Product Name: Obeticholic Acid
Chemical Formula: C26H44O4
CAS Number: 459789-99-2
Synonyms: 6-Ethylchenodeoxycholic acid, OCA
Recommended Use: Pharmaceutical ingredient
Manufacturer: Contact supplier or manufacturer directly for updated details
Emergency Contact: Refer to local emergency numbers or Poison Control
Restrictions: For use by professional personnel only
Classification: Not classified as hazardous under GHS criteria
Main Hazards: May cause irritation to eyes, skin, and respiratory system in handling bulk powder
Signal Word: Caution
Hazard Statements: May cause mild skin or eye irritation
Precautionary Statements: Avoid breathing dust, use with adequate ventilation
Pictograms: No pictograms required under most regulations
Target Organ Effects: Possible liver, kidney, and gastrointestinal effects from repeated exposure
Chemical Name: Obeticholic Acid
Percentage: >98% (pharmaceutical grade)
Impurities and Stabilizing Additives: May contain trace synthetic by-products; levels depend on manufacturer
Other Ingredients: None (report only pure substance in API form)
Inhalation: Move person to fresh air, seek medical attention if symptoms occur (cough, difficulty breathing)
Skin Contact: Wash area thoroughly with soap and water; remove contaminated clothing
Eye Contact: Rinse eyes with water for at least 15 minutes; seek medical help for persistent irritation
Ingestion: Rinse mouth, seek medical advice; do not induce vomiting unless directed by medical personnel
Special Instructions for Physicians: Provide symptomatic treatment and supportive care
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide
Unsuitable Extinguishing Media: Avoid high-pressure water jets
Special Hazards from Combustion: Produces carbon monoxide, carbon dioxide, and possibly other toxic vapors
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and protective suit
Firefighting Instructions: Move containers from fire area if safe to do so; prevent fire water runoff from contaminating surface water or groundwater
Personal Precautions: Use appropriate PPE (gloves, eye protection, dust mask); avoid inhalation and skin contact
Environmental Precautions: Prevent further leakage or spillage as safe to do so; keep material out of drains and waterways
Clean-Up Methods: Pick up and transfer spilled material to properly labeled containers; use damp cloth or vacuum with HEPA filter for dust control
Decontamination: Wash spill area with water and detergent; ventilate area
Emergency Procedures: Restrict access to spill area until cleanup is complete; dispose in accordance with local regulations
Handling: Use in well-ventilated areas; minimize dust generation and accumulation; avoid exposure by skin contact or inhalation
Safe Handling Advice: Wear personal protective equipment, wash hands after handling, never eat, drink, or smoke when using this substance
Storage Conditions: Keep tightly closed in original container; store in cool, dry, and well-ventilated location away from incompatible substances
Incompatibles: Strong oxidizers, strong acids, strong bases
Special Packaging Needs: Keep container clearly labeled and tightly sealed when not in use
Exposure Limits: No occupational exposure limits established by OSHA, NIOSH, or ACGIH
Engineering Controls: Use local exhaust ventilation or work in chemical fume hood to control airborne dust
Personal Protective Equipment (PPE):
Appearance: White to off-white crystalline powder
Odor: Odorless
Molecular Weight: 420.63 g/mol
Melting Point: Approximately 165-169°C
Boiling Point: Decomposes before boiling
Solubility: Practically insoluble in water; slightly soluble in ethanol, methanol, DMSO
pH: Not applicable (solid)
Chemical Stability: Stable under normal storage and handling conditions
Reactivity: No significant reactivity hazard under normal conditions
Conditions to Avoid: Excessive heat, moisture, incompatible substances
Incompatible Materials: Strong oxidizing agents, strong bases, strong acids
Hazardous Decomposition Products: CO, CO2, possibly irritant fumes at high temperatures
Polymerization: Will not occur
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Acute Toxicity: Data limited; structurally related bile acids show low acute toxicity
Chronic Toxicity: Chronic animal studies: main effects on liver at high doses
Possible Health Effects: Skin and eye irritation, respiratory discomfort, allergic reactions rare but possible
Carcinogenicity: Not listed as carcinogen by IARC, NTP, or OSHA
Mutagenicity: Not genotoxic in standard assays
Reproductive Toxicity: No adverse reproductive effects reported for this compound in animal studies
Specific Target Organ Toxicity: High doses: risk of liver toxicity; OCA alters bile acid metabolism
Environmental Toxicity: Limited data; low solubility and minimal bioaccumulation potential predicted
Mobility in Soil: Likely low due to poor water solubility
Persistence and Degradability: Expected to degrade slowly in environment; does not persist indefinitely
Bioaccumulation Potential: Low, based on structure and metabolic data
Other Adverse Effects: Avoid release into waterways or soil; unknown risk to aquatic organisms in large spill
Waste Disposal: Collect and dispose of material by incineration in accordance with local, regional, and national regulations
Unused Product: Do not discharge into sewer or environment
Disposal of Containers: Rinse thoroughly before recycling or disposal; consult local authorities for approved methods
Physical/Chemical Properties Affecting Disposal: Low volatility; avoid dust during disposal
UN Number: No UN number assigned
Transport Hazard Class: Not regulated as dangerous good under UN, IMO, ADR, IATA, DOT
Proper Shipping Name: Obeticholic Acid, bulk API or research grade
Packing Group: Not applicable
Environmental Hazards: None identified for transport in small or moderate quantities
Special Precautions: Avoid generating dust; ship in sealed, labeled packages
U.S. Regulations: Not subject to specific TSCA, SARA 313, or CERCLA reporting
EU Regulations: Not classified as hazardous under EU CLP Regulation (EC No. 1272/2008)
Canada: Not listed in Canadian DSL/NDSL for substance control
Australia/New Zealand: Not scheduled as hazardous
Workplace Classification: Handle as pharmaceutical/R&D substance with internal oversight
Other Local Regulations: Consult relevant national and regional authorities for current details
Labeling Requirements: Name of substance, hazard statements if applicable, supplier information