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Product Name: Ganciclovir
Chemical Formula: C9H13N5O4
CAS Number: 82410-32-0
Intended Use: Antiviral agent for cytomegalovirus infections
Synonyms: 9-[(1,3-dihydroxy-2-propoxy)methyl]guanine
Supplier Identification: Details provided on designated product label
Emergency Contact: Consult national poison control center or local emergency number
GHS Classification: Toxic to reproduction (Category 2), Mutagenic (Category 2), Harmful if swallowed (Category 4)
Signal Word: Warning
Hazard Statements: May cause genetic mutations, suspected of damaging fertility or the unborn child, harmful if swallowed
Pictograms: Health hazard, exclamation mark
Precautionary Statements: Wash hands thoroughly after handling; avoid contact with skin, eyes, and clothing; use only outdoors or in well-ventilated areas; do not eat, drink, or smoke when using this product
Potential Health Effects: Eye irritation, skin sensitization, mutagenic effects, possible carcinogenic risk with prolonged exposure
Chemical Name: Ganciclovir
Concentration: >98% (by weight)
Impurities: Not generally expected at significant levels, but trace production by-products might be present
Other Components: No significant stabilizers, solvents, or carriers in pure substance form
Inhalation: Move to fresh air promptly. Provide oxygen if breathing is difficult. Seek medical attention if symptoms persist.
Skin Contact: Remove contaminated clothing. Wash skin thoroughly with soap and water. Consult a healthcare provider if irritation persists or increases.
Eye Contact: Rinse eyes with plenty of water for at least 10–15 minutes, lifting upper and lower eyelids occasionally. Get prompt medical help.
Ingestion: Do not induce vomiting unless directed by medical personnel. Rinse mouth with water. Get immediate medical attention.
Most Important Symptoms: Headache, nausea, respiratory irritation, potential allergic skin or eye reaction, gastrointestinal upset with large doses
Medical Attention: Symptomatic treatment required. Inform doctor of specific exposure details and underlying health conditions.
Suitable Extinguishing Media: Use water spray, foam, dry powder, or carbon dioxide. Select extinguishing agent appropriate for surrounding materials.
Hazardous Combustion Products: May release nitrogen oxides, carbon dioxide, carbon monoxide, hydrogen chloride, toxic fumes as decomposition products.
Firefighter Protection: Wear self-contained breathing apparatus and protective clothing. Prevent runoff from entering drains or water sources.
Special Precautions: Promptly evacuate area if there’s a large fire; fight fire from a safe protected location.
Personal Precautions: Use gloves, safety glasses, lab coat or protective suit. Avoid dust formation. Do not breathe dust.
Environmental Precautions: Prevent entry into waterways, drains, basements, or confined spaces. Keep away from soil and vegetation.
Methods for Cleanup: Collect spilled material using wet methods or HEPA vacuum. Place in an approved container for disposal. Ventilate area and wash residue with water and detergent to prevent dust generation.
Decontamination: Double-bag waste and decontaminate all contaminated surfaces and equipment as per institution protocol.
Handling: Minimize dust generation and accumulation. Handle in well-ventilated area. Use tools and PPE to avoid direct contact.
Storage: Store in tightly closed container. Maintain temperature between 2°C and 8°C (refrigerated, not frozen). Store away from food, incompatible chemicals (oxidizers, acids, bases), and moisture.
Incompatibilities: Sensitive to strong oxidizing agents and extreme pH conditions.
Special Storage: Avoid exposure to light; keep out of reach of unauthorized personnel; label storage clearly.
Exposure Limits: No established occupational exposure limit, but treat as hazardous substance with careful adherence to control measures.
Engineering Controls: Use local exhaust ventilation or work inside an appropriate safety cabinet if available.
Personal Protective Equipment: Wear chemical-resistant gloves, safety goggles, lab coat. Use particulate respirator if dust is generated or airborne levels increase.
Hygiene Measures: Wash hands and face after handling. Do not eat, drink, or smoke near work area. Remove contaminated clothing and wash before reuse.
