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Anhydrous Lactose Material Safety Data Sheet

Identification

Product Name: Anhydrous Lactose
Chemical Formula: C12H22O11
CAS Number: 63-42-3
Synonyms: Milk sugar, Anhydrous milk sugar
Manufacturer: Common pharmaceutical and food additive producers
Recommended Use: Pharmaceutical excipient, food ingredient, laboratory chemical
Contact Information: Refer to local supplier or manufacturer for specifics

Hazard Identification

GHS Classification: Not classified as hazardous under GHS
Label Elements: No signal word or pictogram required
Emergency Overview: White powder, dust may cause minor irritation to eyes and respiratory tract
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Environmental Hazards: Not expected to pose significant environmental risks
Chronic Effects: Some lactose intolerance symptoms with ingestion

Composition / Information on Ingredients

Chemical Name: Lactose
Concentration: 98.0% - 100% (by dry weight)
Impurities: Water (<0.5%), trace sugars, and minerals
Molecular Weight: 342.3 g/mol
Hazardous Components: None identified at typical concentrations

First Aid Measures

Inhalation: Move to fresh air, seek medical attention if coughing or irritation persists
Skin Contact: Wash with soap and water, seek care if irritation occurs
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if easy
Ingestion: Rinse mouth, drink water to dilute, seek help if discomfort develops
Symptoms: Possible coughing, mild irritation, gastrointestinal upset in those with intolerance

Fire-Fighting Measures

Suitable Extinguishing Media: Water, dry chemical, foam, carbon dioxide
Special Hazards: Dust can form explosive mixtures with air in confined spaces
Protection of Firefighters: Wear full protective gear and self-contained breathing apparatus
Thermal Decomposition Products: Carbon monoxide, carbon dioxide
Special Procedures: Keep containers cool, avoid generating airborne dust

Accidental Release Measures

Personal Protection: Use dust mask or respirator, gloves, and goggles
Spill Cleanup: Avoid raising dust, sweep up material and place in suitable container for disposal
Environmental Precautions: Prevent large quantities from entering waterways
Disposal: Follow local regulations for non-hazardous organic waste
Reference to Other Sections: Refer to sections on exposure controls and disposal for further guidance

Handling and Storage

Precautions for Handling: Avoid creating and inhaling airborne dust, ground all equipment to prevent static discharge
Storage Conditions: Store in a dry, cool, well-ventilated area, keep tightly sealed
Incompatibles: Strong oxidizers
Special Requirements: Use clean utensils and containers to reduce contamination risk

Exposure Controls and Personal Protection

Occupational Exposure Limits: No specific regulatory limits, but recommended TWA for nuisance dust is 10 mg/m3 (total) and 3 mg/m3 (respirable)
Engineering Controls: Use local exhaust ventilation in dusty environments
Personal Protection: Dust mask or respirator, safety glasses, gloves
Hygiene Measures: Wash hands before eating or drinking, remove contaminated clothing and wash before reuse

Physical and Chemical Properties

Appearance: White crystalline, odorless powder
Melting Point: 202 °C (decomposes)
Solubility: Soluble in water, practically insoluble in ethanol
pH (aqueous solution): Approximately 4.5 – 7.0
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Negligible at room temperature
Density: 1.545 g/cm3

Stability and Reactivity

Chemical Stability: Stable under normal storage and handling conditions
Reactivity: Not reactive with common materials
Conditions to Avoid: Heat, moisture, ignition sources, strong oxidizers
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide if heated or burned

Toxicological Information

Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: LD50 (oral, rat) > 10,000 mg/kg
Irritation: May cause mild eye, skin, or respiratory irritation
Sensitization: Not a known sensitizer
Chronic Effects: Repeated ingestion can affect individuals with lactose intolerance—bloating, gas, diarrhea possible
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, ACGIH, OSHA

Ecological Information

Ecotoxicity: Not expected to harm aquatic or terrestrial species
Persistence and Biodegradability: Readily biodegradable, breaks down via natural processes
Bioaccumulation Potential: None anticipated
Mobility in Soil: High solubility leads to rapid dispersion and degradation in water and soil
Other Adverse Effects: No significant environmental hazards identified

Disposal Considerations

Waste Treatment Methods: Dispose as non-hazardous organic waste
Contaminated Packaging: Rinse and recycle or dispose as appropriate
Regulatory Waste Status: Not regulated as hazardous waste under federal, state, or local guidelines
Best Practice: Use up product in intended application before disposal, follow local waste disposal requirements

Transport Information

UN Number: Not regulated
Transport Hazard Class: Not a dangerous good
Packing Group: Not classified
Environmental Hazards: Not regulated as a marine pollutant
Special Transport Precautions: Avoid spillage during transit, keep product dry to prevent clumping

Regulatory Information

United States: Not listed as a hazardous chemical by OSHA, TSCA listed, FDA GRAS status for certain uses
European Union: Included in EINECS/ELINCS, REACH registration not required for typical uses as food or pharma additive
Other International Listings: Complies with major pharmacopoeia standards (USP, EP, JP)
Workplace Exposure Limits: No specific legal limits, observe general dust exposure regulations
Safety, Health, and Environmental Regulations: No restrictions expected on use, handling, or disposal for common applications