The probable future of toxicology - probabilistic risk assessment.

Journal: ALTEX
PMID:

Abstract

Both because of the shortcomings of existing risk assessment methodologies, as well as newly available tools to predict hazard and risk with machine learning approaches, there has been an emerging emphasis on probabilistic risk assessment. Increasingly sophisticated AI models can be applied to a plethora of exposure and hazard data to obtain not only predictions for particular endpoints but also to estimate the uncertainty of the risk assessment outcome. This provides the basis for a shift from deterministic to more probabilistic approaches but comes at the cost of an increased complexity of the process as it requires more resources and human expertise. There are still challenges to overcome before a probabilistic paradigm is fully embraced by regulators. Based on an earlier white paper (Maertens et al., 2022), a workshop discussed the prospects, challenges and path forward for implementing such AI-based probabilistic hazard assessment. Moving forward, we will see the transition from categorized into probabilistic and dose-dependent hazard outcomes, the application of internal thresholds of toxicological concern for data-poor substances, the acknowledgement of user-friendly open-source software, a rise in the expertise of toxicologists required to understand and interpret artificial intelligence models, and the honest communication of uncertainty in risk assessment to the public.

Authors

  • Alexandra Maertens
    Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.
  • Eric Antignac
    L'Oréal, Research & Innovation, Clichy, France.
  • Emilio Benfenati
    Laboratory of Environmental Chemistry and Toxicology, Department of Environmental Health Sciences, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Via Giuseppe La Masa 19, 20156 Milan, Italy.
  • Denise Bloch
    Department of Pesticides Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.
  • Ellen Fritsche
    IUF-Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany, and Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.
  • Sebastian Hoffmann
    seh consulting + services, Paderborn, Germany.
  • Joanna Jaworska
    Procter & Gamble, Brussels Innovation Center, Brussels, Belgium.
  • George Loizou
    HSE Science and Research Centre, Harpur Hill, Buxton, UK.
  • Kevin McNally
    HSE Science and Research Centre, Harpur Hill, Buxton, UK.
  • Przemyslaw Piechota
    Johns Hopkins University, Bloomberg School of Public Health and Whiting School of Engineering, Center for Alternatives to Animal Testing (CAAT), Doerenkamp-Zbinden Chair for Evidence-based Toxicology, Baltimore, MD, USA.
  • Erwin L Roggen
    3Rs Management and Consulting ApS, Kongens Lyngby, Denmark.
  • Marc Teunis
    Innovative Testing in Life Sciences & Chemistry, University of Applied Sciences, Utrecht, The Netherlands.
  • Thomas Hartung
    Center for Alternatives to Animal Testing (CAAT), Health and Whiting School of Engineering, Johns Hopkins University, Baltimore, MD, United States.