site
Hygiene Measures: Wash hands and exposed skin thoroughly after use; do not re-wear contaminated garments
Appearance: Off-white to light beige crystalline powder
Odor: Faint medicinal odor, not pungent
Odor Threshold: Not established
pH: About 4.0–5.5 (1% solution in water)
Melting Point: Decomposes before melting
Freezing Point: Not applicable
Boiling Point: Not determined; decomposes on heating
Flash Point: Not applicable; non-volatile solid
Flammability: Not highly flammable; may burn upon external ignition
Vapor Pressure: Negligible at room temperature
Solubility: Freely soluble in water, slightly soluble in organic solvents
Partition Coefficient: Not established
Decomposition Temperature: >150°C with breakdown to noxious fumes
Evaporation Rate: Not relevant
Density: Approx. 1.2 g/cm³ (powder bulk density may vary)
Chemical Stability: Stable under normal operating and storage conditions. Sensitive to strong acids, alkalis, prolonged exposure to air, and moisture
Reactivity: Generally inert, though may react with oxidizing agents or undergo slow degradation
Hazardous Decomposition Products: May yield carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides under combustion or high temperature
Polymerization: Will not polymerize
Conditions to Avoid: Open flames, high heat, direct sunlight, moisture, strong acids or bases
Routes of Exposure: Inhalation, skin or eye contact, accidental ingestion
Acute Toxicity (Oral LD50, rat): >1500 mg/kg (reported in range for active ingredient)
Symptoms: Headache, dizziness, skin rash, eye irritation, possible bronchial symptoms in susceptible individuals
Skin Sensitization: Documented allergic skin reactions in some cases
Chronic Exposure Risks: Repeated inhalation or handling may cause sensitization, possible mild hepatic or renal effects in laboratory animals
Carcinogenicity/Mutagenicity/Reproductive Toxicity: Not listed as carcinogen by IARC, NTP, or OSHA. No mutagenic findings in standard assays. No evidence of developmental harm under authorized use.
Other Information: Some individuals with antibiotic allergies may react at lower thresholds; strict hygiene and personal protection play key roles in prevention.
Aquatic Toxicity: May exhibit toxicity to aquatic organisms such as fish and invertebrates in lab assays
Persistence and Degradability: Tylvalosin tartrate degrades slowly in the environment; sunlight and microbial action assist breakdown
Bioaccumulation Potential: Not prone to significant bioaccumulation in higher organisms
Mobility in Soil: Moderately mobile; can leach if released in significant quantities
Other Ecological Effects: Avoid uncontrolled discharge into surface waters or sewage systems
Environmental Precautions: Product should not be released untreated to the environment; collect contaminated rinse water and waste for authorized disposal.
Waste from Residues: Incinerate or dispose of according to local regulations for antibiotics/pharmaceutical substances
Contaminated Packaging: Decontaminate and recycle or dispose as hazardous pharmaceutical waste
Disposal Methods: Use approved waste contractor; follow recommendations for pharmaceutical incinerator or hazardous landfill. Do not discharge into drains or natural watercourses.
EU Waste Code: Consult local and regional regulatory lists for specific assignment.
Precautions: Do not reuse empty containers; avoid environmental exposure. Trace amounts should be managed carefully.
UN Number: Not classified as dangerous goods by ADR/RID/IMDG/IATA
Proper Shipping Name: Tylvalosin tartrate (veterinary antibiotic)
Hazard Class: Not regulated for transport; treat as low risk material
Packing Group: Not assigned
Label Requirements: No special label required for transport, but product label and contents must be clear
Transport Precautions: Keep packaging secure and sealed; avoid rupture of containers.
Special Provisions: Not subject to special transport rules but maintain separation from food and animal feed during carriage.
U.S. Regulations: Not classified as a controlled substance under US law; subject to FDA rules for veterinary use
EU Directives: Listed under veterinary medicinal product regulations; not classified as hazardous under current CLP regulations
Canadian WHMIS Classification: Not controlled product; observe general workplace safety practices
International Inventories: Listed in relevant national and regional chemical inventories
Labelling Requirements: Follow applicable labeling standards for antibiotics. Product information must include ingredient name, strength, veterinary use restrictions, and protective equipment instructions.
Additional Recommendations: End users should stay updated on guidance from authoritative sources such as WHO, CDC, or EFSA regarding prudent use, resistance monitoring, disposal practices, and environmental stewardship.
