ArticleToxicological sciences : an official journal of the Society of Toxicology2020
A Next-Generation Risk Assessment Case Study for Coumarin in Cosmetic Products.
Article in Toxicological sciences : an official journal of the Society of Toxicology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers.
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Who cites it
62 citing papers in PubMed, 139 citations in OpenAlex.
- NGRA in Cosmetic Safety: Moving From the Frameworks and Case Studies to Wide Adoption.Current opinion in toxicology · 2026Article
- AI/ML-based computational models for toxicity prediction.Environmental science and pollution research international · 2026Review
- New approach methodologies for next-generation risk assessment of nanomaterials and nano-enabled products.Nano convergence · 2026Review
- PBK modelling of phthalates and their metabolites and the application in next generation risk assessment.Archives of toxicology · 2026Article
- Advances in the application of computational toxicology in cosmetic safety assessment.Archives of toxicology · 2026Review
- The way forward for assessing the human health safety of cosmetics in the EU: Proceedings of Workshop 2.Archives of toxicology · 2026Article
- Rewriting paracelsus: linking chemical assessment to public health.Frontiers in toxicology · 2026Review
- Next generation validation for next generation risk assessment.Frontiers in toxicology · 2026Review
- Establishing scientific confidence in a two-chamber co-culture system to evaluate androgenic response in the presence of hepatic metabolism.Toxicology letters · 2025Article
- Requirements for Alternative In Vitro and In Silico Skin Models of Irritant and Allergic Contact Dermatitis.Contact dermatitis · 2025Review
- Optimizing the implementation of safe and sustainable by design to better enable sustainable innovation.iScience · 2025Review
- Integrating Transcriptomic and Targeted New Approach Methodologies into a Tiered Framework for Chemical Bioactivity Screening.Environmental health perspectives · 2025Article
- Machine Learning for Toxicity Prediction Using Chemical Structures: Pillars for Success in the Real World.Chemical research in toxicology · 2025Review
- Exposure to Long- and Short-Chain Per- and Polyfluoroalkyl Substances in Mice and Ovarian-Related Outcomes: AnEnvironmental health perspectives · 2025Article
- Advancing systemic toxicity risk assessment: Evaluation of a NAM-based toolbox approach.Toxicological sciences : an official journal of the Society of Toxicology · 2025Article
- An advancement in developmental and reproductive toxicity (DART) risk assessment: evaluation of a bioactivity and exposure-based NAM toolbox.Frontiers in toxicology · 2025Article
- Review
- TIRESIA and TISBE: Explainable Artificial Intelligence Based Web Platforms for the Transparent Assessment of the Developmental Toxicity of Chemicals and Drugs.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Unlocking the future of environmental safety: a framework for integrating new approach methodologies in decision-making.NAM journal · 2025Article
- Highlighting best practices to advance next-generation risk assessment of cosmetic ingredients.NAM journal · 2025Article
2 more citing papers are in PubMed but not listed here.
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Authors and funding
22 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Next-Generation Risk Assessment is defined as an exposure-led, hypothesis-driven risk assessment approach that integrates new approach methodologies (NAMs) to assure safety without the use of animal testing. These principles were applied to a hypothetical safety assessment of 0.1% coumarin in face cream and body lotion. For the purpose of evaluating the use of NAMs, existing animal and human data on coumarin were excluded. Internal concentrations (plasma Cmax) were estimated using a physiologically based kinetic model for dermally applied coumarin. Systemic toxicity was assessed using a battery of in vitro NAMs to identify points of departure (PoDs) for a variety of biological effects such as receptor-mediated and immunomodulatory effects (Eurofins SafetyScreen44 and BioMap Diversity 8 Panel, respectively), and general bioactivity (ToxCast data, an in vitro cell stress panel and high-throughput transcriptomics). In addition, in silico alerts for genotoxicity were followed up with the ToxTracker tool. The PoDs from the in vitro assays were plotted against the calculated in vivo exposure to calculate a margin of safety with associated uncertainty. The predicted Cmax values for face cream and body lotion were lower than all PoDs with margin of safety higher than 100. Furthermore, coumarin was not genotoxic, did not bind to any of the 44 receptors tested and did not show any immunomodulatory effects at consumer-relevant exposures. In conclusion, this case study demonstrated the value of integrating exposure science, computational modeling and in vitro bioactivity data, to reach a safety decision without animal data.
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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.