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 2 000 Lu & Lavallée, 1964
In experiments with guinea-pigs it was found that this colour has no
sensitizing activity (Bär & Griepentrog, 1960). Cats received daily
doses of 0.1 g/kg colour for seven days. No increase in Heinz bodies
was noted in the blood of test animals (Oettel et al., 1965).
Rat. This colour was fed to 21 rats at 0.1 per cent. in the diet for
184 days. No increased tumour incidence was observed. Eight rats which
survived for more than 400 days (432-683) showed no abnormality.
Twelve rats also received monthly subcutaneous injections of 2 ml of a
2.5 per cent. aqueous suspension of the colour. Six rats survived for
417-570 days. No tumours were seen at the site of injection (Umeda,
Rat. Eighty-five rats received this colour at 0.1 per cent. in their
diet. No increased tumour incidence was observed over their life-span.
Twenty rats, given one per cent. of the colour in their diet for two
years, showed no increased tumour incidence. Eleven animals died
before the end of the experiment DFG, 1957).
Groups of 20 male and 20 female rats or more were fed diets containing
0 ppm and one per cent. of the colour for two years. A similar test
group was formed from the first filial generation and was fed the one
per cent. level for a similar period. No deleterious effects appeared
in the test groups, and gross add 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).
The available long-term study in rats provides useful information and
does not indicate carcinogenic potential but the other toxicological
data are rather sparse.
One per cent. (= 10 000 ppm) in the diet equivalent to 500 g/kg
bodyweight per day.
Estimate of acceptable daily intake for man:
Temporary acceptance 0 - 1
Further work required by June 1974
Metabolic studies in several species, preferably including man;
two-year studies in a non-rodent mammalian species, and long-term
studies in the rat or another species.
Bär, F. & Griepentrog, F. (1960) Med. U. Ernär., 1, 9
Deutsche Forschungsgemeinschaft,.Farbstoff Kommission (1957)
Lu, F. C. & Lavallée, A. (1964) Canad. pharm. J., 97, 30
Oettel, H., Frohberg, H., Nothdurft, H. & Wilhelm, G. (1965) Arch.
für Toxikol., 21, 9
Umeda, M. (1956) Gann 47, 57