Toxicological evaluation of some food colours, thickening
    agents, and certain other substancse


    The evaluations contained in this publication were prepared
    by the Joint FAO/WHO Expert Committee on Food Additives which
    met in Geneva, 14-23 April 19751

    World Health Organization, Geneva 1975

    1 Nineteenth Report of the Joint FAO/WHO Expert Committee on Food
    Additives, Wld Hlth Org. techn. Rep. Ser., 1975, No. 576;
    FAO Nutrition Meetings Report Series, 1975, No. 55.

    The monographs contained in the present volume are
    also issued by the Food and Agriculture Organization
    of the United Nations, Rome, as
    FAO Nutrition Meetings Report Series, No. 55A

    ISBN 92 4 166008 2

    (C) FAO and WHO 1975



         Non-amidated pectin was evaluated for acceptable daily intake for
    man by the Joint FAO/WHO Expert Committee on Food Additives (see Annex
    1, Refs No. 20 and No. 33) in 1969 and 1973. Amidated pectin was
    evaluated in 1973 and 1974 (see Annex 1, Refs No. 33 and No. 35).

         Since the previous evaluation of amidated pectin, additional data
    have become available and are summarized and discussed in the
    following monograph addendum.



    Long-term studies


         Four groups of 10 male and 10 female rats were fed on diets
    containing 0%, 5%, 10%, or 15% pectin (21% amidated) for 90 days. No
    adverse effects were noted on general condition, behaviour and
    survival. Growth was slightly decreased at the 15% level and this
    finding was also noted in a range finding test using 20% pectin, in
    the diet. Some decrease in growth occurred inconsistently also at the
    10% dietary level. Food intake and food efficiency were not affected
    at any level. Haematological parameters showed no significant
    treatment related changes. Total serum protein and albumin were
    reduced at the 15% level but the other clinical biochemical parameters
    and urinalysis were essentially normal. Caecal weights were increased
    at all levels but in a dose-related manner. These findings are
    reminiscent of what is seen when high amounts of starch, modified
    starch or certain other carbohydrates are fed. Gross and
    histopathology were normal but a slight degree of hyperkeratosis of
    the fore-stomach in some males was seen at the 10% and 15% level but
    is probably not of toxicological significance (Til et al., 1972).

         Groups of 20 male weanling Wistar rats were fed diets of purina
    laboratory meal to which was added L.M. pectin (approximately 18%
    amidated) or pectin, N.F. at 10% of the diet. Control diets contained
    10% alphacellulose (alphacel). The rats were fed for two years. The
    diets were made isocaloric by supplementing the alphacel with dextrose
    assuming a caloric equivalent for pectin of 0.6187 cal/g. Mortality
    did not vary significantly between groups. Body weights for the pectin
    fed groups were similar but significantly less than that of the
    control animals. A comparison of grams of diet/kg body weight showed a
    slightly greater food utilization for the pectin fed groups. The

    controls, however, consumed more food and gained more weight. There
    was no significant difference in average organ to body weight ratios
    for adrenal, heart, kidney, liver and spleen. The testes/body of the
    pectin fed groups did not differ from each other but both were
    significantly larger than those of the control group. Blood chemistry,
    SGOT and SPGT done at sacrifice showed no abnormalities in the pectin
    groups. Gross examination at necropsy showed no unusual findings. Two
    tumours were noted in the control group and one in the amidated pectin
    group. All gross lesions and adrenal, heart, kidney, liver, lung,
    spleen and testes were examined histologically. No compound related
    effects were observed (Palmer & Jones, 1974; Abdul-Haj & Palmer,

         Wistar rats of the Center for Investigation and Medical Research
    at Marseille strain were administered 100 mg/kg body weight of 18.4%
    amidated pectin, daily in the synthetic diet of Lacassagne MABI.
    Feeding was ad lib. Group of 20 males and 20 females housed five to
    a cage were used. Controls consisted of an identical group of rats fed
    the basic synthetic diet. At this level of pectin in the diet there
    appeared to be no effects on growth and body weights of fed animals as
    compared to historic controls. Also, there appeared to be no effects
    on the serum of fed rats. Since many of the experimental details are
    lacking it is difficult to reconstruct the complete design of the
    study. It is clear, however, that tissues from 20 males and 20 females
    sacrificed at 24 months were studied histologically. Rats dying prior
    to termination of the study were also said to have been examined
    microscopically, however, no mention of such animals is made in the
    detailed pathology. The histopathology revealed no adverse effects on
    the stomachs or testes of fed males. It should be noted that these
    were very small rats. Only one male reached 640 g the remainder ranged
    from 210-420 g with seven of the rats weighing 270 g or less. The
    weight of the females at sacrifice was similar to the males. A first
    generation produced by mating 10 animals produced a total of 21
    offspring and a second generation produced by mating five animals
    resulted in only 18 offspring (Mosinger, 1974).


         There are three studies with amidated pectin available for
    evaluation. Neither of the two long-term studies was considered
    adequate. There were no major adverse findings noted.


    Level causing no toxicological effect in the rat

         5% in the rat equivalent to 2500 mg/kg body weight.

    Estimate of acceptable daily intake for man

         0-25 mg/kg body weight.*


    Required by 1980.

    (1)  Adequate reproduction and embryotoxicity studies including
    teratology studies in rats.

    (2)  Adequate long-term study in a rodent species.


    Abdul-Haj & Palmer, G. H. (1974) Two-year pectin feeding study:
         histopathological studies. Unpublished report from Sunkist
         Growers, Inc. submitted to the World Health Organization by
         Sunkist Growers, Inc.

    Mosinger, M. (1974) Experimentation d'epreuve concernant les effets de
         l'administration orale prolongée du produit pectine L.M. NST de
         la Societé Unipectine SA. Unpublished report from the "Centre
         d'explorations et de recherches medicales", Marseille, submitted
         to the World Health Organization by the International Pectin
         Producers Association

    Til, H. P., Seinen, W. & de Groot, A. P. (1972) Sub-chronic (90-day)
         toxicity study with two samples of pectin (Mélange A2 and C2)
         in rats. Unpublished report from Centraal Instituut voor
         Voedingsonderzoek TNO submitted to the World Health Organization
         by the Inst. Eur. des Ind. de la Pectine

    Palmer, G. H. & Jones, T. R. (1974) Two-year pectin feeding study.
         Unpublished report from Sunkist Growers, Inc. submitted to the
         World Health Organization by Sunkist Growers, Inc.


    *    Temporary.

    See Also:
       Toxicological Abbreviations
       Pectin (amidated) (WHO Food Additives Series 6)