Extension of the EFSA Pesticides Genotoxicity Database

In 2012 the EFSA Panel on Plant Protection Products and their Residues, the Panel pointed out to the need for a well-curated database of genotoxicity data to support reliable use of in silico methods for predicting genotoxicity of chemicals in this domain. Subsequently, EFSA developed a database of genotoxicity extracted from data submitted in the course of regulatory approval of pesticides, and this database was used to test the performance of existing tools for predicting genotoxicity. It was concluded that, at present, QSAR works well for Ames mutagenicity, but not for other endpoints. BfR has developed its own internal database of curated genotoxicity data extracted from original study reports, focusing initially on Ames and subsequently expanded to include in vitro micronucleus (MN) results. To facilitate extension the EFSA database with Ames and in vitro MN data from the BfR database, a workflow for the migration of the data in the BfR Genotoxicity Database to a IUCLID format was developed and applied. After migration to IUCLID, there were 349 files for Ames and 183 for MN, one for each substance per endpoint. In the course of performing the data migration to the IUCLID/OHT template, several changes to the structure of the OHT 70 (Genetic toxicity in vitro) which would improve its usefulness were recognized. The BfR genotoxicity database, available in https://zenodo.org/communities/efsa-kj, represents a valuable extension, provides additional dose-response information and might offer opportunities to validate the EFSA genotoxicity database.