Diiron tris(sulphate)

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Publication, reasonably documented, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

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)

Author:

EFSA European Food Safety Authority

Year:

2004

Bibliographic source:

The EFSA Journal 125:1-34. http://www.efsa.europa.eu/fr/scdocs/doc/125.pdf

Report date:

2004

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

Test material information

Constituent 1

Reference substance name:

Iron

EC Number:

231-096-4

EC Name:

Iron

Cas Number:

7439-89-6

IUPAC Name:

iron(2+)

Constituent 2

Reference substance name:

iron element

IUPAC Name:

iron element

Results and discussion

Results:

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.