INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF SOME
FOOD COLOURS, EMULSIFIERS, STABILIZERS,
ANTI-CAKING AGENTS AND CERTAIN
FAO Nutrition Meetings Report Series
No. 46A WHO/FOOD ADD/70.36
The content of this document is the result of the deliberations of the
Joint FAO/WHO Expert Committee on Food Additives which met in Rome,
27 May - 4 June 19691
Food and Agriculture Organization of the United Nations
World Health Organization
1 Thirteenth report of the Joint FAO/WHO Expert Committee on Food
Additives, FAO Nutrition Meetings Report Series, in press;
Wld Hlth Org. techn. Rep. Ser., in press.
No data available.
Animal Route LD50 Reference
mg/kg body weight
Rat oral 2000 Lu & Lavallée, 1964
In guinea-pigs it was found that this colour had no sensitization
activity (Bär & Griepentrog, 1960). Cats received daily doses of 0.1
g/kg colour for seven days. No increase in Heinz bodies in the blood
of the test animals was noted (Oettel et al., 1965).
This colour was tested for mutagenic effect in a concentration of 0.5
and 1.0 g/100 ml in cultures of Escherichia coli. No mutagenic
effect was found (Lück & Rickerl, 1960).
Rat. Groups of five male and five female rats were fed diets
containing 0., 0.25 per cent., 0.5 per cent., 1.0 per cent., 2.0 per
cent. and 5.0 per cent. for 90 days. No effect on body weight, food
intake, blood cell counts and organ weights were observed (Hansen et
Ten male and 10 female rats were given a total of 55 subcutaneous
injections of 1 ml of two per cent. aqueous solution over a period of
seven months, then observed until death. No local tumours developed
and total tumour incidence was less than in control groups given
similar injections of glucose or salt solution (Oettel et al., 1965).
Rat. Groups of 20 male and 20 female rats or more were fed diets
containing 0 and one per cent. of the colour for two years. A similar
test group was formed from the first filial generation and was fed at
one per cent. level for a similar period of time. No effect of the
diet was noted in the test groups and gross and microscopic
examination of the animals disclosed no changes attributable to the
test diet. There was no significant difference in tumour incidence
between the groups (Oettel et al., 1965).
Biochemical information is absent but an adequate long-term study is
available in the rat. No other species has been studied.
Level causing no toxicological effect in the rat
One per cent, (= 10 000 ppm) in the diet equivalent to 500 mg/kg body
Estimate of acceptable daily intake for man
mg/kg body weight
Temporary acceptance 0 - 1
Further work required by June 1974
Metabolic studies in several species preferably including man and a
two year study in a non-rodent mammalian species.
Bär, F. & Griepentrog, F. (1960) Med. u. Ernähr, 1, 99
Hansen, W. H, Wilson, D. C. & Fitzhugh, O. C. (1960) Fed. Proc., 19,
Lu, F. C. & Lavallée, A. (1964) Canad. pharm J., 97, 30
Lück, H. & Rickerl, E. (1960) Z. Lebensm.-Untersuch., 112, 157
Oettel, H, et al. (1965) Arch. für Toxikol., 21, 9