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Product Name: Pancreatin
Chemical Family: Enzyme preparation
Synonyms: Pancreatic extract, Pancreatic enzymes
Recommended Use: Pharmaceutical ingredient, digestive aid, laboratory reagent
CAS Number: 8049-47-6
Supplier: Listed by product seller or manufacturer
Emergency Phone Number: Manufacturer or local emergency services
Contact Address: Listed by product producer
Classification: Respiratory sensitizer (Category 1), Skin sensitizer (Category 1), Eye irritant (Category 2A)
Label Elements: Exclamation mark (GHS pictogram)
Signal Word: Warning
Hazard Statements: May cause allergy or asthma symptoms or breathing difficulties if inhaled, may cause an allergic skin reaction, causes serious eye irritation
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, use only outdoors or in a well-ventilated area, wear protective gloves/eye protection
Substance: Mixture
Main Components: Amylase 8-50%, Lipase 10-20%, Protease 20-60%
Other Ingredients: Inactive excipients or diluents, less than 10% (not all mixtures use these)
Impurities: Minimal, addressed by manufacturing standards
Inhalation: Move person to fresh air, assist breathing if needed, seek medical attention for persistent symptoms
Skin Contact: Wash with plenty of soap and water, remove contaminated clothing, obtain medical advice if irritation or rash develops
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, continue rinsing, consult medical care if eye irritation persists
Ingestion: Rinse mouth with water if conscious, drink water to dilute, do not induce vomiting, consult physician if symptoms appear
Most Important Symptoms: Allergic reactions in sensitive individuals, respiratory trouble, skin or eye irritation
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Specific Hazards: Fine powder may form explosible dust-air mixtures, hazardous combustion products include carbon oxides and nitrogen oxides
Special Protective Equipment: Wear self-contained breathing apparatus and protective clothing
Precautions: Avoid inhaling fumes or dust, contain contaminated runoff to prevent entering waterways
Personal Precautions: Avoid breathing dust, use protective clothing, gloves, and an appropriate mask
Environmental Precautions: Prevent spillage from entering drains or watercourses
Containment Methods: Sweep up or vacuum spillage using methods that minimize dust creation
Clean-Up Methods: Collect into a suitable, sealed container for disposal, ventilate area, clean surfaces with water after spill removal
Handling: Minimize dust formation, use in a well-ventilated space, avoid direct skin or eye contact, clean work areas after use
Storage Conditions: Store in tightly closed original containers, in a cool and dry location, keep away from moisture and incompatible chemicals
Incompatible Materials: Strong oxidizers, acids, and bases, avoid high humidity which can deactivate enzymes
Storage Temperature: 2–8°C recommended, do not freeze, protect from heat and direct sunlight
Occupational Exposure Limits: No established limit for Pancreatin, handle as a sensitizing agent
Engineering Controls: Use local exhaust ventilation, general room ventilation, keep containers closed
Personal Protective Equipment: Safety glasses or goggles, gloves made from nitrile or latex, laboratory coat
Respiratory Protection: NIOSH-certified dust mask or respirator if airborne concentration may be significant
Hygiene Measures: Wash hands after handling, do not eat, drink, or smoke in work areas, remove and wash clothing before reuse
Appearance: Off-white to light beige powder
Odor: Faint, protein-like
pH (1% solution): 5.5–7.0
Solubility: Partially soluble in water
Melting Point: Not applicable (decomposes)
Boiling Point: Not applicable
Flash Point: No data available, low flammability under normal conditions
Bulk Density: 0.5–0.7 g/cm3
Vapor Pressure: Negligible
Explosive Properties: Fine dust may form explosible mixtures with air
Chemical Stability: Stable under normal storage and handling conditions
Reactivity: Not reactive under normal use
Conditions to Avoid: Moisture, heat, direct sunlight, exposure to acids or strong oxidants
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides may form at high temperatures
Polymerization: Does not occur
Incompatibility: Avoid mixing with strong oxidizers and acids
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Acute Effects: May cause respiratory irritation, eye irritation, skin sensitization
Chronic Effects: Sensitization possible with repeated exposure, especially via inhalation
LD50 (oral, rat): Not precisely established; generally recognized as safe in small, controlled exposures
Carcinogenicity: Not listed by IARC, NTP, or OSHA
Mutagenicity or Teratogenicity: No data confirming effects
Symptoms: Allergic reactions including asthma, rash, eye redness, coughing, shortness of breath
Ecotoxicity: Not expected to be hazardous in small quantities, large amounts may affect aquatic organisms due to organic load
Mobility in Soil: Enzymes may bind to soil, rarely persist
Persistence and Degradability: Biodegradable by natural processes
Bioaccumulation: Not expected, enzymes break down into amino acids
Other Adverse Effects: Minimal environmental risk when managed properly, avoid uncontrolled releases
Waste Disposal Methods: Dispose as non-hazardous biological waste unless local regulations require treatment as controlled waste
Container Disposal: Rinse empty packaging and offer recycling or comply with regional disposal guidelines
Precautions: Do not allow uncontrolled discharge into drains, water, or soil, consult waste contractor if disposing large quantities
UN Number: Not regulated
Proper Shipping Name: Biological enzyme preparation, not dangerous for transport
Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Not considered marine pollutant
Transport Precautions: Shield from extremes of temperature and humidity, protect against spillage or leaks
OSHA: Considered hazardous under definition for sensitization
WHMIS Classification (Canada): D2A, D2B—sensitizer
TSCA (USA): Listed
DSL/NDSL (Canada): Listed
REACH (EU): Not subject to registration when used as an enzyme preparation
Labeling Requirements: Sensitization warnings must be displayed, use proper workplace labels as mandated
Additional Regulations: Compliance with local, state, and national guidelines required for use and disposal
