In vitro genotoxicity and in vivo single-dose oral toxicity of polysaccharide fraction from the leaves of Diospyros kaki thunb

Background: Polysaccharides isolated from medicinal herbs are regarded as important bioactive materials due to their various physiological activities. In our previous study, the polysaccharide fraction (PLE0) was separated from pectinase-digested persimmon (Diospyros kaki Thunb.) leaves and showed immunostimulatory and anti-osteoporotic effects. However, there is currently no information regarding the toxicity of PLE0. Materials and Methods: As a toxicological evaluation, acute oral toxicity and in vitro genotoxicity assays (chromosomal aberration and bacterial reverse mutation tests) were performed. Results: In the single-dose acute oral toxicity test in female and male Sprague-Dawley (SD) rats, the median lethal dose of PLE0 was higher than 5000 mg/kg and adverse effects were not observed in terms of mortality and abnormal changes in clinical signs. Furthermore, chromosomal abnormality and bacterial reverse mutation tests showed that PLE0 displays no mutagenicity or clastogenicity. Conclusion: Based on these results, PLE0 was not mutagenic and did not induce chromosomal aberration in vitro under our experimental conditions and exhibited no acute oral toxicity at up to 5000 mg/kg in SD rats.