WORLD HEALTH ORGANIZATION
Toxicological evaluation of some food colours, thickening
agents, and certain other substancse
WHO FOOD ADDITIVES SERIES NO. 8
The evaluations contained in this publication were prepared
by the Joint FAO/WHO Expert Committee on Food Additives which
met in Geneva, 14-23 April 19751
World Health Organization, Geneva 1975
1 Nineteenth Report of the Joint FAO/WHO Expert Committee on Food
Additives, Wld Hlth Org. techn. Rep. Ser., 1975, No. 576;
FAO Nutrition Meetings Report Series, 1975, No. 55.
The monographs contained in the present volume are
also issued by the Food and Agriculture Organization
of the United Nations, Rome, as
FAO Nutrition Meetings Report Series, No. 55A
ISBN 92 4 166008 2
(C) FAO and WHO 1975
Gluconic acid has been evaluated for acceptable daily intake by
the Joint FAO/WHO Expert Committee on Food Additives (see glucono-
delta-lactone, Refs No. 13 and No. 35) in 1966 and 1974; iron ion has
been evaluated in the context of the evaluation of iron oxides and
hydrated iron oxides (Ref. No. 35) in 1974.
See reference 13, page 139; reference 35, pages 100 and 182.
Species Route mg/kg body weight Reference
Mouse Oral 3 700 ± 145 Hoppe, 1955
6 600 Anonymous, 1967
Rat Oral 4 600 ± 560 Hoppe, 1955
Guinea-pig Oral 2 100 Anonymous, 1967
Rabbit Oral 3 500 Anonymous, 1967
Dog Oral >2 200 Hoppe, 1955
Cats given doses of 100-1600 mg/kg for five days per week for two
weeks showed no toxic effects.
The therapeutic dose for the treatment of anaemia is 1.2-2.4 g
per day, long-term treatment is given at doses of 1 g/day.
Short-term studies )
) none available
Long-term studies )
Although there are no specific short-term and long-term studies
available on ferrous gluconate, the knowledge of its conversion into
ferrous iron and gluconate ion together with the observations from the
long-standing therapeutic use of ferrous gluconate in man at doses of
1 g or more per day, constitute a basis for evaluation. Nutritional
supplementation with iron has not been included in the consideration
of this compound.
Estimate of acceptable daily intake for man
Acceptable daily intake not specified. 1*
Anonymous (1967) Unpublished report submitted to the World Health
Organization by Pfizer, Ltd.
Hoppe, J. O., Agnew-Marcelli, G. M. & Tainter, M. L. (1955) An
experimental study of the toxicity of ferrous gluconate,
Am. J. Med. Sci., 230, 491-498
1 The statement "ADI not specified" means that, on the basis of
the available data (toxicological, biochemical, and other), the total
daily intake of the substance, arising from its use or uses at the
levels necessary to achieve the desired effect and from its acceptable
background in food, does not, in the opinion of the Committee,
represent a hazard to health. For this reason, and for the reasons
stated in individual evaluations, the establishment of an acceptable
daily intake (ADI) in mg/kg bw is not deemed necessary.
* However the contribution from ferrous gluconate to the total
dietary gluconic acid intake from all sources should be included in
the ADI of gluconic acid.