RISE participates in a European validation project regarding in vitro test methods that assess the endocrine disrupting potential of chemicals. The methods can ideally be used for regulatory safety assessment, thus reducing negative human health and environmental impacts caused by endocrine disruptors and reducing the use of laboratoratory animals.
The EU has been working for many years to replace animal testing with animal-free (i.e. in vitro) test methods, and to limit human and animal exposure to endocrine disruptors, which are suspected of both affecting reproduction and being carcinogenic. This project aims to further develop and to validate in vitro test methods that can assess the endocrine disrupting potential of chemicals.
To assess a chemical, one must first identify if it has endocrine disrupting potential, and if so, which type. For the assessment to be reliable, the test method must be validated. A validation involves a comprehensive evaluation of the method to determine its reliability and relevance for the intended purpose.
With our extensive experience in both in vitro methods and the quality requirements for methods aimed for regulatory purposes, we are now participating in our second major validation study organized by EURL ECVAM, the EU reference laboratory for alternatives to animal testing. The study aims to further develop and then validate in vitro methods for the detection of chemicals which disrupt thyroid function. This work largely involves generation of quality assured (GLP) experimental data and documentation. We have previously successfully participated in a similar validation study for a test method concerning androgen disrupting properties.
Following successful validation, the method is expected to be included in the OECD guidelines for the testing of chemicals, thereby obtaining both global impact and application for regulatory safety assessment. Thus, the project can contribute to reducing human and animal exposure to endocrine disruptors and to reducing the use of experimental animals.
Validation of an in vitro test method
RISE has been selected by EURL ECVAM to assess one out of 17 methods with the potential to detect thyroid disrupting chemicals. RISE is responsible for further developing and finalizing the method (part 1) and as a first lab validating the method (part 2)
Part 1: 2018-2020, Part 2: 2021-2022
5.3 MSEK for Part 1 (Definition of the method)