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Material Safety Data Sheet – Tilmicosin

Identification

Product Name: Tilmicosin
Chemical Name: 20-Deoxo-20-(3,5-dimethylpiperidin-1-yl)-desmycosin
Common Use: Veterinary antibiotic for livestock
CAS Number: 108050-54-0
Manufacturer: Major veterinary pharmaceutical producers
Contact Information: Emergency phone numbers and addresses from suppliers and poison control centers
Recommended Use: Animal health, prescription or under veterinary guidance
Product Type: Macrolide antibiotic, available in injectable and oral forms for animals
Synonyms: Pulmotil, Tilmax
Distributor Contact Details: Details from authorized resellers required for supply chain traceability

Hazard Identification

GHS Classification: Acute toxicity (Oral, Inhalation, Dermal) - Category 2, Skin sensitizer, Specific target organ toxicity
Signal Word: Danger
Hazard Statements: Fatal if inhaled or swallowed, may cause sensitization by skin contact, harmful by inhalation, causes serious eye irritation
Pictograms: Skull and crossbones, exclamation mark
Precautionary Statements: Avoid breathing dust or droplets, use protective gloves, clothing and respiratory protection, wash hands thoroughly after handling, don’t eat or drink during use
Routes of Exposure: Ingestion, inhalation, skin, and eye contact
Health Hazard Effects: Cardiovascular toxicity in humans, highly hazardous for injection and inhalation, risks for people with cardiac conditions
Other Hazards: Highly toxic to certain animal species, environmental hazards if spilled

Composition / Information on Ingredients

Chemical Name: Tilmicosin phosphate
Concentration: Active ingredient: typically 20-25% in commercial liquids, remainder made up of sterile water, stabilizers, and buffers
Other Ingredients: Sodium phosphate, water for injection, trace excipients
Impurities: Trace macrolide-related compounds from manufacturing
Mixture: Single compound or mixture depending on formulation
CAS Numbers of Excipients: Not typically assigned except for regulated diluents
Component Data: Full composition provided by supplier for safety review and regulations compliance

First Aid Measures

Inhalation: Remove person from exposure area. Seek immediate medical attention if symptoms (respiratory distress, chest pain) occur. Oxygen or artificial respiration if required. Avoid mouth-to-mouth resuscitation for contaminated person.
Skin Contact: Remove contaminated clothing, wash skin with water and mild soap for at least 15 minutes. Immediate medical attention if rash, blisters, or irritation develop.
Eye Contact: Flush eyes gently under running water for 15 minutes, holding eyelids open. Medical evaluation recommended.
Ingestion: Immediate medical attention. Do not induce vomiting unless directed by a physician. Rinse mouth with water, keep person calm.
Notes to Physician: Severe human toxicity, risk of fatal cardiovascular reactions. Thorough cardiac monitoring essential.
Symptoms: Difficulty breathing, coughing, skin or eye redness, arrhythmia, collapse in severe cases.
Special Equipment for First Responders: Gloves, protective clothing, positive-pressure respirator

Fire-Fighting Measures

Suitable Extinguishing Media: Carbon dioxide, dry chemical, foam, water spray
Unsuitable Media: Avoid high-pressure water streams
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, nitrogen oxides, toxic fumes
Fire-Fighting Procedures: Evacuate area, fight fire from safe distance, avoid inhalation of hazardous fumes, use self-contained breathing apparatus and full turnout gear
Special Hazards: Fire may release toxins, closed containers may rupture due to heat
Explosion Data: Not explosive, but dust buildup could pose combustion hazard
Other Recommendations: Cool nearby containers with water spray to prevent overheating and rupture

Accidental Release Measures

Personal Precautions: Wear protective gloves, goggles, mask or respirator to minimize dust or vapor exposure. Prevent contact with skin and eyes. Avoid inhalation.
Environmental Precautions: Contain spill to prevent entry into drains, soil, or water sources. Avoid release to aquatic systems.
Methods for Cleanup: Scoop or sweep up solid spills with minimum dust, use absorbent materials for liquids. Dispose of in accordance with regulatory requirements. Clean spill area with soap and water.
Decontamination: Ventilate area, disinfect surfaces after cleanup. Do not allow contaminated materials to remain.
Notification Procedures: Report significant spills to health, safety, and environmental authorities if required

Handling and Storage

Handling: Use only in well-ventilated spaces or fume hoods. Avoid aerosol or mist creation. Wear protective clothing, gloves and eye protection. Do not smoke, eat, or drink during handling. Handle open containers with care.
Storage: Store in original container tightly closed. Keep product in cool, dry, well-ventilated area, away from food and animal feed. Protect from sunlight and excessive heat.
Segregation: Keep away from incompatible substances (e.g., strong acids, bases, oxidizers).
Specific Procedures: Ensure secondary containment to prevent accidental leaks or spills.
Incompatibles: Avoid contact with alkali, alkaline earth, strong oxidizing agents
Other Considerations: Store away from children, pets, and unauthorized personnel

