FAO Nutrition Meetings
Resort Series No. 44A
TOXICOLOGICAL EVALUATION OF SOME
FLAVOURING SUBSTANCES AND
NON-NUTRITIVE SWEETENING AGENTS
Geneva, 21-28 August 1967
The Eleventh Report of the Joint FAO/WHO Expert Committee on Food
Additives is published as FAO Nutrition Meetings Report Series,
1967, No. 44; Wld Hlth Org. techn. Rep. Ser., 1968, 383. This
Report contains general considerations, including the principles
adopted for the evaluation, and a summary of the results of the
evaluations of a number of food additives. Additional information,
such as biological data and a toxicological evaluation, considered at
that meeting, is to be found in this document.
Food and Agriculture Organization of the United Nations
World Health Organization
Chemical name Isoamyl butyrate
Empirical formula C9H18O2
Structural formula CH3(CH2)2COOC5H11
Molecular weight 158.24
Definition Isoamyl butyrate contains not less than 98
per cent. and not more than the equivalent
of 101 per cent. C9H18O2.
Description A colourless liquid having a strong,
characteristic fruity odour. It is usually
prepared by esterification of isoamyl
alcohols with butyric acid.
There are no experimental data on this compound available.
Animal Route LD50 References
Rat oral 12 210 Jenner et al., 1964
Guinea-pig oral 11 950 Jenner et al., 1964
Rat. Groups of 10 male and 10 females were fed diets containing
0, 0.1, 0.25 and 1.0 per cent. ester for 16 weeks. No adverse effects
were noted on body-weight gain, food intake and general condition.
Haematological investigation and histological examination of all major
tissues revealed no abnormality, and the weights of the major organs
were comparable with those of the control group (Hagan et al., 1967).
This ester is probably hydrolyzed to amyl alcohol and butyric
acid. The short-term animal studies permit evaluation. Metabolic
studies are essential
Level causing no toxicological effect
Rat. 1 per cent. (= 10 000 ppm) in the diet, equivalent to 500
Estimate of acceptable daily intake for man
Conditional acceptance 0-5
Further work required
Biochenical and metabolic studies in animals and man.
Hagan, E. C., Hansen, W. H, Fitzhugh, O. G, Jenner, P. M., Jones, W.
I., Taylor, J. M., Long, E. L., Nelson, A. A. & Brouwer, J. B. (1967)
Fd Cosmet. Toxicol., 5(2), 141
Jenner, P. M., Hagan, E. C., Taylor, J. M., Cook, E. L. & Fitzhugh, O.
G. (1964) Fd Cosmet. Toxicol., 2, 327