Leveraging public NAM data to support regulatory hazard assessment: A tebuconazole case study under Korean and EU...

The biocidal products regulation (BPR) increases the need for timely assessment of existing biocidal active substances under constraints on animal use, time, and resources. We used tebuconazole, a triazole fungicide relevant to both Korean and European BPR frameworks, as a case study to examine how publicly accessible new approach methodologies (NAMs) data can complement legacy regulatory hazard assessment. We integrated three evidence streams: the historical EU product-type 8 assessment as a legacy benchmark, a structured review of tebuconazole-specific NAM studies published from January 2013 to 2025, and mechanistically annotated ToxCast/Tox21 assay activity. Relative to the legacy benchmark, NAM evidence indicated steroidogenic and thyroid-related perturbations for endocrine endpoints, genotoxicity-related DNA-damage and stress-response signals, and mechanistic support for reproductive/developmental effects. These findings do not justify direct regulatory reclassification. Instead, they illustrate three practical uses of NAM data: prioritizing further evaluation when legacy information is insufficient; identifying supporting information for residual uncertainty and guiding targeted clarification when mechanistic signals emerge; and strengthening mechanistic interpretation.