ArticleToxicological sciences : an official journal of the Society of Toxicology2025
Advancing systemic toxicity risk assessment: Evaluation of a NAM-based toolbox approach.
Article in Toxicological sciences : an official journal of the Society of Toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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The trial behind it
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Who cites it
16 citing papers in PubMed.
- NGRA in Cosmetic Safety: Moving From the Frameworks and Case Studies to Wide Adoption.Current opinion in toxicology · 2026Article
- Current and emerging new approach & methodologies for skin hazard assessment.Toxicological research · 2026Review
- PBK modelling of phthalates and their metabolites and the application in next generation risk assessment.Archives of toxicology · 2026Article
- Extrapolation of in vitro effect concentrations to in vivo bioavailable concentrations using PBK modelling in humans for two classes of persistent and mobile compounds: triazoles and triazines.Archives of toxicology · 2026Article
- Integration of in vitro and in silico approaches enables prediction of drug-induced liver injury.Archives of toxicology · 2026Article
- Quantitative estimates of inter-individual variability for new approach methodologies-based systemic safety toolbox using a population-based human in vitro model.Toxicological sciences : an official journal of the Society of Toxicology · 2026Article
- The way forward for assessing the human health safety of cosmetics in the EU: Proceedings of Workshop 2.Archives of toxicology · 2026Article
- From Reduction to Replacement: Challenges and Proposed Solutions for Animal-Free Safety Assessment of Hydrocarbon UVCB Substances.NAM journal · 2026Review
- A Novel Workflow for Non-Animal PBK Modelling of UV Filters: Oxybenzone as a Case Study.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Modernizing Preclinical Drug Development: The Role of New Approach Methodologies.ACS pharmacology & translational science · 2025Review
- Deciphering per- and polyfluoroalkyl substances mode of action: comparative gene expression analysis in human liver spheroids.Toxicological sciences : an official journal of the Society of Toxicology · 2025Article
- Occupational exposure and its mechanistic link to allergic asthma and lung function decline; a data-driven approach coupled to mining of adverse outcome pathway signatures.Frontiers in toxicology · 2025Article
- Evaluation of a non-animal toolbox informed by adverse outcome pathways for human inhalation safety.Frontiers in toxicology · 2025Article
- Sensitivity Analysis of the Inputs for Bioactivity-Exposure Ratio Calculations in a NAM-Based Systemic Safety Toolbox.NAM journal · 2025Article
- An advancement in developmental and reproductive toxicity (DART) risk assessment: evaluation of a bioactivity and exposure-based NAM toolbox.Frontiers in toxicology · 2025Article
- Highlighting best practices to advance next-generation risk assessment of cosmetic ingredients.NAM journal · 2025Article
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
For many years, a method that allowed systemic toxicity safety assessments to be conducted without generating new animal test data, seemed out of reach. However, several different research groups and regulatory authorities are beginning to use a variety of in silico, in chemico, and in vitro techniques to inform safety decisions. To manage this transition to animal-free safety assessments responsibly, it is important to ensure that the level of protection offered by a safety assessment based on new approach methodologies (NAMs), is at least as high as that provided by a safety assessment based on traditional animal studies. To this end, we have developed an evaluation strategy to assess both the level of protection and the utility offered by a NAM-based systemic safety "toolbox." The toolbox comprises physiologically based kinetic models to predict internal exposures, and bioactivity NAMs designed to give broad coverage across many different toxicity modes of action. The output of the toolbox is the calculation of a bioactivity:exposure ratio (analogous to a margin of internal exposure), which can be used to inform decision-making. In this work, we have expanded upon an initial pilot study of 10 chemicals with an additional 38 chemicals and 70 consumer exposure scenarios. We found that, for the majority of these (>90%), the NAM-based workflow is protective of human health, enabling us to make animal-free safety decisions for systemic toxicity and preventing unnecessary animal use. We have also identified critical areas for improvement to further increase our confidence in the robustness of the approach.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.