Abstract
The genotoxicity study of a synthetic progestin ethynodiol diacetate, used as oral contraceptives, was carried out on human lymphocyte chromosomes using sister chromatid exchanges (SCEs), replication index (RI) and chromosomal aberrations (CAs) as parameters. The study was carried out in the presence as well as in the absence of metabolic activation (S9 mix). The aim of the present study is to achieve a precise characterization of the genotoxic activity of ethynodiol diacetate and to establish the value of cytogenetic assays in order to determine the effect of the drugs, at therapeutic doses, to settle an improved risk assessment. Ethynodiol diacetate was studied at three different concentrations (50, 100 and 150 μg/ml of peripheral blood lymphocyte culture) and was found non-genotoxic in the absence of metabolic activation (S9 mix). But in the presence of S9 mix ethynodiol diacetate increases SCE (P < 0.03) and CA (P < 0.005) frequencies and inhibits lymphocyte proliferation (P < 0.03) at 150 μg/ml. The results suggest a genotoxic and cytotoxic effect of ethynodiol diacetate in human peripheral blood cultures in vitro.