MSDS for Shandong Kunda Biotechnology Mecobalamin

1. Identification

Product Name: Mecobalamin
Other Names: Methylcobalamin, Vitamin B12 Methylated
SYNONYMS: MeCbl, Cobamamide, Methyl-B12
Manufacturer: Shandong Kunda Biotechnology Co., Ltd.
Product Use: Pharmaceutical ingredient, dietary supplement, feed additive
Contact Details: Kunshan Road, Zhangqiu, Shandong, China, service@kundabio.com
Emergency Phone: +86-531-81216166

2. Hazard Identification

GHS Classification: Not classified as hazardous under GHS
Label Elements: Not required
Signal Word: None
Hazard Statements: Mecobalamin presents minimal acute or chronic health hazards under normal usage conditions
Precautionary Statements: Avoid dust formation, use personal protection, wash after use
Potential Health Effects: May cause slight irritation to eyes, skin, or if inhaled; very low toxicity if ingested
Environmental Hazards: No known significant effects

3. Composition / Information on Ingredients

Chemical Name: Mecobalamin (Methylcobalamin)
Formula: C63H91CoN13O14P
CAS Number: 13422-55-4
Content (%): Over 98% purity
Impurities/Decomposition Products: None significant at recommended use
Other Ingredients: Trace excipients, inert carriers (less than 2%)

4. First Aid Measures

Inhalation: Move person to fresh air, monitor breathing, get medical help if symptoms persist
Skin Contact: Remove contaminated clothing, wash skin thoroughly with water and soap
Eye Contact: Rinse eyes with plenty of water for several minutes, lift eyelids during flushing, seek medical attention if irritation develops
Ingestion: Rinse mouth with water, drink water if conscious, medical attention needed if large amounts consumed or symptoms appear
Acute/Delayed Effects: Irritation, allergy risk extremely low
Notes for Doctor: Treat symptomatically, support vital functions if needed

5. Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, CO₂, dry powder, foam
Fire Hazards: May produce toxic fumes (carbon oxides, nitrogen oxides, cobalt oxides) if burnt
Special Protective Equipment: Firefighters wear self-contained breathing apparatus and protective suit
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, cobalt compounds
Advice for Firefighters: Prevent water runoff from contaminating soil or groundwater, avoid inhaling combustion gases

6. Accidental Release Measures

Personal Precautions: Use personal protective equipment—gloves, eye protection, masks to avoid inhalation
Methods for Cleaning Up: Sweep up without creating dust, put in suitable containers, ventilate area
Avoid: Dispersing airborne particles, contact with skin, eyes, clothing
Environmental Precautions: Do not flush to sewer, prevent product entry into drains, waterways, or soil
Disposal: Use labeled waste containers following local waste regulations

7. Handling and Storage

Precautions for Safe Handling: Wear protective gear, wash hands after handling, avoid generating dust or airborne particles
Conditions for Safe Storage: Store in original, tightly closed containers
Storage Environment: Dry place, temperature 2–8°C, away from direct sunlight, incompatible chemicals, moisture
Safe Packaging Materials: Glass, polypropylene, high-density polyethylene
Avoid: Contact with oxidizers, acids, open fire, high humidity

8. Exposure Controls / Personal Protection

Occupational Exposure Limits: No established ACGIH, OSHA, or NIOSH limits for Mecobalamin
Engineering Controls: Adequate ventilation, local exhaust in mixing/processing areas
Personal Protective Equipment: Chemical safety goggles, lab coats, nitrile gloves, dust masks
Hygiene Practices: Wash thoroughly before eating, drinking, smoking, or leaving the workplace
Environmental Controls: Avoid discharge to waterways or open soil

9. Physical and Chemical Properties

Appearance: Crimson or dark red crystalline powder
Odor: Odorless
Molecular Weight: 1344.38 g/mol
Solubility: Soluble in water, insoluble in most organic solvents
pH (1% Solution): About 4.0–6.0
Melting Point: Decomposes before melting above 200°C
Vapor Pressure: Negligible at room temperature
Bulk Density: 0.5–0.65 g/cm³
Flash Point: Not applicable (non-flammable solid)
Auto-ignition Temperature: Not determined

10. Stability and Reactivity

Chemical Stability: Stable under recommended handling and storage conditions
Reactivity: Low; does not react with most materials during normal use
Hazardous Reactions: Avoid strong oxidizers, acids, alkalis
Conditions to Avoid: Excessive heat, direct sunlight, humidity
Decomposition Products: Toxic fumes (cobalt oxides, nitrogen oxides, carbon oxides) possible at high temperature
Polymerization: Will not occur

11. Toxicological Information

Acute Toxicity: Extremely low—oral LD₅₀ in rats reported as over 10,000 mg/kg
Skin/Eye Irritation: Rare reports of irritation, more common after prolonged/repeated exposure
Respiratory Sensitization: Negligible risk under normal workplace exposure
Carcinogenicity: Not listed by IARC, NTP, OSHA as carcinogen
Mutagenicity/Genotoxicity: Studies show no appreciable mutagenic risk
Chronic Toxicity: No evidence for long-term toxicity at expected doses in humans
Reproductive/Developmental Effects: No documented reproductive toxicity
Target Organs: None identified
Other Effects: Possible allergies in rare cases, especially with repeated massive overdosing

12. Ecological Information

Aquatic Toxicity: Low toxicity to aquatic organisms
Bioaccumulative Potential: Unlikely, given low persistence and quick breakdown in environment
Soil Mobility: Moderate; binds to soil but degrades by microorganisms
Persistence/Degradability: Biodegradable in typical waste treatment systems
Ecotoxicity Data: No significant adverse effects in common models reported
Other Environmental Effects: Not known to cause ozone depletion or other environmental hazards

13. Disposal Considerations

Waste Disposal Methods: Dispose of as non-hazardous organic pharmaceutical waste in accordance with local, national, and regional laws
Prevent Release: Avoid spillage into drains, water bodies, or open soil
Container Disposal: Rinse containers, recycle or dispose under local regulations
Sewage Disposal: Do not flush down toilets or into untreated sewer systems
Special Considerations: Packaging with residues must undergo proper treatment or disposal as pharmaceutical waste

14. Transport Information

UN Number: Not regulated as hazardous under UN transport regulations
Transport Hazard Class: None
Packing Group: None
Labeling Requirements: No danger labels necessary
Special Precautions: Keep away from moisture during shipping, pack to protect against physical damage
Mode of Transport: Suitable for air, sea, road, and rail—use standard materials for pharmaceuticals
Environmentally Hazardous Substance: Not regulated for bulk or packaged transport

15. Regulatory Information

International Status: Approved for use in food and pharmaceuticals in many regions
TSCA: Exempt as a food/nutrient
EU Regulation: Not classified under CLP; available as an additive per EU Pharmacopoeia
U.S. FDA: Authorized as a source of Vitamin B12
China Regulations: Listed for use by National Institutes and China Food and Drug Administration (CFDA)
Workplace Regulation: No exposure limits assigned, observe good manufacturing practice
Hazard Labelling: No requirement for hazard pictograms or GHS labeling for end users