In vitro and in vivo toxicogenic study of the hydroalcoholic extract of red propolis in mammalian cells

Abstract

Red propolis produced in the northeastern coast has great potential for drug development, and toxicological genetics tests are a basic component for the preclinical safety assessment of drug candidate compounds, with the purpose of identifying substances with potential risk of inducing mutations. In this regard, genotoxicity tests have been used, mainly, for the prediction of carcinogenic potential. The present study aims to evaluate the cytotoxic and genotoxic potential of the hydroalcoholic extract of red propolis in mammalian cells in vitro and in vivo. The red propolis will be obtained from the city of Canavieiras, Bahia, which will be frozen, crushed and subjected to extraction with ethanol-water 7: 3. The extract obtained will be lyophilized and kept in a freezer. In this study, the Chinese hamster lung fibroblast cell line (V79) will be used and the cytotoxicity will be evaluated through the clonogenic efficiency assay. Analysis of the genotoxic potential of the extract will be performed by the micronucleus test. The concentrations of the extract to be used will be defined from the screening with different concentrations that will vary from the highest concentration allowed for in vitro assays. For in vivo micronucleus testing, preliminary experiments will be performed for the determination of three different doses of the extract to be evaluated in the assays, considering that the highest permitted dose for these assays is 2000 mg / kg b.p.