ToxTracker for regulatory applications
We are frequently asked whether ToxTracker data have ever been included in safety dossiers to the regulatory authorities. The answer is yes, but often this information is not publicly available. And in many cases we simply don’t know. But now there is an example available of a regulatory dossier in which ToxTracker data have been applied in a weight of evidence strategie. In this case, the standard regulatory battery of genotoxicity assay gave equivocal results and ToxTracker was used to understand the mode-of-action of the substance and argue that the compound was not genotoxic.
Please find the use case (including link to regulatory file) here