Final Report Summary - RAINBOW (Research on Animal and In vitro studies and Numerical methods: Bridging Opportunities through a Workshop)
There is an urgent need for test systems that can fill the enormous data gap for untested or insufficiently tested substances as efficiently as possible. The recent approval of the REACH regulation by the European Parliament is an important step towards solving this society request. An efficient test strategy must take into account the limitations in economic resources and testing capacity. It also has to be in line with the aim to reduce the use of animals in toxicological testing. By the year 2009, the seventh amendment to the Cosmetics Directive prohibits the use of animals for premarketing toxicity testing for cosmetic products in the in the EU (Directive 2003/15/EC, Official Journal L66:26-35).
Individual toxicological and ecotoxicological tests can be described in terms of their cost, validity, reliability, and sensitivity, and there is no such thing as the perfect test. If we had, for all important endpoints, tests that fulfil the criteria of low cost, sufficient sensitivity and high validity and reliability, then the scientific uncertainties inherent in testing and risk assessment could be substantially reduced. In reality, every test is a trade-off between these requirements. Since every test represents a trade-off between these aspects, we face the challenge to combine tests with different strengths and weaknesses into scientifically well-founded and resource-efficient test systems in which the tests compensate for each other's weaknesses as far as possible. The integration of the various possibilities offered by in vivo, in vitro and in silico methods is the most mature solution to the knowledge gap which is huge; integration can take advantage of the possibilities of each approach. In regulatory applications, toxicological tests are combined into test systems.
A test system contains rules for when and in what order the different tests should be performed. With the resources presently available it will be necessary to use tiered systems in which relatively simple tests are performed for all chemicals that are up for assessment, and the outcomes of these simple tests are used to prioritise substances for further, more resource-intensive testing. Furthermore, efforts toward integration should address a more flexible scheme beyond the classical tiered approach, in which in silico screening is the first step, followed by in vitro and finally in vivo. A feed-back mechanism may offer advantages, and multiple parallel inputs may increase the understanding. In the future a large number of data, from in vivo, in vitro and in silico studies, will become available. A strategy to integrate the different methods has to keep into account the evolving situation.
The RAINBOW project main objective was to organise a workshop addressing the integration of in vivo, in vitro and computer based methods (in silico) to study toxic properties of chemicals. The workshop was aimed at regulators, academic, industrial scientists and stakeholders such as chemical industries, animal welfare experts and public organisations: about 50 participants from 14 EU and not-EU countries attended the workshop, organised within the EC funded project RAINBOW.
The workshop discussion was useful to break down barriers between scientific and societal areas, and the REACH legislation has been discussed in its implications on the integration of methodologies. Furthermore a website it has been created where it is possible to have details of the project, its aims and outcomes.
Synergies and information exchange between members of the consortium were assured by the constant e-mailing along the whole duration of the project, and by meetings involving the members of the steering committee.
Concerning dissemination aspects, these were ensured during the preparation of the workshop through the website of the project (built up with the help of a web designer as subcontractor for the graphical part and for animations), and through advertising circulated via e-mail by the coordinator. The workshop event has been publicised also through the participation of members of the consortium to meetings and conferences. After the workshop, the dissemination activities included a summary of the discussion at the workshop, with main results, a list of database and 'strengths, weaknesses, opportunities, and threats (SWOT) analysis for risk assessment, submitted papers, including one which summarise the project results and that will be published on ATLA (with contributions by both members of the steering committee and participants of the workshop), and the final update of the web site.
Individual toxicological and ecotoxicological tests can be described in terms of their cost, validity, reliability, and sensitivity, and there is no such thing as the perfect test. If we had, for all important endpoints, tests that fulfil the criteria of low cost, sufficient sensitivity and high validity and reliability, then the scientific uncertainties inherent in testing and risk assessment could be substantially reduced. In reality, every test is a trade-off between these requirements. Since every test represents a trade-off between these aspects, we face the challenge to combine tests with different strengths and weaknesses into scientifically well-founded and resource-efficient test systems in which the tests compensate for each other's weaknesses as far as possible. The integration of the various possibilities offered by in vivo, in vitro and in silico methods is the most mature solution to the knowledge gap which is huge; integration can take advantage of the possibilities of each approach. In regulatory applications, toxicological tests are combined into test systems.
A test system contains rules for when and in what order the different tests should be performed. With the resources presently available it will be necessary to use tiered systems in which relatively simple tests are performed for all chemicals that are up for assessment, and the outcomes of these simple tests are used to prioritise substances for further, more resource-intensive testing. Furthermore, efforts toward integration should address a more flexible scheme beyond the classical tiered approach, in which in silico screening is the first step, followed by in vitro and finally in vivo. A feed-back mechanism may offer advantages, and multiple parallel inputs may increase the understanding. In the future a large number of data, from in vivo, in vitro and in silico studies, will become available. A strategy to integrate the different methods has to keep into account the evolving situation.
The RAINBOW project main objective was to organise a workshop addressing the integration of in vivo, in vitro and computer based methods (in silico) to study toxic properties of chemicals. The workshop was aimed at regulators, academic, industrial scientists and stakeholders such as chemical industries, animal welfare experts and public organisations: about 50 participants from 14 EU and not-EU countries attended the workshop, organised within the EC funded project RAINBOW.
The workshop discussion was useful to break down barriers between scientific and societal areas, and the REACH legislation has been discussed in its implications on the integration of methodologies. Furthermore a website it has been created where it is possible to have details of the project, its aims and outcomes.
Synergies and information exchange between members of the consortium were assured by the constant e-mailing along the whole duration of the project, and by meetings involving the members of the steering committee.
Concerning dissemination aspects, these were ensured during the preparation of the workshop through the website of the project (built up with the help of a web designer as subcontractor for the graphical part and for animations), and through advertising circulated via e-mail by the coordinator. The workshop event has been publicised also through the participation of members of the consortium to meetings and conferences. After the workshop, the dissemination activities included a summary of the discussion at the workshop, with main results, a list of database and 'strengths, weaknesses, opportunities, and threats (SWOT) analysis for risk assessment, submitted papers, including one which summarise the project results and that will be published on ATLA (with contributions by both members of the steering committee and participants of the workshop), and the final update of the web site.
