Acute and Subacute Toxicity Tests of Madder Root, Natural Colorant Extracted from Madder (Rubia tinctorium), in (C57BL/6 x C3H) F₁ Mice

Abstract

The toxicity test of madder root colorant (MR), a food colorant extracted from madder (Rubia tinctorium), was undertaken using (C57BL/6 x C3H)F₁ mice of both sexes for the safety assessment of this product. The acute toxicity test was performed by administration of MR disolved in distilled water by gavage at doses of 5000, 3500, 2000, 500, and 0 mg/body weight to groups of 4, 6 or 7 males and 6 or 7 females, maintained for 14 days. One mouse of either sex dosed at 5000 mg/kg body weight were dead before the end of the study, indicating that the tolerated dose of MD was over 5000 mg/kg body weight. The subacute toxicity test of MD was examined using 124 mice of both sexes (62 males and 62 females) by feeding a diet mixed with MD at concentrations of 5, 2.5, 1.25, 0.6, 0.3, and 0% for 90 days. All mice tolerated these doses of MD well. The body weight gains of either sex were not affected by the treatment. Histopathological examinations showed that retention cyst of the kidney, epididymitis, chronic cystitis or epidermal cyst of vagina in treated or control mice. No hyperplastic or neoplastic lesions were found. These results suggest that MR has no acute and subacute toxic effects in mice.