The carcinogenic potential of L-isoleucine, used as a food fortifier, was examined in both sexes of F344 rats. Groups of 50 female and 50 male animals were given diet containing L-isoleucine at concentrations of 0%, 2.5% or 5.0%. No treatment-related changes in the survival rate, general condition, body weight, food consumption, urinalysis, hematology or clinical chemistry data and organ weights were noted. Detailed histopathological examination revealed no treatment-related increase in the incidences of any non-neoplastic or neoplastic lesions. The results indicate that L-isoleucine is not carcinogenic in F344 rats of either sex.
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