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Material Safety Data Sheet for Calcitriol

Identification

Product Name: Calcitriol
Chemical Name: 1α,25-dihydroxyvitamin D3
Synonyms: 1,25-Dihydroxycholecalciferol, Rocaltrol
Molecular Formula: C27H44O3
Molecular Weight: 416.64 g/mol
CAS Number: 32222-06-3
Intended Use: Pharmaceutical active ingredient, laboratory reagent
Manufacturer/Supplier: Pharmaceutical manufacturers, research suppliers
Emergency Contact Number: Refer to company Emergency Response Center

Hazard Identification

Hazard Class: Toxic if swallowed, may cause damage to organs through prolonged or repeated exposure
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Health Hazards: Hypercalcemia, nausea, vomiting, loss of appetite, headache, constipation, weakness
Chronic Effects: Long-term overdoses may result in bone pain, kidney stones, renal impairment
Physical Hazards: No significant physical hazards under normal handling
Label Elements: Danger: Toxic if ingested or absorbed, may cause serious health effects if not handled properly
Signal Word: Danger

Composition / Information on Ingredients

Substance: Calcitriol
Chemical Formula: C27H44O3
CAS Number: 32222-06-3
Content: >99% purity as an active pharmaceutical ingredient
Impurities: Contains negligible levels of process and degradation-related byproducts
Additives: None unless in formulated products, in which case refer to product label

First Aid Measures

Inhalation: Remove person to fresh air, seek medical advice if symptoms develop
Skin Contact: Remove contaminated clothing, wash affected skin thoroughly with soap and water
Eye Contact: Rinse eyes cautiously with water for several minutes, remove contact lenses if present and easy to do, seek medical attention if irritation persists
Ingestion: Rinse mouth with water, do not induce vomiting, seek immediate medical attention
Symptoms: Nausea, vomiting, abdominal pain, confusion, weakness, potential cardiac arrhythmias if overdose occurs
Medical Attention: Seek urgent care for any persistent symptoms, monitor calcium levels for suspected overdose

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Unsuitable Extinguishing Media: No restrictions on media for small quantities
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, possibly toxic fumes
Protective Equipment: Firefighters require self-contained breathing apparatus and protective clothing
Fire Hazards: Fine dust can form explosive mixtures with air
Special Procedures: Move undamaged containers from fire area, cool containers with water

Accidental Release Measures

Personal Precautions: Use protective gloves, goggles, and dust mask, avoid contact with skin, eyes, and clothing
Environmental Precautions: Prevent entry into drains, surface and groundwater, minimize release to the environment
Methods for Cleanup: Ventilate the area, collect spilled material with suitable absorbent material, use common laboratory spill kits
Disposal: Place collected material in appropriate waste container for disposal according to local regulations
Avoid: Generating dust, eating and drinking in contaminated areas

Handling and Storage

Handling: Work in a well-ventilated space, avoid direct contact, wear protective clothing
Hygiene Practices: Wash hands thoroughly after handling, do not eat, drink, or smoke during use
Storage Conditions: Store refrigerated between 2-8°C, protected from light and moisture, in tightly closed containers
Incompatibilities: Strong oxidizing agents, acids, and bases
Safe Transfer: Avoid creating dust or aerosols, use proper lab techniques for weighing and dispensing

Exposure Controls and Personal Protection

Occupational Exposure Limits: Not established for pure calcitriol; handle as hazardous pharmaceutical ingredient
Engineering Controls: Use chemical fume hood, local exhaust ventilation, or closed systems
Respiratory Protection: Wear NIOSH-approved dust mask or respirator if airborne particles are present
Eye Protection: Chemical safety goggles with side shields
Skin Protection: Disposable gloves, laboratory coat, closed footwear
General Safety: Wash hands after contact, keep away from food, maintain good workplace hygiene

Physical and Chemical Properties

Physical State: White to off-white crystalline powder
Odor: Practically odorless
Melting Point: 116-120°C
Solubility: Soluble in ethanol, chloroform, lipids; practically insoluble in water
pH: Not determined (insoluble in water)
Partition Coefficient: High lipid solubility
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Not determined
Flash Point: Not applicable
Density: Approx. 1.12 g/cm³
Stability: Sensitive to light, air, and heat

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Conditions to Avoid: Heat, light, exposure to air
Materials to Avoid: Strong acids, bases, oxidizing agents
Hazardous Decomposition Products: Carbon oxides, other unidentified toxic vapors
Polymerization: Will not occur
Special Sensitivities: Very sensitive to photodegradation and oxidative decomposition

Toxicological Information

Acute Toxicity: LD50 (oral, rat): <1 mg/kg, indicating high toxicity
Chronic Effects: Prolonged exposure may lead to hypercalcemia, nephrocalcinosis, psychiatric disturbances
Routes of Exposure: Oral, dermal, inhalation, parenteral
Symptoms of Overdose: Nausea, vomiting, diarrhea, dehydration, weakness, confusion, arrhythmia, increased thirst and urination
Carcinogenicity: No data supporting carcinogenic risk
Developmental Effects: Teratogenic in animal studies at high doses
Mutagenicity: Not mutagenic in standard assays

Ecological Information

Ecotoxicity: Not expected to be toxic to aquatic organisms in dilute concentrations, but improper disposal can cause harm
Persistence and Degradability: Degrades by photolysis and microbial action in soil and water over time
Bioaccumulation Potential: No significant bioaccumulation expected
Mobility in Soil: Low mobility when released to soil due to lipophilic nature
Other Adverse Effects: Potential disruption to aquatic environments if released in large quantities

Disposal Considerations

Waste Disposal Methods: Dispose of as hazardous pharmaceutical waste through licensed chemical disposal contractors
Contaminated Packaging: Dispose of containers via chemical waste streams after thorough decontamination
Environmental Cautions: Do not discharge into drains, surface waters, or soil
Local Regulations: Follow strict municipal, state, and national disposal guidelines for drugs and research chemicals
Preferred Methods: High-temperature incineration at approved facilities

Transport Information

UN Number: Not regulated under dangerous goods transport codes for lab scale quantities
Proper Shipping Name: Pharmaceutical product, non-hazardous for transport at dilute levels
Transport Hazard Class: None
Packing Group: None
Marine Pollutant: No
Special Transport Precautions: Protect from light, temperature extremes, and physical damage during transport
Labelling: Requires clear labelling if shipped in bulk or concentrated form for research or pharmaceutical use

Regulatory Information

OSHA Status: Considered hazardous due to toxicity in concentrated forms
TSCA Status: Not listed for commercial chemicals, intended only for research and pharmaceutical use
EPA Regulations: Subject to hazardous waste disposal regulations
FDA Status: Approved medication with specific prescription guidelines
WHMIS Classification (Canada): Toxic material
EU Regulations: Not classified as a substance of very high concern; subject to REACH limitations for handling
Other National Regulations: Subject to national pharmaceutical and environmental legislation