Developmental neurotoxicity

Time: 23 January 2014 – 24 January 2014, 09.00 – 17.00

Venue: Institute of Pharmacology and Toxicology, Universityof Zürich, Switzerland

The currently used regulatory test methods in the fields of neurotoxicity (NT) and developmental neurotoxicity (DNT) have several limitations. One of them is that the species differences between rodent and human nervous systems are pronounced, and also cellular signaling may differ considerably. Differences in signal transduction between rodents and man can change the toxicodynamic and thus the effects of compounds on organs and organisms.  Therefore, new concepts for safety testing which are based on human biology are being developed. To date, this process has been SCIENCE-driven, i.e. the direction of research and the output obtained were mainly driven by academic interest, and theoretical considerations. This approach has largely failed to deliver validated test methods. We therefore promote a NEED-driven process, i.e. focus of research activities on regulatory requirements. For this purpose, we want to bring together the regulatory experts together with test developers and potential users to start a constructive dialog on test requirements, right from the start of new developments. A first step will be a common workshop. In this meeting we will gather an expert panel including representatives of regulatory bodies and test developers from academia and industry. The regulatory experts will present the requirements for new human cell -based NT/DNT tests for risk assessment and management. This meeting will serve as an a starting point for discussion  between scientists from academia and industry and scientists from regulatory bodies to define the requirements for in vitro NT/DNT toxicity tests ready for regulatory purpose.

This workshop involved international experts affiliated with OECD, EFSA, US EPA, Danish National Food Institute, Danish EPA,RIVM, Bayer, Nestle, Harlan, Regulatory Science Associates, SCAHT and CAAT/CAAT-Europe. The report of this event with all participants as co-authors can be found here!