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Material Safety Data Sheet: Difloxacin Hydrochloride

Identification

Product Name: Difloxacin Hydrochloride
Chemical Formula: C19H19F2N3O3•HCl
CAS Number: 91296-87-6
Synonyms: Difloxacin Hydrochloride Monohydrate, Rofenaid
Recommended Use: Veterinary antibiotic, research applications
Supplier Details: Supplier and address must be referenced on individual documentation
Emergency Contact: Refer to local regulations and supplier emergency number

Hazard Identification

Classification: Harmful if swallowed, irritating to skin, irritating to eyes
GHS Label Elements: Exclamation mark symbol
Signal Word: Warning
Hazard Statements: Causes skin and eye irritation; may cause respiratory irritation; harmful if inhaled or ingested
Precautionary Statements: Wear protective gloves, avoid breathing dust or fumes, wash thoroughly after handling, keep container tightly closed
Potential Health Effects: Short-term exposure can trigger irritation to mucous membranes, nausea, or dizziness; chronic exposure may impact liver or kidney function

Composition / Information on Ingredients

Main Ingredient: Difloxacin Hydrochloride
Chemical Composition: Pure substance
Concentration: More than 98%
Impurities: Trace solvent residues possible based on synthesis route
Stabilizers: None stated

First Aid Measures

Inhalation: Remove person to fresh air, keep at rest in position comfortable for breathing, get medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, rinse skin with plenty of water, seek medical help if irritation continues
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if easy, continue rinsing, seek ophthalmologist if pain or redness remains
Ingestion: Rinse mouth with water, do not induce vomiting, call poison control or physician
Important Symptoms: Redness, burning, cough, shortness of breath, stomach pain, allergic reactions possible for sensitive individuals

Fire-Fighting Measures

Extinguishing Media: Use dry chemical powder, carbon dioxide (CO2), or foam
Special Hazards: Toxic fumes, including hydrogen chloride, fluorinated compounds, and nitrogen oxides, can form on combustion
Protective Equipment: Wear self-contained breathing apparatus, suitable gloves, and full protective gear
Advice for Firefighters: Move containers from fire area if safe, use water spray to cool unopened containers, stay upwind to avoid smoke exposure

Accidental Release Measures

Personal Precautions: Evacuate unnecessary personnel, avoid dust generation, wear suitable protective clothing and respirators
Environmental Precautions: Prevent product from entering drains or watercourses
Methods for Containment: Collect spillage via mechanically or with damp paper to avoid dust clouds
Cleaning Methods: Wash spill area with water and detergent after material collection, ventilate area, dispose of waste following regulations

Handling and Storage

Safe Handling: Avoid breathing dust, handle in a well-ventilated area, use caution during weighing or transfer
Protective Measures: Use gloves, eye protection, dust masks or laboratory respirators as needed
Storage Conditions: Store container tightly closed, in a dry and cool place
Incompatibilities: Avoid storing near strong acids, bases, or oxidizing agents
Special Considerations: Keep away from sunlight and heat sources, restrict access to trained handlers

Exposure Controls and Personal Protection

Exposure Limits: No established occupational exposure limits; handle as hazardous
Engineering Controls: Use chemical hoods or local exhaust ventilation
Respiratory Protection: NIOSH-approved respirator recommended if dust is present
Hand Protection: Chemical-resistant gloves such as nitrile
Eye Protection: Safety goggles or face shield
Skin Protection: Laboratory coat, long pants, closed shoes
Hygiene Measures: Wash hands thoroughly after use, remove contaminated clothing

Physical and Chemical Properties

Appearance: White or almost white crystalline powder
Odor: Odorless or slightly pungent
pH: Approximately 3.5 – 5.5 (1% solution in water)
Melting Point: About 194–198°C
Solubility: Soluble in water, slightly soluble in alcohol
Boiling Point: Not applicable (decomposes)
Flash Point: Not available
Density: Not specified
Vapor Pressure: Not available
Partition coefficient (log Kow): Data not provided
Other Properties: Stable under normal conditions; dust may form explosive mixtures with air if sufficiently dispersed

Stability and Reactivity

Chemical Stability: Stable under standard temperatures and pressures
Reactivity: May react with strong oxidizers or acids
Polymerization: Not known to occur
Conditions to Avoid: High humidity, intense heat, strong light
Hazardous Decomposition Products: Hydrochloric acid, nitrogen oxides, fluorinated gases possible on thermal breakdown

Toxicological Information

Routes of Exposure: Inhalation, ingestion, dermal, ocular
Acute Effects: May cause skin and eye irritation, gastrointestinal symptoms if ingested
Chronic Effects: Animal studies report mild hepatic and renal changes after repeated high doses
Allergic Reactions: Some individuals may show hypersensitivity with symptoms like rashes, asthmatic signs
LD50 (oral/rat): Approximately 2000 mg/kg
Carcinogenicity: Not classified as carcinogen by IARC, NTP, or OSHA
Mutagenicity: No known significant mutagenic risk based on available data

Ecological Information

Ecotoxicity: Harmful to aquatic organisms even in low concentrations, can disrupt bacterial flora in waterways
Persistence and Degradability: Not easily degraded in soil or water, may persist
Bioaccumulative Potential: Risk of accumulation in aquatic species
Mobility in Soil: Moderate movement through soil likely
Other Adverse Effects: May contribute to development of antibiotic-resistant bacteria in environment

Disposal Considerations

Waste Treatment Methods: Dispose of material through certified hazardous waste contractor
Disposal of Packaging: Rinse containers thoroughly, puncture, and send to licensed disposal service
Environmental Considerations: Do not discharge into sewer systems or waterways
Local Regulations: Disposal must observe national and regional hazardous waste laws to limit environmental impact

Transport Information

UN Number: No special UN classification assigned
Transport Hazard Class: Not regulated as dangerous material for land, sea, or air
Packing Group: Not applicable
Special Precautions: Secure packaging to prevent leaks or releases, segregate from food items during transport
Emergency Response: Spillages during transport need containment and reporting to local environmental authorities

Regulatory Information

Inventory Listings: Confirmed for use in controlled veterinary and laboratory research applications
Regulatory Status: Not approved for human use by FDA or EMA; governed by local veterinary drug laws
Label Requirements: Accurate chemical labeling, hazard pictogram, and supplier contact
Other Information: Observe national substance control regulations, occupational safety codes, and environmental guidelines relevant to application and handling