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Send EmailCalcium Disodium EDTA, Calcium Disodium Ethylene Diamine Tetra Acetate, Calcium Disodium Edetate, E385, Ca2Na EDTA, 62-33-9
Calcium Disodium EDTA (E385)
CAS Number: 62-33-9
Chemical Formula: C₁₀H₁₂O₈CaN₂Na₂·2H₂O (dihydrate)
Molecular Weight: 410.31 g/mol (dihydrate)
E Number: E385
Synonyms: Calcium Disodium Ethylenediamine Tetraacetate, Calcium Disodium Edetate, EDTA Calcium Disodium, Disodium Calcium EDTA, Calcium Disodium Ethylene Diamine Tetra Acetate, Edetate Calcium Disodium, Calcium Disodium Edathamil, Calcitetracemate, Calciumsodique édétate (French)
1. CHEMICAL IDENTITY
| Parameter | Information |
|---|---|
| Product Name | Calcium Disodium EDTA |
| IUPAC Name | Calcium disodium [[(ethylenedinitrilo)tetraacetato]] |
| CAS Number | 62-33-9 |
| Molecular Formula | C₁₀H₁₂O₈CaN₂Na₂·2H₂O (dihydrate) |
| Molecular Weight | 410.31 g/mol (dihydrate); 374.27 g/mol (anhydrous) |
| E Number | E385 |
| Chemical Class | EDTA Salt, Chelating Agent, Sequesterant |
| EC Number | 200-529-9 |
2. PHYSICAL PROPERTIES
| Parameter | Value |
|---|---|
| Physical State | Solid |
| Color | White to off-white |
| Appearance | Crystalline powder or granules |
| Odor | Odorless |
| Taste | Slightly salty |
| Melting Point | Decomposes above 250°C (no distinct melting point) |
| Density (20°C) | ~0.85 g/cm³ (bulk density) |
| pH (1% solution) | 6.5 - 7.5 (near neutral) |
| Moisture Content | 8.0 - 12.0% (as dihydrate) |
3. SOLUBILITY PROPERTIES
| Solvent | Solubility (20°C) |
|---|---|
| Water (cold) | Freely soluble (~10 g/100 mL) |
| Water (hot) | Very freely soluble |
| Ethanol (95%) | Practically insoluble |
| Acetone | Practically insoluble |
| Ether | Practically insoluble |
| Chloroform | Practically insoluble |
4. CHEMICAL STRUCTURE AND COMPOSITION
| Parameter | Description |
|---|---|
| Chelating Agent Type | Hexadentate ligand (6 coordination sites) |
| Central Ion | Calcium (Ca²⁺) |
| Counter Ions | Two Sodium (Na⁺) ions |
| Hydrate Forms | Dihydrate (major), trihydrate (minor) |
| Water Content | 8.0-12.0% (corresponds to approximately 2H₂O) |
| Active Chelating Capacity | Binds divalent and trivalent metal ions (Fe³⁺, Cu²⁺, Zn²⁺, Mg²⁺, Mn²⁺) |
Chemical Structure Note: EDTA molecule forms stable, water-soluble complexes with metal ions. In Calcium Disodium EDTA, one calcium ion is bound within the EDTA molecule, while two sodium ions serve as counterions. This structure allows the compound to exchange calcium for other heavy metal ions (such as lead), making it useful for chelation therapy and food preservation.
