INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF SOME
FOOD COLOURS, EMULSIFIERS, STABILIZERS,
ANTI-CAKING AGENTS AND CERTAIN
OTHER SUBSTANCES
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.
HYDROXYPROPYL DISTARCH GLYCEROL
Modification is performed by the use of 0.1 per cent. epichlorhydrin
and 10 per cent. propylene oxide. Cross-linkage would be no greater
than expected on edification with 0.1 per cent. epichlorhydrin.
Substitution by treatment with 10 per cent. propylene oxide would
probably add no more than 15-20 ether linkages per 100 glucopyranose
units.
Biological Data
Biochemical aspects
None available.
Acute toxicity
None available.
Short-term studies
Rat. Groups of 25 male and 25 female rats were fed for 13 weeks on a
diet containing one per cent. and five per cent. of modified starch or
five per cent. of native starch. The general appearance and behaviour
of test rats was comparable with the controls. One male and one female
rat died at the lowest test level. Growth, feed consumption,
bodyweight haematology at one and three months, urinalysis at one and
three months, gross and histopathological findings were comparable in
all groups (Knapp, 1967a).
Dog. Three groups of four male and four female beagle dogs were
given in their diet one per cent, and five per cent. of modified
starch or five per cent. of native starch for 13 weeks. Haematological
studies, blood sugar, blood urea, serum GPT and alkaline phosphatase
as well as urinalysis were comparable for all groups. Appearance and
behaviour were normal. Body weight changes were unrelated to the
administration of the test substance. Gross and histopathology showed
no consistent abnormalities. Organ weights of thyroid, heart, liver,
spleen, kidneys, adrenals and testes showed no test-related changes
(Knapp, 1967b).
Long-term studies
None available.
Comments
No biochemical data are available on enzymatic hydrolosis or the fate
of the moiety containing propylene glycol radical. Metabolic studies
in man are desirable. The 90-day tests reveal no significant
abnormalities and are used as a basis for evaluation.
EVALUATION
Level causing no toxicological effect in the rat
Five per cent. (= 50 000 ppm) in the diet equivalent to 2500 mg/kg
body weight/day.
Estimate of acceptable daily intake for man
Temporary acceptance mg/kg body weight
0 - 12.5
Further work required by June 1972
Metabolic studies in several species.
REFERENCES
Knapp, W. A. jr (1967a) Report by Hazleton Laboratories Inc., 14th
April 1967 submitted by the International Latex and Chemical
Corporation
Knapp, W. A. jr (1967b) Report by Hazleton Laboratories Inc., 28th
February 1967 submitted by the International Latex and Chemical
Corporation