Product Name: Ursodeoxycholic Acid
Chemical Formula: C24H40O4
Synonyms: UDCA, Ursodiol
CAS Number: 128-13-2
Recommended Uses: Pharmaceutical applications, research laboratory work, treatment of primary biliary cholangitis
Supplier Identification: Full company name, address, emergency phone number required for real-world supply chain traceability and on-hand safety support
Relevant Identified Uses: Intended for use as a therapeutic agent and for chemical analysis in controlled settings
Classification: Not classified as hazardous under GHS standards for raw chemical substances, but can be an irritant to eyes and respiratory tract at high concentrations or if handled without proper controls
Hazard Statements: Causes mild eye irritation, may cause skin discomfort in rare sensitive individuals; dust may aggravate conditions like asthma and other respiratory diseases
Signal Word: None required for pure substance, but attention highlighted for bulk handling
Precautionary Statements: Avoid inhalation of dust, wash any exposed skin after handling, avoid contact with eyes, store in a ventilated area
Chemical Name: Ursodeoxycholic Acid
Purity: ≥98% for pharmaceutical grade; trace impurities should be listed by analytical testing
Main Impurities: Isomeric bile acids, trace inorganic salts unique to production lots
Inhalation: Move person to fresh air, ensure clear breathing passage, seek medical attention if dizziness or irritation continues
Skin Contact: Rinse affected area using running water, remove contaminated clothing and wash thoroughly, consult physician if rash or allergic response appears
Eye Contact: Immediately flush eyes with plenty of water for at least 10 minutes, keep eyelids apart, access medical attention for ongoing pain or redness
Ingestion: Rinse mouth with water, do not induce vomiting without medical advice, obtain prompt medical evaluation especially for high dosages or accidental ingestion in vulnerable populations
Suitable Extinguishing Media: Use water spray, dry powder, carbon dioxide, or foam; chemical is not highly flammable but thermal decomposition can cause hazardous fumes
Special Hazards: Decomposition releases carbon monoxide, carbon dioxide, and possibly other irritant gases such as acrolein and bile acid derivatives
Protective Equipment and Precautions: Firefighters need self-contained breathing apparatus, full-body protective clothing, and adequate ventilation for confined fire scenarios
Advice for Specialists: Isolate area from unnecessary personnel, prevent water runoff from entering drains or natural water bodies if possible
Personal Precautions: Wear safety goggles, gloves, dust mask in case of bulk powder; avoid breathing dust or vapor, limit unnecessary movement in the area
Environmental Precautions: Prevent product from entering sewer systems, soil or waterways; contain with sand, earth, or suitable non-combustible absorbent material
Clean-Up Methods: Scoop spilled powder using non-sparking tools, place in sealed chemical waste containers, ventilate area after removal, decontaminate surfaces with detergent and water
Handling Guidelines: Operate with local exhaust ventilation, wear appropriate gloves and eye protection during transfer or mixing, avoid aerosolization and jobsite eating or drinking
Safe Storage Conditions: Store in a cool, dry, well-ventilated place, away from direct sunlight and incompatible materials (strong oxidizers, acids), keep container tightly closed when not in use
General Practices: Maintain good industrial hygiene, label containers clearly, educate workers on risks and first response
Exposure Limits: No occupational exposure limits set by OSHA or ACGIH for ursodeoxycholic acid specifically
Engineering Controls: Use fume hoods or local exhaust for handling powders or large volumes, implement closed transfers for bulk work
Personal Protective Equipment: Safety goggles, nitrile or neoprene gloves, laboratory coats, dust mask or respirator where dust formation likely, safety shoes for industrial settings
Hygiene Measures: Wash hands before meals and after finishing work, prohibit smoking or food in handling areas
Appearance: White to off-white crystalline powder
Odor: Slight, characteristic organic odor
Molecular Weight: 392.57 g/mol
Melting Point: 197–203°C
Solubility: Slightly soluble in water, soluble in alcohol and chloroform
pH: No relevant pH due to low aqueous solubility (approximately neutral suspension)
Boiling Point: Decomposes before boiling
Vapor Pressure: Negligible at room temperature
Flash Point: Not applicable for solid form
Explosion Limits: Not expected to form explosive dust clouds under standard use
Chemical Stability: Stable under recommended storage and handling, decomposes on strong heating
Conditions to Avoid: Excessive moisture, exposure to heat sources, incompatible chemicals (oxidizers, strong acids)
Incompatible Materials: Strong oxidizing agents, strong mineral acids
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, small amounts of irritant aldehydes under fire conditions
Hazardous Polymerization: Not known to occur
Acute Toxicity: Low oral toxicity for humans at therapeutic doses, higher doses in animal studies show mild liver effects and gastrointestinal discomfort; no severe acute inhalation or dermal toxicity documented
Chronic Effects: Prolonged or repeated exposure may affect digestive system, rare allergic reactions possible in predisposed individuals
Irritation: Mild irritant to eyes and respiratory mucosa; little or no skin irritation in healthy subjects
Sensitization: Rare cases of skin allergy reported with prolonged handling
Carcinogenicity/Mutagenicity: No evidence for carcinogenic or genetic risk based on available animal and human studies
Reproductive Toxicity: No conclusive research linking it to reproductive harm at prescribed doses
Aquatic Toxicity: Low bioaccumulation potential, not classified as hazardous to aquatic life in environmental concentrations expected from pharmaceutical use and manufacture
Persistence and Degradability: Biodegrades slowly in natural conditions but expected to break down over weeks to months in activated sludge or wastewater treatment
Bioaccumulation: Not prone to significant accumulation in organisms
Soil Mobility: Minimal mobility due to low water solubility, unlikely to reach groundwater from spills
Other Adverse Effects: No evidence for hormone disruption or long-term ecological harm at trace levels
Waste Handling: Collect solid or solution waste in suitable containers, segregate contaminated materials from regular trash, label for hazardous chemical pickup, follow institutional and local guidelines for chemical disposal
Regulations: Disposal methods must comply with local, regional, and national environmental protection regulations; avoid release and dilution beyond permissible limits
UN Number: Not classified as a hazardous good for road (ADR), air (IATA), or sea (IMDG) transport categories
Proper Shipping Name: Ursodeoxycholic acid, not regulated
Transport Hazard Class: Not assigned due to low acute hazard
Packing Group: None required for ambient shipments
Environmental Hazards: Not considered a marine pollutant
Special Precautions: Minimize package breakage in transit, use secondary containment for large volumes
TSCA Inventory: Listed in the United States Toxic Substances Control Act Inventory for laboratory and medical uses
OSHA Status: Not classified as hazardous under OSHA Standard 29 CFR 1910.1200
EU Classification: Not assigned specific hazard classes under CLP Regulation (EC) No 1272/2008 for pure substance
Other: Ensure all packaging bears compliant labeling as defined by applicable pharmaceutical and industrial chemical guidelines
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