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    FAO Nutrition Meetings
    Resort Series No. 44A
    WHO/Food Add./68.33




    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
    1967


    alpha-IONONE

    Chemical name            alpha-Ionone

    Empirical formula        C13H20O

    Structural formula

    MOLECULAR STRUCTURE 11

    Molecular weight         192.30

    Definition               alpha-Ionone contains not less than 95 per
                             cent. of ketones expressed as C13H20O.

    Description              A colourless to pale yellow liquid having a
                             woody-violet odour.

    Biological Data

    Biochemical aspects

         This ketone is metabolized in the dog to 5-hydroxy-alpha-ionone
    (Prelog et al., 1951).

    Acute toxicity

                                                                       

    Animal        Route       LD50               References
                              (mg/kg 
                              body-weight)
                                                                       

    Mouse         i.p.        2277               Sporn et al., 1963

    Rat           oral        4590               Jenner et al., 1964
                                                                       

    Feeding 13-115 mg daily to rats for 5-9 days has been reported to
    cause fatty infiltration of liver parenchymal cells (Shillinger,
    1950).

    Short-term studies

         Rat. In a 90-day study on groups of 15 males and 15 females
    given either 0 or 11.5 mg/kg body-weight/day, no adverse effects were
    observed (Oser et al.,1965). Another study on groups of 10 males and
    10 females used a mixture of 65 per cent. alpha- and 40 per cent.
    -ionone at 0, 0.1, 0.25 and 1.0 per cent. of the diet for 17 weeks. A
    dose-dependent moderate swelling of liver parenchyma was noted which
    occurred to a very slight degree at the lowest level. No other adverse
    effects were seen (Hagan et al., 1967).

    Long-term studies

         None available.

    Comments

         There is some biochemical information available and this together
    with the short-term studies allows assessment. Further metabolic
    studies and long-term studies are needed.

    EVALUATION

    Level causing no toxicological effect

         Rat. 11.5 mg/kg body-weight/day equivalent to 230 ppm in the
    diet.

    Estimate of acceptable daily intake for man

                                         mg/kg body-weight

         Conditional acceptance               0-0.1

    Further work required

         Biochemical and metabolic as well as long-term studies, with
    special emphasis on effects on the liver.

    REFERENCES

    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), 327

    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,
    563

    Prelog, V., Wursch, J. & Meier, H. L. (1951) Helv. Chim. Acta, 34,
    859

    Shillinger, J. I. (1950) Gig. i. San., 3, 37

    Sporn, A., Schobesch, D., Manu, V., Panaitescu, E. L Runcanu, L.
    (1963) Igiena, 12, 437
    


    See Also:
       Toxicological Abbreviations
       Ionone, alpha- (WHO Food Additives Series 14)