loading page

A global AOP network for genotoxicity to drive the integration of NAMs
  • +17
  • Emmanuel Demuynck,
  • Tamara Vanhaecke,
  • Anouck Thienpont,
  • Davie Cappoen,
  • Freddy Van Goethem,
  • Levi Winkelman,
  • Joost Beltman,
  • Sivakumar Murugadoss,
  • Ann-Karin Olsen,
  • Francesca Marcon,
  • Cecilia Bossa,
  • Sanah Majid ,
  • Dimitra Nikolopoulou,
  • Vasiliki Hatzi,
  • Jeroen L.A. Pennings,
  • Mirjam Luijten,
  • Christelle Adam-Guillermin,
  • Martin Paparella,
  • Marc Audebert,
  • Birgit Mertens
Emmanuel Demuynck
Sciensano

Corresponding Author:emmanuel.demuynck@sciensano.be

Author Profile
Tamara Vanhaecke
Vrije Universiteit Brussel
Author Profile
Anouck Thienpont
Sciensano
Author Profile
Davie Cappoen
Sciensano
Author Profile
Freddy Van Goethem
Vrije Universiteit Brussel
Author Profile
Levi Winkelman
Leiden University Leiden Academic Centre for Drug Research
Author Profile
Joost Beltman
Leiden University Leiden Academic Centre for Drug Research
Author Profile
Sivakumar Murugadoss
NILU
Author Profile
Ann-Karin Olsen
NILU
Author Profile
Francesca Marcon
Istituto Superiore di Sanità
Author Profile
Cecilia Bossa
Istituto Superiore di Sanita'
Author Profile
Sanah Majid
KWR Water Research Institute
Author Profile
Dimitra Nikolopoulou
Benaki Phytopathological Institute
Author Profile
Vasiliki Hatzi
Benaki Phytopathological Institute
Author Profile
Jeroen L.A. Pennings
RIVM
Author Profile
Mirjam Luijten
National Institute for Public Health and the Environment (RIVM)
Author Profile
Christelle Adam-Guillermin
IRSN
Author Profile
Martin Paparella
Medical University of Innsbruck
Author Profile
Marc Audebert
INRA
Author Profile
Birgit Mertens
Sciensano
Author Profile

Abstract

Current genotoxicity testing strategies face several challenges, including a high incidence of misleading positive results that lead to unnecessary animal testing, limited mechanistic insights, insufficient integration of innovative methodologies, and a lack of quantitative assessment. Despite rapid advancements in technology and scientific understanding, genotoxicity testing batteries have remained largely unchanged for years. To modernize genotoxicity assessment and incorporate innovative approaches, the development of Integrated Approaches for Testing and Assessment (IATAs) is essential. These frameworks combine existing knowledge with data from New Approach Methodologies (NAMs) aiming to reduce or eliminate reliance on in vivo testing. Genotoxicity is particularly well-suited for IATA development as numerous cutting-edge, non-animal methods have emerged in recent years, including 3D test systems, Prediscreen®, MultiFlow®, ToxTracker®, and transcriptomic-based biomarkers such as GENOMARK and TGx-DDI. However, the integration of NAMs into IATAs must be systematic and scientifically robust. In this process, the Adverse Outcome Pathway (AOP) framework plays a crucial role by linking molecular-level events to adverse health effects, thereby supporting the structured selection of NAMs. This article explores the key challenges and gaps within the current European regulatory frameworks for chemical compound genotoxicity assessment and discuss how an AOP-based IATA can address these issues. Additionally, we present a global AOP network for permanent DNA damage, designed to guide IATA development and improve regulatory decision-making. This integrated approach has the potential to enhance the accuracy, efficiency, and ethical standards of genotoxicity assessment while reducing reliance on animal testing.