Genotoxicity – Assessment, Regulation, Testing, Modelling and Prediction

This conference aims at providing compact and relevant information on current issues regarding the assessment of chemical substances with the potential for genotoxic effects.

03.11. — 04.11.2022
Online Conference | Die Akademie Fresenius GmbH
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Übersicht

This conference aims at providing compact and relevant updates on current issues regarding the assessment of chemical substances with the potential for genotoxic effects. Geared to the requirements the different industries are facing, it offers an overview of regulatory developments, new assessment and testing approaches as well as news on modelling and prediction.

Highlights

  • Update of the GHS classification
  • EFSA on their Pesticides Genotoxicity Database
  • Genotoxicity assessment of biocides: update from ECHA
  • Aneugenicity: guidance, in vivo follow-up testing, choice of methods and appropriate target organs
  • Weight of evidence approach for assessing the genotoxic potential of titanium dioxide
  • Nitrosamine impurities in drugs
  • Revision of OECD Test Guideline 488
  • In vitro micronucleus assay for nanomaterial testing: application of the OECD 487 protocol and suggested modifications
  • Principle and scoring approaches of the Pig-a gene mutation assay
  • Application and OECD validation of the ToxTracker assay
  • In vitro 3D tissue models for safety assessment of cosmetics
  • Use of QSAR: pesticides, pharmaceuticals, industrial chemicals and FCM

Who do you meet?

Professionals working in the fields of:

  • Toxicology
  • Hazard, exposure and risk assessment for human health
  • Regulatory affairs
  • Research and development
  • Legal and general counselling

Sectors that should take part:

  • Chemical, biocide, agrochemical, pharmaceutical, cosmetic, food and feed, FCM industries
  • Competent authorities, regulatory bodies and research institutes
  • Testing laboratories and contract research organisations (CROs)
  • Consultancies
  • Professional associations

Picture Credit: © Sashkin – Fotolia.com

 

Programm

PLEASE NOTE: The indicated times refer to Central European Time CET.

For further time zones, please view here.



Thursday, 3 November 2022


Morning Session | 09:30 – 12:30 CET
Welcoming speech by the organisers and the Chairs

Krista Meurer, BASF, Germany
Paschalina Papadaki, European Chemicals Agency (ECHA), Finland

Regulatory Developments
Update of the GHS classification

Jan van Benthem, National Institute for Public Health and the Environment (RIVM), The Netherlands

Update on genotoxicity and biocides

Paschalina Papadaki, European Chemicals Agency (ECHA), Finland

Short break
Update and extension of the EFSA Pesticides Genotoxicity Database
  • History and the existing database
  • EFSA Strategy 2027
  • Update and extension of the database
  • The overall picture: related projects

Juan Parra Morte, European Food Safety Authority (EFSA), Italy

Assessment of aneugenicity and incorporation of this endpoint in risk assessments
  • Definition of aneugenicity and aneugens: target structures, dose-response and AOP
  • Recent information and guidances
  • In vivo follow-up testing, choice of methods and target organs
  • Risk assessment for substances that exhibit aneugenicity but do not induce clastogenicity or gene mutations

Annette Bitsch and Christina Ziemann, both Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany



Afternoon Session | 13:30 – 17:15 CET
Modelling and Prediction of Genotoxicity
ICH M7 classification and involvement of QSAR methods
  • ICH M7 hazard assessments
  • In silico systems and use of expert knowledge
  • Case studies for ICH M7 classes 3, 4 and 5
  • Compound-specific risk assessment and case studies for ICH M7 class 1 molecules

Susanne Glowienke, Novartis, Switzerland

QSAR and read-across in the assessment of plant protection products

Markus Frericks, BASF, Germany

Use of (quantitative) structure-activity relationship ((Q)SAR) predictions for industrial chemicals and food contact material assessments
  • Strategies for identifying potentially mutagenic substances by combination of multiple (Q)SAR tools
  • Support of experimental data or read across assessments with (Q)SAR predictions

