biostudies-literatureRecio LNational Institute of Environmental Health SciencesProctor and Gamble CoSBIR 2BCharles River Laboratories478-491https://www.ebi.ac.uk/biostudies/studies/S-EPMC12703573biostudies-literatureUnknown66(9)This interlaboratory evaluation of HepaRG CometChip was conducted to assess transferability and reproducibility of this new approach methodology (NAM) across four laboratories. Concentrations inducing up to ~70% relative cytotoxicity were determined by the organizing laboratory, and frozen chemical formulation blocks were sent to each participant. When noncytotoxic, 10 mM was the maximum dose. Cultures were exposed once daily for three consecutive days, and both cytotoxicity assessment, via ATP quantification, and comet analysis, commenced 3-4 h after initiation of the final exposure. Positive response was statistical pairwise significance (p < 0.05) with concentration-related increases in %Tail DNA across ≥ 2 consecutive exposures. For 8 of 11 compounds, all four labs generated unanimous Environmental and molecular mutagenesisTransferability and Reproducibility of the HepaRG CometChip Assay.PMC127035735U44ES024698‐055U44ES024698-05Swartz CMartin LRottinger EPinkus EStankowski LFEngelward BPRecio LPfuhler SKaushal SRoberts DJOwiti NAfalseTransferability and Reproducibility of the HepaRG CometChip Assay.This interlaboratory evaluation of HepaRG CometChip was conducted to assess transferability and reproducibility of this new approach methodology (NAM) across four laboratories. Concentrations inducing up to ~70% relative cytotoxicity were determined by the organizing laboratory, and frozen chemical formulation blocks were sent to each participant. When noncytotoxic, 10 mM was the maximum dose. Cultures were exposed once daily for three consecutive days, and both cytotoxicity assessment, via ATP quantification, and comet analysis, commenced 3-4 h after initiation of the final exposure. Positive response was statistical pairwise significance (p < 0.05) with concentration-related increases in %Tail DNA across ≥ 2 consecutive exposures. For 8 of 11 compounds, all four labs generated unanimous 2025-01-01T00:00:00Z2025 Nov2026-05-26T14:01:08.364Z2026-05-24T03:12:50.153ZS-EPMC127035734129920310.1002/em.70037