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Product Name: Vitamin D3 Pharmaceutical Grade (Vd3)
Chemical Name: Cholecalciferol
CAS Number: 67-97-0
EC Number: 200-673-2
Recommended Use: Active pharmaceutical ingredient for use in vitamin supplements, fortification, and medical formulations
Supplier Details: Manufacturer address, emergency contact phone number, company email, hours of operation
Synonyms: Vitamin D3, Colecalciferol, Cholecalciferol
Classification: Acute toxicity (oral, dermal, inhalation); Reproductive toxicity Category 1B; Specific target organ toxicity (repeated exposure); Hazardous to aquatic environment (acute and chronic)
Signal Word: Danger
Hazard Statements: Toxic if swallowed; Suspected of damaging fertility or the unborn child; May damage organs through prolonged or repeated exposure; Very toxic to aquatic life with long lasting effects
Precautionary Statements: Avoid all unnecessary exposure. Do not breathe dust or vapors. Wash hands thoroughly after handling. Do not eat, drink, or smoke when using this product. Avoid release into the environment. Wear protective gloves, clothing, and eye protection as required.
Emergency Overview: Yellowish white, crystalline powder; may form dust; can irritate eyes, skin, respiratory tract; can be toxic if ingested in significant amounts.
Main Ingredient: Cholecalciferol (Vitamin D3) 98% and above
CAS Number: 67-97-0
Other Ingredients: Pharmaceutical excipients <1% (specific inert carriers such as lactose or starch, batch dependent)
Molecular Formula: C27H44O
Molecular Weight: 384.65 g/mol
Impurities: Unreacted starting materials or degradation products controlled below 0.5%
Ingestion: Seek medical attention immediately. Do not induce vomiting unless instructed. Rinse mouth with water.
Inhalation: Remove victim to fresh air. Keep at rest. Seek medical attention if symptoms persist.
Skin Contact: Remove contaminated clothing. Gently wash affected skin with plenty of soap and water. If irritation occurs, seek medical attention.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. Obtain medical advice if irritation persists.
Most Important Symptoms/Effects: Drowsiness, nausea, vomiting, headache, hypercalcemia, confusion
Advice for Physicians: Treat symptomatically; monitor electrolyte levels, particularly calcium.
Suitable Extinguishing Media: Use carbon dioxide, dry chemical powder, foam or water spray for large fires. Avoid high-pressure water jets.
Fire/Explosion Hazards: Combustible solid; dust may form explosive mixtures in air. Decomposition can produce carbon oxides and other toxic vapors.
Special Protective Equipment: Firefighters should wear full protective gear, self-contained breathing apparatus. Avoid inhaling combustion products.
Precautions: Move containers away from fire if safe to do so. Use water to keep fire-exposed containers cool. Prevent runoff from entering drains or watercourses.
Personal Precautions: Evacuate personnel from area. Avoid creating dust. Wear appropriate protective equipment including gloves, mask, goggles, and protective clothing.
Environmental Precautions: Prevent further leakage or spillage. Do not allow material into waterways or soil. Notify responsible authorities if product contaminates environment.
Methods for Clean-up: Do not sweep dry dust. Moisten with water to prevent dust formation. Collect spilled material using non-sparking tools and place in sealed containers for disposal. Clean with detergent and water. Ventilate area and wash spill site after material pickup complete.
Safe Handling: Keep containers tightly closed. Minimize dust generation. Use only in well-ventilated areas. Avoid breathing dust, vapor, or mist. Keep away from incompatible materials.
Hygiene Measures: Wash hands and any exposed skin thoroughly after handling. Remove contaminated clothing before entering eating areas.
Storage Conditions: Store in a cool, dry, well-ventilated room. Protect from light, heat, humidity, and oxidizing agents. Store in original container, tightly closed, away from food, feedstuff, and incompatible chemicals.
Incompatibilities: Strong acids, oxidizers, reducing agents, high temperatures.
Engineering Controls: Use local exhaust ventilation, containment, or other engineering controls to keep airborne levels below exposure limits.
Respiratory Protection: Use approved respirators if dust or aerosols are generated.
