Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 239-802-2 | CAS number: 15708-41-5
Endpoint summary
Administrative data
Description of key information
NOAEL is > 84 mg/kg bw/day for rats after 31/61 days of exposure via the food.
Key value for chemical safety assessment
Additional information
There are no repeated dose studies available for the dermal and inhalation route.
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 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. Therefore, the NOAEL most probably is much higher than 84 mg/kg bw day.
In two other oral repeated dose studies where NaFeEDTA was administered via the food (Sichuan Station, 1993; Su et al., 1999), the NOAEL was determined to be at least 640 and 250 mg/kg bw/day, respectively. However these studies were given a reliability rating of 4 (not assignable), since the only available information consisted of short inofficial English translations of the unpublished reports that were submitted to the WHO and that did not contain many details about conduct or results. The studies did not at all appear to have been conducted according to current standards. The concentrations of test material in the diet were not analytically confirmed. Also in the Su et al. study (1999), the effects observed in the lungs and intestines of high-dose rats may have been indicative of an underlying illness that may have exaggerated the effects of ferric sodium EDTA in this study.
Justification for classification or non-classification
As the NOAEL most probably is in excess of 100 mg/kg bw, no classification is needed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
