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"SEURAT-1 meets Tox21": international cooperation in safety assessment of chemicals using animal-free methods

Workshop brings forward concrete proposals for working together towards common research aims

conf-SEURAT-1-meets-Tox-21For the first time, principal scientists from the two largest research initiatives in the USA (Tox21) and the EU (SEURAT-1) in the field of animal-free safety assessment were brought together for a three-day workshop (25-27 June 2013) to discuss opportunities for cooperation. Hosted by the European Commission's Joint Research Centre in Ispra (Italy), the event facilitated a detailed exchange of ideas and results covering topics of mutual interest such as human-relevant in vitro methods, ultra-high throughput screening, bioreactors for tissue based testing, chemo-informatics, biophysical modelling for toxicity prediction, and reference chemical selection for system development and validation. Time was also dedicated to discussing efforts underway in developing decision-making frameworks for chemical safety assessment using novel data sources that address different regulatory needs.

In his welcoming address, Prof. Krzysztof Maruszewski (Director of the JRC's Institute for Health and Consumer Protection - IHCP) acknowledged the considerable scientific challenge of gaining enough knowledge on human physiology and metabolism to be able to predict the potential toxicological effects of chemicals in humans instead of having to relying on observing adverse effects in animal experiments. However he expressed his optimism of what the future holds due to the recent scientific advances being made in the field and the willingness of research consortia such as SEURAT-1 and Tox21 to work together to achieve greater impact.

The European Union Reference Laboratory for Alternative to Animal Testing (EURL ECVAM), an integral part of the Systems Toxicology Unit of the IHCP, is heavily involved in the SEURAT-1 initiative, which reflects its mandate under the Directive 2010/63/EU for the protection of animals used for scientific purposes: to help in guiding the development of alternative methods and ensuring that research results are translated into solutions fit for regulatory use.

The format of the workshop comprised five different sessions, as described below. The key outcome of the information exchange and discussion was a comprehensive list of cooperation topics at both the technical level, including the sharing of research materials, such as data, cells, assays, computational models, and at the application level, by teaming up on predictive toxicity and safety assessment proof-of-concept case studies.

Details of the workshop's five sessions

  • An introduction to ToxCast, Tox21 and SEURAT-1 research programmes in terms of their strategic aims, structure, research focus and selected highlights – also exploring opportunities for cooperation between the USA and EU in the area of health related research in the framework of Horizon 2020.
  • Description of the chemical inventories assembled for ToxCast, Tox21 and SEURAT-1 and the different approaches employed for chemical selection.
  • Detailed overview of the various in vitro assays and test systems that are being developed and applied within the consortia, including the cell/tissue models, biomarkers and measurement techniques that they are based upon. Attention was given to the rationale used to select the assays and the mechanistic information derived from them.
  • Review of the various computational approaches being employed to predict toxicokinetic and toxicodynamic properties of chemicals and also to integrate property data from in vitro and computational methods in order to make toxicity predictions.
  • How the output and efforts of this research can be best exploited for the purposes of chemical safety assessment, exploring how data from 'non-standard' (non-animal) methods can be used in different decision-making contexts and frameworks.


Background

Tox21, the Toxicology in the 21st Century program, is a US federal collaboration involving the Environmental Protection Agency (EPA, including its ToxCast Programme), National Center for Advancing Translational Sciences (NCATS), National Institute for Environmental Health Sciences (NIEHS), and Food and Drug Administration (FDA). The goal of Tox21 is to quickly and efficiently test whether certain chemical compounds have the potential to disrupt processes in the human body that may lead to adverse health effects, using in vitro high throughput screening and computational methods.
See http://www.ncats.nih.gov/research/reengineering/tox21/tox21.html and http://www.epa.gov/ncct/toxcast/

SEURAT-1 is the largest EU initiative ever on alternative methods to animal testing, such as in vitro and computational prediction methods, to be used as a basis for an improved and more informed safety assessment of chemicals focussing on health effects after repeated exposure. SEURAT-1 is a 50 million Euro 5-year research programme that started in 2011, co-sponsored by the European Commission (FP7) and Cosmetics Europe, the industrial personal care association. See www.seurat-1.eu


Photos:
a) Group of participants. Copyright EU 2013; b) A session of the workshop. Copyright EU 2013.
 

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