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Validation of an impedance-based test for eye damage which allows the identification of all GHS categories (ImAI)

06/2020-05/2023

Funding programme / funding institution: Bundesministerium für Bildung und Forschung

Grant number: 031L0227B

Project description:

The primary goal of the project is to develop and validate a test method assessing eye damage that will detect all categories under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). At the OECD level, with the available alternative methods, the identification of irritating substances (GHS cat 2) has not been possible so far, so that the impedance-based eye damage test (ImAi) could fill a large gap. The identification of category 1 persistent substances could also be improved. To this end, the already established test method will be further developed and pre-validated as a method of analysis from a combination of an in vitro cornea model and non-invasive impedance spectroscopy with the aim of replacing the long-term "Draize Eye Test", which is performed on living rabbits.

At the beginning of the project, the Draize Eye Test Reference Database (DRD) as well as the "Proficiency Chemicals" and Performance Standards of the in vitro methods available on the OECD level for eye hazard assessment will be analyzed to define a set of suitable substances. A training set and a test set should be created. The training set of 40-70 substances is used to parameterize the method, determine the scope of application and transfer the method to the laboratories involved in the validation, including the BfR. The test set of 20-30 substances will be tested in three different laboratories as part of the validation study carried out in the second half of the project.

As part of the implementation of the project, the validation report should be submitted to EURL ECVAM and a proposal for the development of an OECD test guideline should be submitted.

Project partners:

  • Fraunhofer Institut für Silikat Forschung (ISC)
  • Goethe-Universität
  • Clariant Produkte GmbH
  • Courage + Khazaka Electronic GmbH

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