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Product Name: Roxithromycin
Chemical Name: 9-{O-[(2-methoxyethoxy)methyl]oxime}erythromycin
Chemical Formula: C41H76N2O15
CAS Number: 80214-83-1
Use: Antibiotic for bacterial infections
Manufacturer Contact: See company label or package for supplier and emergency contact details
Synonyms: RU 965
Recommended restrictions: For professional use only, not for household or untrained person handling
Classification: Not classified as hazardous under standard GHS criteria; may still present risks with misuse
Physical hazards: May produce irritating dust if handled improperly
Health hazards: Possible allergic reactions, may impact liver function in sensitive individuals, can cause mild gastrointestinal disturbance
Environmental hazards: Potential harm to aquatic life on significant release, avoid uncontrolled disposal
Label elements: Avoid breathing dust, wash skin thoroughly after handling, handle with care
Signal word: Caution
Pictograms: No pictogram requirement by GHS for standard use
Chemical Name: Roxithromycin
Concentration: >95% by weight
Impurities and stabilizing additives: Less than 5%, largely related to pharmaceutical formulations, not considered hazardous
Other ingredients: Pharmaceutical grade excipients if formulated product (microcrystalline cellulose, starch, magnesium stearate, etc.)
CAS Number (main component): 80214-83-1
Inhalation: Move to fresh air, seek medical attention if cough or irritation continues
Skin Contact: Wash with soap and water, remove contaminated clothing, seek medical attention for persistent irritation
Eye Contact: Rinse immediately with plenty of water, remove any contact lenses, continue rinsing for at least ten minutes, get medical help if irritation does not subside
Ingestion: Rinse mouth, do not induce vomiting, seek medical advice if symptoms appear
Important symptoms: Mild irritation, nausea, headache, or rash may occur, hypersensitivity reactions possible but rare
Medical attention: Get help if you feel unwell or show allergic symptoms such as rash, swelling, or difficulty breathing
Suitable extinguishing media: Use dry chemical, carbon dioxide, water spray, or foam
Specific hazards: Thermal decomposition can result in production of toxic fumes including oxides of nitrogen and carbon
Protective equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Advice for firefighters: Avoid smoke inhalation, keep unnecessary personnel away, use water spray to cool containers exposed to fire
Special procedures: Avoid direct runoff into sewers or waterways, contain and collect extinguishing media
Personal precautions: Avoid inhalation of dust, provide adequate ventilation, use recommended personal protective equipment
Environmental precautions: Prevent entry into waterways, sewers, basements or confined areas, collect spillage
Clean up methods: Use damp cloth or absorbent material, sweep up carefully to avoid dust generation, transfer to waste container
Disposal: Send to approved chemical waste facility, avoid uncontrolled disposal
Decontamination: Wash contaminated area thoroughly with water and mild detergent
Further handling: Ensure area is well-ventilated before resuming normal operations
Precautions for safe handling: Minimize dust generation, avoid breathing dust, avoid skin or eye contact, use protective gear including gloves and goggles
Hygiene measures: Wash hands after handling, do not eat, drink, or smoke in handling areas
Conditions for safe storage: Keep container tightly closed, store in a cool, dry, well-ventilated place, store away from incompatible substances like strong acids and oxidizers
Incompatible materials: Strong oxidizers, strong acids
Bulk storage guidance: Avoid sources of ignition, static discharge, and excessive moisture
Occupational exposure limits: Not established for Roxithromycin, handle as a pharmaceutical active
Engineering controls: Use with adequate ventilation, possibly local exhaust
Personal protective equipment (PPE): Safety goggles, lab coat, suitable gloves (e.g., nitrile), dust mask or respirator in circumstances of high dust
Environmental controls: Prevent product from entering environment through drains or watercourses
Special instructions: Remove contaminated clothing and wash before reuse, provide eye-wash stations in work area
Appearance: White to off-white crystalline powder
Odor: Nearly odorless
Odor threshold: Not determined
pH: Not applicable for dry powder; solution pH 6–8
Melting point/freezing point: 125–130°C (dec.)
Boiling point/range: Decomposes before boiling
Flash point: Not determined
Evaporation rate: Not applicable
Flammability: Not flammable under normal conditions, may burn when heated
Vapor pressure: Not applicable
Vapor density: Not applicable
Relative density: Approx. 1.15–1.25 (water=1)
Solubility: Poor in water; better in organic solvents like methanol, acetone
Partition coefficient (n-octanol/water): Not available
Decomposition temperature: Decomposes > 125°C
Viscosity: Not applicable
Chemical stability: Stable under ordinary conditions of storage and use
Stability notes: Sensitive to light and moisture, best stored in tightly closed container
Hazardous reactions: May react with strong oxidizing agents and acids
Conditions to avoid: High temperatures, exposure to sunlight, moisture
Incompatible materials: Strong acids, oxidizing materials
Decomposition products: Oxides of carbon, nitrogen compounds, and other hazardous fumes under fire conditions
Likely routes of exposure: Inhalation, skin, eye contact, and ingestion
Acute toxicity: Low toxicity by oral or dermal routes; LD50 values (animal studies): oral rat >2000 mg/kg
Skin corrosion/irritation: Minimal irritation possible
Serious eye damage/irritation: Slight irritation may be possible
Respiratory sensitization: Not established, though pharmaceutical actives should be handled as potential sensitizers
Skin sensitization: Hypersensitivity reactions possible in predisposed individuals
Germ cell mutagenicity: No known data indicating mutagenic risk
Carcinogenicity: Not classified as carcinogenic
Reproductive toxicity: No known literature showing reproductive risk in humans, animal studies indicate low risk
STOT-single exposure: Not expected to produce systemic organ toxicity with acute exposure
STOT-repeated exposure: High doses over extended periods may affect liver
Aspiration hazard: Not expected for solid material
Ecotoxicity: May pose a risk to aquatic organisms in large or repeated releases
Persistence and degradability: Not readily biodegradable, may persist in environment for extended periods
Bioaccumulative potential: Low; based on physical–chemical properties
Mobility in soil: Limited mobility, adsorbs to soil particles
Other adverse effects: Pharmaceutical residues may contribute to antibiotic resistance if released in large amounts
Aquatic toxicity: Specific LC50 or EC50 data not broadly available; treat as potentially harmful to aquatic life
Disposal of product: Incinerate or dispose as hazardous pharmaceutical waste in line with local regulations
Disposal of packaging: Decontaminate and recycle or dispose of as regulated waste
Special precautions: Do not dispose of in household drains or general refuse
Contaminated materials: Treat as hazardous, collect and dispose through authorized contractor
RCRA classification (USA): Not listed specifically, always defer to most stringent local disposal requirements
UN number: Not classified as a dangerous good under transport regulations
Proper shipping name: Roxithromycin (for research or pharmaceutical use, non-regulated)
Transport hazard class: Not regulated
Packing group: Not assigned
Environmental hazards: Not considered a marine pollutant
Special precautions: Prevent material damage or spillage; ensure packages remain intact during transport
Labeling: No transport warning label required for standard quantities
Safety, health, and environmental regulations: Regulated as a prescription pharmaceutical active, not classified as hazardous or toxic under standard chemical laws
OSHA status: Not regulated as hazardous chemical
DSCL (EEC): Not classified as dangerous according to EU regulations
WHMIS (Canada): Not controlled
TSCA (USA): Not listed
SARA Title III: Not listed as a toxic or hazardous substance
Other regulations: Subject to national drug and medicine disposal rules; follow all applicable local, state, and federal laws
Inventory status: Not listed on commercial chemical inventories; used in pharmaceutical manufacture and supply
