INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF SOME
FOOD COLOURS, ENZYMES, FLAVOUR
ENHANCERS, THICKENING AGENTS, AND
CERTAIN FOOD ADDITIVES
WHO FOOD ADDITIVES SERIES 6
The evaluations contained in this publication were prepared by the
Joint FAO/WHO Expert Committee on Food Additives which met in Rome,
4-13 June 19741
World Health Organization Geneva 1975
1 Eighteenth Report of the Joint FAO/WHO Expert Committee on
Food Additives, Wld Hlth Org. techn. Rep. Ser., 1974, No. 557.
FAO Nutrition Meetings Report Series, 1974, No. 54.
No information available.
Special studies on mutagenicity
This colour was tested for mutagenic effect in a concentration of
0.5 g/100 ml in cultures of Escherichia coli. No mutagenic effect
was found (Lück et al., 1960).
Animal Route LD50 References
per kg bw
Rat Intraperitoneal > 2.0 g Deutsche Forsch.
Rat Intravenous approx. 2.5 g " "
Ten rats were given subcutaneous twice weekly 0.5 ml of a 1%
solution of the colour for 365 days. Total administrated quantity of
the colour was 0.5 g/animal. Observation period 521 days. Two animals
died during the experiment. No tumours were found (Deutsche Forsch.,
In experiments with guinea-pigs it was found that this colour had
no sensitization activity (Bär et al., 1960).
Nine cats were subjected to doses of a 5% aqueous solution
orally of 1 g on the first day and 0.1 g on the eighth and on the
nineteenth day. A negative test for Heinz bodies was obtained. There
was no appearance of Heinz bodies (Deutsche Forsch., 1957).
This colour was fed to 10 rats at a level of 0.2% in the diet for
417 days. The average daily dose was 0.1 g/kg bw and the total intake
11 g/animal and the total intake about 51 g per animal. Nine of the 10
animals lived to the end of the experiment, a total of 770 days. A
carcinoma possibly originating from the pancreas was observed in one
animal (Deutsche Forsch., 1957).
Thirteen rats were fed this colour at a level of 1% in the
drinking water for 176 days. The average daily dose was 1.4 g/kg bw.
The animals were kept under observation for 861 days. No tumours were
observed (Deutsche Forsch., 1957).
Eleven rats received subcutaneous injections twice weekly of
0.5 ml of a 1% solution for a period of 365 days, total administered
0.5 g/animal. The animals were kept under observation for 784 days.
Two died before the end of the experiment. A sarcoma in the
mediastinum was found in one animal (Deutsche Forsch., 1957).
Twelve rats were injected subcutaneously 40 mg of this colour
as a 4% solution thrice monthly until a total of 1.8 g had been
administered in 830 days. The animals were kept under observation for
840 days. A benign sweat-gland adenoma was observed in one animal
(Deutsche Forsch., 1957).
OBSERVATIONS IN MAN
Sensitivity reactions in people allergic to benzoates and aspirin
have been reported (Michaelson & Juhlin, 1973).
No information on metabolism is available on this colour. The
long-term studies with this colour aimed solely at discovering
potential carcinogenicity and therefore did not include the detailed
observations usually made in these tests. Only small numbers of
animals were used so that these tests are inadequate to assess long-
term toxicity. Information on reproductive effects and embryotoxicity
including teratogenicity is absent except for a teratology study in
mice. Sensitization in man has been reported after oral intake.
Adequate long-term studies in two species as well as reproduction,
embryotoxicity including teratogenicity studies would be needed before
this colour could be evaluated.
Not possible on the data provided.
Bär, F. & Griepentrog, F. (1960) Med. u. Ernähr., 1, 99
Deutsche Forschungsgemeinschaft, Bad Godesberg, Federal Republic of
Germany, Farbstoff Kommission (1957) Mitteilung 6
Lück, H. & Rickerl, E. (1960) Zeitschr. Lebensmittel-Untersuch., 112,
Michaelson, G. & Juhlin, L. (1973) Brit. J. Derm., 88, 525