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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Epidemiological data

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Administrative data

epidemiological data
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication, reasonably documented, acceptable for assessment

Data source

Reference Type:
Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the Tolerable Upper Intake Level of Iron (Request N° EFSA-Q-2003-018)
EFSA European Food Safety Authority
Bibliographic source:
The EFSA Journal 125:1-34.
Report date:

Materials and methods

Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
review of the information available on the absorption of iron and its toxicity

Test material

Constituent 1
Reference substance name:
EC Number:
EC Name:
Cas Number:
Constituent 2
Reference substance name:
iron element
iron element

Results and discussion

A review of the information available on the absorption of iron and its toxicity has concluded that the evidence that suggests that luminal exposure to excessive iron plays a role in the development of colon carcinoma is limited and unconvincing. Few data are available for other cancers, and the evidence is unconvincing. Epidemiological associations between high iron intake and/or stores and increased risk of chronic diseases such as cardiovascular disease, type II diabetes and cancer of the gastrointestinal tract are not considered to provide convincing evidence of a causal relationship between iron intake or stores and such chronic diseases.

Any other information on results incl. tables

Justification for read-across

The surrogate material dissociates in physiological pH to the same species produced by the (iron III & II) salts after equilibration. As discussed in the category justification section, such equilibrium is quickly established. In result, iron species burden is assumed to be comparable to equimolar exposure within the iron category member salts.

Applicant's summary and conclusion