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Material Safety Data Sheet: Oxytetracycline Hydrochloride

Identification

Product Name: Oxytetracycline Hydrochloride
Chemical Formula: C22H24N2O9·HCl
CAS Number: 2058-46-0
Synonyms: OTC HCl, Terramycin Hydrochloride
Intended Use: Antibiotic for veterinary and pharmaceutical applications
Manufacturer Information: Refer to supplier label for address, emergency advisory hotline, and responsible party schedules
Emergency Contact: Poison Control Center, regional authority for toxic exposure

Hazard Identification

Classification: Acute toxicity (oral, dermal), Skin sensitizer, Eye irritant
Hazard Statements: Harmful if swallowed. May cause allergic skin reaction. Causes serious eye irritation. Prolonged or excessive exposure may harm kidneys and liver.
Signal Word: Warning
Pictograms: Exclamation mark, Health hazard symbol
Precautionary Statements: Avoid breathing dust. Wear protective gloves and clothing. Wash thoroughly after handling. Use only in well-ventilated areas.
Potential Health Effects: Inhalation may irritate respiratory tract. Skin contact may cause sensitization. Eye contact provokes redness and damage. Accidental ingestion upsets stomach, induces vomiting, diarrhea, and in severe cases may injure internal organs.

Composition / Information on Ingredients

Chemical Name: Oxytetracycline Hydrochloride
Concentration: 99-100% by weight
Impurities: No significant impurities influencing hazard classification
Other Ingredients: None declared

First Aid Measures

Inhalation: Remove person from exposure to fresh air. Monitor for breathing difficulty. If symptoms persist, seek immediate medical advice.
Skin Contact: Wash with plenty of soap and water. Remove contaminated clothing. For irritated or sensitized skin, obtain medical support.
Eye Contact: Rinse thoroughly under running water for several minutes, lifting eyelids to remove all residue. Contact ophthalmologist if irritation continues.
Ingestion: Do not induce vomiting. Rinse mouth. Offer water. Medical evaluation required if adverse reactions develop or if a substantial amount was consumed.
Most Important Symptoms: Rash, redness, gastrointestinal upset, dizziness, breathing trouble.
Advice for Medical Staff: Emergency treatments include symptom management and supportive care. Possibility of allergic reaction or anaphylaxis should not be ignored.

Fire-Fighting Measures

Suitable Extinguishing Media: Carbon dioxide, dry chemical, foam, water spray
Unsuitable Media: Direct water jets may scatter powder
Fire Hazards: Dust can contribute to combustion if airborne. During fire, nitrogen oxides, carbon monoxide, hydrogen chloride fumes may form.
Protective Equipment: Full protective suit, self-contained breathing apparatus required for responders
Special Procedures: Evacuate area, cool exposed containers with water fog. Avoid inhaling combustion gases and product-derived fumes.

Accidental Release Measures

Personal Precautions: Evacuate unprotected personnel. Use respirators and gloves. Prevent dust build-up. Avoid skin and eye contact.
Environmental Precautions: Keep spills out of water bodies, sewer systems, soil exposure. Alert authorities in case of large leak.
Clean-Up Methods: Gather spills using damp cloth or HEPA-filter vacuum. Scoop into clearly labeled, sealed containers. Wash residue with water and detergent. Ventilate area post-cleanup.
Disposal: Dispose of material collected from clean-up as hazardous waste, refer to local waste regulations.

Handling and Storage

Handling: Avoid generating dust. Use extraction vents in processing areas. Keep away from food, drinks, and incompatible chemicals.
Hygiene Practices: Do not eat, drink, or smoke while using. Wash hands and face after work. Change contaminated clothing and launder before reuse.
Storage: Store in original tightly closed containers. Place in dry, cool, well-ventilated rooms. Separate from acids, oxidizers. Protect from sunlight, excessive heat, and moisture.
Incompatibles: Strong acids, bases, reducing agents, oxidizing chemicals
Storage Life: Stable up to 2 years under recommended conditions

Exposure Controls and Personal Protection

Exposure Limits: No OSHA PEL or ACGIH TLV established. Precautionary limits based on internal risk assessment at 1 mg/m³ (inhalable fraction).
Engineering Controls: Effective general ventilation, local exhaust at dust sources, closed handling systems, dust suppression techniques.
Personal Protection: Respirators (N95 or P2 standard), chemical-resistant gloves, goggles or face shield, work uniforms, disposable overalls for high-exposure work.
Hygienic Measures: Emergency eyewash and safety shower in work area. Prohibit application of makeup or skin creams at work.
Environmental Controls: Prevent dust emission and effluent discharge to ensure minimization of environmental contamination.

