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EC number: 231-096-4
CAS number: 7439-89-6
Further elucidation of the justifications above is provided in the
various endpoint summaries that are presented in this chapter, in
particular the endpoint summary of IUCLID Section 7.1 and
The establishement of a DNEL for long term oral exposure of the general
population is discussed below.
No extrapolation from animal studies is possible, because experimental
animals, in particular rats, differ strongly in the regulation of iron
homeostasis and, as a result, are much more prone to become overloaded.
Overload-related adverse effects in humans after oral exposure are only
observed in relation to pathological conditions.
A number of human studies were concerned with the iron status. Several
indicators of iron homeostasis were followed during a period of iron
supplementation. It is hard to interpret these studies in terms of oral
iron hazard assessment. Important questions are: Are the endpoints
reflecting adverse effects, or do they just indicate the adaptation of
iron status to the changing intake levels? How reliable is serum
ferritin as an indicator of total amount of stored iron? How are the
results affected by the nutritional and pathological history of the
It is clear that an additional 10 mg of absorbable iron
(iron(II)sulphate) per day over a long period in iron replete subjects
has no effect on serum ferritin. One study shows that 50 mg of
absorbable iron had hardly any effect on serum ferritin, while another
study did not yield hepatotoxicity and hematotoxicity after 21 days of
1.8 g of carbonyl iron per day in iron deplete women.
The amount of iron absorbed from metallic iron, in particular when the
particles are large, will be lower than the amount absorbed from soluble
substances like iron(II)sulphate. It was demonstrated in one study that
1.8 grams of iron carbonyl resulted in the absorption of only in 1.5
times the amount absorbed from the 0.180 g of iron(II)sulphate. This
difference in absorption rate is confirmed in other studies. A review
states that the "average relative bioavailability" of carbonyl iron in
humans compared to iron(II)sulphate is 5 -20%. A much lower absorption
of iron from carbonyl iron than fron iron(II)sulphate is demonstrated in
a study that used radiolabelled iron.
These results show that the earlier mentioned value of 10 mg/day for
absorbable iron can be multiplied by a factor of at least 5 for metallic
iron. Thus it is concluded that a long-term oral dose of 50 mg carbonyl
iron represents a worst-case, and should be used as a DNEL. Assuming a
body weight of 70 kg, this value equals 0.71 mg/kg bw/day.
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