FAO Nutrition Meetings Report Series 
    No. 46A WHO/FOOD ADD/70.36

    The content of this document is the result of the deliberations of the
    Joint FAO/WHO Expert Committee on Food Additives which met in Rome,
    27 May - 4 June 19691

    Food and Agriculture Organization of the United Nations

    World Health Organization

    1 Thirteenth report of the Joint FAO/WHO Expert Committee on Food
    Additives, FAO Nutrition Meetings Report Series, in press;
    Wld Hlth Org. techn.  Rep. Ser., in press.


    Biological Data

    Biochemical aspects

    Rats were injected i.v. and the bile collected for six hours. The
    recovery of the colour was approximately 34 per cent. (30-45 per
    cent.) of the administered quantity (Ryan & Wright, 1961).

    Acute Toxicity


    Animal   Route          LD50                  Reference
                        mg/kg body-weight

    mouse    oral           8000                  Gaunt et al., 1967

             i.p.          >1750 approx.          Gaunt et al., 1967

    rat      oral          >8000                  Gaunt et al., 1967

             i.p.           2000 approx.          DFG, 1957

    female   i.p.           2600                  Gaunt et al., 1967

    male     i.p.            600                  Gaunt et al., 1967

             i.v.           1000                  DFG, 1957

    In experiments with guinea-pigs it was found that this colour had no
    sensitization activity (Bär & Griepentrog, 1960). A negative test for
    Heinz bodies was obtained after administering this colour in a five
    per cent. aqueous solution by stomach tube to four cats (DFG, 1957).

    Special studies

    This colour was tested for mutagenic effect in a concentration of 0.5
    g/100 ml in cultures of Escherichia coli. No mutagenic effect was
    found (Lück & Rickerl, 1960).

    Short-term studies

    Groups of 16 male and 16 female rats were fed diets containing 0, 0.5
    per cent., 1 per cent. and 2 per cent. dye for 90 days. No adverse
    effects were seen in appearance, behaviour, growth, food consumption,
    haematological indices, SGPT and SGOT serum levels except at two per
    cent. level, when females had slightly lowered transammiase values,
    red cell counts and haemoglobin concentration. Renal function tests

    and organ weights were normal. Gross and histopathology showed no
    difference between the test groups (Gaunt et al., 1967).

    Eleven rats were given 1.0 per cent. of the colour in their drinking
    water for 216 days and observed for 791 days. Two animals died during
    the experiment, one had a sarcoma of the liver (DFG, 1957).

    Rat. Ten rats were given 0.2 per cent. of the colour in their diet
    for 417 days. The total intake was 11g/animal. Observation extended
    for 101 days. One rat died. No tumours were found (DFG, 1957).

    Four groups of 10 male and 10 female rats were given diets containing
    0, 0.03 per cent., 0.3 per cent. and 3.0 per cent. of the colour for
    64 weeks. No effect was noted on mortality. Females at the highest
    level had a lower food consumption throughout the experiment than the
    controls with a significant decrease in body-weight at 16 and 64
    weeks. In females the relative weights of heart, liver and kidney were
    increased. No effects were found on histopathology and as regard
    haemoglobin levels (Allmark et al., 1957).

    Seventy-five rats were fed the colour at a level of 0.1 per cent. of
    the diet. No tumours were observed. Similar results were obtained with
    10 rats fed at 0.2 per cent. of the diet. Feeding extended for

    Thirteen rats were given twice weekly s.c. injections of 0.5 ml of 1.0
    per cent. of the colour for 365 days. Observation extended for 857
    days. Five animals died during the experiment. No tumours were found
    (DFG, 1957).


    Several long-term studies have been performed in the rat. There is no
    information on the metabolism of the colour. A short-term study in
    pigs is in progress.


    Level causing no toxicological effect in the rat

    0.3 per cent. (= 3000 ppm) in the diet equivalent to 150 mg

    Estimate of acceptable daily intake in man

    Temporary acceptance                  mg/kg body-weight

                                             0 - 0.75

    Further work required by June 1974

    Metabolic studies in several species preferably including man and a
    two-year study in a non-rodent mammalian species.


    Allmark, M, G., Mannell, W. A. & Grice, H. C. (1957) J. Pharm.
    Pharmacol., 9, 622

    Bär, F. & Griepentrog, F. (1960) Med. u. Ernähr., 1, 99

    Deutsche Forschungsgemeinschaft, Farbstoff Kommission (1957)
    Mitteilung 6

    Gaunt, I. F. et al. (1967) Fd. Cosmet. Toxicol., 5, 187

    Lück, H. & Rickerl, E. (1960) Z. Lebensmitt.-Untersuch., 112, 157

    Ryan, A. J. & Wright, S. E. (1961) J. Pharm. Pharmacol., 13, 492

    See Also:
       Toxicological Abbreviations
       Ponceau 4R (WHO Food Additives Series 6)
       Ponceau 4R (WHO Food Additives Series 13)
       Ponceau 4R (WHO Food Additives Series 18)
       PONCEAU 4R (JECFA Evaluation)