Physical and Chemical Properties

Appearance: Yellow, crystalline powder
Odor: Slight medicinal odor
pH (1% solution): Around 2.0 - 3.0
Solubility: Freely soluble in water. Sparingly soluble in ethanol.
Melting Point: 181–183°C
Boiling Point: Not applicable (decomposes)
Vapor Pressure: Negligible at room temperature
Particle Size: Fine powder, average 20–60 µm
Density: Approximately 1.9 g/cm³
Partition Coefficient (log Kow): -0.9 to -0.6

Stability and Reactivity

Chemical Stability: Stable under cool, dry, dark conditions.
Conditions to Avoid: High moisture, elevated temperatures, UV exposure facilitates degradation and loss of potency.
Reactivity: Reacts with strong acids, alkalis, oxidants resulting in exothermic or hazardous breakdown products.
Decomposition Products: Produces toxic fumes including carbon monoxide, carbon dioxide, nitrogen oxides, hydrochloric acid on heating or burning.
Polymerization: Hazardous polymerization does not occur.

Toxicological Information

Acute Oral Toxicity (LD50): 500–2000 mg/kg (rat)
Acute Dermal Toxicity: No reliable quantitative data; skin irritation noted in sensitive individuals.
Inhalation Toxicity: No chronic studies, but may irritate respiratory tract.
Skin Sensitization: Repeated exposure increases risk of allergic dermatitis.
Eye Damage: Irritant to conjunctiva and cornea.
Subchronic/Chronic Effects: Liver and kidney damage possible in long-term high-dose exposure. Prolonged ingestion also linked to gastrointestinal flora disturbance.
Other Effects: Teratogenicity and reproductive toxicity not fully explored. Antibiotic resistance risk with improper use.

Ecological Information

Ecotoxicity: Acute toxicity in aquatic organisms, especially fish and invertebrates. Disrupts aquatic microbial communities, impacting nitrogen cycling.
Persistence/Degradability: Biodegradable under favorable soil and water conditions, but persists in anaerobic, cold, or dry environments.
Bioaccumulation: No evidence of significant bioaccumulation in aquatic food chains.
Mobility: Mobile in aqueous environments; binds to clays and organic matter, may persist in sediments.
Other Impacts: Environmental concern tied to induction of antimicrobial resistance and disruption of soil fertility in agricultural run-off zones.

Disposal Considerations

Disposal Methods: Incinerate at high temperatures in approved facilities. Some regions allow landfill in sealed containers if incineration unavailable.
Preparation for Disposal: Avoid dust emission. Decontaminate and triple rinse containers prior to discarding.
Waste Codes: Subject to hazardous waste legislation. EPA, EU, and other codes may apply based on jurisdiction.
Special Precautions: Prevent product from polluting ground or surface waters. Large-scale disposal requires notification to environmental regulatory authorities.

Transport Information

UN Number: Not assigned for small quantities, may vary by carrier.
Transport Hazard Class: Not classified as dangerous under ADR, IMDG, IATA for standard packaging.
Packing Group: III for bulk consignments by some regulators
Special Transport Conditions: Keep dry and shielded from sunlight. Prevent damage to inner packaging.
Labeling: Clearly label with chemical name, hazard and emergency contacts. Notify transport staff of potential hazards.

Regulatory Information

Inventory Listings: Listed in US TSCA, EU REACH, Canadian DSL, Australian AICS
Classification: Subject to regulation as a pharmaceutical and pesticide active in several jurisdictions.
SARA Title III: Not a listed substance but its spills or releases subject to reporting if impact thresholds hit.
OSHA: Subject to Hazard Communication Standard as hazardous chemical
WHMIS Classification: D2B (Toxic material causing other toxic effects)
Other: Follow FDA, EMA, APVMA, and local FDA-equivalent agency rules for product quality, worker exposure, and end-user safety.