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.
Rats were injected i.v. and the bile collected for six hours. The
recovery of the colour was approximately 34 per cent. (30-45 per
cent.) of the administered quantity (Ryan & Wright, 1961).
Animal Route LD50 Reference
mouse oral 8000 Gaunt et al., 1967
i.p. >1750 approx. Gaunt et al., 1967
rat oral >8000 Gaunt et al., 1967
i.p. 2000 approx. DFG, 1957
female i.p. 2600 Gaunt et al., 1967
male i.p. 600 Gaunt et al., 1967
i.v. 1000 DFG, 1957
In experiments with guinea-pigs it was found that this colour had no
sensitization activity (Bär & Griepentrog, 1960). A negative test for
Heinz bodies was obtained after administering this colour in a five
per cent. aqueous solution by stomach tube to four cats (DFG, 1957).
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 & Rickerl, 1960).
Groups of 16 male and 16 female rats were fed diets containing 0, 0.5
per cent., 1 per cent. and 2 per cent. dye for 90 days. No adverse
effects were seen in appearance, behaviour, growth, food consumption,
haematological indices, SGPT and SGOT serum levels except at two per
cent. level, when females had slightly lowered transammiase values,
red cell counts and haemoglobin concentration. Renal function tests
and organ weights were normal. Gross and histopathology showed no
difference between the test groups (Gaunt et al., 1967).
Eleven rats were given 1.0 per cent. of the colour in their drinking
water for 216 days and observed for 791 days. Two animals died during
the experiment, one had a sarcoma of the liver (DFG, 1957).
Rat. Ten rats were given 0.2 per cent. of the colour in their diet
for 417 days. The total intake was 11g/animal. Observation extended
for 101 days. One rat died. No tumours were found (DFG, 1957).
Four groups of 10 male and 10 female rats were given diets containing
0, 0.03 per cent., 0.3 per cent. and 3.0 per cent. of the colour for
64 weeks. No effect was noted on mortality. Females at the highest
level had a lower food consumption throughout the experiment than the
controls with a significant decrease in body-weight at 16 and 64
weeks. In females the relative weights of heart, liver and kidney were
increased. No effects were found on histopathology and as regard
haemoglobin levels (Allmark et al., 1957).
Seventy-five rats were fed the colour at a level of 0.1 per cent. of
the diet. No tumours were observed. Similar results were obtained with
10 rats fed at 0.2 per cent. of the diet. Feeding extended for
Thirteen rats were given twice weekly s.c. injections of 0.5 ml of 1.0
per cent. of the colour for 365 days. Observation extended for 857
days. Five animals died during the experiment. No tumours were found
Several long-term studies have been performed in the rat. There is no
information on the metabolism of the colour. A short-term study in
pigs is in progress.
Level causing no toxicological effect in the rat
0.3 per cent. (= 3000 ppm) in the diet equivalent to 150 mg
Estimate of acceptable daily intake in man
Temporary acceptance mg/kg body-weight
0 - 0.75
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.
Allmark, M, G., Mannell, W. A. & Grice, H. C. (1957) J. Pharm.
Pharmacol., 9, 622
Bär, F. & Griepentrog, F. (1960) Med. u. Ernähr., 1, 99
Deutsche Forschungsgemeinschaft, Farbstoff Kommission (1957)
Gaunt, I. F. et al. (1967) Fd. Cosmet. Toxicol., 5, 187
Lück, H. & Rickerl, E. (1960) Z. Lebensmitt.-Untersuch., 112, 157
Ryan, A. J. & Wright, S. E. (1961) J. Pharm. Pharmacol., 13, 492