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Male and female Fischer 344/DuCrj rats were treated with Food Red No. 106 (acid red) mixed in the basal diet at doses of 5.0% and 2.5% by weight in a two year toxicity/carcinogenicity study. The mean cumulative intake of Red 106 over the 106 experimental week duration was computed to be 738g/rat and 356g/rat for males at the 5.0 and 2.5% levels, respectively, while females consumed an average of 523 and 252g/animal in the high and low dose group, respectively. Body and organ weights, hematology, urinalysis, and histopathological evaluations revealed no evidence of adverse effects associated with the compound relative to the untreated controls. The spectrum, incidence, and histology of tumors developing in both treated and control animals were consistent with spontaneous incidences reported in this strain of rat. This study thus indicates that Red 106 is not carcinogenic to F344 rats after 2 years of dietary administration at a maximal level of 5.0% in the basal diet by weight.

Carcinogenicity Testing of Food Red No. 106(Acid Red) in Fischer 344 Rats.