Rodolfo Gonella Diaza, knoell Germany, Germany´

Short break
Quantitative Risk Assessment
Quantitative interpretation of in vivo mutagenicity dose-response data for chemical prioritisation and risk assessment: recent progress and persistent challenges
  • Interpretation of genetic toxicity test data: paradigm shaft from qualitative to quantitative
  • Quantitative PoD (point-of-departure) metrics for chemical prioritisation and regulatory decision-making
  • UFs (uncertainty factors) required for extrapolation below a PoD

Paul A. White, Health Canada, Canada

Nitrosamin impurities in drugs
  • Developing assays for a better detection of nitrosamines: the EMA/Fraunhofer project
  • Current approaches in developing structure-activity relationships for risk assessment

Kevin P. Cross, Instem, United States of America



Friday, 4 November 2022


Morning Session | 09:30 – 12:30 CET
Relevance in Case of Positive Results – Weight of Evidence
Application of a weight of evidence approach to assessment of genotoxic potential – the example of titanium dioxide
  • Occurrence and current assessment of titanium dioxide
  • Use of structured weight of evidence (WoE) approach for assessing the genotoxic potential
  • Results and interpretation of observed genotoxic effects

David Kirkland, Kirkland Consulting, United Kingdom

Development of Test Methods and Guidelines
Feedback from the 8th International Workshop on Genotoxicity Tests (IWGT)

Hans-Jörg Martus, Novartis, Switzerland

Short break
Revision of the OECD Test Guideline 488
  • Transgenic rodent gene mutation: methodologies and role in regulatory testing strategies
  • Background to the 2020 and 2022 updates to OECD 488
  • CRO landscape for conducting these assays

Carol Beevers, Corteva Agriscience, Broughton, United Kingdom

Applications of the ToxTracker assay to investigate the mode-of-action of genotoxic compounds
  • Mechanistic insight into genotoxicity
  • Quantitative genotoxic dose response modelling
  • OECD validation of ToxTracker

Giel Hendriks, Toxys, The Netherlands



Afternoon Session | 13:00 – 15:00 CET
A status update: adaption of the in vitro micronucleus assay for nanomaterial testing
  • OECD 487 protocol for testing the mutagenic potential of nanoparticles
  • Application of the assay testing BaSO4, CeO2, Au5nm, Au30nm and SiO2: analytical method, control and results
  • Conclusion and suggested modifications of the protocol

Naveed Honarvar, BASF, Germany

In vitro 3D tissue models in genotoxicity testing
  • Regulatory status
  • Strategic fit in the context of cosmetic`s safety assessment

Kerstin Reisinger, Henkel, Germany

Key attributes of the rodent erythrocyte-based Pig-a gene mutation assay
  • Pig-a assay principle and scoring approaches
  • Mutant phenotype cell attributes that inform study design
  • Brief overview of OECD Test Guideline 470

Stephen D. Dertinger, Litron Laboratories, United States of America

End of the conference

Referent:innen

Name

Unternehmen

Beevers

Carol Beevers

Corteva Agriscience, United Kingdom

Carol Beevers is a Regulatory Toxicologist, specialising in genetic toxicology. After gaining a degree in Microbiology and a PhD in Bacterial Genetics, Carol joined the Genetic Toxicology department at Covance Laboratories (now Labcorp) as an in vitro and in vivo Study Director. After almost 20 years in contract research, she moved to consultancy, first in the Human Health Toxicology group at Exponent International and then the Toxicology Group at Broughton Life Sciences. More recently, Carol has joined the toxicology team at Corteva Agriscience. Carol has worked across a variety of industry areas including pharmaceuticals, agrochemicals, food and food contact materials, and industrial chemicals, where she has specialised in genetic toxicology risk and mode of action assessments. Since 2015 she has been a member of the UK Committee on Mutagenicity of Chemicals in Food, Consumer Products, and the Environment. She is also a member of the OECD Expert Groups for the guidelines on the transgenic rodent gene mutation assay and the comet assay, the Health and Environmental Sciences Institute Genetic Toxicology Testing Committee and the International Workshops on Genotoxicity Testing.

