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EC number: 257-036-7
CAS number: 51181-50-1
In an extended oral OECD 422 study with DTPA-FeHNa male animals were exposed for at least 13 weeks and females for almost 14 weeks. At the high dose level the following effects were observed: soft faeces (both sexes), decreased body weight gain (males), prolonged prothrombin time (males), increased haemoglobin concentration (males), decreased ALAT activity and chloride concentration (males) and decreased ALP activity and increased relative weights of kidneys and liver (both sexes). No toxicologically relevant changes were observed at the lower levels of 500 and 150 mg/kg bw. See also st Discussion.
In a repeated inhalation toxicity with
DTPA-CaNa3 in rats only a mild, focal and reversible pulmonary
histiocytosis was induced. At a level of 0.42 mg/L (420 mg/m3), the
incidence and severity of the histiocytosis was comparable to that in
the chamber- and aerosol control group; this level, therefore, was
considered a NOAEC. Similar results are also expected for DTPA-FeHNa
(see also read across document in section 13).
With regard to EDTA-FeNa, in the key study
in which rats were administered NaFeEDTA via the food (Appel et al.,
2001), no toxicologically significant effects were observed. It can be
concluded from this study that the NOAEL is > 84 mg/kg bw/day. In the
studyby Yeung et al (2005) rats received EDTA-FeNa at a level of
1200 mg Fe per kg diet for up to 39 days. Taking into account a
consumption of ca. 25 g per day, and a mean weight of ca. 250 g during
the study, rats received 30 mg Fe per day or 120 mg Fe per kg bw per
day. This corresponds to: 421/56 x 120 = 900 mg EDTA-FeNa.3H2O per kg
bw/day. At this level no changes in growth rate were seen. Therefore,
the NOAEL most probably is much higher than 84 mg/kg bw day.
Similar results are expected for HEDTA-FeNa.
Based on a NOAEL of 500 mg/kg bw in a study
with DTPA-FeHNa in which male rats were treated for at least 13 weeks
and females for almost 14 weeks, and in view of all other studies
carried out with chelates and metal chelates (see also read across
document in section 13), no classification is needed for STOT repeated
exposure for HEDTA-FeNa.
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