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Product Name: Sulfadoxine
Chemical Family: Sulfonamide
Chemical Formula: C12H14N4O4S
CAS Number: 2447-57-6
Synonyms: 4-Amino-N-(5,6-dimethoxy-4-pyrimidinyl)benzenesulfonamide
Recommended Use: Pharmaceutical intermediate, antimalarial agent
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Classification: Not classified as hazardous under GHS
Health Hazards: May cause irritation to eyes, skin, and respiratory tract; possible allergic reactions for sensitive individuals; ingestion can trigger digestive discomfort, nausea, headache
Environmental Hazards: Potential risk to aquatic life in concentrated spills
Label Elements: No specific hazard pictograms; precautionary statements for handling and exposure
Specific Target Organ Toxicity: Not listed as a specific organ toxin
Risk Phrases: R36/37/38 – Irritating to eyes, respiratory system, and skin for susceptible individuals
Safety Phrases: S22, S24/25 – Do not breathe dust; avoid contact with skin and eyes
Chemical Name: Sulfadoxine
Purity: 97-99%
Impurities: Less than 1% (mainly related compounds as defined by manufacturer)
Additives: None detected in active pharmaceutical ingredient
Ingredient List: No significant additives or stabilizers
Molecular Weight: 310.33 g/mol
Inhalation: Remove from exposure to fresh air; keep person warm and comfortable; seek medical attention if symptoms occur or persist
Skin Contact: Immediately wash affected area with plenty of soap and water; remove contaminated clothing; medical advice if irritation continues
Eye Contact: Rinse with large volumes of water, lifting eyelids occasionally, for at least 15 minutes; obtain medical assistance
Ingestion: Rinse mouth with water, do not induce vomiting, give water if conscious; seek prompt medical attention; provide product label to doctor
Important Symptoms: Possible rash, itching, redness, gastrointestinal upset
Advice for Physicians: Treat symptomatically based on clinical presentation; monitor for hypersensitivity reactions
Suitable Extinguishing Media: Dry chemical powder, foam, carbon dioxide, water-spray for large fires
Unsuitable Media: Avoid high-pressure water streams
Specific Hazards: Sulfadoxine dust may contribute to fire through combustible organic material
Hazardous Combustion Products: Nitrogen oxides, sulfur oxides, carbon monoxide, carbon dioxide
Protective Equipment: Full protective clothing, self-contained breathing apparatus recommended
Special Precautions: Keep away from ignition sources, ventilate area post-fire
Explosion Data: This agent does not present an explosive hazard in typical pharmaceutical form
Personal Precautions: Use personal protective equipment, avoid breathing dust, prevent contact with eyes and skin
Environmental Precautions: Prevent material from entering water sources and drains; confine spill with non-combustible absorbent material
Clean-Up Methods: Sweep up carefully without raising dust, transfer to labeled waste container; thoroughly ventilate affected area
Additional Advice: Dispose of according to local, national, and regional regulations; clean area with water after collection
Handling: Use in well-ventilated areas, minimize dust generation; wear protective clothing and equipment; avoid eating, drinking, or smoking during work
Storage Conditions: Keep tightly closed in original container; store in cool, dry, well-ventilated location; protect from excessive heat, moisture, sunlight
Incompatibilities: Strong oxidizers
Hygiene Measures: Wash hands thoroughly after handling; change contaminated clothing promptly
Storage Temperature: Stable between 15–25°C in sealed containers; avoid freezing or overheating
Occupational Exposure Limit: Not established for this ingredient; practice general dust control measures
Engineering Controls: Local exhaust or process enclosure for dust minimization; eyewash stations within reach
Personal Protection: Wear chemical safety goggles, lab coat or disposable coveralls, dust mask or respirator (N95 or equivalent), gloves made of nitrile or PVC
Respiratory Protection: Use appropriate particle respirator if airborne concentration increases
Skin Protection: Avoid direct contact; remove contaminated clothing and accessories
Monitoring Methods: Regular inspection of ventilation systems and personal protective gear
Appearance: White to off-white crystalline powder
Odor: Odorless
Melting Point: Approximately 190–194°C
Boiling Point: Not applicable (decomposes)
Flash Point: Not available
Solubility: Slightly soluble in water, more soluble in alcohols
Vapor Pressure: Negligible at room temperature
Relative Density: 1.47 g/cm³
pH: 5.0–7.0 (1% solution in water)
Partition Coefficient (log P): 1.35
Chemical Stability: Stable under recommended storage and handling conditions
Conditions to Avoid: High temperatures, humidity, direct sunlight, contact with strong oxidizers
Materials to Avoid: Oxidizing agents, strong acids
Reactivity: Non-reactive under normal laboratory or manufacturing use
Hazardous Decomposition Products: Formation of toxic fumes (sulfur oxides, nitrogen oxides, carbon monoxide) under fire or extreme heat
Polymerization: Will not occur under normal circumstances
Acute Toxicity: LD50 (oral, rat) >4000 mg/kg; low toxicity by single oral exposure
Chronic Effects: Possible hypersensitivity and blood disorders in susceptible individuals; not considered carcinogenic to humans
Skin Contact: Mild irritation reported in some cases
Eye Contact: Mild to moderate irritation based on animal studies
Inhalation: Irritation to respiratory tract at high exposure levels
Sensitization: Reports of skin sensitization in rare instances
Carcinogenicity: Not listed as a carcinogen by IARC, NTP, OSHA
Mutagenicity: No evidence of mutagenicity from available data; negative Ames test results
Reproductive Toxicity: No direct evidence of teratogenic effects observed; not recommended during pregnancy without supervision
Other Information: Prolonged or repeated exposure may provoke allergies in predisposed persons
Ecotoxicity: Harmful in the environment in concentrated quantities; aquatic toxicity not fully characterized, but related sulfonamides show moderate toxicity to fish and daphnia
Mobility: Low to moderate mobility in soil, more mobile in waterlogged conditions
Persistence and Degradability: Slow decomposition in the environment, not readily biodegradable
Bioaccumulative Potential: Potential low risk based on structure and log P
Other Adverse Effects: No ozone depletion or photochemical smog potential identified
Aquatic Toxicity: Avoid release into waterways or sewer systems
Disposal Methods: Follow local, regional, and national regulations for disposal of pharmaceuticals
Waste Treatment: Suitable incineration with flue gas cleaning; landfilling only if permitted for pharmaceutical materials
Container Handling: Ensure containers are empty and cleaned before recycling or disposal
Precautions: Do not dispose of via sinks, watercourses, or household garbage
EU Waste Code: 20 01 31 (for pharmaceuticals except cytotoxics)
UN Number: Not regulated for transport
Transport Hazard Class: Not classified as dangerous goods under ADR, IMDG, IATA regulations
Packing Group: Not applicable
Proper Shipping Name: Sulfadoxine
Marine Pollutant: Product is not identified as a marine pollutant
Special Precautions: Avoid spills during transport
Reportable Quantity: Not listed as hazardous for transport or environmental release
OSHA Regulation: Not classified as hazardous according to OSHA Hazard Communication Standard
TSCA (United States): Not specifically listed; for research and pharmaceutical manufacturing only
DSL/NDSL (Canada): May not be listed, check with supplier for status
EU Regulation: Complies with REACH for pharmaceutical substances
WHMIS Classification (Canada): D2B: Toxic material causing other toxic effects where applicable
California Proposition 65: Not listed
Other Regulatory Requirements: Product used only under professional supervision; prescription-only for end use
Safety Assessment: Handled with care to protect workers and the environment
