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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

direct observations: clinical cases, poisoning incidents and other
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: Publication, reasonably documented, acceptable for assessment.

Data source

Reference Type:
secondary source
Safe Upper levels for Vitamins and Minerals
EVM; Expert Group on Vitamins and Minerals
Bibliographic source:

Materials and methods

Study type:
other: published review
Endpoint addressed:
other: establishment of safe limit for humans
Test guideline
no guideline available
Principles of method if other than guideline:
Review: with the aim of establishing a safe limit for human dietary exposure
GLP compliance:

Test material

Constituent 1
Reference substance name:
Iron sulphate
EC Number:
EC Name:
Iron sulphate
Cas Number:
iron(2+) sulfate
Test material form:
not specified
Details on test material:
Iron sulphate


Type of population:
Ethical approval:
not applicable
Route of exposure:

Results and discussion

Applicant's summary and conclusion

This published review aimed to establish safe upper levels for iron intake based on its biological function, extent of absorption, toxicity and effects of deficiency in humans.
Executive summary:

A review of the safety of vitamin and mineral supplements in food looked at: exposure to iron; the biological function of iron; iron deficiency; interactions with other metals; absorption and bioavailability; distribution, metabolism and excretion; toxicity. Guidance levels were established. The review reported average daily losses of 1.0 mg/day in healthy adult male humans, and 1.3 mg/day in pre-menopausal women. The acute doses were considered to be: 20 mg/kg for infants (under the age of six) by gastrointestinal irritation, with systemic effects not occurring below 60mg/kg bw; 200-300 mg/kg for children; 1400 mg/kg bw for adults. It was considered that there is not enough evidence to reach conclusions on specific links between iron and development of cancers.