Chemical Name: Eliglustat Tartrate
Synonyms: None widely used
CAS Number: 491833-29-5
Product Code: Not established
Recommended Use: Used in the treatment of Gaucher disease Type 1
Manufacturer Information: Manufacturer name and contact details provided in product documentation, including emergency phone numbers and address
Emergency Contact: Refer to local poison control center or designated safety professional
Classification: Substance not classified as hazardous under normal conditions in pharmaceutical setting, but can pose risks in case of large-scale exposure or improper handling
Signal Word: Warning
Hazard Statements: May cause respiratory tract irritation, eye irritation, skin irritation; can be harmful if swallowed in large amounts; exposure may lead to allergic reactions in sensitive individuals
Pictograms: Exclamation mark (irritation), health hazard (if applicable), avoid dust formation
Precautionary Statements: Avoid breathing dust or powder, wear gloves and protective goggles, wash hands thoroughly after handling, use only in a well-ventilated area, avoid contaminating food sources
Main Substance: Eliglustat Tartrate
Chemical Formula: C23H33N3O4·C4H6O6
Purity: Typically >98% by HPLC
Impurities: Trace levels of process-related impurities; detailed impurity profile provided by manufacturer
Additives/Excipients: None unless in formulated product; pure substance contains only active pharmaceutical ingredient
Inhalation: Remove individual to fresh air, give oxygen if breathing is difficult, seek medical attention in case of persistent symptoms
Skin Contact: Remove contaminated clothing, wash exposed skin thoroughly using soap and water; if irritation develops, get medical advice
Eye Contact: Rinse immediately with plenty of clean, running water for 15 minutes minimum, seek ophthalmologist review if discomfort or redness continues
Ingestion: Rinse mouth with water, do not induce vomiting unless instructed by medical professional, seek medical help without delay
Most Important Symptoms: Irritation to skin, eyes, respiratory tract; possible gastrointestinal upset if swallowed; allergic reactions (in rare cases); monitor for breathing difficulties and rash
Suitable Extinguishing Media: Use water spray, carbon dioxide, dry chemical, or foam
Unsuitable Extinguishing Media: Avoid high-pressure water streams
Specific Hazards Arising from Fire: Produces toxic gases on combustion including carbon monoxide, carbon dioxide, nitrogen oxides
Protective Equipment for Firefighters: Wear full protective gear including self-contained breathing apparatus
Fire-Fighting Procedures: Cool exposed containers with water, contain runoff to prevent entry into drains
Explosion Hazard: No data suggesting explosivity, but fine dust can generate dust clouds—take precautions against static discharge
Personal Precautions: Avoid generating dust, wear protective clothing, eye protection, and appropriate respirator
Environmental Precautions: Prevent spillage from entering drains, surface water, or soil
Containment and Clean-Up Methods: Sweep up using a method minimizing dust, use HEPA-filtered vacuum equipment where possible, collect in suitable, labelled containers for disposal, ventilate area thoroughly after clean-up
Decontamination: Wash area with detergent and excessive water, dispose of absorbent and contaminated materials in line with local regulations
Handling: Handle in a controlled area using engineering controls to prevent dust and aerosols, avoid direct contact with skin, eyes, and clothing, never eat, drink, or smoke during handling
Storage: Store in a tight, light-resistant container away from incompatible substances, maintain temperature as specified in product data—generally controlled room temperature between 15-30°C
Special Storage Requirements: Protect from moisture, store away from strong oxidizers or acids
Labeling: Properly label all containers and secondary packaging
Control Parameters: Occupational exposure limits not established; minimize workplace exposure through best practices
Engineering Controls: Work in a chemical fume hood or with local exhaust ventilation, keep workspaces clean and free from accumulation of dust
Personal Protection: Wear laboratory coat, nitrile gloves, splash-resistant goggles or face shield, and suitable respiratory protection if dust becomes airborne
Hygiene Measures: Wash hands and exposed skin after working; avoid touching face; remove contaminated clothing immediately
Appearance: White to off-white crystalline powder
Odor: Odorless or mild
pH Value: Data unavailable; neutral in solution
Melting Point/Range: Approx. 180-190°C (decomposes)
Boiling Point/Range: Not applicable (decomposes before boiling)
Solubility: Soluble in water and dimethyl sulfoxide (DMSO); low solubility in organic solvents
Vapor Pressure: Negligible at ambient temperature
Density: No established data for bulk density
Partition Coefficient (log Kow): Not widely published
Viscosity: Not relevant for solid
Other Properties: Stable under recommended storage conditions; forms dust in powder form
Chemical Stability: Stable under standard conditions, sensitive to moisture and strong oxidizers
Conditions to Avoid: High temperatures, sources of ignition, moisture, and strong acids or bases
Incompatible Materials: Oxidizing agents, strong acids
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, other unidentified decomposition products that may be toxic
Reactivity: No violent reactivity reported in literature; take standard steps to prevent contamination with incompatible substances
Acute Toxicity: Animal studies suggest low acute toxicity; high doses may cause gastrointestinal distress, CNS effects
Skin Corrosion/Irritation: May cause mild, reversible irritation
Serious Eye Damage/Irritation: May cause mild irritation with redness, tearing, or discomfort
Inhalation Risk: Inhalation can cause respiratory tract irritation, coughing, or throat discomfort
Ingestion Effects: Nausea, vomiting, abdominal discomfort at significant exposure
Sensitization: Rare risk of allergic reactions; no widespread sensitization established
Genotoxicity: Preclinical studies suggest low genotoxic potential; long-term effects not fully characterized
Carcinogenicity: Not classified as a carcinogen by IARC, NTP, or OSHA
Reproductive Toxicity: No direct evidence of reproductive toxicity, caution advised
Target Organ Effects: Potential for mild liver enzyme changes in animal models at high doses
Ecotoxicity: No detailed data available; expected low acute toxicity to aquatic organisms based on structure and use pattern
Persistence and Degradability: Environmental breakdown not rapid, may persist under certain conditions
Bioaccumulative Potential: Low to moderate based on structure; unlikely to bioaccumulate significantly
Mobility in Soil: Moderate to low; tends not to leach extensively
Other Adverse Effects: Use best practices to avoid environmental contamination; do not allow material to reach waterways, drains, or soil in significant quantities
Product Disposal: Collect and dispose of substance in accordance with local, regional, and national waste regulations; incinerate or dispose through licensed chemical waste contractor
Contaminated Packaging: Dispose of empty containers as hazardous waste; triple rinse if regulations permit
Special Precautions: Avoid direct release into environment, document and track disposal as required for pharmaceuticals
UN Number: Not applicable (not classified as dangerous for transport under UN conventions)
Proper Shipping Name: Not regulated for transport
Transport Hazard Class: Non-hazardous under transport regulations
Packing Group: Not assigned
Environmental Hazards: Not considered marine pollutant
Special Precautions: Package securely to prevent breakage; transport using practices that minimize risk of spillage or accidental exposure
Regulation Compliance: Subject to pharmaceutical handling guidelines; not a controlled substance
GHS Labelling: Meets GHS requirements for workplace chemicals deemed potentially irritating
OSHA: Not listed as hazardous by OSHA
TSCA: Not listed due to pharmaceutical application
REACH: Exempted as active pharmaceutical ingredient
Other Regulations: Review national inventory status and comply with local authorities; documentation must be available for workplace controls and medical surveillance when requested