POTENTIAL GENOTOXICITY AND HISTOPATHOLOGICAL ALTERATION EVALUATION OF HEPTEX®
Keywords:
Heptex, Genotoxicity, In vivo, In vitro, Chromosome aberrations, Micronucleus, Bacterial reverse mutation, HistopathologyAbstract
Objective: The present study was performed in order to evaluate potential genotoxicity and the histopathological alteration of a traditional herbal prescription Heptex that used in the treatment of liver disease.
Methods: The genotoxicity were evaluated using the in vivo chromosome aberration and micronucleus assays in bone marrow cells of male and female Sprague-Dawley rats. In addition, in vitro chromosome aberration assay in Chinese hamster ovary (CHO) cells and bacterial reverse mutations assay in Salmonella typhimurium strains and Escherichia coli (WP2-uvrA/) with and without metabolic activation system (S9 mix) were performed. Histopathological study was conducted in liver, ovary and testis tissue of Sprague-Dawley rats.
Results: The genotoxicity assessment showed that Heptex did not significantly increase the number of chromosomal aberrations and frequencies of micro nucleated polychromatic erythrocytes in bone marrow cells of both male and female rats. In addition, there were no increases in the number of revertant colonies at any concentrations of Heptex used in the study. Heptex did not produce any structural aberration in CHO cells in the presence or absence of S9 mix. In addition, there were no histopathological changes induced by Heptex in rat liver, ovary and testis.
Conclusion: Based on abovementioned findings, we can conclude that Heptex is generally non-toxic and does not exhibit genotoxicity or histopathological alteration.
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