Workgroup Report: Incorporating In Vitro Alternative Methods for Developmental Neurotoxicity into International Hazard and Risk Assessment Strategies Sandra Coecke,1 Alan M Goldberg,2 Sandra Allen,3 Leonora Buzanska,1,4 Gemma Calamandrei,5 Kevin Crofton,6 Lars Hareng,1 Thomas Hartung,1 Holger Knaut,7 Paul Honegger,8 Miriam Jacobs,1 Pamela Lein,9 Abby Li,10 William Mundy,6 David Owen,11 Steffen Schneider,12 Ellen Silbergeld,2 Torsten Reum,13 Tomas Trnovec,14 Florianne Monnet-Tschudi,8 and Anna Bal-Price1 1ECVAM—European Centre for the Validation of Alternative Methods, Institute for Health and Consumer Protection, European Commission, Joint Research Center, Ispra, Italy; 2Johns Hopkins University, Center for Alternatives to Animal Testing (CAAT), Baltimore, Maryland, USA; 3Syngenta CTL, Macclesfield, United Kingdom; 4Polish Academy of Sciences, Warsaw, Poland; 5Istituto Superiore di Sanità, Rome, Italy; 6U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, USA; 7New York University School of Medicine, New York, New York, USA; 8University of Lausanne, Lausanne, Switzerland; 9Oregon Health & Science University, Portland, Oregon, USA; 10Exponent, San Francisco, California, USA; 11CEFIC—European Chemical Industry Council, Shell Chemicals Limited, London, United Kingdom; 12BASF, Ludwigshafen, Germany; 13Federal Institute for Drugs and Medical Devices, Bonn, Germany; 14Slovak Medical University, Bratislava, Slovak Republic Abstract This is the report of the first workshop on Incorporating In Vitro Alternative Methods for Developmental Neurotoxicity (DNT) Testing into International Hazard and Risk Assessment Strategies, held in Ispra, Italy, on 19–21 April 2005. The workshop was hosted by the European Centre for the Validation of Alternative Methods (ECVAM) and jointly organized by ECVAM, the European Chemical Industry Council, and the Johns Hopkins University Center for Alternatives to Animal Testing. The primary aim of the workshop was to identify and catalog potential methods that could be used to assess how data from in vitro alternative methods could help to predict and identify DNT hazards. Working groups focused on two different aspects: a) details on the science available in the field of DNT, including discussions on the models available to capture the critical DNT mechanisms and processes, and b) policy and strategy aspects to assess the integration of alternative methods in a regulatory framework. This report summarizes these discussions and details the recommendations and priorities for future work. Key words: high-throughput screening, in vitro developmental neurotoxicity models, regulatory use, validation. Environ Health Perspect 115:924–931 (2007) . doi:10.1289/ehp.9427 available via http://dx.doi.org/ [Online 6 February 2007] Address correspondence to S. Coecke, European Centre for the Validation of Alternative Methods, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Via E. Fermi 1, 21020 Ispra, Italy. Telephone: +39 0332 789806. Fax: +39 0332 786297. E-mail: sandra.coecke@jrc.it We gratefully acknowledge J. Gartlon for the editorial assistance in finalizing this manuscript. This report has been generated through a partnership between The Johns Hopkins Center for Alternatives to Animal Testing, The European Centre for the Validation of Alternative Methods and The European Chemical Industry Council. The Johns Hopkins Center initiated a Developmental Neurotoxicity TestSmart Programme with an international group of stakeholders. This workshop is the first event to support this initiative. Financial support for this workshop was made possible through The European Chemical Industry Council and The European Centre for the Validation of Alternative Methods. The authors declare they have no competing financial interests. Received 15 June 2006 ; accepted 6 February 2007. The full version of this article is available for free in HTML or PDF formats. |