Review and enhancement of new risk assessment concepts under REACH

Within REACH, it is possible to waive standard tests that would be required for a chemical, if the available information from other tests and / or non-testing information (e.g. QSARs, grouping, read across) is considered sufficient to draw a reliable conclusion on the endpoint of concern. This concept is described as non-testing approach in the REACH guidance document R.6, and as weight-of-evidence approach in guidance document R.7b. The objective of the present project was to evaluate the practicability and usefulness of these approaches. Three potentially endocrine disrupting chemicals were selected as model substances to evaluate the guidance documents. For these chemicals, the endpoints acute toxicity to fish, daphnids and algae were considered using the non-testing and the weight-of-evidence approach. In addition, potential endocrine activity in aquatic vertebrates was evaluated based on literature data, several in vitro tests and one in vivo test that were performed for two of the selected substances. Based on the experiences gained during this evaluation, suggestions for possible improvements of the guidance documents R.6 and R.7b were developed.

The final report of this project is available [read more].