Document: 

orchestra-workshop-summaryreport.pdf

More information about the workshop and the outcomes here

Foreword

The REACH Regulation contains the commitment to minimize the amount of animal testing necessary to achieve its aims. To do this, firms are providing justifications to waive animal tests in preference for in vitro or in silico methods. In silico methods rely on computer simulation or modeling and use results from existing tests to model the ways in which a chemical may be hazardous in the body and/or in the environment. Therefore the toxicity of chemicals can be assessed without further tests on animals when suitable methods are available.

In the REACH context, ORCHESTRA is an EU funded project with the aim of disseminating recent research on in silico methods for evaluating the toxicity of chemicals such as quantitative structure-activity relationships (QSARs). The project aims to promote a wider understanding, awareness and appropriate use of in silico methods. It will communicate and exploit the findings of nine previous EU-funded projects relating to several areas, including food, environment and health.

The stakeholder involvement strategy is one of the central components within the ORCHESTRA project. The dissemination workshop REACH and QSAR - What can we learn from case studies? was held on April 6th 2011 in Milan, and 112 experts and stakeholders from various groups and countries participated. All participants got the opportunity to discuss about in silico methods, their potential and limitations. The Mario Negri Institute (IRFMN) organized and hosted the workshop, in close cooperation with the ORCHESTRA Partners Universität Stuttgart, PublicSpace Ltd, Politecnico di Milano, Institut Symlog, Centro Reach S.r.l. and University of Patras.

The stakeholder workshop was designed to demonstrate how in silico methods could meet REACH requirements with respect to human and ecological endpoints. The workshop included four case studies on the application of different methods. In a round table, representatives from industry, regulation and consultants discussed how in silico methods can be transferred into practice. The most important point is to improve the communication and the understanding of the models to facilitate all the actors involved in the registration of the substances for REACH. The experts explained that non-test information is a valuable tool to use in the REACH context.

Furthermore, in silico methods or QSAR can be seen both as a supporter to offer information on chemicals, delivering a supporting evidence or as a key study as well in the REACH evaluation. In the first case QSAR can be used in combination with read-across, in vitro tests and experimental test data in a weight of evidence approach. QSAR can give explanations about a fact or a certain results and allow the detailed analysis of the applicability domain.

In conclusion, the workshop showed that there is the possibility and intention to use QSAR models, even though this is a process which needs more examples and successful cases to adopt in silico methods. In order to achieve this, more training and transparency in the applicability and reliability of models would be helpful.