IN-VITRO MUTAGENIC, GENOTOXIC AND ANEUGENIC POTENTIAL OF OMEPRAZOLEAbstract
The aim of this investigation was to re-evaluate the in-vitro mutagenic, genotoxic, and aneugenic potential of omeprazole through the Ames test, comet (SCGE), and cytokinesis-block micronucleus assays (CBMN), as previous reports on the mutagenic and genotoxic effects of omeprazole are scarce and inconclusive. The results of this study indicated a negative mutagenic effect through the Ames test. Comet assay endpoints such as tail length, tail intensity, and tail moment showed a mild genotoxic effect with dose-dependence. The CBMN assay endpoints were implemented according to the requirements for in-vitro evaluation of genotoxicity after 4 h of exposure, with or without metabolic activation. Endpoints, such as binucleated cells with micronuclei (BNMN), total micronuclei (MN), arrested metaphasis (AM), nuclear buds (NB), nucleoplasmic bridges (NPB), and necrotic cells (NC), showed a dose-dependent effect. The number of apoptotic cells (AP) showed a statistically significant increase compare to the control value but was without dose-dependence. This in-vitro study suggests omeprazole exhibits mild genotoxic and aneugenic effects.
V. Kutsar, S. LaFolette, J. Ringenberg, R. Dudley and A. Vaglenov *
Department of Pharmaceutical Science, University of Findlay, 1000 North Main Street, Findlay, Ohio, USA.
01 April 2020
13 July 2020
11 August 2020
01 April 2021