EMA-funded project to predict in-vivo mutagenicity / mutagenicity classification

Mutamind update (in vitro Comet assay project stream): https://onlinelibrary.wiley.com/doi/epdf/10.1002/lemi.202452042
(poster abstract, not open access, a 1 page summary in German)

As part of the EMA Mutamind Consortium, our task was to evaluate the in vitro comet assay in primary rat hepatocytes (PRH) as a potential test system for predicting the genotoxicity and mutagenicity of structurally diverse NAs. The reproducibility, sensitivity, and specificity of the test system were assessed. Additionally, the genotoxicity data were subjected to potency ranking using a benchmark dose modeling (BMD).

NPro, NMA, NDELA, NMIPA, (S)-NNN, NMtBu and NSDRIs NFA, NFluo, and NND were studied.
(I assume NFA = nitroso folic acid, NFluo = nitroso fluoxetine, NND I’m not sure).

Further details/updates on this in vitro workstream:
Better models to shed light on the mutagenicity of N-nitrosamines - Fraunhofer ITEM
EuroTox 2023 - Fraunhofer ITEM
P03-22: Sensitivity of primary human hepatocytes and HepG2 cells for genotoxicity testing of N-nitrosamines in the in vitro alkaline comet assay - ScienceDirect
57th Congress of the European Societies of Toxicology (EUROTOX 2023) - Events / Workshops / Webinars - Nitrosamines Exchange (usp.org)
https://www.item.fraunhofer.de/en/events/sot-2024/ehs-mutamind.html

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