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.
Analyses of diets and feces of rats maintained for one month in diets
containing five to 15 per cent. oxystearin, showed that 70 per cent.
of the ingested oxystearin was absorbed. Liver lipids remained normal,
but carcass lipids showed decreasing iodine values, with increasing
dietary oxystearin (Mattson, 1951). In another experiment, utilization
of the ether soluble material at three and 15 months in rats
maintained on a 15 per cent. oxystearin diet was 61-83 per cent.
Rat. per os, intraperitoneally, LD50 have not been established.
Female rats were able to tolerate doses as high as 15 g/kg without any
marked ill-effects. (Hodge, 1952)
Rat. Groups each of 20 rats (10 of each sex) were maintained for 30
days on diets containing 0, 0.5, 2.0 and 20 per cent, oxystearin. No
deaths occurred. Retarded growth rates were reported at the 20 per
cent. level. Organ weights were normal. (Hodge, 1952)
In another study, groups of 20 rats (10 of each sex) were maintained
on diets containing 0, 0.15, 5, 10 and 15 per cent. oxystearin for one
month. There was no effect on weight gain or haematological indices of
blood. The weights of all organs were normal (Hodge, 1952).
Dogs. A single female dog tolerated a diet containing 25 per cent.
oxystearin for one month. Haematologic indices of blood were normal as
were urine sugar and protein. At autopsy, organ weights were within
normal limits and there were no compound related histological changes
Groups each of four dogs (two of each sex) were fed diets containing
0, 0.25 and 2.5 per cent. oxystearin for one year. Observations
included general condition, growth rate, food intake, urine analyses,
hematological indices of blood, organ weight and histopathology. All
findings were negative. (Hodge, 1954)
Mouse. 300 mg per week of oxystearin was administered to the skin of
38 mice in three doses for 75 weeks. The tumour index (per cent -
weeks) was negative for a cottonseed oil control, a 40 per cent.
solution of oxystearin in cottonseed oil, and a 40 per cent.
unsaponifiable fraction of oxystearin in cottonseed oil. The positive
control methylcholanthrene had a tumour index of 89 per cent. - 69
Rats. Groups each of 100 rats (50 of each sex) were fed a diet
containing 0, 0.5, 5.0 and 15.0 per cent. oxystearin for two years.
There was no indication that oxystearin shortened the life span.
Growth rate and food consumption was normal, with the exception of the
15 per cent. group, where there was a slight retardation in growth
during the first 90 days, but this difference had disappeared by the
end of the first year. Urine analyses gave normal values for sugar
protein. Haematological indices of blood were normal, with the
exception of females at the 15 per cent. level, where there was a
slight depression in haemoglobin and red blood cell counts. At
autopsy, organ weights were normal with the exception of liver weight,
at the 5 per cent. and 15 per cent. level. No histological changes
occurred in the liver or other organs and tissues examined that could
be related to the test substances. A study of femur length and
radiographs of these bones showed no effect on bone structure (Hodge,
A three generation reproduction study in rats selected from the 0, 0.5
and 5 per cent. groups (16 females and 8 males), showed that there
were no effects on reproductive performance as measured by number of
pregnancies, rats born, pups per litter, mortality 0-5 days, 6-12
days; and average weight at end of 21 days. Organ weights of the F3b
generation were within normal range; although organ/ body weight
ratios of test groups were greater than control, because of slightly
lower body-weight of these groups (Hodge, 1954).
Metabolic studies indicate that the fatty acids are absorbed and
utilized and there are adequate short-term and long-term studies
available for assessment. There is no evidence of accumulation of the
saturated fatty acids in the liver cells, although compositional
changes in body fat are reported. Provision is made in the
specification for limitation of epoxide content.
Level causing no significant toxicological effect in the rat
Five per cent. (= 50 000 ppm) in the diet equivalent to 2500 mg/kg
Estimate of acceptable daily intakes for man
Unconditional acceptance 0 - 25
Hodge, H. (1952) Unpublished report, Proctor & Gamble Co.
Hodge, H. (1954) Unpublished report, Procter & Gamble Co.
Horton, A. W, (1956) Unpublished report, Proctor & Gamble Co.
Mattson, F. H. (1951) cited in Hodge, H. (1952) Unpublished report
submitted by Procter & Gamble Co.