An Alternative Safety Profiling Algorithm (ASPA) to transform next generation risk assessment into a structured and transparent process
ALTEX, vol. 43, pp. 158–175
Abstract
Next generation risk assessment (NGRA) strategies use animal-free new approach methodologies (NAMs) to generate information concerning chemical hazard, toxicokinetics (ADME), and exposure. The information from these major pillars of data gathering is used to inform risk assessment and classification decisions. While the required types of data are widely agreed upon, the processes for data collection, integration and reporting, as well as several decisions on the depth and granularity of required data, are poorly standardized. Here, we present the Alternative Safety Profiling Algorithm (ASPA), a broad-purpose, transparent, and reproducible risk assessment workflow that allows documentation and integration of all types of information required for NGRA. ASPA aims to make safety assessments fully traceable for the recipient (e.g., a regulator), delineating which steps and decisions have led to the final outcome and why certain decisions were made. An overarching objective of ASPA is to ensure that identical data input yields identical outcomes in the hands of independent assessors. Therefore, ASPA is not just a data gathering workflow; it also considers data interdependencies and requires precise justification of intermediate decisions. This includes the monitoring and assessment of uncertainties. To assist users, the ASPA-assist software was developed. It formalizes the reporting process in a reproducible and standardized fashion. By guiding an operator step-by-step through the ASPA workflow, a complete and comprehensive report is assembled, whereby all data, methods, operator activities, and intermediate decisions are recorded. Practical examples illustrating the broader applicability of ASPA across various regulations and problem formulations are provided through case studies.
Authors 26
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Affiliation as printed
In vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden foundation, University of Konstanz, Konstanz, Germany
CAAT-Europe, Konstanz, Germany
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Affiliation as printed
In vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden foundation, University of Konstanz, Konstanz, Germany
CAAT-Europe, Konstanz, Germany
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National Institute for Public Health and the Environment
Affiliation as printed
Centre for Safety of Substances and Products, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands
Centre for Safety of Substances and Products, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands
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Netherlands Organisation for Applied Scientific Research
Affiliation as printed
Department of Risk Analysis for Prevention, Innovation and Development, Netherlands Organisation for Applied Scientific Research (TNO), Utrecht, The Netherlands
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Affiliation as printed
Centre for Environmental Research and Justice, and School of Biosciences, University of Birmingham, Birmingham, United Kingdom
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Affiliation as printed
In vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden foundation, University of Konstanz, Konstanz, Germany
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Affiliation as printed
In vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden foundation, University of Konstanz, Konstanz, Germany
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Fraunhofer Institute for Toxicology and Experimental Medicine
Affiliation as printed
Fraunhofer ITEM, Safety Assessment and Toxicology, Hannover, Germany
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Affiliation as printed
Certara Predictive Technologies, Sheffield, United Kingdom
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Fraunhofer Institute for Toxicology and Experimental Medicine
Affiliation as printed
Fraunhofer ITEM, Safety Assessment and Toxicology, Hannover, Germany
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Edelweiss Connect (Switzerland)
Affiliation as printed
Edelweiss Connect GmbH, Basel, Switzerland
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Federal Institute for Risk Assessment
Affiliation as printed
German Federal Institute for Risk Assessment (BfR), Berlin, Germany
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Affiliation as printed
Certara Predictive Technologies, Sheffield, United Kingdom
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Affiliation as printed
BASF Metabolome Solutions GmbH, Berlin, Germany
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Affiliation as printed
In vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden foundation, University of Konstanz, Konstanz, Germany
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Federal Institute for Risk Assessment
Affiliation as printed
German Federal Institute for Risk Assessment (BfR), Berlin, Germany
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Affiliation as printed
Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands
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Affiliation as printed
Department of Pharmacy, Uppsala University, Uppsala, Sweden
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Netherlands Organisation for Applied Scientific Research
Affiliation as printed
Department of Risk Analysis for Prevention, Innovation and Development, Netherlands Organisation for Applied Scientific Research (TNO), Utrecht, The Netherlands
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Affiliation as printed
L'Oréal Research & Innovation, Aulnay-sous-Bois, France
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Affiliation as printed
Humane World for Animals Europe, Brussels, Belgium
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Affiliation as printed
Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands
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Affiliation as printed
Vrije Universiteit Brussel, Brussels, Belgium
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Affiliation as printed
Unilever PLC, Sharnbrook, United Kingdom
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Universitat Pompeu Fabra · Hospital Del Mar · Hospital del Mar Research Institute
Affiliation as printed
Research Programme on Biomedical Informatics (GRIB), Department of Medicine and Life Sciences, Universitat Pompeu Fabra, Hospital del Mar Medical Research Institute, Barcelona, Spain
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National Institute for Public Health and the Environment
Affiliation as printed
Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands
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