Genetic Toxicology Technical Committee (GTTC)

Mission Statement

The mission of this committee is to improve the scientific basis of the interpretation of results from genetic toxicology tests for purposes of more accurate hazard identification and assessment of human risk; to develop follow-up strategies for determining the relevance of test results to human health; to provide a framework for integration of testing results into a risk-based assessment of the effects of chemical exposures on human health; to promote the integration and use of new techniques and scientific knowledge in the evaluation of genetic toxicology; and to monitor and promote the development of innovative tests and testing strategies.

Working Groups

  • Evaluation of New Compounds: Nanomaterials

    The work group has evaluated the current testing paradigm for genotoxicity assessment of nanomaterials and is publishing the findings and recommendations for modifying the tests as needed. They are currently considering publishing a series of protocols for genetic toxicity testing of products containing nanomaterials.

    Leadership Team:
    Rosalie Elespuru, PhD (US Food and Drug Administration)
    Shareen Doak, PhD (Swansea University)

    HESI Staff:
    Connie Chen, PhD, MPH

  • In Vivo Follow-Up

    This work group was formed in 2016. This working group focused on providing more detailed advice about which in vivo tests to choose to follow-up on in vitro positive results and how to conduct the tests. As a first step, the group compared data for 90 chemicals for the transgenic rodent assay, the in vivo comet assay, and cancer data. This work was published in Mutation Research/Genetic Toxicology and Environmental Mutagenesis in January 2019 in an article titled “A Comparison of Transgenic Rodent Mutation and In Vivo Comet Assay Responses for 91 Chemicals.” Two follow-up areas include (1) providing best practices on the in vivo comet assay and collecting data on substances that are positive (i.e., induce micronuclei [MN]) in vivo and (2) comparing the plasma concentrations at the lowest effective dose (LOED) with the lowest effective concentration (LOEC) for MN induction in vitro, which could shed some light as to whether there is any relationship between LOEC and LOED for MN-inducing compounds.

    Leadership Team:
    Dan Roberts, PhD (Charles River Laboratories)
    David Lovell, PhD (St. George’s University of London)
    Matt LeBaron, PhD (Dow Chemical Company)

    HESI Staff:
    E’Lissa Flores, PhD

  • Mode of Action

    The MOA Work Group established four subteams to develop tubulin binding, topoisomerase II inhibition, aurora kinase inhibition, and reactive oxygen species activation adverse outcome pathways (AOPs). These AOPs will be submitted to the OECD AOPWiki site, a public repository for approved AOPs. Once these four subteams complete their work, the goal will be to merge them with the Clean Sheet Work Group.

    Leadership Team:
    Mirjam Luitjen, PhD (National Institute for Public Health and the Environment, RIVM, The Netherlands)
    Jan van Benthem, PhD (National Institute for Public Health and the Environment, RIVM, The Netherlands)
    Stefan Pfuhler, PhD (Procter & Gamble Company)

    HESI Staff:
    Carolina Morell-Pérez, MS

  • Germ Cells

    Work for this group is centered around establishing/enhancing protocols for conducting genotoxicity assessment of effects to germ cells. After a series of publications in 2019, the group is finalizing a review on the impact of analyzing mutations in fast proliferating tissues at 28+28. This group is also considering future projects and the course of action for 2020–2021.

    Leadership Team:
    Jan van Benthem, PhD (National Institute for Public Health and the Environment, RIVM, The Netherlands)
    Francesco Marchetti, PhD (Health Canada)

    HESI Staff:
    Connie Chen, PhD, MPH

  • Pig-a Assay

    This work group had their Detailed Review Paper (DRP) and a Validation/Retrospective Performance Analysis document accepted by OECD. It is currently drafting a Test Guideline to be reviewed and accepted by OECD in the future.

    Leadership Team:
    Steven Dertinger, PhD (Litron Laboratories)
    Bob Heflich, PhD (US Food and Drug Administration)

    HESI Staff:
    Connie Chen, PhD, MPH

  • Quantitative Analysis

    The work group is evaluating chemical data and enhancing tools for genetic toxicology dose-response modeling. The group has a planned 2020 virtual EMGS workshop scheduled for December 2020. Additionally, the group is planning to present at the International Workshops on Genotoxicity Testing (IWGT) 2021 meeting and is working on publishing guidance for the standard use and regulatory acceptance of using the benchmark dose (BMD) approach with genetic toxicology data.

