Workshop Report 30



Open to all ECETOC member companies and invited guests


10:30-11:00       Registration and coffee

11:00-11;10       Welcome and Introduction                                                                                                                      Alan Poole

ECETOC SG, Belgium


Session 1

Level Setting: Reproductive Toxicity Studies and Epigenetic Studies


11:10-11:40       What are reproductive toxicity guideline studies?                                                       Jessica LaRocca

Why are they conducted? What can they achieve?                                                                   Dow, USA

Where are the gaps?

11:40-12:00       What are epigenetic studies?                                                                                                            John Greally

Technical aspects and data interpretation to achieve                       Albert Einstein College of

confidence in epigenetic studies (human                               Medicine, Yeshiva University, USA

epidemiology and animal-based studies)

12:00-12:20       Effects on rat reproductive development produced by                                                        Paul Foster

antiandrogens: upstream indicators of downstream effects                                          NIEHS, USA

12:20-12:40       Effects on rat reproductive development produced by                                                             Earl Gray

antiandrogens: AOPs and transgenerational effects                                                                  EPA, USA

12:40-13:00       The lack of Transgenerational Inheritance of Anti-                                                         Roland Buesen

androgenic effects after Vinclozolin Treatment                                                              BASF, Germany

13:00-14:00       Lunch

14:00-14:20       The potential application of microRNAs in regulatory toxicology                      Emma Marczylo

Public Health, England

14:20-14:40       Introduction of Percellome Project, highlighting the concept of                                     Jun Kanno

“signal toxicity”. Case study: Single exposure adult studies and                                NIHS, Japan

developmental cases, at signal dose levels, i.e. at the level of

No overt cytotoxicity or organ toxicity monitorable by histopathology




Session 2

Understand the Relationship between Epigenetic Change and Adverse Endpoints


14:40-15:00       What are the general principles for indicating whether the epigenetic                 Bob Chapin

change is causal (adverse) or adaptive?                                                                                 Pfizer Inc, USA

15:00-15:20       Practical experience with rodent species used in toxicology studies:         Richard Meehan

what is a normal epigenetic background?                                        Medical Research Council, UK

15:20-15:40       Determining clear and robust biomarkers of epigenetic change                            Daniele Fallin

and adversity                                                                                                        Johns Hopkins University, USA

15:40-16:00       Scoping Discussion: Can we start to identify key biomarkers           Tim Gant/Miriam Jacobs

and potential mechanisms associated with the phenotypic                                               CRCE, UK

adverse change? (sound techniques, robust data interpretation


16:00-16:20       The concept of “repeated exposure” and possible links to epigenetic                       Jun Kanno

regulations. Repeated dose studies introducing baseline responses                    NIHS, Japan

and transient responses with possible link to epigenetics

16:20-17:00       Zebrafish Model – applications to address what is relevant for                          Peter Aleström

multiple generational studies                                                                      Norwegian University of Life

Sciences, Oslo, Norway

17:00-17:20       How can these be applied to current regulatory test paradigms?                 Ioanna Katsiadaki

CEFAS Weymouth Laboratory, UK

17:20-17:40       Consensus on what and how?                                                                                 Tim Gant/Miriam Jacobs


17:40-18:00       Closure and guidance for Day 2                                                                                                             Alan Poole

ECETOC SG, Belgium

18:30-20:00       Networking cocktail for Day 2 participants






08:30-08:45       Registration and coffee

11:00-11;10       Welcome and Objectives for the day                                                                                                Alan Poole

Instructions for Breakouts                                                                                                   ECETOC SG, Belgium


09:10-11:15                                                                   Breakout Topic 1:

                                              Develop a Roadmap for the Practical Use of Epigenetic Studies

                                               to Underpin Regulatory Applications

Topic 1                   Epigenetic Design Studies:                                                                                       Moderator: Miram Jacobs

45 minutes         Relevance to Regulatory Applications?                                                      Rapporteur: Jessica LaRocca

Topic 2                   How to Design Epigenetic Studies?                                                                       Moderator: John Greally

45 minutes                                                                                                                                               Rapporteur: Madeleine Laffont

Topic 3                   What is necessary to interpret Epigenetics                                                 Moderator: Roland Buesen

45 minutes         in light of Reprotoxocity Studies                                                                     Rapporteur: Kamin Johnson

11:15-11:45       Coffee Break

11:45-13:00       Plenary: Breakout Conclusions                                                                                                           Moderators

13:00-14:00       Lunch

                                                                                                Breakout Topic 2:

                                                                Generating a Prioritised Research Agenda

14:00-15:30       Generate Prioritised Research Agenda

15:30-16:30       Plenary: Breakout Conclusions                                                                                                          Rapporteurs

16:30-17:00       Summary and Closure                                                                                                                                  Alan Poole

ECETOC SG, Belgium