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
CHOCOLATE BROWN FB
This material is known to be a complex mixture of dyes. The
Committee was unable to relate the available toxicological data to a
substance of defined chemical specifications.
EVALUATION FOR ACCEPTABLE DAILY INTAKE
No information available.
Animal Route (mg/kg bw) References
Mouse, male i.p. 220 (190-250) Gaunt et al., 1967
Mouse, female i.p. 210 (170-250) Gaunt et al., 1967
Rat, both sexes i.p. Approx. 250-500 Gaunt et al., 1967
Daily intubation of 1000 mg/kg for three weeks gave no signs of
intoxication (Gaunt et al., 1967).
Daily intubation of 2000 mg/kg gave no signs of intoxication
(Gaunt et al., 1967).
No ill effects followed ingestion by three weanling rats of an
0.1% solution for 28 days, daily intake of the dye was about 15 mg/rat
(Goldblatt and Frodsham, 1952).
In a 90-day study in four groups of 32 rats (16 males and
16 females) given dietary levels of 0, 0.3. 1 and 3% of the dye
(stated purity 81.8%) no departure from normality was seen with
respect to food consumption, haematology, liver and kidney function
and organ weights. A slight, but non-significant retardation of growth
was noted in males at the 3% level. Pathological examination revealed
presence of pigment in the Kupffer-cells of the liver at the 3% level,
and in the alimentary canal, lymph nodes and renal tubules at the 1%
and 3% levels (Gaunt et al., 1967).
Four groups of three male and three female pigs (large white
strain) received the dye (stated purity 81.8%) dietary for 16 weeks at
doses of 0, 25, 250 and 1000 mg/kg body weight/day. There were no
significant differences between the control and treated groups in body
weight gain, haematological examinations, urine analyses or organ
weight, except for a decrease in abs. weight of lungs in the males.
The effect attributable to treatment was a pigmentation of lymph nodes
in the pigs of the highest dose groups and in one female given
250 mg/kg/day; traces of pigment were also detected in some of the
macrophages in the lymph nodes of two males given 25 mg/kg/day.
Further pigmentation was detected in the mucosa of the alimentary
tract and in the lymphoid collections within it, in the pigs of
the highest dose group. The kidneys of one male pig receiving
1000 mg/kg/day were dark brown as a result of pigmentation of the
convoluted tubules (no extensive histopathological study was done)
(Butterworth et al., 1975).
Five groups of 50 male and 50 female mice (strain CFW) received
the dye (stated purity 81.8%) dietary for 80 weeks at doses of 0, 300,
1000, 3000 and 10 000 ppm. There were no dose-related effects on body
weight gain, haematology or organ weights, though there was a decrease
in abs. body weight of the males receiving 300 ppm and an increase in
relative weight of kidneys in the males receiving 300 and 10 000 ppm.
There was no evidence of any increase in tumour production in mice
given the dye. Pigment was found in the Kupffer-cells of the liver,
the phagocytic cells of the lymph nodes and spleen, the alveolar
macrophages of the lungs and the epithelial cells of the small
intestine in mice fed on diet containing 10 000 ppm of the dye (Gaunt
et al., 1973).
Five groups of 30 male and 30 female rats (strain CFE) were fed
for two years on diets containing 0, 1000, 3000, 10 000 or 30 000 ppm
of the dye (stated purity 81.8%). No effects attributable to treatment
were found in mortality, body weight gain, haematology, serum
chemistry, organ weights (except for a significant increase in
relative weight of spleen) or incidence of tumours. There was pigment
deposition in the renal tubular cells at dietary levels of 3000 ppm
and above. Pigment was also found in Kupffel-cells of the liver and in
cells of the lymph nodes, spleen and intestinal mucosa of a few female
rats at the 30 000 ppm level (Gaunt and Brantom, 1972).
Butterworth, K. R., Gaunt, I. F., Grasso, P. and Gangolli, S. D.
(1976) Short-term toxicity of chocolate Brown FB in pigs, Fd. and
Cosm. Toxicol., 14, 435-438
Gaunt, I. F., Hall, D. E., Farmer, M. and Fairweather, F. A. (1967)
Acute (mouse and rat) and shortterm (rat) toxicity studies on
chocolate Brown FB, Fd. and Cosm. Toxicol., 5, 159-164
Gaunt, I. F., Brantom, P. G., Grasso, P. and Kiss, I. S. (1973)
Longterm toxicity studies of chocolate Brown FB in mice, Fd. and
Cosm. Toxicol., 11, 375-382
Gaunt, I. F. and Brantom, P. G. (1972) Longterm feeding study on
chocolate Brown FB in rats, Fd. and Cosm, Toxicol., 10, 3-15
Goldblatt and Frodsham (1952) Unpublished report from ICI