ArticleArchives of toxicology2022
A framework for chemical safety assessment incorporating new approach methodologies within REACH.
Article in Archives of toxicology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.
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Who cites it
44 citing papers in PubMed.
- Article
- Plant-derived exosome-like nanovesicles as programmable bio-organic excipients: a next-generation platform for precision and immuno-silent drug delivery.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026Review
- High-throughput PBK modelling for dermal exposure: a pragmatic approach to predict systemic pharmacokinetics.Archives of toxicology · 2026Article
- Multimodal Cross-Attentive Graph-Based Framework for Predicting In Vivo Endocrine Disruptors.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Perspective on applicability of data-driven machine learning computational new approach methodologies for hazard identification in chemicals risk assessment.Journal of cheminformatics · 2026Review
- Mechanism-based new approach methodologies for in vitro detection of chemical-induced liver steatosis.Archives of toxicology · 2026Review
- Uncertainty-aware machine learning to predict non-cancer human toxicity for the global chemicals market.Nature communications · 2026Article
- Combined exposure to emergingFrontiers in toxicology · 2026Article
- From Reduction to Replacement: Challenges and Proposed Solutions for Animal-Free Safety Assessment of Hydrocarbon UVCB Substances.NAM journal · 2026Review
- Biomimetic Chromatography as a High-Throughput Tool for Screening Bioaccumulation and Acute Aquatic Toxicity of Pesticides.Journal of xenobiotics · 2025Article
- Alternative Vertebrate and Invertebrate Model Organisms Show Similar Sensitivity as Rodents to a Diverse Set of Chemicals.Environmental science & technology · 2025Article
- Navigating complexity in modern toxicology: the role of omics in short-term in vivo studies.Toxicological sciences : an official journal of the Society of Toxicology · 2025Review
- In Silico Forensic Toxicology: Is It Feasible?Toxics · 2025Review
- Application of new approach methodologies for nonclinical safety assessment of drug candidates.Nature reviews. Drug discovery · 2025Review
- Framework for classifying chemicals for repeat dose toxicity using NAMs.Archives of toxicology · 2025Article
- A tiered next-generation risk assessment framework integrating toxicokinetics and NAM-based toxicodynamics: "proof of concept" case study using pyrethroids.Archives of toxicology · 2025Article
- Pursuing societal impact in research projects on NAM development: An analysis of routes to impact.NAM journal · 2025Article
- Animal-free safety assessment of chemicals: an innovation system perspective.Archives of toxicology · 2025Review
- Advancing human health risk assessment: the role of new approach methodologies.Frontiers in toxicology · 2025Review
- CHIASMA: Advancing chemicals and materials safety and sustainability assessments through innovative integration of in vitro and in silico (new approach) methodologies.Computational and structural biotechnology journal · 2025Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The long-term investment in new approach methodologies (NAMs) within the EU and other parts of the world is beginning to result in an emerging consensus of how to use information from in silico, in vitro and targeted in vivo sources to assess the safety of chemicals. However, this methodology is being adopted very slowly for regulatory purposes. Here, we have developed a framework incorporating in silico, in vitro and in vivo methods designed to meet the requirements of REACH in which both hazard and exposure can be assessed using a tiered approach. The outputs from each tier are classification categories, safe doses, and risk assessments, and progress through the tiers depends on the output from previous tiers. We have exemplified the use of the framework with three examples. The outputs were the same or more conservative than parallel assessments based on conventional studies. The framework allows a transparent and phased introduction of NAMs in chemical safety assessment and enables science-based safety decisions which provide the same level of public health protection using fewer animals, taking less time, and using less financial and expert resource. Furthermore, it would also allow new methods to be incorporated as they develop through continuous selective evolution rather than periodic revolution.
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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.