Opinion on the impact of non-monotonic dose responses on EFSA's human health risk assessments.
Résumé
This Opinion assesses the biological relevance of the non-monotonic dose responses (NMDR) identifiedin a previous EFSA External Report (Beausoleil et al., 2016) produced under GP/EFSA/SCER/2014/01and the follow-up probabilistic assessment (Chevillotte et al., 2017a,b), focusing on thein vivodatasets fulfilling most of the checkpoints of the visual/statistical-based analysis identified in Beausoleilet al. (2016). The evaluation was completed with cases discussed in EFSA assessments and the updateof the scientific literature. Observations of NMDR were confirmed in certain studies and are particularlyrelevant for receptor-mediated effects. Based on the results of the evaluation, the Opinion proposes anapproach to be applied during the risk assessment process when apparent non-monotonicity isobserved, also providing advice on specific elements to be considered to facilitate the assessment ofNMDR in EFSA risk assessments. The proposed approach was applied to two case studies, BisphenolA and bis(2-ethylhexyl phthalate (DEHP) and these evaluations are reported in dedicated annexes.Considering the potential impact of NMDRs in regulatory risk assessment, the Scientific Committeerecommends a concerted international effort on developing internationally agreed guidance andharmonised frameworks for identifying and addressing NMDRs in the risk assessment process
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EFSA Journal - 2021 - - Opinion on the impact of non‐monotonic dose responses on EFSA s human health risk assessments.pdf (6.44 Mo)
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