Registration Dossier
Registration Dossier
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EC number: 270-232-7 | CAS number: 68413-60-5
Endpoint summary
Administrative data
Description of key information
Based on read across, the data of very structurally related substances were used. In rats, the NOAEL of EDTA-FeNa was >= 84 mg/kg bw/day (61 days) and for DTPA-FeNaH (at least 13 weeks) 500 mg/kg bw/day.
Key value for chemical safety assessment
Additional information
There are no repeated dose studies available for the oral, dermal and inhalation route of EDTA-Fe(NH4)NH4OH. However, data obtained via oral apllication were available for the structurally-related compounds EDTA-FeNa and DTPA-FeNaH.
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. The NOAEL for DTPA-FeNaH was 500 mg/kg bw/day. In the study by 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.
Justification for classification or non-classification
As the NOAEL for the structurally related compounds EDTA-FeNA and DTPA-FeNaH was in excess of 100 mg/kg bw, no classification is needed for STOT RE 1 or 2.
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