A conceptual framework is presented for the incorporation of in vitro-derived toxicity data into the risk assessment process and the determination of a proper point-of-departure (PoD) for in vitro-in vivo extrapolation, allowing implementation in risk assessment procedures.
The transition towards Next Generation Risk Assessment (NGRA) aims at increasing human relevance and efficiency of chemical risk assessment, by using human-based in vitro and in silico methods. Quantitative in vitro to in vivo Extrapolation (QIVIVE) is central to this approach and enables the derivation of health-based...
M. J. M. Benschop, J. Minnema, E. Kasteel et al.· Current Research in Toxicolo...· 0 citations
In vitro toxicity data can be used for comparative hazard assessment of the problematic plastic chemical bisphenol A (BPA) and its replacement chemicals. Hazard assessment is exclusively based on nominal effect concentrations of the BPA alternatives, but due to their diversity of physicochemical properties and stabil...
L. Henneberger, Sophia Bardehly, Arina Kremser et al.· Chemical Research in Toxicol...· 0 citations
Abstract One of EFSA research priority research areas is to better understand the role of toxicokinetic and its implementation into next generation risk assessment. Food ingredients and contaminants often lack data on their absorption, distribution, metabolism and excretion (ADME) properties, which are needed to model...
Christina Drake, A. Roncaglioni, Domenico Gadaleta et al.· EFSA Supporting Publications· 0 citations
Acute oral toxicity (AOT) testing is widely used for hazard identification in chemical safety assessment, but traditional animal methods are still implemented despite their scientific limitations and ethical implications. Despite the availability of non-animal methods, regulatory uptake has been inconsistent, also due...
G. Pallocca, P. Bishop, P. Browne et al.· Regulatory toxicology and ph...· 0 citations
Five key recommendations for future health risk assessments are concluded, prioritizing PFAS; improving analytical methods; promoting generation of robust data and data gap filling; promoting open science, including the development of shared data infrastructure and cross-institutional knowledge exchange; and strengthen...
J. Kowalczyk, Klaus Abraham, Christina August et al.· Archives of Toxicology· 0 citations
The evaluation of 28- and 90-day repeated-dose toxicity studies in rodents is typically performed at the highest tier of regulatory toxicology. Despite detailed guidance from the European Food Safety Authority (EFSA) and Organisation for Economic Co-operation and Development (OECD), the practical implementation and eva...
S. Favilla, Eugenio Traini, M. Ardizzone et al.· Regulatory toxicology and ph...· 0 citations
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