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Driven by a desire for reliable, human-relevant, and efficient testing approaches, regulatory agencies and companies around the world are striving to implement new approach methodologies (NAMs) for chemical toxicity testing. In fact, many have instated goals or requirements to reduce and replace tests on ...

Driven by a desire for reliable, human-relevant, and efficient testing approaches, regulatory agencies and companies around the world are striving to implement new approach methodologies (NAMs) for chemical toxicity testing. In fact, many have instated goals or requirements to reduce and replace tests on animals with robust animal-free testing approaches.

The elucidation of biological mechanisms and the emergence of new technologies have led to substantial advancement of NAMs, which include in vitro and computational methods. A bottleneck in their implementation has been a lack of widespread regulatory acceptance, often slowed by the historical process of validation, which involves direct comparison to animal tests that were never validated for their reproducibility or relevance to humans. There is growing consensus that the validation paradigm needs to be viewed through a new lens to ensure new methods that are as good as or better than currently used methods can be identified and implemented in a timely manner.

This Research Topic will include case study examples of NAMs that may be applied to regulatory decision-making. It will highlight innovative NAM research, and elucidate how NAMs can be used in an integrated approach to provide information that answers regulatory questions used to protect humans and the environment. Contributions may also highlight new ways of thinking about how to show the validity of NAMs while ensuring greater human-relevance and more timely incorporation into the regulatory decision-making process.

Gaining confidence in NAMs is critical to their implementation and widespread regulatory acceptance. This Research Topic will facilitate that process by sharing NAM case studies that demonstrate their utility based on an understanding of human biology. The Topic Editors welcome any contributions related to the use of NAMs to meet or support regulatory requirements for chemical toxicity testing. Potential topics include, but are not limited to:

• NAMs to assess endpoints of interest in regulatory toxicology, including skin and eye irritation, skin sensitization, respiratory sensitization, systemic toxicity, genotoxicity, developmental and reproductive toxicity, carcinogenicity, and ecotoxicity.
• Weight of evidence approaches incorporating exposure considerations, physical-chemical properties, existing information, non-testing information, and in vitro and in silico models.
• Lesson learned from successful or unsuccessful regulatory submissions of NAMs.
• High-throughput in vitro screening tests as well as advanced in vitro methods, such as 3D organotypic tissue models, microphysiological systems/organ-on-a-chip, organoids, and tissue slices.
In vitro or in silico systems to address questions of chemical mode-of-action, metabolism, or toxicokinetics.
• The application of a read across assessment framework.
• Adverse Outcome Pathways to be used for toxicity assessment.
• Retrospective reviews to identify whether a test produces information used in regulatory decision-making.
• Data analyses of the repeatability and reproducibility of a test method.
• The creation or use of databases of curated toxicology data.


Different Article Types can be submitted to the Research Topic including Original Research, Review, Mini-Review, Brief Research Report, Perspective articles, among others. You can find detailed information here.


We look forward to receiving your valuable contributions to our Research Topic.


Carole Hirn and Claire Terry declare competing interests as they are employed by companies that use the technologies discussed in this issue for toxicological evaluation purposes and for the determination of product safety, respectively. The other Topic Editors have no competing interests to declare.

Keywords: New approach methodologies (NAM), in vitro, in silico, chemical toxicity, human-relevant testing


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