Product Name: Tylosintartrate, BP
Chemical Name: Tylosin tartrate
Synonyms: Tylan tartrate, Tylosin hydrogen tartrate
CAS Number: 74610-55-2
Recommended Use: Veterinary antibiotic, pharmaceutical ingredient
Supplier Details: Manufacturer or supplier address, contact phone, and emergency contact for reporting spills or exposure
Emergency Telephone Number: Local poison control or manufacturer’s emergency hotline
Classification: May cause allergic skin reactions, respiratory irritation, or eye irritation upon contact.
Label Elements: Hazard statement indicating potential for allergic dermatitis, caution regarding respiratory effects in susceptible individuals.
GHS Pictograms: Exclamation mark, health hazard
Signal Word: Warning
Precautionary Statements: Avoid breathing dust, wash hands after handling, wear gloves and protective clothing to reduce risk of sensitization.
Symptoms of Exposure: Rash, skin irritation, wheezing, cough, or eye redness.
Main Ingredient: Tylosin tartrate
Chemical Formula: C46H77NO17•C4H6O6
Concentration: 95-100% active ingredient, trace contaminants possible from manufacturing
Impurities: Minor residual solvents, possible by-products of synthesis
Other Components: Water content less than 2% if present, no known stabilizers or non-active components in pharmaceutical grade material.
Inhalation: Move affected person to fresh air, keep at rest, seek medical attention if symptoms like coughing or shortness of breath continue.
Skin Contact: Remove contaminated clothing, wash affected area with soap and water for at least 15 minutes, seek medical advice for irritation or rashes.
Eye Contact: Rinse slowly with plenty of water for 15 minutes, lifting eyelids occasionally, remove contact lenses if present and easy to do, consult a physician if redness or discomfort persists.
Ingestion: Rinse mouth with water, avoid inducing vomiting, call poison control or get medical aid if large amounts swallowed.
Most Important Symptoms: Allergic reactions such as skin rash, eye irritation, cough; treat symptomatically and supportively.
Suitable Extinguishing Media: Use water spray, dry chemical, CO2, or foam depending on source of fire.
Specific Hazards: Emits toxic fumes of nitrogen oxides and carbon oxides upon burning; avoid smoke inhalation.
Fire-Fighting Equipment: Firefighters should wear self-contained breathing apparatus and protective gear.
Special Procedures: Cool containers with water jet to prevent pressure build-up and potential rupture.
Hazardous Combustion Products: May produce hazardous vapors or gases when burned; ventilate area as much as possible after fire event.
Personal Precautions: Use respiratory protection, gloves, eye protection, avoid dust formation.
Environmental Precautions: Prevent product from entering drains, surface water, or soil.
Methods for Cleaning Up: Sweep up and collect spilled material using non-sparking tools, place in sealed container for proper disposal.
Decontamination: Wipe area with damp absorbent material to remove traces, ventilate space.
Disposal of Materials: Dispose material as hazardous pharmaceutical waste in accordance with local environmental regulations.
Handling: Provide ventilation in processing areas, minimize dust generation, avoid contact with skin, eyes, and clothing; use personal protective equipment appropriate for powder pharmaceuticals.
Safe Storage Conditions: Store in tightly closed original packaging in cool, dry, well-ventilated area, away from direct sunlight and incompatible substances.
Storage Temperature: Maintain storage at 15–30°C, protect from moisture.
Incompatibility: Strong oxidizers and acids; segregate from food and drink.
Hygiene Measures: Wash hands and exposed areas after handling, do not eat or drink around the product.
Occupational Exposure Limits (OELs): No specific OEL established for tylosin tartrate, use pharmaceutical dust standards where available.
Engineering Controls: Ventilation systems, local exhaust, or enclosed processing recommended in bulk handling.
Personal Protective Equipment: Use NIOSH-approved dust mask or respirator, nitrile or latex gloves, eye protection with side shields, clean lab coat or protective clothing.
General Safety Practices: Remove contaminated clothing before entering eating areas, shower and change clothes after working with powders.
Monitoring: Routine air sampling for dust in working environment to protect workers from accidental overexposure.
