TY - JOUR T1 - The Vitotox and ToxTracker assays: a two-test combination for quick and reliable assessment of genotoxic hazards JF - Mutation research Y1 - 2016 A1 - Ates, Gamze A1 - Favyts, Dorien A1 - Hendriks, Giel A1 - Derr, Remco A1 - Birgit Mertens A1 - Luc Verschaeve A1 - Rogiers, Vera A1 - Tatyana Yordanova Doktorova KW - an KW - analysi KW - analysis KW - approach KW - AS KW - assessment KW - chemicals KW - Combination KW - cosmetic KW - Development KW - Europe KW - Follow up KW - FOLLOW-UP KW - genotoxicity KW - hazard KW - health KW - Human KW - human health KW - INFORMATION KW - IS KW - Less KW - Paper KW - performance KW - result KW - results KW - SENSITIVITY KW - Test KW - variety KW - Vitotox AB -

To ensure human health, it is essential to characterize the genotoxic potential of new chemical entities such as pharmaceutical and cosmetic substances. In a first tier a battery of regulatory accepted in vitro tests is recommended. These tests have a relatively high sensitivity, but a low specificity. Furthermore, they are time-consuming, laborious and require large quantities of the individual chemicals. New assays overcoming these drawbacks are under development, the majority of them being reporter-based assays. In this paper we investigate the performance of two in vitro reporter-based assays, namely the Vitotox and the ToxTracker. A set of reference compounds were selected to cover not only different mechanisms of genotoxic action, but also a variety of applicability domains (e.g. pharmaceutical and cosmetic ingredients). Results show that both assays can be valuable tools in genotoxicity hazard assessment, especially when combined in a test battery. An interesting property of both assays for drug-development is the possibility of time-efficient analysis of a large amount of drug-candidates while using small quantities and high throughput (automatized) technologies. Furthermore, the tests are less laborious. For the cosmetic industry, the generated information can be added in a weight-of-evidence approach to derisk false positive results as in vivo follow-up testing is no longer allowed in Europe.

VL - 810 M3 - j.mrgentox.2016.09.005 ER -