Medical expenditures for devices are increasing along with the ageing of human population and the synthesis of materials such as
silicone polymers is on upsurge for manufacturing these devices. The International Organization for Standardization (ISO) emphasizes a battery of tests for preclinical assessment of biocompatibility of medical devices. Genotoxicity assays have become an integral component of these test procedures and it employs a set of in vitro and in vivo experiments to detect
mutagens. Hence, this study was performed with an intention to investigate the genotoxic potential of the physiological saline extracts of three medical grade
silicone polymer materials by the in vitro
chromosomal aberration assay using human peripheral blood lymphocytes. Further, the oxidative stress inducing potential of the material extracts was investigated in vivo in mice liver homogenates using
cyclophosphamide as positive control. The investigation revealed that none of the three materials were able to produce marked human lymphocyte
chromosomal aberration, suggesting the absence of
mutagens. The materials also showed negative results in their oxidative stress inducing potential, which was revealed by the normal levels of lipid peroxidation and unaltered levels of
glutathione and its metabolizing
enzymes in the mice liver tissue homogenates. It was interesting to observe a significant correlation between the genotoxic and
antioxidant parameters investigated. Hence, it is suggested that the estimation of
antioxidant status would serve as a better preliminary testing procedure prior to evaluating the genetic and molecular toxicity mechanisms of medical devices and/or materials intended for manufacture of such devices.