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Product Name: Tiamulin Fumarate
Chemical Family: Pleuromutilin antibiotic
Molecular Formula: C28H47NO4•C4H4O4
CAS Number: 55297-95-5
Synonyms: Tiamutin Fumarate; Tiamulin Hydrogen Fumarate
Intended Use: Veterinary antibiotic (primarily for swine and poultry)
Manufacturer Contact: Manufacturer address and emergency telephone number listed on packaging
Recommended Restrictions: Use only as directed for animal health, not for human use
Hazard Classifications: Irritant to eyes, skin, and respiratory tract; Skin Sensitization
Label Elements: Caution – Harmful if swallowed; may cause allergic skin reaction
Signal Word: Warning
Hazard Statements: Causes skin and eye irritation, may cause allergic skin reactions, may be harmful if inhaled or ingested
Precautionary Statements: Avoid skin and eye contact, prevent dust formation, use personal protective equipment
Symptoms of Exposure: Redness, itching, rashes, respiratory irritation, headache, nausea, gastrointestinal distress
Active Ingredient: Tiamulin Fumarate (CAS 55297-95-5)
Concentration: 98% or as specified by supplier
Other Ingredients: Fumaric acid (CAS 110-17-8), residual solvents, trace impurities
Impurities and Stabilizers: None reported above relevant concentrations
Inhalation: Move to fresh air, ensure breathing is unimpeded, seek medical attention if symptoms persist
Eye Contact: Rinse carefully with plenty of clean water for at least 15 minutes, remove contact lenses if present, get medical attention
Skin Contact: Remove contaminated clothing, rinse skin with soap and water for at least 15 minutes
Ingestion: Rinse mouth, do not induce vomiting, seek medical advice
Most Important Symptoms/Effects, Acute and Delayed: Allergic reactions, skin rashes, eye irritation, respiratory distress
Indication of Immediate Medical Attention and Special Treatment Needed: Sensitized individuals may require medical assistance, monitor for allergic reaction or breathing difficulties
Suitable Extinguishing Media: Water spray, foam, dry chemical, carbon dioxide
Unsuitable Extinguishing Media: High-pressure water stream
Specific Hazards: Forms toxic fumes under fire conditions (CO, CO2, NOx, sulfur oxides)
Special Protective Equipment: Full protective gear and self-contained breathing apparatus required
Firefighting Instructions: Prevent runoff into drains, keep containers cool with water spray, evacuate area as necessary
Personal Precautions: Use protective clothing, gloves, safety goggles, and dust mask
Environmental Precautions: Prevent contamination of water sources and soil, avoid runoff
Methods for Containment and Clean Up: Use tools to collect spilled powder, avoid generating dust, sweep up and place in clearly labeled waste containers
Decontamination Procedures: Wash spill area with plenty of water and ordinary detergent after removal of bulk material
Safe Handling: Minimize dust formation and inhalation, wear protective gear, wash hands thoroughly after use, avoid eating or drinking in work area
Storage Conditions: Store in tightly closed original containers, in a cool, dry, well-ventilated location away from food and feed
Incompatible Products: Strong oxidizing agents, acids
Storage Temperature: Below 25°C, protect from light, moisture, and excessive heat
Exposure Limits: No ACGIH or OSHA exposure limits established; minimize exposure as a precaution
Engineering Controls: Use with local exhaust ventilation, handle in well-ventilated spaces
Personal Protective Equipment: Chemical-resistant gloves, lab coat or protective coveralls, chemical goggles, dust mask or respirator (P2 or equivalent), safety shoes
Hygiene Measures: Wash hands after handling, remove contaminated clothing, do not eat, drink, or smoke while handling
Environmental Controls: Use containment to avoid environmental discharge, comply with local regulations on air emission
Appearance: White to off-white crystalline powder
Odor: Faint characteristic
Boiling Point: Not established
Melting Point: Approximately 151–154°C (fumarate salt)
Flammability: Not flammable under normal conditions
Solubility: Slightly soluble in water, soluble in methanol and dimethyl sulfoxide
Density: Around 1.22 g/cm³
pH: 4.5-6.5 (10% solution)
Vapor Pressure: Not volatile
Partition Coefficient: Not available
Evaporation Rate: Not relevant for solid materials
Chemical Stability: Stable under recommended storage and usage conditions
Conditions to Avoid: Excess moisture, heat, strong sunlight, sources of ignition
Incompatible Materials: Strong acids, bases, oxidizers
Hazardous Decomposition Products: Carbon dioxide, carbon monoxide, nitrogen oxides, sulfur compounds during combustion
Dangerous Reactions: No hazardous polymerization anticipated under normal usage
Acute Toxicity: Oral LD50 (rat): > 1,000 mg/kg; less toxic by dermal or inhalation
Skin Corrosion/Irritation: Irritating to skin with prolonged exposure
Eye Damage/Irritation: Causes moderate to severe irritation
Respiratory Sensitization: May induce allergy symptoms in sensitive individuals
Chronic Toxicity: Long-term exposure may affect liver, digestive system, skin
Carcinogenicity: Not classified as carcinogenic (IARC, NTP, OSHA)
Mutagenicity and Reproductive Toxicity: No evidence of DNA damage or reproductive toxicity at occupational exposure levels in published studies, but high doses discouraged outside veterinary prescription
Target Organs: Skin, eyes, respiratory tract
Toxicity to Aquatic Life: Moderately toxic to fish and aquatic invertebrates
Aquatic Persistence: Degrades slowly in aquatic environments, risk for bioaccumulation is low
Soil Mobility: Tiamulin and metabolites may persist in soil; avoid direct application or spillage
Bioaccumulation: Bioaccumulation potential expected to be low
Ecological Effects: May pose risk to non-target organisms around treatment facilities, particularly aquatic systems
Waste Disposal Methods: Dispose of in accordance with local, regional, and national regulations as pharmaceutical waste
Disposal of Containers: Rinse containers thoroughly and crush before disposal, do not reuse
Environmental Precautions: Do not release to sewers or open watercourses; incinerate in approved facilities if possible
Special Instructions: Notify authorities in case of large-scale spill or environmental contamination
UN Number: Not regulated as a hazardous material for ground, air, or sea transport
Proper Shipping Name: Tiamulin Fumarate
Transport Hazard Class: Non-hazardous
Packing Group: Not assigned
Environmental Hazards: Not classified as a marine pollutant
Special Transport Precautions: Secure well to prevent spillage, keep dry during transit, segregate from chemicals with oxidizing properties
OSHA Status: Not specifically regulated, but considered a hazardous substance under Hazard Communication Standard (29 CFR 1910.1200)
TSCA Status: Listed
EPA Status: Not classified as hazardous waste per RCRA
Other Federal Regulations: Subject to FDA controls for veterinary pharmaceuticals
EU Classification: Xn – Harmful, R43 – May cause sensitization by skin contact
Local/State Regulations: Regulations vary, check municipal and state requirements for pharmaceutical substances
International Inventories: Listed in EINECS and other chemical inventories