mehrweniger
Bitsch

Annette Bitsch

Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany

Annette Bitsch is Biologist and Toxicologist and currently division director for “Chemical Safety and Toxicology” at the German Fraunhofer Institute for Toxicology and Experimental Medicine ITEM where she focuses on risk assessment in regulatory affairs and the development of new risk assessment strategies including alternative and new methods such as in-silico toxicology and enhanced exposure modelling. Her past career stages include the Leibniz University in Hannover, the Institute of Toxicology of the University Würzburg where she focused on genotoxicity, molecular mechanism in multistep carcinogenesis and cellular adaptive responses as well as the biocides division at Fraunhofer ITEM.

mehrweniger
Cross

Kevin P. Cross

Instem, United States of America

Kevin P. Cross is a Vice-President at Instem, where he is Principal Investigator of U.S. FDA/Leadscope collaborations. His current responsibilities include the collaborative research and development of QSAR models and databases with U.S. FDA. He is also responsible for the development of the Leadscope Enterprise product and leads the software development and database production groups. He received his Ph.D. in chemistry and has been developing chemoinformatics tools and products for over 35 years. He is also involved in several collaborative efforts to create protocols and procedures for performing in silico assessments for regulatory purposes as well as to assess their performance.

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Stephen D. Dertinger

Litron Laboratories, United States of America

Stephen D. Dertinger holds a PhD in Toxicology and has been serving as Director of Research at Litron Laboratories since 2000. Over these years, Stephen and his team have focused on the development of high throughput, high information content genetic toxicology assays, with an emphasis on biomarkers that can be applied across cell and animal models. Recently, he has been involved in the development of an OECD Test Guideline for the Pig-a gene mutation assay.

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Frericks

Markus Frericks

BASF, Germany

Markus Frericks is a Biologist and European Registered Toxicologist, working as a Regulatory Toxicologist at BASF in Limburgerhof. He is the Vice Chair of the Working Group on Computational Toxicology of the German Society of Toxicology (GT) and the Chair of the CropLife Europe Working Group on Genotoxicity-QSAR.

mehrweniger
Glowienke

Susanne Glowienke

Novartis, Switzerland

Susanne Glowienke obtained a PhD degree from the Faculty of Food Technology (Cereal Chemistry) from the University of Stuttgart-Hohenheim. She joined Novartis in 2000 as a postdoc in the area of (Q)SAR for toxicological endpoints. She held several positions at Novartis including positions in Genetic Toxicology and QSAR modelling and is currently Director in Preclinical Safety. Susanne is head of the Impurity Safety Group and as such responsible for contaminant issues including nitrosamines. She is also part and has led a number of industry expert groups within DruSafe IQ (US), European Federation of Pharmaceutical Industries and Associations (EFPIA), the Extractables and Leachables Safety Information Exchange (ELSIE) and several data sharing initiatives.

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Gonella Diaza

Rodolfo Gonella Diaza

knoell Germany, Germany

Rodolfo Gonella Diaza is a bio- and chemoinformatician, working for knoell Germany in the chemistry and analytics group and in the QSAR team since 2016. He has 15 years of experience in the in silico models field and is currently involved in developing strategies and applying QSAR and read-across for the (eco)toxicological evaluation within several regulatory frameworks.

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Hendriks

Giel Hendriks

Toxys, The Netherlands

Giel Hendriks has a PhD in molecular cell biology from Utrecht University and worked for four years as a post-doctoral fellow at Leiden University, studying the relationship between DNA damage and gene mutations. After this he moved to the Leiden University Medical Center to develop in vitro reporter systems to understand the mechanisms of genotoxicity. Currently, he is the CEO of Toxys, a contract research organisation (CRO) he started in 2014. During the past years, Toxys has developed various in vitro assays to ensure the safety of novel medicines, chemicals and consumer products without the use of animals.

mehrweniger
Honarvar

Naveed Honarvar

BASF, Germany

Naveed Honarvar holds a PhD in biology and is currently Leader of the laboratory for mutagenic and endocrine effects in the Experimental Toxicology and Ecology Unit of BASF. Priorly, he worked as Toxicologist in the Contract Management Team and as Regulatory Toxicologist in the Product Safety Department. Before joining BASF, he was Head of the in vivo genotoxicity group of the contract research company Harlan Laboratories.

mehrweniger
Kirkland

David Kirkland

Kirkland Consulting, United Kingdom

David Kirkland is a Professor with over 40 years of experience in regulatory genetic toxicology and has worked as an Independent Consultant since 2009. He has received recognition awards from the US, Japanese and UK environmental mutagen societies, was chair of IWGT for 20 years and was a member of the UK Government Advisory Committee on Mutagenicity for 10 years.

