Sodium iron EDTA

Whittaker E, Vanderveen JE, Dinovi MJ, Kuznesof PM, and Dunkel VC (1993) Toxicological profile, current use, and regulatory issues on EDTA compounds for assessing use of sodium iron EDTA for food fortification. Regulatory Toxicology and Pharmacology 18 419-427. 

Sodium iron III-ethylenediamine tetraacetatetrihydrate Ferric sodium edeteate sodium iron EDTA sodium feredetate Nutrient supplement (provisionally considered to be safe in food fortification programs) ADI acceptable... 

Calmosine CCRIS 6795 Edathamil monosodium ferric salt EINECS 239-802-2 Feredalo sodico Feredetate de sodium Ferisan Ferric sodium edetate Ferric sodium EDTA Ferrostrane Ferrostrene Monosodium ferric EDTA Natrii feredetas NSC 5237 Sequestrene Na Fe iron chelate Sequestrene NaFe Sodium feredetate Sodium ferric EDTA Sodium iron EDTA Sodium ironedetate Sybron Sytron. Used as a source of iron, a hematinic. Crystals. 

SODIUM IRON(III) ETHYLENEDIAMINETETRAACETIC ACID (SODIUM IRON EDTA) (addendum)... 

Sodium iron EDTA-fortified fish sauce. 135... 

Sodium iron EDTA-fortified whoie maize fiour. 139... 

At the request of the Codex Committee on Food Additives and Contaminants at its thirty-eighth session (Codex Alimentarius Commission, 2006), the Committee re-evaluated the safety of sodium iron(lll) ethyienediaminetetraacetic acid trihydrate (in short, sodium iron EDTA) as to its use for iron fortification. 

Sodium iron EDTA exists in the trihydrate form, as represented in Figure 1. 

Sodium iron EDTA was evaluated previousiy by the Committee. At its forty-first meeting (Annex 1, referenoe 107), the Committee was asked to provide an assessment of the safety of sodium iron EDTA for its use as a dietary suppiement in supervised food fortifioation programmes in popuiations in which iron deficiency anaemia is endemic. The Committee at that meeting was informed that use of iron... 

Figure 1. Chemical structure of sodium iron EDTA...

To study absorption, distribution and excretion of iron from sodium iron EDTA and iron(ll) sulfate, 24 male weanling Sprague-Dawley rats were first fed... 

Several studies with humans were conducted to assess the absorption and bioavailability of iron from meals fortified with sodium iron EDTA or other common forms of iron fortification. A few studies were performed to investigate whether addition of disodium EDTA to other iron fortificants improved iron absorption. Summaries of a number of these studies published after the fifty-third meeting of the Committee are presented below. 

The bioavailability of iron from meals based on corn tortillas and black bean paste fortified with iron(ll)fumarate with and without disodium EDTA, iron(ll) sulfate or sodium iron EDTA (as derived from mixing iron(lll) chloride with disodium EDTA in a 1 1 molar ratio of iron to disodium EDTA) was measured in a crossover study with 33 healthy Guatemalan girls (aged 12-13 years and weighing maximally 45 kg) via a stable isotope technique based on erythrocyte incorporation. The test... 

Following the same study design, 11 healthy infants (5 boys and 6 girls, 18-27 weeks old and weighing 5.5-8 kg) received an infant cereal (based on wheat flour and soy flour) fortified with 2 mg Fe from either radiolabelled sodium iron EDTA or iron(ll) sulfate, the latter plus added ascorbic acid (to optimize conditions... 

The acute oral toxicity of sodium iron EDTA was examined in one study in young male Sprague-Dawley rats (4-8 per dose) given the substance at a single dose of 5, 10, 12.5, 15, 20, 30 or 40 g/kg bw by gavage. The LDso was 10 g/kg bw (Whittaker et al., 2002). 

With and without metabolic activation (S9). Without S9, a positive response was seen only at 325 pg/ml (2.4-fold increase in mutation frequency), which also produced cytotoxicity (relative total growth, 33.5% of control). With S9, positive responses were observed at 1.625, 3.25 and 6.5 pg/ml (2.2-, 2.5- and 2.7-foid increases in mutation frequency, respectively), which also produced cytotoxicity (relative total growth, 53%, 38% and 19% of control, respectively). The Committee noted that other iron(ll) or iron(lll) salts also showed positive results at the higher (mostly cytotoxic) concentrations tested, whereas disodium EDTA, the non-iron-oontaining control substance for sodium iron EDTA, tested negative. 

Sodium iron EDTA-fortified whole maize flour... 

Table 2. Suggested maximum intakes of iron as sodium iron EDTA (as compared with RDA values for iron) and corresponding maximum intakes of EDTA...

In addition to the studies already evaluated by the Committee at its earlier meetings, several new studies on the biochemical and toxicological aspects and on the efficacy of sodium iron EDTA were submitted. 

The new data provided on the biochemical aspects following administration of sodium iron EDTA corroborate the findings from earlier studies, i.e. that... 

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