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HESI GTTC Workshop:Developing Consensus on the Use of Quantitative Dose-response Analysis for Risk Assessment of Mutagenic Substances

International workshop, Bratislava – venue hotel, June 2nd, 2025, 1-5pm

Co-chairs:

George Johnson, Swansea University, UK

Paul White, Health Canada, Ottawa, Canada

Although interpretation of genetic toxicity data has traditionally been restricted to qualitative hazard identification, the last decade has seen a concerted movement toward quantitative interpretation of genotoxicity dose-response data for risk assessment and regulatory decision-making. The most robust method for quantitative analysis of mutagenicity dose-response data is the Benchmark Dose (BMD) approach, which determines the dose that elicits a set fractional increase in response over background. Standardised methods and software have been developed for effective BMD analysis; the current approach advocates model averaging and, where necessary, covariate analyses to investigate effects related to compound potency, treatment duration, cell type, repair capacity, etc. For human health risk assessment, quantitative methods have been developed to extrapolate below in vivo BMD values to determine exposure limits below which the likelihood of effect can be deemed negligible. Nevertheless, there is a pressing need to quantitatively define relationships between mutation and disease (e.g., cancer); moreover, determine how mutagenicity risk assessment should account for inter- and intra-species variability, exposure duration, and effect severity. Importantly, and despite significant advancements, quantitative methods for human health risk assessment of environmental mutagens have hitherto not been accepted by regulatory authorities. This workshop will provide an overview of current approaches for quantitative interpretation of mutagenicity dose-response data, an overview of applications for evaluations of drug impurities and polycyclic aromatic hydrocarbons (PAHs), an overview of novel in vitro approaches for quantitative assessment of mutagenic hazard, and lastly, an overview of issues and concerns regarding risk assessment and regulatory decision-making.

The workshop will include five 30 minute presentations, followed by 60 minutes of open discussion.

  1. Quantitative Interpretation of Mutagenicity Dose-response Data – Concepts, Considerations, and Concerns – George Johnson, Swansea University, Swansea, UK
  2. Mutagenicity Assessment of Nitrosamines and NDSRIs – Anthony Lynch, GSK, Stevenage, UK
  3. Quantitative Interpretation of Polycyclic Aromatic Hydrocarbons (PAH) Mutagenicity Dose-response Data in a Risk Assessment Context – Paul White, Health Canada, Ottawa, Canada
  4. Mutagenicity Assessment Using In Vitro Approaches – Birgit Mertens, Sciensano, Brussel, Belgium
  5. Regulatory Perspective on Quantitative Use of Mutagenicity Dose-response Data for Regulatory Decision-making – Alisa Vespa, Health Canada, Ottawa, Canada

    Beyond the Petri Dish: Micronucleus Assay Using Human 3D Skin Models

    International workshop, Bratislava – MatTek In Vitro Science Laboratories,

    June 5th, 2025, 4:30-6:30 pm

    Organizers:

    MatTek In Vitro Life Science Laboratories

    Location:

    Mlynské nivy 73, 821 05 Bratislava

    Date, costs and registration:

    June 5th, from 4:30 PM to 6:30 PM, at MatTek In Vitro Life Science Laboratories in Bratislava. Participation is free of charge; however, prior registration is required via the registration form below.

    Please note: To apply for this workshop, you must first be registered for the EEMGS / CSSMS 2025 conference. The workshop is limited to 10 participants.

    The registration is open until April 27, 2025!

    Topics and background information:

    This workshop will introduce the Reconstructed Skin Micronucleus Assay (RSMN), a 3D in vitro method using the EpiDerm™ human skin model to assess the genotoxic potential of chemicals applied topically. Developed as an alternative to in vivo testing, the RSMN assay aligns with current EU regulations and ethical testing approaches.

    Participants will be introduced to the biological principles, methodological workflow, and practical considerations of the RSMN assay, including:

    • Scientific background and regulatory context
    • Structure and relevance of the EpiDerm™ model
    • RSMN assay protocols (48h and 72h treatments)
    • Tissue dosing, cell harvesting, and staining
    • Slide scoring, cytotoxicity analysis, and statistical evaluation
    • Criteria for result interpretation and assay validity

    This session will combine theoretical knowledge with practical demonstrations and, is particularly relevant for professionals working in genetic toxicology, regulatory science, or the development of non-animal test methods for chemical safety evaluation.

    Capacity:

    10 participants

    To register, please click the link below:

    Check the flyer in the link below:

    Use of Genotoxicity Methods for Human Biomonitoring: Prevention – Diagnosis and Therapy of Cancer

    International workshop, Vienna, June 6th, 2025, 10am-6pm

    Organizers:

    Miroslav Mišík,

    Georg Wultsch,

    Siegfried Knasmüller

    Organizing Institutions:

    Center for Cancer Research, Medical University of Vienna, Austria

    ASU Experts group (Occupational-Social and Environmental Medicine) Graz, Austria

    Comprehensive Cancer Center, Vienna, Medical University of Vienna, Austria

    Institute of the Radiobiology, Belgrade, Serbia

    Location:

    General Hospital Vienna, Währinger Gürtel 18-20, 1090 Wien (please check the details in the link below).

    Date, costs and registration:

    June 6th, 10 a.m. till 6 p.m. Participation will be free of charge (including lunch and coffee break), but participants have to register via the link in the registration site of the main conference or should contact the organiser directly – miroslav.misik@meduniwien.ac.at

    Topics and background information:

    The workshop will be a satellite event of the 53rd Congress of the European Environmental Mutagenesis and Genomics Society. In the frame of the workshop, international experts will give lectures, which describe the use of human biomonitoring techniques detecting damage of the genetic material in different areas of research. They will include genotoxicity studies in occupational settings, induction and prevention of DNA damage by nutritional factors, effects of lifestyle and environmental exposures, and the predictive value of different genotoxicity tests for the detection of human cancer risks and for the assessment of adverse therapeutic effects.

    Check the program and how to get there in the link below: