Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

basic toxicokinetics
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
The study was not peformed according to guideline or GLP. No data on test substance composition or purity. The retention of zinc and calcium was studied after food fortification, not the absoption of NaFe(III)-EDTA (as the data is used in a read-across approach, a maximal reliability score of 2 was attributed).

Data source

Reference Type:
Sodium iron EDTA [NaFe(III)EDTA] as a food fortificant: the effect on the absorption and retention of zinc and calcium in women
Davidsson, L., Kastenmayer, P., Hurrell. R.F.
Bibliographic source:
Am J Clin Nutr 60:231-7

Materials and methods

Test material

Constituent 1
Reference substance name:

Results and discussion

Applicant's summary and conclusion

Executive summary:

The iron fortifcant NaFeEDTA could have a potential negative effect on the metabolism of other minerals. We have used stable isotopes to monitor zinc and calcium metabolism in 10 women consuming a single meal of high-extraction wheat rolls (100 g flour) fortified with 5 mg Fe as either

FeS04 or NaFeEDTA. Six-day chemical balances were made simultaneously to study apparent zinc and calcium retention from the complete diet containing the differently iron-fortified breads (200 g flour; 10 mg added Fe/d). Mean 70Zn absorption from the bread meal increased from 20.9% with FeSO4 to 33.5% with NaFeEDTA (P < 0.05) whereas mean 44Ca absorption was 53.3% from both breads. When NaFeEDTA-fortified bread was consumed, there was a small but significant increase in urinary excretion of 70Zn and 44Ca. There was a similar small increase in urinary zinc excretion during the 6-d balance, although the apparent retention of zinc and calcium was not different. Thus, we found no negative overall effect of NaFeEDTA consumption on the metabolism of zinc and calcium. In contrast, the results suggest that NaFeEDTA added to low-bioavailability diets might increase zinc absorption as well as provide iron with high bioavailability.