5. COMPOSITION AND SPECIFICATIONS
| Parameter | Specification | Method |
|---|---|---|
| Assay (dried basis) | 97.0 - 102.0% | Titration |
| Calcium Content | 9.0 - 10.5% | Titration/AAS |
| Sodium Content | 10.5 - 12.0% | Flame Photometry |
| Water (Karl Fischer) | 8.0 - 12.0% | Karl Fischer |
| pH (1% solution) | 6.5 - 7.5 | Potentiometric |
| Heavy Metals (as Pb) | Max. 10 ppm | AAS/ICP |
| Arsenic (As) | Max. 3 ppm | AAS |
| Lead (Pb) | Max. 5 ppm | AAS |
| Iron (Fe) | Max. 50 ppm | AAS |
| Nitrilotriacetic Acid (NTA) | Max. 0.1% | HPLC |
| Free EDTA | Max. 1.0% | Titration |
| Chloride (as Cl) | Max. 0.05% | Titration |
| Sulfate (as SO₄) | Max. 0.05% | Gravimetric |
6. FUNCTIONAL PROPERTIES IN FOOD SYSTEMS
| Function | Description |
|---|---|
| Chelating Agent (Sequestrant) | Binds metal ions (Fe³⁺, Cu²⁺, Zn²⁺, Mg²⁺, Mn²⁺) that catalyze oxidative reactions |
| Preservative | Prevents spoilage by removing metal ions required for microbial growth |
| Antioxidant (Synergist) | Works synergistically with antioxidants by chelating pro-oxidant metal ions |
| Color Stabilizer | Prevents discoloration caused by metal-catalyzed reactions in fruits and vegetables |
| Flavor Protector | Prevents off-flavor development from metal-catalyzed oxidation of fats and oils |
| Texture Preserver | Prevents texture degradation in canned foods |
| Clarifying Agent | Prevents haze formation in beverages |
7. APPLICATIONS - FOOD INDUSTRY
| Product Category | Function | Typical Use Level (mg/kg) |
|---|---|---|
| Canned Carbonated Soft Drinks | Flavor protection, color stability | 25 - 50 |
| Mayonnaise and Salad Dressings | Emulsion stabilization, oxidative protection | 50 - 100 |
| Pickled Vegetables (Cucumbers, Cabbage) | Color preservation, texture retention | 150 - 250 |
| Canned White Potatoes | Discoloration prevention | 50 - 100 |
| Canned Beans (Lima, Pinto, Red, Pink) | Color retention | 100 - 250 |
| Canned Mushrooms | Color stabilization | 100 - 200 |
| Canned Shrimp and Crab Meat | Color preservation, off-flavor prevention | 250 - 500 |
| Canned Clams and Mussels | Texture and color retention | 200 - 400 |
| Fermented Malt Beverages | Haze prevention, metal ion control | 25 - 50 |
| Sandwich Spreads | Emulsion stabilization | 100 - 200 |
| Potato Salad | Discoloration prevention | 50 - 100 |
| Pecan Pie Filling | Rancidity prevention | 100 - 200 |
| Hard Cooked Egg Products | Color and texture preservation | 200 - 400 |
| Processed Dry Pinto Beans | Color retention (rehydration) | 100 - 250 |
| Oleomargarine | Oxidative stability | 50 - 100 |
| Sauces and Relishes | Metal ion control | 50 - 150 |
8. APPLICATIONS - BEVERAGE INDUSTRY
| Beverage Type | Function | Typical Use Level (mg/kg) |
|---|---|---|
| Carbonated Soft Drinks (Cola, Citrus) | Flavor protection, color stability | 25 - 50 |
| Vitamin-Enriched Beverages | Protects vitamins (A, B, C, D, E) from metal-catalyzed degradation | 50 - 100 |
| Fruit Juices | Color preservation, haze prevention | 30 - 80 |
| Sports Drinks | Mineral stabilization | 30 - 60 |
| Flavored Waters | Flavor protection | 10 - 30 |
9. APPLICATIONS - OTHER INDUSTRIES
| Industry | Application |
|---|---|
| Pharmaceutical | Treatment of lead poisoning (chelation therapy), heavy metal detoxification |
| Cosmetics and Personal Care | Chelating agent in lotions, creams, soaps, shampoos, conditioners |
| Industrial | Water treatment, metal decontamination, textile processing, paper manufacturing |
| Diagnostic Medicine | Anticoagulant in blood collection tubes |
| Agricultural | Micronutrient stabilization in fertilizers |
10. MECHANISM OF ACTION IN FOOD PRESERVATION
| Problem | Mechanism | Solution with E385 |
|---|---|---|
| Oxidative Rancidity | Metal ions (Fe³⁺, Cu²⁺) catalyze lipid oxidation | Chelates metal ions, preventing catalysis |
| Enzymatic Browning | Polyphenol oxidase requires metal cofactors | Removes metal cofactors, inhibiting enzymes |
