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The need for epigenotoxicity testing.

Thomas Hartung1,2, Lena Smirnova1, Stefan Platz3

  • 1Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Doerenkamp-Zbinden Chair for Evidence-based Toxicology, Bloomberg School of Public Health and Whiting School of Engineering, Baltimore, MD, USA.

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|October 14, 2025
PubMed
Summary
This summary is machine-generated.

Epigenetics, the study of gene expression changes from environmental factors, offers new ways to understand and predict disease risk. Incorporating epigenetic analysis into toxicology can lead to safer products and better protection for vulnerable populations.

Keywords:
DNA methylationepigeneticsmicroRNAnon-coding RNAtoxicity testing

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Area of Science:

  • Toxicology
  • Genetics
  • Environmental Health

Background:

  • Cell phenotype is determined by genetics and external factors (exposome), involving gene x environment interaction (GxE).
  • Epigenetics, including DNA methylation and histone modifications, influences gene accessibility and protein expression.
  • Epigenetic changes can retain memory of exposures, impacting susceptibility to subsequent environmental factors.

Purpose of the Study:

  • To provide an overview of epigenetics in toxicology.
  • To advocate for systematic assessment of epigenetic changes in toxicity evaluations.
  • To propose strategies for predicting individual risk using human-relevant models, biomarkers, and AI.

Main Methods:

  • Review of epigenetic mechanisms (DNA methylation, histone modifications, non-coding RNAs, DNA packaging).
  • Discussion of epigenetics' role in gene x environment interaction (GxE) and disease pathology.
  • Proposal of tools and strategies including human-relevant models, biomarkers, and artificial intelligence (AI).

Main Results:

  • Epigenetics provides a mechanism for understanding how environmental exposures influence health outcomes.
  • Epigenetic memory of exposure can reveal insights into mixture toxicity and non-simultaneous exposures.
  • Understanding epigenetics can inform the development of novel drugs for diseases like cancer and neurodegenerative disorders.

Conclusions:

  • Integrating epigenetics into toxicology assessments is crucial for understanding disease and predicting risk.
  • Systematic assessment of epigenetic changes can enhance toxicity evaluations and regulatory practices.
  • Utilizing epigenetics can lead to safer products and improved protection for individuals and future generations.