Leveraging public NAM data to support regulatory hazard assessment: A tebuconazole case study under Korean and EU biocidal product regulation frameworks.
Aug 2026· Regulatory toxicology and pharmacology : RTP· pp.
106226
· 0 citations· 32 references
Medicine
Abstract
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.
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