Genotoxicity evaluation of a commonly used synthetic androgen, Oxymetholone, was carried out in human peripheral blood lymphocytes in vitro. Sister chromatid exchange (SCE) was used as genetic end point. The concentrations of the drug were determined after observing its effects on the mitotic index. A wide range of concentrations, i.e., 25, 50, and 100 micro g/ml of the drug, were used to determine the genotoxic effects in the absence as well as in the presence of rat liver microsomal activation system (S9 mix). The drug did not induce any significant increase in the SCE frequency at any of the concentrations either in the presence or in the absence of S9 mix. The maximum value of SCE was observed in the absence of S9 mix at 100 microg/ml concentration (i.e., 1.38+/-0.080/cell), which was not significant statistically. Moreover, the drug was not effective in increasing the SCE frequency even in the presence of S9 mix. The maximum value of SCE (i.e., 1.78+/-0.103/cell) was observed at 50 microg/ml of concentration in the presence of S9 mix. A dose relationship was also not observed. It was concluded that Oxymetholone does not affect the genetic material in human lymphocytes at a wide range of concentrations in the SCE assay.
Copyright 2003 Wiley-Liss, Inc.