Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication, reasonably documented, acceptable for assessment.

Data source

Reference
Reference Type:
secondary source
Title:
Safe Upper levels for Vitamins and Minerals
Author:
EVM; Expert Group on Vitamins and Minerals
Year:
2003
Bibliographic source:
http://www.food.gov.uk/multimedia/pdfs/vitmin2003.pdf

Materials and methods

Study type:
other: published review
Endpoint addressed:
other: establishment of safe limit for humans
Test guideline
Qualifier:
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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Iron sulphate

Method

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

Results and discussion

Applicant's summary and conclusion

Conclusions:
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.