The data contained in this document were examined by the
    Joint FAO/WHO Expert Committee on Food Additives*
    Rome, 3-12 April 1978

    Food and Agriculture Organization of the United Nations
    World Health Organization

    * Twenty-second Report of the Joint FAO/WHO Expert Committee on Food
    Additives, Geneva, 1978, WHO Technical Report Series No. 631



         This colour was evaluated at the Joint FAO/WHO Expert Committee
    on Food additives in 1964, 1972 and 1975. Since the previous
    evaluation, additional data have become available and are summarized


    Special studies on teratology


         A collaborative government-industry study was initiated to
    evaluate the teratogenic potential of amaranth which involved three
    laboratories: Food and Drug Administration (FDA), Industrial Bio-Test
    Laboratories (IBT) and the National Center for Toxicological Research

         Groups of 20 to 30 pregnant females received 200 mg/kg bw
    amaranth by gavage during days 0-19, 6-15 or 7-9 of gestation. Another
    group received amaranth at the same dose level in their drinking-water
    from day 0 to day 20. Appropriate controls were utilized. The 
    Osborne-Mendel strain of rat was used by FDA while IBT used Charles 
    River and NCTR both strains. The Charles River strain in the IBT and 
    NCTR studies showed a significant increase in litters with two or more
    resorptions after dams had been given 200 mg/kg by gavage from
    day 0-19. As well, a significant increase in the percentage
    resorption/litter was observed in this strain in the NCTR study. A
    significant increase in resorptions was not observed in the 
    Osborne-Mendel strain. There were no apparent compound-related skeletal
    or visceral effects (Collins et al., 1976a, 1976b; Keplinger et al.,
    1976; Holsen et al., 1976a, 1976b).


         Amaranth was administered daily by gelatin capsule to adult
    female cats at dose levels of 0, 92, 187 or 264 mg/kg bw extending
    from 22 days before gestation to day 61 or 62 of gestation. Seven
    trials commencing at time intervals of 10 to 38 days were conducted.
    Six trials contained 20 cats each and one contained 11 cats. The cats
    in each trial were assigned randomly to five groups, three groups were
    treated with amaranth and the remaining two groups served as controls.
    The pregnancies were timed by having controlled copulation of females
    that were in oestrus which occurred spontaneously or was stimulated by
    gonadotrophin. Caesarian section was performed on day 61 or 62 of
    gestation. No significant effects which could be related to the

    ingestion of this colour were observed with respect to total implants,
    ratio of corpora lutea to total implants, dead foetuses, deciduomas,
    live foetuses, 24-hour viability of live foetuses in an incubator,
    mean live foetal weight, sex ratio and foetal abnormalities (Khera et
    al., 1976).

    Special studies on mutagenicity

         Groups of 12 male mice were injected intraperitoneally with a 5%
    aqueous solution of amaranth at dose levels of 0, 250 or 500 mg/kg bw.
    Each male was then mated with three untreated females each week for
    six weeks. Females were killed one week after their removal from
    breeding cages and were examined for signs of pregnancy. The mating
    indices and mutation rates gave no indication of a dominant lethal
    response (Arnold et al., 1976).

    Short-term studies


         Groups of weanling rats were fed diets containing amaranth at
    levels of 0, 1200, 3000, 10 000 or 20 000 ppm for 10 days. The test
    and control groups contained nine and 12 rats/group respectively. All
    rats received 30 µg of vitamin A daily. No significant changes were
    observed in body weight, food consumption, liver weight and vitamin A
    content of the liver (Truhaut and Ferrando, 1975).

    Long-term studies


         Groups of 50 male and 50 female weanling rats were fed amaranth
    at 0, 0.003, 0.03, 0.3 or 3% (0, 1.5, 15, 150 or 1500 mg/kg bw) in the
    diet for approximately two-and-a-half years. The rats used in this
    study were randomly selected from the F2a litters of parents treated
    with amaranth. During the study certain animals were inadvertently
    placed in the wrong cages so that a number of animals were shifted
    among the control and treated animals. A variety of benign and
    malignant tumours was observed with no apparent differences between
    the treated and control groups. When the pathological data, however,
    were subjected to biostatistical analysis, a significant increase
    in the number of malignant tumours was observed in the female rats
    maintained at the 1500 mg/kg bw dietary level. There was no
    significant difference in the total number of tumours, both benign and
    malignant, between high dose and control animals. No compound-related
    effects were noted with respect to general condition, survival, body
    weight gain, haematology, clinical chemistry or relative organ weights
    (Gordon and Taylor, 1975).


    Arnold, D. W., Kennedy, G. L., jr, Keplinger, M. L. and Calandra, J.
    C. (1976) Failure of FD and C Red No. 2 to produce dominant lethal
    effects in the mouse, Food Cosmet. Toxicol., 14, 163

    Collins, T. F. X., Ruggles, D. I., Holson, J. F., jr, Schumacher, H.,
    Gaylor, D. W. and Kennedy, G. L., jr (1976a) Teratological evaluation
    of FD and C Red No. 2 - a collaborative government-industry study.
    I. Introduction, Experimental Materials, and Procedures, J. Toxicol.
    and Environ. Health, 1, 851

    Collins, T. F. X., Black, T. N., Ruggles, D. I. and Gray, G. C.
    (1976b) Teratological evaluation of FD and C Red No. 2. A
    collaborative government-industry study. II. FDA's study,
    J. Toxicol. and Environ. Health, 1, 857

    Gordon, L. A. and Taylor, J. M. (1975) Chronic feeding study of
    amaranth in rats, unpublished data from FDA-US

    Holson, J. F., jr, Schumacher, H. J., Gaylor, D. W. and Gaines,
    T. B. (1976a) Teratological evaluation of FD and C Red No. 2 - A
    collaborative government-industry study. IV. NCTR's study,
    J. Toxicol. and Environ. Health, 1, 867

    Holson, J. F., jr, Gaylor, D. W., Schumacher, H. J., Collins, T. F.
    X., Ruggles, D. I., Keplinger, M. L. and Kennedy, G. L., jr (1976b)
    Teratological evaluation of FD and C Red No. 2 - A collaborative
    government-industry study. V. Combined findings and discussion,
    J. Toxicol. and Environ. Health, 1, 875

    Keplinger, M. L., Kinoshita, F. K., Smith, S. H. and Kennedy, G. L.,
    jr (1976) Teratological evaluation of FD and C Red No. 2 - A
    government-industry study. III. IBT's study, J. Toxicol. and
    Environ. Health, 1, 863

    Khera, K. S., Roberts, G., Trivett, G., Terry, G. and Whalen, C.
    (1976) A teratogenicity study with amaranth in cats, Toxicol. appl.
    Pharmacol., 38, 389

    Truhaut, R. and Ferrando, R. (1975) Influence de l'administration par
    voie orale, de differentes doses de deux colorants azoiques,
    l'Amarante et le Jaune Soleil FCF, sur la mise en réserve de la
    vitamine A dans le foie du rat, C.R. Acad. Sci., Paris t. 281
    (4, 11, 18, 25 août 1975)

    See Also:
       Toxicological Abbreviations
       Amaranth (WHO Food Additives Series 4)
       Amaranth (WHO Food Additives Series 8)
       Amaranth (WHO Food Additives Series 19)
       AMARANTH (JECFA Evaluation)
       Amaranth (IARC Summary & Evaluation, Volume 8, 1975)