| Vitamin Degradation | Metal ions catalyze vitamin oxidation | Protects vitamins A, C, D, E |
| Color Fading | Metal-catalyzed pigment degradation | Stabilizes anthocyanins and other pigments |
| Haze Formation | Metal-polyphenol complexes precipitate | Prevents complex formation |
| Off-Flavor Development | Metal-catalyzed oxidation of flavor compounds | Protects sensitive flavor molecules |
11. REGULATORY STATUS - FDA (USA)
| Regulation | Information |
|---|---|
| 21 CFR 172.135 | Calcium Disodium EDTA as a food additive |
| GRAS Status | Approved for specified food categories |
| Maximum Use Levels | 25 - 800 mg/kg (depending on food category) |
FDA Approved Food Categories and Maximum Levels:
| Food Category | Maximum Level (ppm/mg/kg) |
|---|---|
| Pickled cabbage and cucumbers | 220 |
| Canned carbonated soft drinks | 33 |
| Fermented malt beverages | 25 |
| Canned white potatoes | 110 |
| Cooked canned clams | 340 |
| Canned crab meat | 275 |
| Dried lima beans | 310 |
| Legumes (beans, peas) | 310 |
| Pink beans | 310 |
| Red beans | 310 |
| Canned mushrooms | 200 |
| Canned shrimp | 250 |
| French dressing, salad dressing, relishes, sauces | 75 |
| Mayonnaise, oleomargarine, pecan pie filling, potato salad | 100 |
| Processed dry pinto beans | 800 |
| Sandwich spread, artificially colored lemon or orange flavored | 100 |
| Hard cooked egg products | 400 |
12. REGULATORY STATUS - OTHER REGIONS
| Region/Agency | Status | ADI / Maximum Limits |
|---|---|---|
| EFSA (Europe) | Approved as E385 | 75 - 250 mg/kg depending on food category |
| JECFA (UN/WHO) | Approved | ADI: 2.5 mg/kg body weight/day (established 1973) |
| UK Food Standards Agency | Approved (category "Others") | As per EU regulations |
| Food Standards Australia New Zealand | Approved (Code 385) | As per international standards |
| Health Canada | Approved | As per FDA similar limits |
| Türkiye (TGK) | Approved | As per EU regulations |
| Japan (MHLW) | Approved | As per local regulations |
EU Authorized Maximum Levels (selected examples):
| Food Category | Maximum Level (mg/kg) |
|---|---|
| Spreadable fats | 75 |
| Legumes, pulses, mushrooms, artichokes | 250 |
| Heat-treated meat products | 100 |
| Frozen and deep-frozen crustaceans | 75 |
| Canned and bottled fish, crustaceans, mollusks | 250 |
| Emulsified sauces | 75 |
13. SAFETY AND TOXICOLOGICAL PROFILE
| Parameter | Value |
|---|---|
| Acute oral toxicity (rat, LD₅₀) | >5,000 mg/kg (low toxicity) |
| Acute dermal toxicity (rabbit, LD₅₀) | >2,000 mg/kg |
| Acute inhalation (rat, LC₅₀) | >5 mg/L (4 hours) |
| Skin irritation | Non-irritating |
| Eye irritation | Mildly irritating |
| Skin sensitization | Not a sensitizer |
| ADI (JECFA) | 2.5 mg/kg body weight/day |
| ADI for 60 kg adult | 150 mg/day |
| Genotoxicity | Negative |
| Carcinogenicity | Not classified as carcinogenic |
| Reproductive toxicity | No evidence at approved levels |
| Mutagenicity | Negative |
14. POTENTIAL HEALTH CONCERNS
| Concern | Scientific Finding |
|---|---|
| Mineral Depletion (High Doses) | Large doses may chelate essential minerals (iron, zinc, copper) from the body |
| Acute Toxicity (Overdose) | Very high doses (>5,000 mg/kg) may cause vomiting, diarrhea, abdominal pain |
| Calcium Metabolism | Not a concern at approved food additive levels |
| Nephrotoxicity (Kidney) | Not observed at food additive levels (concern only for injected pharmaceutical use) |
| FDA/EFSA Conclusion | Safe for use as a food additive within approved limits |
| JECAF Statement (2023) | Re-evaluation ongoing; current ADI considered adequate |
Note: Calcium Disodium EDTA is generally recognized as safe (GRAS) when used according to good manufacturing practices. The primary difference from Disodium EDTA is that Calcium Disodium EDTA does not cause hypocalcemia (low blood calcium) when used in chelation therapy.
