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Product Name: Alfa Glucosidase-α
Chemical Family: Enzyme, Glycoside Hydrolase
Synonyms: Alpha-glucosidase, Maltase, Glucan 1,4-α-glucosidase
CAS Number: 9001-42-7
Recommended Use: Biopharmaceutical ingredient, laboratory reagent
Supplier Details: Manufacturer address and emergency contact phone numbers direct to company’s health & safety division
Emergency Telephone: 24/7 line through regional poison control or chemical safety hotlines
GHS Classification: Eye irritation (Category 2A), Skin sensitization (Category 1), Respiratory sensitization (Category 1)
Signal Word: Warning
Hazard Statements: May cause allergic skin reaction. Causes serious eye irritation. May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Pictograms: Exclamation mark, Health hazard symbol
Precautionary Statements: Avoid breathing dust or spray. Wear protective gloves, protective eyewear, and suitable respiratory protection. Wash hands thoroughly after handling. In case of inadequate ventilation, wear respiratory protection. Contaminated clothing should not be allowed out of the workplace.
Potential Health Effects: Eyes—irritating to mucous membranes. Skin—potential allergen, can trigger reactions in sensitized individuals. Respiratory—risk of asthma-like symptoms and allergic response with prolonged exposure, particularly in occupational settings. Ingestion—gastrointestinal upset, nausea, mild irritation. Chronic exposure—may heighten allergic reactions, asthma, or dermatitis.
Chemical Name: Alfa Glucosidase-α
Concentration: 90–100% (as pure isolate, activity standardized by manufacturer)
CAS Number: 9001-42-7
Impurities: Trace amounts of stabilizing agents, buffer salts (phosphate, sodium citrate, occasionally calcium chloride depending on product variant), possible residual water, minimal host cell proteins (if recombinant extraction method used)
Ingredient Disclosure: Enzyme produced through fermentation (usually Aspergillus oryzae, or Saccharomyces cerevisiae lines), followed by ultrafiltration and purification steps
Inhalation: Move individual into fresh air. Observe for signs of respiratory distress. If breathing is irregular or stops, perform artificial respiration and call emergency medical services. Remove contaminated clothing and seek immediate medical help.
Skin Contact: Wash affected area thoroughly with soap and water for at least 15 minutes. Remove contaminated clothing and wash before reuse. Monitor for signs of prolonged irritation; consult a health professional if symptoms persist.
Eye Contact: Rinse cautiously with water for at least 15 minutes, keeping eyelids open. Remove contact lenses if present and easy to do. Seek immediate medical attention.
Ingestion: Rinse mouth. Do not induce vomiting unless directed by medical personnel. Offer water to drink if the affected person is conscious. Contact poison control or seek medical advice.
Notes for Physicians: Treat symptomatically. Monitor for delayed allergic reactions, bronchospasm, and provide supportive therapy as indicated.
Suitable Extinguishing Media: Foam, dry chemical powder, carbon dioxide, or water spray.
Unsuitable Extinguishing Media: Direct high-pressure water jets on enzyme powders may disperse material and increase exposure risk.
Fire and Explosion Hazards: Organic powder, dust cloud can increase potential for combustion under severe conditions. Byproducts from incomplete combustion contain carbon oxides and nitrogen oxides.
Special Protective Equipment: Firefighters should wear full protective gear, including self-contained breathing apparatus.
Firefighting Procedures: Limit spread of dust, evacuate area of non-essential personnel, cool containers exposed to fire with water, and thoroughly ventilate after fire suppression.
Thermal Decomposition Products: Carbon dioxide, carbon monoxide, nitrogen oxides, and other unidentified toxic fumes possible during burning.
Personal Precautions: Use personal protective equipment including gloves, safety goggles, and dust mask or respirator certified for organic particulates. Avoid dust formation, avoid breathing dust or aerosol. Evacuate unnecessary personnel.
Environmental Precautions: Prevent further leakage or spillage if safe to do so. Do not allow to enter drains, surface water, or soil.
Methods for Containment and Clean Up: Provide adequate ventilation. Carefully sweep or vacuum up spilled material, avoiding dust generation. Place in suitable container for disposal according to local regulations. Thoroughly wash contaminated area with water after removal. Dispose of in accordance with section on disposal consideration.
Handling: Minimize dust generation and accumulation. Avoid inhalation, ingestion, and direct contact. Only handle with appropriate personal protective equipment. Wash hands and face after handling, especially before eating, drinking, or smoking.
Storage: Store in tightly closed containers away from heat and direct sunlight. Optimal storage temperature usually between 2–8°C (specific range per manufacturer specification). Keep containers dry. Prevent humidity and moisture ingress, which can degrade enzyme activity. Segregate from incompatible substances, such as strong acids, oxidizers, or alkalis. Post clear labeling and access restrictions to authorized personnel only.
Incompatible Materials: Strong oxidizers, strong acids, and bases can cause degradation or hazardous decomposition.
Engineering Controls: Use local exhaust ventilation to minimize airborne concentrations in process areas. Provide eyewash stations and safety showers.
Exposure Limits: No specific occupational exposure limit published for this enzyme, but minimize exposure as with all respiratory sensitizers.
Personal Protective Equipment (PPE):
– Respiratory: Approved particulate respirator mask (P2 or N95 or higher), especially in bulk handling or powder processing.