    Leadership Team:
    George Johnson, PhD (Swansea University)
    Andreas Zeller, PhD (Roche)

    HESI Staff:
    E’Lissa Flores, PhD

  • Clean Sheet Testing Strategy

    This work group published a conceptual framework for a next-generation testing strategy for assessment of genomic damage for risk assessment and decision-making in 2016, and a case study applying those concepts in industrial chemicals was published in 2019. The group is currently finalizing an additional case study looking at a pharmaceutical compound for 2020. Afterward, this work group will merge with the MOA Work Group.

    Leadership Team:
    Mirjam Luitjen, PhD (National Institute for Public Health and the Environment, RIVM, The Netherlands)
    Jan van Benthem, PhD (National Institute for Public Health and the Environment, RIVM, The Netherlands)
    Stefan Pfuhler, PhD (Procter & Gamble Company)

    HESI Staff:
    Carolina Morell-Pérez, MS

  • Error-Corrected Sequencing

    This group is evaluating error-corrected next-generation sequencing (NGS) as an alternative methodology for evaluating in vivo mutagenesis. Over the past year, the group worked to qualify this platform in a second species and other mouse strains and began to work out the details on a technology transfer. Currently, the group is discussing the different workstreams/subgroups that would need to be established to move this project to the next phase, along with collaborations with both the eSTAR and CT-TRACs committees.

    Leadership Team:
    Bob Young, MS (MilliporeSigma)
    Francesco Marchetti, PhD (Health Canada)
    Sheroy Minocherhomji, PhD (Amgen)

    HESI Staff:
    Carolina Morell-Pérez, MS

  • In Vitro

    This newly established work group started this year with the following goals: (1) critically evaluate NAMs for in vitro genotoxicity testing, (2) envision how NAMs could expand current in vitro genetic toxicology testing strategies (e.g., developing a weight-of-evidence approach), and (3) make recommendations for creating an “in vitro only” approach for genetic toxicology testing that would meet the needs of various regulatory decision-makers.

    Leadership Team:
    Giel Hendriks, PhD (Toxys B.V.)
    Stepahnie Smith-Roe, PhD (National Institute of Environmental Health Sciences, National Toxicology Program)

    HESI Staff:
    Connie Chen, PhD, MPH

HESI Staff

Leadership Team

  • Mirjam Luitjen, PhD

    National Institute for Public Health and the Environment, RIVM, The Netherlands

  • Leon Stankowski, PhD

    Charles River Laboratories

Committee Events

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Committee Publications

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Permitted Daily Exposure Limits for Noteworthy N-Nitrosamines

A genotoxic carcinogen, N-nitrosodimethylamine (NDMA), was detected as a synthesis impurity in some valsartan drugs in 2018, and other N-nitrosamines, such as N-nitrosodiethylamine (NDEA), were later detected in other sartan products. N-nitrosamines are pro-mutagens that can react with DNA following metabolism to produce ...

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Recommendations for Conducting the Rodent Erythrocyte Pig‐a Assay: A Report from the HESI GTTC Pig‐a Workgroup

The rodent Pig‐a assay is a flow cytometric, phenotype‐based method used to measure in vivo somatic cell mutation. An Organization for Economic Co‐operation and Development (OECD) test guideline is currently being developed to support routine use of the assay for regulatory purposes (OECD project number ...

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A Comparison of Transgenic Rodent Mutation and In Vivo Comet Assay Responses for 91 Chemicals

Whilst the TGR and comet assays are available for measuring genotoxic effects in multiple rodent tissues, there has been no systematic comparison of their performance in detecting genotoxicity per se. A working group of the Genetic Toxicology Technical Committee (GTTC), part of the Health and Environmental Sciences Institute ...

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Identifying Germ Cell Mutagens Using OECD Test Guideline 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays) and Integration with Somatic Cell Testing

The Organisation for Economic Co-operation and Development Test Guideline 488 (TG 488) provides recommendations for assessing germ cell and somatic cell mutagenicity using transgenic rodent (TGR) models. However, important data gaps exist for selecting an optimal approach for simultaneously evaluating mutagenicity in ...

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Simulation of Mouse and Rat Spermatogenesis to Inform Genotoxicity Testing Using OECD Test Guideline 488

The Germ Cell Workgroup of the Genetic Toxicology (GTTC) Committee of the Health and Environmental Sciences Institute modeled mouse and rat spermatogenesis to better define the exposure history of the cell population collected from seminiferous tubules.

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