Toxicological evaluation of some food additives including anticaking agents, antimicrobials, antioxidants, emulsifiers and thickening agents WHO FOOD ADDITIVES SERIES NO. 5 The evaluations contained in this publication were prepared by the Joint FAO/WHO Expert Committee on Food Additives which met in Geneva, 25 June - 4 July 19731 World Health Organization Geneva 1974 1 Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, Wld Hlth Org. techn. Rep. Ser., 1974, No. 539; FAO Nutrition Meetings Report Series, 1974, No. 53. OXYSTEARIN Explanation This substance has been evaluated for acceptable daily intake by the Joint FAO/WHO Expert Committee on Food Additives (see Annex 1, Ref. No. 20) in 1969. Since the previous evaluation, additional data have become available and are summarized and discussed in the following monograph. The previously published monograph has been revised and is reproduced in its entirety below. BIOLOGICAL DATA BIOCHEMICAL ASPECTS Analyses of diets and faeces of rats maintained for one month in diets containing 5 to 15% oxystearin, showed that 70% 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% oxystearin diet was 61 to 83% (Hodge, 1954). TOXICOLOGICAL STUDIES Acute toxicity 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). Short-term studies 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% oxystearin. No deaths occurred. Retarded growth rates were reported at the 20% 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% 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). Dog A single female dog tolerated a diet containing 25% 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 (Hodge, 1952). Groups each of four dogs (two of each sex) were fed diets containing 0, 0.25 and 2.5% oxystearin for one year. Observations included general condition, growth rate, food intake, urine analyses, haematologic indices of blood, organ weight and histopathology. All findings were negative (Hodge, 1954). Long-term studies Mouse 300 mg per week of oxystearin was administered to the skin of 38 mice in three doses for 75 weeks. The tumour index (% - weeks) was negative for a cotton-seed oil control, a 40% solution of oxystearin in cotton-seed oil, and a 40% unsaponifiable fraction of oxystearin in cotton-seed oil. The positive control methylcholanthrene had a tumour index of 89% (Horton, 1956). Rat Groups each of 100 rats (50 of each sex) were fed a diet containing 0, 0.5, 5.0 and 15.0% 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% 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 and protein. Haematological indices of blood were normal, with the exception of females at the 15% 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 and 15% 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, 1954). A three generation reproduction study in rats selected from the 0, 0.5 and 5% groups (16 females and eight 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). Comments: 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. EVALUATION Level causing no significant toxicological effect Rat: 50 000 ppm (5%) in the diet equivalent to 2500 mg/kg bw. Estimate of acceptable daily intake for man 0-25 mg/kg bw. REFERENCES Hodge, H. (1952) Unpublished report, Procter & Gamble Co. Hodge, H. (1954) Unpublished report, Procter & Gamble Co. Horton, A. W. (1956) Unpublished report, Procter & Gamble Co. Mattson, F. H. (1951) cited in Hodge, H. (1952) Unpublished report submitted by Procter & Gamble Co.
See Also: Toxicological Abbreviations Oxystearin (FAO Nutrition Meetings Report Series 46a) OXYSTEARIN (JECFA Evaluation)