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.
Stearyl citrate upon enzymic hydrolysis could give rise to stearyl
alcohol, and citric acid. There is evidence that this hydrolysis
readily occurs in the dog, and to a lesser extent in the rat (Calbert,
C. E. et al., 1951).
The effect of stearyl citrate on fat absorption and digestibility, and
the digestibility of the compound itself were studied in rats and
dogs. Four groups of eight - ten female rats were given 15 per cent.
margarine in the diet with or without addition of stearyl citrate at a
rate of five per cent. of margarine. Pat absorption after four and six
hours was unaffected by the presence of the additive. Three groups of
nine - ten female rats were fed 0.13 per cent., 2.5 per cent. and 10
per cent. stearyl citrate, margarine being added to bring the total
level of fat plus test substance to 25 per cent. of the diet.
Digestibility of fat was determined by eight-day balance studies; the
normal value of 95 per cent. was reduced respectively to 77 per cent.
and 71 per cent, at 2.5 per cent. and 10 per cent. level. The
digestibility of stearyl citrate was 55 per cent., 6 per cent. and 20
per cent., at 0.13 per cent., 2.5 per cent. and 20 per cent. level
respectively. Digestibility of fat in dogs was studied over 12 days in
two groups of three, one as control, the other with 3 per cent.
stearyl citrate in the diet. Normal fat digestibility was 95 per cent.
in the controls and 80 per cent. in the test diet, the digestibility
of stearyl citrate was 52 per cent. at 3 per cent. level (Calbert et
Animal Route LD50 Reference
Rat oral > 5400 Deuel et al., 1951
Dog oral > 5000 Deuel et al., 1951
Rat. Groups of 10 male and 10 female rats were fed diets containing
0 per cent., 1.3 per cent., 2.5 per cent., 5 per cent. and 10 per
cent, stearyl citrate for six weeks, There was no demonstrable effect
on growth (Deuel et al.,1951). In another experiment four groups, of
19 male and female weanling rats each, were fed for 10 weeks on a diet
containing unheated margarine, margarine heated continuously for eight
hours to 205°C., 0.86 per cent. stearyl citrate in similarly treated
margarine and 0.68 per cent. stearyl citrate potato chips fried in
margarine with this additive. Growth rates were identical in all four
groups (Deuel et al., 1951).
Three groups of 14 - 15 weanling rats were kept for ten weeks an a
diet containing 0 per cent., 1.9 per cent. and 9.5 per cent. stearyl
citrate, mated when 13 weeks old and continued on the same diet
throughout pregnancy and lactation. The second generation was weaned
at three weeks and treated like the parent generation. Studies were
continued to the weaning of the fifth generation. No deleterious
effects on litter size, fertility, lactation and body-weight on growth
of progeny were noted (Deuel et al., 1951).
Rabbit. Groups of eight rabbits received diets containing 0 per
cent., 2 per cent. and 10 per cent. stearyl citrate for six weeks.
There was no demonstrable effect on growth except for one animal which
lost weight during the early test when it failed to eat; this rabbit
began to regain its weight during the last week of the test. A
complete histopathological examination made on all eight rabbits of
the control and 10 per cent. stearyl citrate group showed no
pathological findings (Deuel et al., 1951).
Dog. Two groups of four animals each were fed 0 per cent. and 3 per
cent. stearyl citrate in the diet for 12 weeks. No difference in
weight gain was noted between controls and treated animals at four,
eight and 12 weeks. Haemoglobin levels at the end of the period were
practically identical for the two groups. Histopathological
examination of the livers and kidneys showed no pathological findings
(Deuel et al., 1951).
Rat. Groups of 10 male and 10 female rats were fed for two years on
diets containing 0 per cent., 0.5 per cent., 2 per cent. and 10 per
cent. stearyl citrate. From 55 per cent. to 65 per cent. survived in
the test groups compared with 44 per cent, in the control group. No
variations in weight gains were noted between test animals and
controls. A complete histopathological examination was carried out in
the animals which received 10 per cent. stearyl citrate. No specific
pathological findings were seen; there were metastatic calcification
and tumours not significantly different from the controls (Deuel et
Addition of this material to the diet reduces absorption of fat in the
rat and to a lesser extent in the dog. The compound itself is poorly
absorbed in the rat at levels above 0.5 per cent. of the diet and for
this reason the lowest level tested in the long-term study evaluated
has been selected as the basis of assessment. The short-term studies
are inadequate as regards absence of organ function tests and failure
to provide evidence on cumulation.
Level causing no significant toxicological effect in the rat
0.5 per cent. (= 5000 ppm) in the diet equivalent to 250 mg/kg
body-weight per day.
Estimate of acceptable daily intake for man
Temporary acceptance 0 - 1.25
Further work required by June 1972
Adequate short-term studies in two species (one a non-rodent mammalian
species); some of these studies should use combinations with hard
fats. Emphasis should be placed on evaluation of kidney function.
Calbert, C.E., Greenberg, S. M., Kryder, G. & Douel, H. J., Jr. (1951)
Rood Res., 16, 294
Deuel, H. J. Jr., Greenberg, S. M., Calbert, C. E., Baker, R. &
Fisher, H. R.(1951) Food Res., 16, 258