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Product Name: Lactose Monohydrate
Chemical Formula: C12H22O11·H2O
CAS Number: 64044-51-5
Synonyms: Milk Sugar, β-D-galactopyranosyl-(1→4)-D-glucose monohydrate
Use: Ingredient in food, pharmaceuticals, and laboratory reagents
Supplier Information: Manufacturer address and emergency contact found on product packaging or certificate of analysis
GHS Classification: Not classified as hazardous under GHS standards
Signal Word: None
Hazard Statements: May cause dust irritation to eyes or respiratory tract with excessive exposure, but not considered toxic; no known severe health hazards
Precautionary Statements: Avoid creating dust clouds, keep away from ignition sources
Potential Health Effects: Eyes: Slight irritation possible; Skin: Low risk; Inhalation: Mild respiratory irritation possible in dusty environments; Ingestion: Expected to have low toxicity
Chemical Name: Lactose Monohydrate
Purity: Typically 99% and above
CAS Number: 64044-51-5
Ingredients: Single-ingredient product, no additional hazardous components detected
Eye Contact: Flush with clean water for 15 minutes, remove contact lenses if present, seek medical attention if discomfort persists
Skin Contact: Wash with soap and water, remove contaminated clothing, no significant skin irritation expected
Inhalation: Move affected person to fresh air, rinse nose and mouth, seek medical support if symptoms worsen
Ingestion: Rinse mouth thoroughly, drink water if conscious, do not induce vomiting, consult a doctor if discomfort occurs
Advice to Physicians: Treat symptoms, no specific antidote known
Suitable Extinguishing Media: Water spray, dry chemical, foam, or carbon dioxide can suppress fire in environments containing lactose dust
Specific Hazards: Dust may form explosive mixtures with air when ignition sources are present; combustion generates carbon monoxide, carbon dioxide
Firefighter Equipment: Wear self-contained breathing apparatus and full protective gear
Special Procedures: Avoid inhalation of smoke, cool containers with water spray from a safe distance, prevent runoff from entering drains or water sources
Personal Precautions: Use personal protective equipment such as gloves and safety goggles, avoid dust generation
Environmental Precautions: Prevent entry into drains or water courses
Methods for Cleanup: Sweep up spilled material without generating dust, place in suitable container for disposal, vacuum area with HEPA filter if available, ventilate space adequately
Other Information: Spill surfaces may become slippery
Handling: Use only with adequate ventilation, avoid inhaling dust, practice good industrial hygiene; do not eat, drink, or smoke when handling materials
Storage Conditions: Store in tightly closed containers in cool, dry, and well-ventilated places, keep away from sources of ignition and strong oxidizers, maintain storage areas free from dust buildup
Incompatible Materials: Strong acids, strong bases, oxidizing agents can react with or degrade lactose
Safe Packaging: Use containers designed for food or pharmaceutical materials, clearly label for identification
Occupational Exposure Limits: No established exposure limits for lactose monohydrate, but minimize dust exposure (< 10 mg/m³ recommended for nuisance particulates)
Engineering Controls: Provide local exhaust ventilation or general dilution ventilation to control airborne dust
Personal Protective Equipment: Eyes: chemical safety glasses or goggles; Hands: protective gloves; Respiratory: dust mask or respirator if dust levels exceed recommended values; Skin/Body: wear protective clothing as needed
Hygiene Measures: Wash hands after handling, remove contaminated clothing before entering public areas
Appearance: White, crystalline powder
Odor: Odorless
pH: 4.5 - 7.0 (10% aqueous solution)
Melting Point: 202°C (396°F) (with decomposition)
Boiling Point: Not applicable
Solubility: Readily soluble in water (18g/100ml at 25°C), insoluble in ethanol/ether/chloroform
Density: Around 1.53 g/cm³
Vapor Pressure: Not relevant
Flammability: May form combustible dust concentrations in air
Explosive Properties: Dust-air mixtures can explode under certain conditions
Other: Stable under recommended storage conditions
Chemical Stability: Stable under normal temperature and pressure, no significant decomposition when stored as specified
Reactivity: Generally unreactive, but incompatible with strong oxidizers and acids
Hazardous Reactions: Dusts can ignite or explode if exposed to heat, spark, or open flame
Decomposition Products: Carbon monoxide, carbon dioxide released on thermal decomposition
Conditions to Avoid: High heat, open flames, static discharge, high humidity, contact with incompatible materials
Acute Toxicity: Oral LD50 (rat): greater than 10,000 mg/kg, low toxicity
Routes of Exposure: Inhalation, ingestion, eye or skin contact
Symptoms: Dust contact may trigger minor eye irritation, mild cough if inhaled in high volumes, no severe outcomes expected for healthy adults
Chronic Effects: No evidence of carcinogenicity, mutagenicity, or reproductive toxicity based on current data
Medical Conditions Aggravated by Exposure: People with lactose intolerance could experience gastrointestinal upsets if ingested in large amounts
Other Effects: Sensitivity varies by individual, rare cases of allergies reported
Ecotoxicity: Considered non-toxic to aquatic and terrestrial organisms
Persistence and Degradability: Readily biodegradable in the environment, breaks down to water and carbon dioxide
Bioaccumulative Potential: Not expected to accumulate in living tissues
Mobility: Highly soluble in water, can travel if spillage escapes containment
Additional Information: No significant global environmental hazards reported
Waste Treatment Methods: Dispose of in accordance with local, regional, and national regulations for non-hazardous chemical waste
Unused Product Disposal: Can be disposed of as conventional waste unless contaminated
Contaminated Packaging: Rinse thoroughly before recycling or disposing, follow all suitable regulatory procedures
Other Considerations: Do not release to environment in large quantities, avoid dust emissions as best practice
UN Number: Not regulated for transport
UN Proper Shipping Name: Lactose Monohydrate
Transport Hazard Class: Not classified as dangerous for transport by air, sea, or land
Packing Group: Not applicable
Special Transport Precautions: Use sealed, labeled packaging to prevent moisture exposure or dust formation
Environmental Hazards: None designated
Safety, Health, Environmental Regulations: Not hazardous according to OSHA Hazard Communication Standard; not listed under SARA, CERCLA, or California Proposition 65
EU Regulations: Not classified as a hazardous chemical by EU Regulation (EC) No 1272/2008 (CLP) or REACH
Other Regulatory Data: Food-grade and pharmaceutical-grade lactose comply with relevant purity and safety benchmarks
Labeling Requirements: General product identification and safety labeling suffice, reference local requirements where stricter controls exist
