Material Safety Data Sheet (MSDS) – Vegan Ferrous Gluconate Dihydrate USP/FCC

Identification

Product Name: Ferrous Gluconate Dihydrate Vegan Grade USP/FCC
Chemical Formula: C12H22FeO14·2H2O
Synonyms: Iron(II) gluconate dihydrate; Ferrous bis(D-gluconate) dihydrate
CAS Number: 299-29-6
Manufacturer: Supplier details provided upon request, address available for regulatory or safety review.
Recommended Use: Iron supplement in food, pharmaceuticals, fortification applications.
Restrictions: Avoid use outside regulated food and medical products.

Hazard Identification

Classification: Not classified as hazardous according to OSHA Hazard Communication Standard.
Signal Word: None
Pictogram: None
Routes of Exposure: Inhalation, eye contact, ingestion, skin contact.
Health Hazards: Eye or skin irritation possible. Ingestion in large quantities may be harmful due to iron toxicity.
Environmental Hazards: Low potential for environmental risk in small quantities. Bulk spills may create localized issues.
GHS Label Elements: Not regulated.

Composition / Information on Ingredients

Chemical Name: Ferrous Gluconate Dihydrate
Common Name: Iron(II) gluconate dihydrate
CAS Number: 299-29-6
Concentration: 100%
Impurities: Heavy metals (as Pb) < 0.001%, Arsenic < 0.0002%
Vegan Statement: Free from animal-origin materials, produced by plant-based fermentation and mineral sources.

First Aid Measures

Inhalation: Remove exposed person to fresh air. Seek medical advice if symptoms continue.
Skin Contact: Wash with plenty of water and soap. Remove contaminated clothing.
Eye Contact: Rinse immediately with clean water for 15 minutes. If irritation persists, consult a physician.
Ingestion: Rinse mouth. Do not induce vomiting unless directed by medical personnel. Urgent attention for high exposures.
Symptoms: May include stomach upset, irritation to sensitive skin, sore eyes.
Special Notes: Chronic ingestion may risk iron overload disorders.

Fire-Fighting Measures

Suitable Extinguishing Media: Use dry chemical, carbon dioxide, foam, or water spray.
Unsuitable Extinguishing Media: Heavy water streams if product is bulk powdered.
Hazardous Combustion Products: Iron oxides, carbon monoxide, carbon dioxide.
Protective Equipment: Firefighters should wear self-contained breathing apparatus and chemical resistant gear.
Special Hazards: Dust can aggravate respiratory tract. No risk of explosion documented.

Accidental Release Measures

Personal Precautions: Wear dust mask and gloves to avoid unnecessary contact.
Environmental Precautions: Prevent large spills from entering watercourses. Report significant spills to local authorities.
Cleanup Methods: Sweep up gently to avoid dust generation. Place material in approved waste containers.
Disposal: See local guidelines. Material is not listed as hazardous waste, but always handle with responsible disposal practices.

Handling and Storage

Handling: Use adequate ventilation. Avoid dust buildup. Minimize exposure by using proper protective equipment.
Storage Conditions: Store in a cool, dry location. Keep tightly closed in original packaging.
Incompatibilities: Strong oxidizing agents, acids.
Hygiene Practices: Clean hands after use. Separate food and chemical storage areas.
Storage Class: Standard chemical storage; not regulated for dangerous goods storage.

Exposure Controls and Personal Protection

Engineering Controls: Local exhaust ventilation recommended for bulk handling.
Personal Protective Equipment: Use chemical-resistant gloves, goggles, and dust respiratory protection when airborne particles might be present.
Occupational Exposure Limits: No OSHA PEL for ferrous gluconate. Nuisance dust: ACGIH TLV – 10 mg/m³ (inhalable), 3 mg/m³ (respirable).
Environmental Controls: Use containment to prevent environmental release in manufacturing settings.

Physical and Chemical Properties

Appearance: Light yellow to grey-green crystalline powder or granule
Odor: Odorless
Odor Threshold: Not applicable
pH (1% solution): 4.0 – 5.5
Melting Point: Decomposes above 100°C
Boiling Point: Not applicable, decomposes before boiling
Solubility: Freely soluble in water, insoluble in ethanol
Density: ~1.8 g/cm³
Partition Coefficient: Not determined
Vapor Density: Not relevant (non-volatile)
Evaporation Rate: Not relevant
Particle Size: Fine to moderate powder (varies by manufacturer)
Flash Point: Not flammable
Auto-ignition Temperature: Not self-igniting

Stability and Reactivity

Chemical Stability: Product is stable under recommended conditions.
Reactivity: Will react with strong oxidizers. Corrosive to metals in presence of moisture.
Hazardous Reactions: None expected in normal settings. Rapid oxidation possible if mixed with strong oxidizers.
Conditions to Avoid: Excessive heat, moisture, strong acids.
Incompatible Materials: Peroxides and strong acids.
Hazardous Decomposition Products: Carbon oxides, iron oxides.

Toxicological Information

Acute Toxicity: Oral LD50 (rat): >5000 mg/kg. Practically non-toxic via acute exposure.
Chronic Toxicity: May cause iron overload if consumed in high doses across long periods. Reports document risk for those with metabolic iron disorders.
Irritation: Minor skin or eye irritation possible on contact.
Inhalation: Inhalation of dust causes respiratory irritation.
Carcinogenicity: Not listed as carcinogenic by IARC, NTP, or OSHA.
Mutagenicity: No evidence found.
Reproductive Toxicity: No known reproductive hazards for intended use.
Routes of Entry: Ingestion, inhalation, skin and eye contact.

Ecological Information

Eco-toxicity: Iron compounds may temporarily cloud water and lower its quality if discharged in significant quantities.
Persistence and Degradability: Degrades naturally in the environment. Not expected to bioaccumulate.
Bioaccumulative Potential: Low. Iron binds readily to soils and sediments.
Mobility in Soil: Moderate—iron becomes immobilized in many soil types.
Aquatic Toxicity: Not acutely toxic at low concentrations, but chronic release may alter aquatic habitats.
Other Adverse Effects: Not classified as environmentally hazardous under standard protocols.

Disposal Considerations

Waste Disposal Methods: Dispose according to local, regional, and national regulations. Incorporate in permitted landfill or combustion facility if allowed.
Contaminated Packaging: Thoroughly rinse or clean before recycling or disposal. Follow standard industrial disposal policies.
Special Disposal Notes: Large bulk residues must not enter water systems without treatment.

Transport Information

UN Number: Not regulated
UN Proper Shipping Name: Not required
Transport Hazard Class: Not classified as dangerous for transport
Packing Group: None
Special Precautions: Secure containers to prevent spillage during handling. Keep dry during transit.
Environmental Hazards during Transport: None expected from standard handling.

Regulatory Information

TSCA Inventory: Listed
DSL/NDSL Status: Listed
FDA Status: Approved as a food additive and dietary supplement (21 CFR 184.1301).
REACH Status (EU): Registered or pre-registered as appropriate.
Proposition 65 (California): Not listed
Other Regulations: Not subject to specific labeling or handling restrictions beyond ordinary chemical good practice.
Workplace Classification: None required under U.S. OSHA HCS.