Eye Protection: Wear safety goggles with side shields.
Skin Protection: Suitable chemical-resistant gloves (nitrile or neoprene). Use protective lab coat or other appropriate clothing.
Exposure Limits: No specific occupational exposure limits established for Vitamin D3 as API, control dust levels as for nuisance dust.
Environmental Controls: Prevent product from entering drains, sewers, or watercourses.
Appearance: White to yellowish-white crystalline powder
Odor: Odorless or faint characteristic
Odor Threshold: Not available
pH: Not applicable (insoluble in water)
Melting Point: 83-86°C
Boiling Point: Not available (decomposes before boiling)
Solubility: Practically insoluble in water; soluble in ethanol, fats, and oils
Partition Coefficient: Log Kow: ~9.4
Relative Density: 0.95–1.0
Vapor Pressure: Negligible
Flash Point: >100°C
Self-ignition Temperature: Not self-igniting
Viscosity: Not applicable
Other Data: Stable under recommended conditions; light-sensitive
Chemical Stability: Stable under normal handling and storage conditions; decomposes in the presence of heat, light, and moisture.
Possibility of Hazardous Reactions: May react with strong oxidizers; avoid acids and alkalis.
Conditions to Avoid: Excessive humidity, sunlight, elevated temperature, dust formation.
Incompatible Materials: Strong acids, strong bases, oxidizing agents.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, toxic fumes, oxides of carbon.
Likely Routes of Exposure: Ingestion, inhalation, skin or eye contact
Acute Toxicity (Oral): LD50 (rat) ~10 mg/kg
Skin Corrosion/Irritation: May cause mild transient irritation
Eye Damage/Irritation: Mild eye irritant
Respiratory Sensitization: May cause irritation to respiratory system, particularly as dust
Chronic Toxicity: Long term overexposure can cause hypercalcemia, kidney stones, vascular calcification
Carcinogenicity: Not listed by NTP, IARC, OSHA
Reproductive Toxicity: Possible risk of harm to unborn child at high exposures
Target Organs: Kidneys, cardiovascular system, nervous system
Other Effects: Dermatitis on prolonged contact; gastrointestinal symptoms on ingestion
Ecotoxicity: Highly toxic to aquatic life in both acute and chronic exposure scenarios; should not be allowed to enter environment
Mobility: Low mobility in soil due to low water solubility
Persistence/Degradability: Persistence expected as breakdown in environment is slow; sensitive to sunlight (photodegradation) but not rapid in soil or water
Bioaccumulation: High potential due to lipophilicity (log Kow > 4)
Aquatic Toxicity Data: LC50 (fish, 96h): <0.1 mg/L (estimated)
Other Adverse Effects: No known ozone depletion or potential for vapor phase transport; accumulation in sediment possible
Product Waste: Dispose as hazardous pharmaceutical waste in accordance with local, national, and international regulations; do not dispose of through sewage systems
Contaminated Packaging: Empty containers should be triple rinsed and offered for recycling or disposal according to official regulations
Other Disposal Recommendations: Do not attempt to incinerate in open air; hand over to licensed waste disposal contractor; do not release to the environment
UN Number: UN3077
UN Proper Shipping Name: Environmentally Hazardous Substance, Solid, N.O.S. (contains Cholecalciferol)
Transport Hazard Class: 9 (Miscellaneous dangerous substances and articles)
Packing Group: III
Label: Environmentally Hazardous Substance
Marine Pollutant: Yes
Special Precautions: Avoid rough handling; keep dry and protected from sunlight; transport in compliance with regulations
US Regulations: FDA-regulated substance; SARA 313 not listed; not subject to TSCA listing as active pharmaceutical ingredient
EU Regulation: Classified under Regulation (EC) No 1272/2008 (CLP/GHS); REACH registration exemption as pharmaceutical
Labeling Requirements: Hazard pictograms, signal word, and hazard statements must be included on shipping containers
Workplace Safety: Handle according to Good Manufacturing Practices and local occupational health laws
Other Registrations: Country-specific premarket or registration required for medicinal use; included in pharmacy-only substance lists in many jurisdictions
