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The EU Working Group on (Q)SARs


Specific Objectives:

To draft a JRC position document on the validation of QSARs, including the definition of acceptability criteria for QSARs and establishment of a formal validation procedure To prepare dossiers containing proposed QSAR models for use in the regulatory assessment of chemicals To perform/coordinate the independent assessment (validation) of proposed QSAR models To assess the scientific validity of QSAR models, based on the independent peer-review of the reports referred to in point 3. Anticipated milestones and schedule 1st quarter, 2003: Organisation of a meeting to reach agreement on the acceptability criteria for the development and validation of QSARs, taking into account ECVAM's validation criteria and the conclusions of the CEFIC workshop on QSARs.

The meeting will involve the following participants: a) IHCP staff involved in the Action; b) the editors of 3-5 major journals that report QSAR studies; and c) representatives from EU regulatory agencies. Initiation of discussions regarding development of publicly-available database for deliverables of this Action. One possibility would be to upload the information onto a newly-developed part of the ECB website. 1st and 2nd quarters, 2003: Establishment of a "QSAR development network" of experts from industry and academia in the EU and Candidate Countries.

Solicitation of dossiers containing the case for the validation of QSAR models. The proposers of QSAR models will not be paid for their work, since it is assumed that they will being developing the models anyway. Establishment of a "QSAR assessment network" of experts from regulatory agencies (e.g. Danish EPA, UK HSE) and recognised validation authorities in the EU. For each dossier, or set of related dossiers, IHCP staff involved in the Action will identify a suitable expert from the network to perform an independent assessment of the proposed QSAR(s), in accordance with agreed validation criteria. 3rd quarter, 2003: Solicitation, via the QSAR assessment network, of dossiers on QSARs in the following areas: local toxicity to the skin (including irritation, corrosion and sensitisation) local toxicity to the eyes (including irritation and corrosion) local toxicity to the respiratory tract (including irritation and sensitisation) genotoxicity non-genotoxic carcinogenicity 4th quarter, 2003: IHCP assessment of submitted dossiers according to agreed QSAR development criteria.

For each dossier, or set of endpoint-related dossiers, that meets the development criteria, a suitable expert from the "QSAR assessment network" will be identified, to perform an independent assessment (validation study) of the proposed QSAR(s). Management of QSAR validation studies under the terms of external contracts. The person/organisation performing the validation will be independent of the person/organisation that submitted the dossier, The report on the QSAR validation study will forwarded to a panel of independent experts, selected from the "QSAR assessment network", for their consideration. A statement on the scientific validity of the QSAR will be issued, and forwarded, via DG ENV, to the appropriate Competent Authorities, for regulatory consideration.
Planned Deliverables:

Document on the establishment of an international network of QSAR experts from industry, academia and regulatory agencies final report of feasibility study on acceptability criteria for QSARs (external contractor's report) document on acceptability criteria for the development and validation of QSARs, for eventual inclusion in the revised EU Technical Guidance Document on Risk Assessment document explaining the selection of QSARs submitted by industry and academia and judged to be potentially useful in the context of the REACH system reports on the validation of QSARs for 2-4 human health and environmental endpoints (2-4 reports by external contractors).
Summary of the Action:

Quantitative structure-activity relationships (QSARs) are mathematical models that relate a quantitative measure of chemical structure (e.g. a physicochemical property) to a biological effect (e.g. a toxicological endpoint). QSARs for human health endpoints and certain ecotoxicological endpoints can be regarded as alternative methods to animal experiments, since they could be used to replace or reduce animal testing. The aim of this Action is to promote the development, validation and dissemination of QSARs that will be useful for the assessment of chemicals in the context of the REACH system. The Action is based mainly on the coordination of expert networks, with a view to providing scientific and technical support to customer DGs, and on communication with international partners, such as the OECD and the US EPA.

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Participants (10)