One-year chronic toxicity of madder color in F344 rats – Induction of preneoplastic/neoplastic lesions in the kidney and liver |
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Authors: | Kaoru Inoue Makoto Shibutani Naoya Masutomi Kazuhiro Toyoda Hironori Takagi Miwa Takahashi Hitoshi Fujimoto Masao Hirose Akiyoshi Nishikawa |
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Institution: | 1. Division of Pathology, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan;2. Food Safety Commission, 2-13-10 Prudential Tower 6th floor, Nagata-cho, Chiyoda-ku, Tokyo 100-8989, Japan |
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Abstract: | To evaluate chronic toxicity of madder color (MC), a natural food colorant extracted from the roots of Rubia tinctorum L., F344 rats were fed diet containing 0%, 0.2%, 1.0% or 5.0% MC for 53 weeks. Hematological changes including anemia and serum biochemical alterations indicating hepatotoxicity were demonstrated at 5.0% in both sexes. Relative weights of the liver were significantly increased from 1.0% in both sexes, and those of the kidney were significantly increased from 1.0% in males and from 0.2% in females. Histopathologically, atypical renal tubule hyperplasias were increased at 1.0% or higher in both sexes in association with increase of cell proliferative activity in the tubules. A renal cell adenoma was observed in a male rat receiving 5.0% MC. In addition, glutathione S-transferase placental form-positive liver cell foci were significantly increased at 5.0% in both sexes. These results indicate that MC has chronic toxicity targeting kidney, liver and blood cells. Moreover, the results strongly suggest that MC may have the carcinogenic potential in the kidney and the liver. |
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Keywords: | A/G albumin:globulin Alb albumin ALP alkaline phosphatase ALT alanine aminotransferase AST aspartate aminotransferase Bil bilirubin BUN blood urea nitrogen BW body weight Ca calcium Cl chlorine CRN creatinine EDTA ethylenediaminetetraacetic acid GST-P glutathione S-transferase placental form Hb hemoglobin HPLC high performance liquid chromatography Ht hematocrit IP inorganic phosphorus K potassium MC madder color MCH mean corpuscular hemoglobin MCHC mean corpuscular hemoglobin concentration MCV mean corpuscular volume Na sodium NOAEL non-observed-adverse-effect level PCNA proliferating cell nuclear antigen PLT platelet RBC red blood cell TC total cholesterol TG triglyceride TP total protein UDS unscheduled DNA synthesis WBC white blood cell |
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