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.
No information available.
No information available.
Animal Route LD50 References
Mouse oral 25 g Tokita
Groups of 10 young rats were fed diets containing L-ascorbyl stearate
in concentrations providing 100, 200, 500, 1000 and 3000 mg/kg
body-weight for six months. No adverse effects were noted (Tokita).
No direct evidence is available on the long-term effects of L-ascorbyl
stearate. However, L-ascorbyl palmitate was fed to rats for two years
(Fitzhugh & Nelson, 1946), no adverse effects being noted at the 0.5
per cent. or 0.25 per cent. levels as determined by growth rate,
mortality and pathological examination. Food grade palmitic acid of
that time period normally contained significant amounts of stearic
acid as evidenced by a statement from a major United States producer
of fatty acids. It is a reasonable inference that the L-ascorbyl
palmitate used in the feeding study probably contained L-ascorbyl
For the assessment of this substance collateral evidence is provided
by the long-term study on the ascorbyl palmitate reviewed in the
evaluation of ascorbyl palmitate.1 The material investigated
contained 5-20 per cent. stearate. The adverse effects in relation to
bladder stone formation then observed (as reflected in the previous
lower ADI of ascorbyl palmitate) have been shown more recently to be
associated with the presence of claculi in the bladder of rodents. It
is therefore reasonable to allocate a higher ADI for both the ascorbyl
palmitate and ascorbyl stearate. Long-term studies in the rat using
well-defined individual compounds are desirable.
Level causing no significant toxicological effect in the rat
0.25 per cent. (= 2500 ppm) in the diet equivalent to 125 mg/kg
Estimate of acceptable daily intake for man
Unconditional acceptance 0 - 1.25a
Fitzhugh, O. G. & Nelson, A. A. (1946) Proc. Soc. exp. Biol., 61,
Tokita (undated) Unpublished report from Toho University, submitted
1 See 6th Report of the Joint FAO/WHO Expert Committee on Food
Additives (1962) Wld Hlth Org. techn. Rep. Ser., 228.
a As the sum of ascorbyl stearate or ascorbyl palmitate or both.