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Product Name: Spironolactone
Chemical Name: 7α-Acetylthiospirolactone
CAS Number: 52-01-7
Synonyms: Aldactone, Spiro-Aldactone
Recommended Use: Pharmaceutical ingredient for management of hypertension, heart failure, and edema
Manufacturer: Please consult your supplier for accurate details
Contact Information: Emergency and technical support numbers available through supplier safety offices
Classification: Harmful if swallowed (GHS Category 4). May cause eye, skin, and respiratory irritation. Not classed as carcinogenic based on available data, but long-term effects not fully studied. Data show reproductive and developmental toxicity potential in animal studies.
Signal Word: Warning
Hazard Statements: Causes mild to moderate skin irritation; harmful to aquatic environments with long-lasting effects; may impair fertility or harm unborn child based on research in non-human subjects
Precautionary Statements: Avoid breathing dust or powder. Wear gloves, protective clothing, and eye protection. Wash hands thoroughly after handling. Avoid release to the environment.
Symptoms of Overexposure: Nausea, vomiting, confusion, drowsiness, rash, difficulty breathing in severe cases
Chemical Identity: Spironolactone
Percent Composition: 98–100% active pharmaceutical ingredient, pharmaceutical excipients added as per formulation requirements
Impurities: May contain trace related compounds and synthesis byproducts lower than 1%
Molecular Formula: C24H32O4S
Molecular Weight: 416.58 g/mol
Inhalation: Move person to fresh air without delay. Seek immediate medical advice if coughing or difficulty breathing occurs.
Skin Contact: Remove contaminated clothing. Wash affected area with soap and water for at least 15 minutes. Seek medical advice if any irritation develops or persists.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. Medical attention necessary if irritation continues.
Ingestion: Rinse mouth thoroughly with water. Do not induce vomiting unless directed to do so by medical personnel. Contact poison control center or emergency room without delay.
Most Important Symptoms and Effects: Gastrointestinal upset, rashes, drowsiness, electrolyte imbalances
Immediate Medical Attention Needed: Seek help if large quantity swallowed or in event of persistent symptoms.
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, or foam suitable for surrounding materials
Specific Hazards: Decomposes producing hazardous gases such as carbon monoxide, carbon dioxide, oxides of sulfur, various organic compounds
Firefighter Protective Equipment: Full protective gear and self-contained breathing apparatus recommended
Advice for Firefighters: Prevent run-off from entering drains. Approach fire from upwind. Use caution due to potential for toxic byproducts
Personal Precautions: Avoid creating and breathing dust. Evacuate area if needed. Ventilate. Wear gloves, goggles, and a dust mask or respirator.
Environmental Precautions: Prevent further leakage or spillage by containing spill. Do not allow to enter drains, watercourses, or soil.
Methods for Clean-up: Sweep up solid material using non-sparking tools. Collect for waste disposal in clearly labeled container. Clean area with detergent and water. Dispose according to local regulations.
Notification Procedures: Report large releases to environmental authorities if water contamination seems likely.
Handling: Use with adequate ventilation. Avoid breathing dust. Wear appropriate protective equipment. Keep away from food, drinks, and animal feed. Practice good personal hygiene.
Storage Conditions: Store in tightly closed original container, in a cool, dry, and well-ventilated area. Keep away from incompatible substances such as acids and strong oxidizers. Store under conditions that protect product from moisture and heat extremes.
Specific End Use: For laboratory, manufacturing, or pharmaceutical processing use only. Not for household use.
Control Parameters: No official occupational exposure limit; handle as hazardous pharmaceutical agent
Engineering Controls: Use local exhaust ventilation or work in fume hood to minimize dust exposure
Personal Protective Equipment: Chemical-resistant gloves, safety glasses with side shields or goggles, lab coat or protective clothing
Respiratory Protection: Dust mask or respirator (N95 or better) if dust generation likely
Hygiene Measures: Wash hands before breaks and after work. Remove contaminated clothing and wash before reuse.
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: Not available
Melting Point: 198–201°C
Boiling Point: Decomposes, does not boil
Flash Point: Not available
Evaporation Rate: Not applicable
Flammability: Non-flammable as solid product
Vapor Pressure: Negligible at room temperature
Vapor Density: Not applicable
Solubility: Insoluble in water, soluble in ethanol and other organic solvents
Partition Coefficient (Log Kow): 2.8–3.1
Auto-Ignition Temperature: No data available
Decomposition Temperature: Above 200°C
Viscosity: Not applicable
Chemical Stability: Stable under normal storage conditions; decomposes at high temperatures
Reactivity: Does not react violently with water or air
Hazardous Reactions: Incompatible with strong oxidizing agents; may undergo hydrolysis in alkaline conditions
Conditions to Avoid: Excessive heat, sparks, open flames, moisture
Hazardous Decomposition Products: Emits toxic fumes of carbon monoxide, carbon dioxide, and sulfur compounds when heated to decomposition
Likely Routes of Exposure: Inhalation, ingestion, skin, and eye contact
Acute Toxicity: Harmful if swallowed; LD50 oral (rat) 410 mg/kg
Chronic Toxicity: Repeated or prolonged exposure may affect liver and kidneys; reproductive toxicity seen in animal testing
Skin Corrosion/Irritation: May cause mild skin irritation
Serious Eye Damage/Irritation: May result in irritation
Respiratory Effects: Possible irritation of respiratory tract
Sensitization: No information available
Mutagenicity/Carcinogenicity: No evidence in humans; genotoxicity not demonstrated clearly in standard assays; IARC not classifying as carcinogen
Reproductive Toxicity: Animal data suggests developmental risks; no controlled human studies
Ecotoxicity: Toxic to aquatic life, especially chronically; harmful in high local concentrations
Persistence and Degradability: Limited information, but structurally persistent in water and soil; not readily biodegradable
Bioaccumulative Potential: Potential to bioaccumulate based on log Kow values
Mobility in Soil: Low to moderate mobility; leaching possible if released.
Other Adverse Effects: Release to groundwater or natural environments should be prevented to keep contamination in check
Waste Treatment Methods: Dispose through licensed chemical waste contractor or according to local hazardous waste regulations
Product Disposal: Do not discharge into drains, soil, or watercourses. Store waste in sealed, labeled container until proper disposal.
Packaging Disposal: Triple-rinse and/or destroy containers; treat as hazardous unless decontaminated
Contaminated Packaging: Dispose of as hazardous material, follow all regional local and national laws
UN Number: Not regulated as hazardous for transport (as per current international shipping laws)
Proper Shipping Name: Not classified as dangerous goods
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Not classified as marine pollutant
Special Precautions for Users: Secure packaging to avoid spillage, follow labeling guidelines for research or pharmaceutical chemicals.
Safety, Health, & Environmental Regulations: Covered under workplace and environmental health regulations for pharmaceuticals
SARA Title III (USA): Not listed as a hazardous chemical
TSCA (USA): Not listed for commercial chemical use
EU Regulations: Regulated as pharmaceutical substance, not classified as REACH-registered chemical
OSHA HazCom: Meets criteria for hazardous chemical due to toxicity; safety practices required
Other International Inventories: Consult individual country or region’s pharmaceutical and workplace control laws
