Toxicological evaluation of a chicory root extract. |
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| Authors: | Barbara M Schmidt Nebojsa Ilic Alexander Poulev Ilya Raskin |
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| Affiliation: | Biotech Center, Cook College, Rutgers University, 59 Dudley Road, New Brunswick, NJ 08901-8520, USA. raskin@aesop.rutgers.edu |
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| Abstract: | An Ames test and a 28-day sub-chronic toxicity study in male and female Sprague-Dawley rats were conducted to evaluate the safety of a chicory root extract being investigated as a therapeutic for inflammation. Chicory extract had no mutagenic activity in the Ames test although it was cytotoxic to certain strains of Salmonella at higher doses with and without metabolic activation. For the 28-day rat study, measurements included clinical observations, body weights, food consumption, clinical pathology, gross necropsy and histology. There were no treatment-related toxic effects from chicory extract administered orally at 70, 350, or 1000 mg/kg/day. Since there were no observed adverse effects of chicory extract in these studies, the NOAEL for the extract is 1000 mg/kg/g administered orally for 28 days. |
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| Keywords: | ANOVA, analysis of variance EAFUS, everything added to food in the United States EPA, Environmental Protection Agency FDA, Food and Drug Administration GLP, good laboratory practices GRAS, generally regarded as safe ICH, International Conference on Harmonization NBF, neutral buffered formalin NIH, National Institutes of Health NOAEL, no observed adverse effect level OECD Organization for Economic Co-operation and Development |
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