– Eye/Face: Chemical safety goggles or full face shield.
– Skin: Nitrile or latex gloves, laboratory coat or chemical protective clothing.
– Hygiene: No eating or drinking in handling area. Wash thoroughly after handling. Change contaminated clothing and launder before reuse.
Environmental Controls: Prevent spillage, provide secondary containment, use closed systems or local exhaust whenever possible.
Appearance: White to off-white powder or lyophilized cake. Commercial forms may be granulated for easier handling.
Odor: Mild proteinaceous scent, not especially pungent.
Odor Threshold: No data available.
pH: 4.0–7.0 (1% solution in water, manufacturer specification)
Boiling Point: Not applicable (decomposes prior to boiling).
Melting Point: Not applicable (denaturation/fusion on heating).
Flash Point: Not flammable in aqueous solution.
Evaporation Rate: Not volatile.
Vapor Pressure: No data available.
Vapor Density: No data available.
Solubility: Freely soluble in water.
Density: 1.2–1.4 g/cm³ (depends on purity and processing)
Partition Coefficient (n-octanol/water): Not determined.
Decomposition Temperature: Above 60°C, enzyme loses activity.
Viscosity: Not relevant.
Particle Size: 5–50 microns (average, depending on processing).
Chemical Stability: Stable under recommended storage conditions.
Reactivity: Not reactive under normal conditions. Hydrolyzes polysaccharides as specific biological activity.
Hazardous Reactions: No hazardous polymerization expected. No significant exothermic reactions under normal use.
Conditions to Avoid: High humidity, prolonged exposure to elevated temperatures, freezing and thawing cycles, strong acids and oxidizers, direct sunlight.
Incompatible Materials: Strong oxidizing agents, strong acids, alkalis—may result in protein precipitation, denaturation, or hazardous decomposition.
Decomposition Products: Thermal decomposition can produce irritating and toxic fumes, including oxides of carbon and nitrogen.
Routes of Exposure: Skin, eyes, inhalation, ingestion.
Acute Health Effects: Eye and skin irritation or allergic reactions, respiratory tract sensitization if inhaled as fine dust. Ingestion produces mild gastrointestinal upset.
Delayed/Chronic Effects: Sensitization from repeated exposure can escalate to skin allergies, asthma, or other hypersensitivities (particularly among workers in manufacturing or formulation facilities).
Toxicity Data: LD50 not established for enzyme as protein; relevant studies focus on allergenic potential over acute toxicity.
Carcinogenicity: No evidence of carcinogenic effects from available data.
Mutagenicity: No mutagenic effects reported.
Reproductive Toxicity: Data not conclusive, no reports of reproductive or developmental toxicity.
Irritation/Corrosivity: Classified as irritant to skin and eye tissue.
Other Observations: Good workplace practices and use of PPE greatly reduce risk of sensitization.
Eco-Toxicity: Enzyme degrades naturally, posing minimal acute risk to aquatic organisms, though large discharges may upset water microorganism activity.
Persistence and Degradability: Readily biodegradable, enzymatic breakdown natural and rapid.
Bioaccumulation Potential: Not expected. As a protein, breaks down through environmental processes.
Mobility in Soil and Water: No harmful long-term residues expected. Product is highly soluble and disperses quickly in an aquatic system.
Other Adverse Effects: High concentrations in wastewater streams can temporarily alter aquatic biological oxygen demand, affecting microbial populations.
Best Environmental Practice: Prevent uncontrolled releases into surface water.
Safe Disposal Methods: Treat as non-hazardous industrial waste unless otherwise regulated. Dispose of contents/container by high-temperature incineration or in accordance with local, regional, and national guidelines for enzyme or protein waste.
Waste Treatment Methods: Dilute residue with copious water, flush downstream to approved municipal treatment plant. Do not pour into open environment or surface water directly. Empty containers retain product residue; follow company’s decontamination guidance before recycling or disposal.
Recycling Information: Where suitable, perform triple rinsing and recycle plastics or metals through regulated streams.
UN Number: Not classified as a hazardous material according to UN, IMO, ICAO, or ADR standards.
Proper Shipping Name: Enzymes, not otherwise specified
Hazard Class: Not applicable.
Packing Group: Not assigned.
Marine Pollutant: No.
Special Precautions: Protect from moisture and physical damage. Keep container sealed during transport. Secure against shifting loads. Follow routine good practices for protein-based powders during transport.
GHS Label: Eye and skin irritant, respiratory sensitizer.
International Inventories: Listed on major chemical inventories (TSCA, EINECS, DSL, AICS, ENCS, KECI, PICCS, NZIoC as an enzyme product).
OSHA Status: Classified as hazardous for workplace safety in terms of respiratory sensitizer.
REACH Registration: Required for manufacture/import in EU at above 1 tonne per year—product falls under biological substances documentation.
SARA/EPCRA: Not covered by specific reporting thresholds.
California Proposition 65: Not listed as causing cancer, birth defects or reproductive harm.
Other National/Regional Standards: Separate requirements possible in jurisdictions for enzyme dust exposure and reporting of occupational respiratory allergens.
Labeling Requirements: Product identification, hazard pictograms, supplier information, recommended protective equipment, first aid summary, safe handling and storage instruction always present on label and shipping documents.