Appearance: Yellow to light brown, crystalline or powder form
Odor: Slight characteristic odor, not strong
pH: 5.0–7.5 (1% aqueous solution)
Melting Point/Range: Decomposes before melting, no clear melting point
Boiling Point: Not applicable (decomposes)
Solubility: Freely soluble in water, slightly soluble in ethanol
Vapor Pressure: Negligible at room temperature
Relative Density: About 1.4 g/cm3 (estimated)
Partition Coefficient (n-octanol/water): Data absent
Flash Point: Non-flammable as a solid, dust hazard still possible.
Chemical Stability: Stable in original unopened packaging under recommended storage conditions.
Reactivity: Stable under normal conditions; reacts with strong oxidizers.
Conditions to Avoid: Excess heat, moisture, sources of ignition.
Incompatible Materials: Strong acids, alkalis, and oxidizing agents.
Hazardous Decomposition Products: Produces carbon oxides, nitrogen oxides, and possibly unidentified organic compounds if heated to decomposition.
Polymerization: Will not polymerize spontaneously.
Acute Toxicity: Low oral toxicity for humans, but can cause digestive upset or allergic reactions for sensitive individuals.
Routes of Exposure: Skin, eyes, inhalation, ingestion
Symptoms: Skin and respiratory sensitization, irritation of eyes and mucous membranes, gastrointestinal discomfort if ingested.
Sensitization: May cause allergic reactions after repeated or prolonged exposure.
Carcinogenicity: No evidence for carcinogenic effect in laboratory animals according to available literature.
Mutagenicity/Teratogenicity: No mutagenic or teratogenic effects reported in standard studies.
Chronic Effects: Prolonged exposure may result in persistent dermatitis or respiratory sensitization in exposed individuals.
Environmental Fate: Degrades slowly in soil and water, persistence depends on local microbial activity.
Aquatic Toxicity: Harmful to aquatic organisms with potential for long-term adverse effects on aquatic environments if large quantities enter waterways.
Bioaccumulation: Low potential for bioaccumulation in aquatic species.
Mobility: Moderate mobility in soil, risk of run-off in case of accidental spill.
Degradability: Partial biodegradation under aerobic conditions, breakdown products generally less toxic than parent compound.
Precautions: Prevent major releases to soil and water to avoid negative impacts on beneficial organisms.
Waste Disposal Methods: Treat waste as hazardous, incinerate in licensed facility or dispose via chemical waste landfill in accordance with local, regional, and national regulations.
Disposal of Packaging: Triple rinse empty containers, render unusable, dispose as regulated pharmaceutical waste.
Do Not Discharge: Avoid release to sewage, surface waters, or landfill unless incinerated or treated for pharmaceutical residues.
Consult Regulations: Follow guidance from environmental protection agencies and waste handlers regarding method and documentation for disposal.
Community Safety: Notify local environmental authorities if accidental large-scale release occurs.
UN Number: Not regulated under UN transport guidelines for typical quantities and packaging.
Proper Shipping Name: Pharmaceutical (non-hazardous)
Transport Hazard Class: Not classified as a hazardous material for land, sea, or air transport.
Packing Group: Not assigned
Environmental Hazards: Not a marine pollutant; still, take care in case of accidental spill.
Special Precautions for Users: Prevent packaging rupture, avoid creating dust during transport and handling.
Bulk Transport: Comply with national bulk transport guidelines for pharmaceutical powders.
International Regulations: Listed in major pharmacopoeias as a veterinary antibiotic with restrictions on human food-producing animal use in some countries.
EU Regulations: Classified as a prescription veterinary product, handled by licensed entities; subject to REACH evaluation for environmental and worker safety.
US FDA: Approved for veterinary uses; not authorized for human medicine.
OSHA/NIOSH: No specific exposure standard, general pharmaceutical dust exposure guidance applies.
Other Regulatory Status: Subject to drug and chemical regulations depending on jurisdiction; refer to local guidance for worker safety training.
Community Right to Know: Material classified for potential occupational respiratory and skin sensitization hazards.
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