INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
SUMMARY OF TOXICOLOGICAL DATA OF CERTAIN FOOD ADDITIVES
WHO FOOD ADDITIVES SERIES NO. 12
The data contained in this document were examined by the
Joint FAO/WHO Expert Committee on Food Additives*
Geneva, 18-27 April 1977
Food and Agriculture Organization of the United Nations
World Health Organization
* Twenty-first Report of the Joint FAO/WHO Expert Committee on Food
Additives, Geneva, 1977, WHO Technical Report Series No. 617
EVALUATION FOR ACCEPTABLE DAILY INTAKE
No data available.
Animal Route LD50 mg/kg Reference
Rat i.p. >1.0 mg Hecht, 1955
Rat i.v. >1.0 mg Hecht, 1955
The colour was tested for mutagenic effect in a concentration of
0.5 g/100 ml in cultures of E. coli. No mutagenic effect was seen
(Lück and Rickerl, 1960).
In studies with guinea-pigs no sensitization was seen (Bär and
Ten rats were given the colour at a level of 2% in drinking-water
for 171 days, with an observation period of 350 days. No tumours were
observed (Hecht, 1955).
A total of 64 male and female mice produced by mixed breeding
from five different strains were given a diet containing 1 mg per
animal per day of the food colour. Mice at the age of 50 to 100 days
were used. A number of the animals were sacrificed after an
observation period of 500 days and the survivors of the rest after
700 days. A total of 168 mice were used as negative controls.
Positive control groups which were given o-aminoazotoluene and
dimethylaminoazobenzene, were also included. In these groups the
formation of liver tumours was noted after approximately 200 days.
The incidence of tumours in mice receiving the colour was not
significantly greater than in the negative controls (Waterman and
Ten rats received a diet containing 2% of the colour in the diet
for 171 days. The daily intake was 1.5 g per kg body weight and the
total intake 51 g per animal. The observation period was 819 days. One
subcutaneous fibrosarcoma was found (Hecht, 1955).
Ten rats were given the colour at a level of 0.2% of the diet for
417 days. The average daily intake was 0.1 g/kg body weight and the
total intake amounted to 11 g per animal. The animals were kept under
observation for a total of 989 days. No tumours were observed (Hecht,
No tumours were induced when 10 rats were given subcutaneous
injections twice weekly of 0.5 ml of a 1% aqueous solution of this
colour for one year. These animals were kept under observation for
855 days (DFG, 1957).
Hecht (1955) In: DFG - Deutsche Forschungsgemeinschaft, Bad Godesberg,
Federal Republic of Germany, Farbstoff Kemmission (1957) Mitteilung 6
Lück, H. and Rickerl, E. (1960) Z. Lebensmitt.-Untersuch., 112,
Bär, F. and Griepentrog, F. (1960) Med. u. Ernähr, 1, 99
Waterman, N. and Lignac, G. O. E. (1958) as summarized by H. van
Genderen, Acta physiol, pharmacol, nerrly., 7, 35