15. COMPARISON: CALCIUM DISODIUM EDTA vs. DISODIUM EDTA
| Property | Calcium Disodium EDTA (E385) | Disodium EDTA (E386) |
|---|---|---|
| CAS Number | 62-33-9 | 139-33-3 |
| Formula | C₁₀H₁₂O₈CaN₂Na₂ | C₁₀H₁₄O₈N₂Na₂ |
| Molecular Weight (anhydrous) | 374.27 g/mol | 336.21 g/mol |
| EU Food Approval | Approved (E385) | Not approved for food |
| FDA Food Approval | Approved (21 CFR 172.135) | Approved (21 CFR 172.120) |
| Medical Use | Lead poisoning treatment | Not used (causes hypocalcemia) |
| Calcium Content | Contains calcium | No calcium |
| Effect on Blood Calcium | No effect | May cause hypocalcemia |
| Primary Use | Food preservation, chelation therapy | Industrial chelating agent, some food uses |
16. PRODUCTION PROCESS
| Step | Description |
|---|---|
| Raw Materials | Disodium EDTA, calcium carbonate (limestone) or calcium chloride |
| Synthesis Reaction | Disodium EDTA + Calcium Carbonate → Calcium Disodium EDTA + CO₂ + H₂O |
| Purification | Crystallization, filtration |
| Drying | Controlled drying to dihydrate form |
| Milling/Granulation | Particle size reduction to powder or granulated form |
| Packaging | Sealed containers to prevent moisture absorption |
Raw Material Sources:
-
Disodium EDTA: Synthesized from ethylenediamine, formaldehyde, and sodium cyanide (followed by hydrolysis)
-
Calcium Carbonate: Naturally occurring mineral (limestone) - not from animal sources
17. STABILITY AND STORAGE
| Parameter | Requirement |
|---|---|
| Storage Temperature | 15-25°C (room temperature) |
| Humidity | Low humidity (<60% RH) |
| Container | Tightly closed (hygroscopic to some extent) |
| Light Protection | Not required (light-stable) |
| Shelf Life (proper storage) | 36 months |
| Signs of Degradation | Caking, discoloration (minimal under proper storage) |
| Special Precautions | Protect from excessive moisture; avoid strong oxidizing agents |
| Chemical Stability | Stable under normal conditions; decompose at >250°C |
18. ENVIRONMENTAL INFORMATION
| Parameter | Assessment |
|---|---|
| Biodegradability | Poor (EDTA compounds are persistent in the environment) |
| Ecotoxicity | Low to moderate; may chelate essential metals in aquatic systems |
| Bioaccumulation | Low potential |
| Wastewater Treatment | Not completely removed in conventional treatment plants |
| Photodegradability | Slow (requires UV light) |
| Environmental Precautions | Avoid large releases to water bodies; follows local regulations for disposal |
19. COMPATIBILITY WITH DIETARY RESTRICTIONS
| Restriction | Compatibility | Explanation |
|---|---|---|
| Vegan | Yes | Derived from mineral sources (limestone), not animal products |
| Vegetarian | Yes | No animal-derived ingredients |
| Halal | Yes | Permissible under Islamic law; meets Halal requirements |
| Kosher | Yes | Kosher pareve; meets all kashruth requirements |
| Gluten-Free | Yes | Does not contain wheat, rye, barley, or hybrids; meets FDA gluten-free definition |
| Dairy-Free | Yes | Calcium from limestone (mineral), not from dairy |
| Lactose-Free | Yes | No milk-derived ingredients |
| Allergen-Free | Yes | Free from major allergens (soy, nuts, eggs, etc.) |
20. SUMMARY AND CRITICAL INFORMATION
Description: Calcium Disodium EDTA (E385, CAS 62-33-9) is a multifunctional food additive that acts as a chelating agent, preservative, antioxidant synergist, color stabilizer, and flavor protector. It works by binding free metal ions (such as iron, copper, zinc, and manganese) that would otherwise catalyze oxidative reactions leading to food spoilage, discoloration, and off-flavors.
Key Advantages (Food Industry):
-
Effective chelating agent across wide pH range (3-10)
-
Prevents oxidative rancidity in fats and oils
-
Protects natural and synthetic colors from degradation
-
Preserves vitamins (A, B, C, D, E) in fortified beverages
-
Prevents haze formation in beverages
-
Extends shelf life of canned and processed foods
-
Approved by major global regulatory bodies (FDA, EFSA, JECFA)
Common Food Applications:
-
Carbonated soft drinks (cola, citrus)
-
Mayonnaise, salad dressings, sauces
-
Pickled vegetables (cucumbers, cabbage)
-
Canned beans, mushrooms, potatoes
-
Canned seafood (shrimp, crab, clams)
-
Processed egg products
-
Emulsified sauces and spreads
Safety Assessment:
-
FDA: GRAS (21 CFR 172.135)
-
EFSA: Approved as E385
-
JECFA: ADI 2.5 mg/kg body weight/day (established 1973)
-
Considered safe for use within approved limits
-
Large doses may cause mineral depletion (iron, zinc, copper)
Key Distinction from Disodium EDTA:
-
Calcium Disodium EDTA (E385) contains calcium; used in food and for lead poisoning treatment
-
Disodium EDTA contains no calcium; not approved for EU food use; can cause hypocalcemia
Critical Safety Note: Calcium Disodium EDTA is different from Disodium EDTA. Calcium Disodium EDTA is safe for human consumption at approved levels and is used medically for lead poisoning treatment. Disodium EDTA is not suitable for internal use as it can cause severe calcium depletion (hypocalcemia).
Dietary Compatibility: Suitable for vegans, vegetarians, halal, kosher, gluten-free, dairy-free, and lactose-free diets.