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established OSHA or ACGIH limits for tilmicosin, general dust and pharmaceutical exposure limits apply
Engineering Controls: Local exhaust ventilation or fume hood recommended for mixing, preparing, administering
Respiratory Protection: NIOSH-approved respirator for dusts/organic vapors when handling bulk compound or spill
Skin Protection: Impermeable gloves (nitrile, neoprene), laboratory coat or coveralls, closed footwear
Eye Protection: Chemical safety goggles
Hygiene Practices: Wash hands and face after handling, remove protective clothing before leaving work area
Other Controls: Provide eyewash stations and safe facilities for emergency use

Physical and Chemical Properties

Appearance: Off-white to beige crystalline powder or clear colorless solution (injection form)
Odor: Slight chemical odor, mild, faint
Odor Threshold: Not established
pH: 5.0–7.0 (aqueous solution)
Melting Point/Freezing Point: 117–120°C (pure compound)
Boiling Point: Not available
Solubility: Sparingly soluble in water, better solubility in methanol, ethanol, some glycols
Partition Coefficient (Log Kow): Not available
Vapor Pressure: Not significant at room temperature
Flash Point: Not flammable
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Decomposition Temperature: Not available
Viscosity: Not applicable
Other: Stable under normal conditions. Forms stable salts for veterinary use

Stability and Reactivity

Chemical Stability: Stable under labeled storage conditions in original container
Reactivity: Chemically inert to most substances under normal conditions
Hazardous Reactions: None under recommended storage and use conditions
Incompatibilities: Strong oxidizing or reducing agents, acids, bases
Polymerization: Does not occur
Decomposition Products: Toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides during fire
Storage Considerations: Avoid moisture, high heat, direct sunlight

Toxicological Information

Acute Toxicity: Extremely toxic by oral, inhalation, or injection routes—humans highly susceptible. LD50 (oral, rat) ≤50 mg/kg. Fatalities reported in accidental human exposure.
Chronic Toxicity: Not well studied in humans; potential for organ toxicity with prolonged or repeated exposure.
Symptoms: Chest pain, arrhythmia, heart failure, skin or eye irritation, allergic responses.
Sensitization: Can cause dangerous allergic or sensitization reactions.
Carcinogenicity: Not classified as carcinogenic by IARC, OSHA, or NTP.
Mutagenicity and Teratogenicity: No significant evidence, but avoid exposure for pregnant women.
Other Effects: May interact with cardiac drugs in animals and humans. Avoid exposure for heart disease and pregnant persons.
Target Organs: Primarily cardiovascular system, lungs, skin

Ecological Information

Ecotoxicity: Highly toxic to aquatic organisms and certain terrestrial animals.
Persistence and Degradability: Persistent in soil, slow to degrade in the environment.
Bioaccumulative Potential: Potential for accumulation in animal tissues; avoid environmental seeding.
Soil Mobility: Low—a tendency to adsorb onto soil particles.
Other Effects: Antibiotic residues can disrupt microbial communities in soil and water, affect non-target species.
Precautions: Avoid contamination of natural waterways; prevent spread from animal waste
Environmental Regulations: Dispose of in accordance with local, regional environmental regulations. Notify if significant environmental release occurs

Disposal Considerations

Safe Handling for Disposal: Collect and seal contaminated waste in approved containers.
Methods of Disposal: Incineration at high-temperature regulated hazardous waste facilities; do not discharge to sewer systems.
Waste Codes: Assign according to state and local regulations (often hazardous pharmaceutical).
Container Disposal: Triple-rinse, render unusable, and dispose via approved pharmaceutical waste streams.
Other Instructions: Only trained, licensed personnel should handle disposal. Include documentation for any transport or disposal movement.
Regulations: Ensure compliance with environmental, pharmaceutical and veterinary waste management statutes
Precautions: Avoid landfill disposal due to environmental hazard

Transport Information

UN Number: Regulated as hazardous (check country/region for specific classification, e.g., UN 2811 for toxic solids, organic, n.o.s.)
Proper Shipping Name: Tilmicosin-based pharmaceutical, toxic, non-combustible
Transport Hazard Class: 6.1 (Toxic Substances)
Packing Group: II or III, depending on form and quantity
Marine Pollutant: Yes
Special Transport Precautions: Secure, labeled, and leak-proof packaging; avoid transport with food, animal feed, or incompatible substances.
Regulatory References: Refer to IATA, IMDG, DOT standards. Transport only by authorized carriers using trained handlers
Emergency Response Guide Number: Refer to the specific emergency response protocols for toxic substances

Regulatory Information

Safety, Health, and Environmental Regulations: Regulated under numerous national veterinary and pharmaceutical guidelines (FDA, EMA, Health Canada)
GHS Labeling Requirements: Signal words, hazard pictograms, and full hazard statements on label
OSHA: Treated as hazardous substance in workplaces
EU Classification: Toxic, dangerous for environment
TSCA Status: Not listed for general chemical use; veterinarian pharmaceuticals have specific exceptions
Other Regulatory Listings: Philippines (PICCS), Canada (DSL/NDSL), Australia (AICS)—check country compliance
Additional Notes: Only for professional use in animals; not authorized for use in humans
Restrictions: Prescription only vet use, restricted to qualified handlers, strict recordkeeping for storage and use required by law