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Extension of the EFSA Pesticide Genotoxicity Database

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NIAID Data Ecosystem2026-05-02 收录
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https://zenodo.org/record/14946068
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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 represents a valuable extension, provides additional dose-response information and might offer opportunities to validate the EFSA genotoxicity database. © German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung; BfR), 2024 DISCLAIMER The publication of this database is without prejudice to existing rules concerning intellectual property rights. The reproduction, redistribution or further re-use of this database and the information contained therein may require prior authorisation from rights holders. The database contains proprietary information. The use of proprietary information for registration purposes in the EU should be in line with the regulatory data protection rules established under Article 59 of Regulation (EC) 1107/2009. It is recommended that proprietary information included in this database would not be accepted to support any registration outside the EU for which the applicant has not demonstrated that it has regulatory access to the information. EFSA does not warrant that the use of this database is error free.
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2025-03-07
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