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: 9–10 (1% solution in water)
Melting Point: 250–255°C (decomposes)
Boiling Point: Not measurable (decomposes before boiling)
Flash Point: Not flammable as solid
Evaporation Rate: Not applicable
Vapor Pressure: Negligible as solid
Solubility: Freely soluble in water, very slightly soluble in ethanol
Auto-Ignition Temperature: Not established
Explosive Properties: Not classified as explosive
Partition Coefficient (log Kow): –1.16 (very hydrophilic)
Viscosity: Not applicable to solids
Chemical Stability: Stable under recommended storage conditions.
Reactivity: Resistant to mild acids and alkalis. Rapid hydrolysis under strong base or acid.
Hazardous Reactions: No dangerous polymerization.
Conditions to Avoid: Excessive heat, strong oxidizing agents, strong acid or base, sunlight, and moisture.
Decomposition Products: Nitrogen oxides, carbon oxides, hydrogen chloride under intense heating or fire conditions.
Incompatible Materials: Powerful oxidizers, concentrated acids or bases may degrade or react violently.
Acute Oral Toxicity (LD50): Rat, ~970 mg/kg
Skin Irritation: Low risk, but still use skin protection.
Eye Irritation: May cause mild and reversible irritation.
Respiratory Sensitization: Not established, but dust can irritate airway.
Chronic Exposure: Mutagenic and reproductive toxicity observed in animal studies. Tumorigenic results observed in some long-term animal studies.
Potential Health Effects: Hematological disturbances, renal effects, bone marrow suppression, fever, nausea, vomiting, possible teratogenic effects in unborn children.
Carcinogenicity: Classified as not classifiable for humans (IARC), but animal studies suggest a risk. Avoid unnecessary exposure.
Target Organs: Bone marrow, kidneys, reproductive organs with repeated exposure.
Aquatic Toxicity: Low water solubility limits risk but excreted drug may persist in water systems; limited data for fish and daphnia.
Persistence and Degradability: Moderately persistent, some breakdown in environment but not readily biodegradable.
Bioaccumulation Potential: Log Kow suggests low bioaccumulation.
Soil Mobility: Likely to migrate in moist environments; may leach to groundwater in large amounts.
Ecotoxicological Effects: Chronic effects not fully studied, but possible risk to aquatic microorganisms at low concentrations. Limit uncontrolled disposal.
Waste Disposal: Collect material in sealed containers, label as pharmaceutical hazardous waste. Dispose through licensed chemical disposal contractor.
Contaminated Packaging: Triple rinse, then containerize and treat as hazardous chemical waste.
Sewage Disposal: Do not dispose in drains or natural waterways, even in small quantities; trace residues may persist and contaminate.
Disposal Regulations: Local and national regulations take precedence—consult with relevant regulatory authorities before disposal.
UN Number: Not regulated for transport under international guidelines
Transport Hazard Class: Not classified as hazardous for bulk road, air, or sea transport
Packing Group: No specific packing group assignment
Special Precautions: Avoid physical damage. Ensure outer packaging prevents loss or spills and all labeling meets local requirements.
Proper Shipping Name: Ganciclovir, pharmaceutical substance, not otherwise specified
Environmental Hazards: Not a marine pollutant or significant environmentally hazardous substance in smaller packaging
Specific Regulations: Ganciclovir is subject to pharmaceutical control laws in many countries; may require controlled substance permits or records.
OSHA Status: Not listed as hazardous under OSHA regulation 29 CFR 1910.1200 in the United States
EINECS/ELINCS Status: Listed or exempt
TSCA Inventory Status: Exempt as a drug
RCRA Status: Usually regulated as hazardous waste by characteristic if discarded in bulk quantities
SARA/Title III: Not subject to Section 302, 304, 313 reporting
GHS Label Elements: Required labels for workplace safety under global harmonization rules
Other Requirements: Ensure all personnel receive training on handling hazardous pharmaceuticals. Observe all workplace and pharmaceutical handling guidelines set down by institutional and government authorities.
