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 gamma-Undecalactone
Empirical formula C11H20O2
Structural formula CH3(CH2)6CHCH2CH2
O -- C = O
Molecular weight 184.28
Definition Gamma-Undecalactone contains not less
than 97 per cent. C11H20O2.
Description A colourless to yellow liquid having a
strong fruity odour suggestive of peach,
particularly upon dilution.
This lactose was found to be fairly resistant to ring-opening in
in vitro experiments using pancreatin or whole rat liver
homogenates. Only 30-70 per cent. was hydrolysed (Oser, 1967).
Animal Route LD50 Reference
Rat oral 18 500 Jenner et al., 1964
Feeding 13-115 mg per animal of gamma-undecalactone to rats for 5-9
days was said to produce fatty infiltration of liver parenchymal cells
Rat. In a 12-week feeding study on 15 males and 15 females,
using mixed compounds, slight growth and food efficiency depression
was noted at the 42.7 mg/kg/day level (Oser, 1967). Groups of 15 males
and 15 females were fed the lactose in their diet at 0 or 15.5
mg/kg/day for 90 days. No adverse effects were noted (Oser, 1967).
Rat. Groups of 20 males and 20 females were fed diets
containing 0, 0.1 and 0.5 per cent. undecalactone for 2 years. No
adverse effects were observed (Baer & Griepentrog, 1967).
The long-term study in rats compensates for the scanty
information on the metabolic fate of this compound and the evaluation
is based on this. Nevertheless, metabolic studies are desirable as
only one species has been investigated. Further studies in other
species are also desirable.
Level causing no toxicological effect
Rat. 0.5 per cent. (= 5000 ppm) in the diet, equivalent to 250
Estimate of acceptable daily intake for man
Unconditional acceptance 0-1.25
Baer, F. & Griepentrog, F. (1967) Med. Ehrnährung, 8, 344
Jenner, P. M., Hagan, E. C., Taylor, J. M., Cook, E. L. & Fitzhugh, O.
G. (1964) Fd Cosmet. Toxicol., 2, 327
Oser, B. L., Carson, S. & Oser, M. (1965) Fd Cosmet. Toxicol., 3,
Oser, B. L. (1967) Unpublished report
Shillinger, J. I. (1950) Gig. i San., 3, 37