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Martus

Hans-Jörg Martus

Novartis, Switzerland

Hans-Joerg Martus is currently the Head of Genome Safety at the Novartis Institutes for BioMedical Research in Basel, Switzerland. Priorly he held positions at Sandoz, the Harvard Medical School and the Institute of Toxicology in Mainz, Germany.

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Krista Meurer

BASF, Germany

Krista Meurer has been a Regulatory Toxicologist for Crop Protection at BASF since 2008. In support of European and global registrations, she is responsible for human health risk assessment for pesticide products and active substances. Based on 10 years experience as a Study Director in contract research, Krista has a special interest in genetic toxicology testing and is a member of the CropLife Europe genotoxicity expert group as well as the Health and Environmental Sciences Institute (HESI) Genetic Technical Committee (GTTC).

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Paschalina Papadaki

European Chemicals Agency (ECHA), Finland

Paschalina Papadaki is currently Scientific Officer in ECHA’s Biocides Unit where she is involved in the peer review programme of active substances. She has also worked in ECHA's REACH Evaluation Unit. She has previously held positions at the Department of Pesticides, Control and Phytopharmacy of Benaki Phytopathological Institute, Greece and at Battelle UK.

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Parra Morte

Juan Parra Morte

European Food Safety Authority (EFSA), Italy

Juan Parra Morte has been Toxicologist in the Pesticide Peer Review Unit of EFSA since 2008. He has been actively involved in the assessment of pesticide active substances, their metabolites and impurities, including the EFSA PPR, the OECD Guidance on Residue Definition and EFSA's outsourced projects on the Genotoxicity Database and QSAR and Read-Across for the genotoxicity of metabolites. He has also been involved in supporting the EFSA Working Group on Genotoxicity, being a co-author of the EFSA Scientific Committee Guidance and Statements regarding genotoxicity since 2017.

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Kerstin Reisinger

Henkel, Germany

Kerstin Reisinger is Biologist and European Registered Toxicologist, currently working on the general product safety of cosmetic products at Henkel. She developed and validated 3D in vitro genotoxicity assays together with project partners, e.g. from Cosmetics Europe and is now pursuing the further regulatory acceptance of assays together with them.

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White

Paul A. White

Health Canada, Canada

Paul A. White holds a PhD in environmental toxicology and joined Health Canada in 1999 where he is currently Senior Research Scientist and Leader of the genetic toxicology lab group in the Environmental Health Science and Research Bureau. In 2002, he was appointed Professor of Chemical and Environmental Toxicology in the Department of Biology at the University of Ottawa. His current work investigates the mutagenic and carcinogenic hazards of complex mixtures, the design and validation of in vitro and in vivo tools for genetic toxicity assessment, the use of molecular biomarkers for mutagen exposure assessment, and the development of quantitative methods for interpretation of genetic toxicity dose-response data. He is the current president of the International Association of Environmental Mutagenesis and Genomics Societies (IAEMGS), and program co-chair for the 13th International Conference on Environmental Mutagens (ICEM).

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Ziemann

Christina Ziemann

Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany

Christina Ziemann is Biologist and GT- and EUROTOX-Registered Toxicologist. She currently heads the work group “Genetic Toxicology & Tumour Research” at the German Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and has almost 20 years of experience in planning and conducting nonclinical genotoxicity studies for regulatory purposes in different fields, in developing test item-adapted testing strategies and testing model systems, and in conducting non-guideline scientific mechanistic studies with a current focus on particles and fibers, medical devices and electromagnetic fields.

mehrweniger

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