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HomeEvaluating results from 55 extended one-generation reproductive toxicity studies under REACH
Final report of the EOGRTS review project : March 2023
Evaluating results from 55 extended one-generation reproductive toxicity studies under REACH
Final report of the EOGRTS review project : March 2023
Publication metadata
The focus of this project was to evaluate the performance of the extended one-generation reproductive toxicity study (EOGRTS) in terms of design, conduct, analysis, and reporting, and how the results support hazard assessment in the EU regulatory context. To achieve this, the study summaries of REACH registration dossiers and the corresponding full study reports of 55 EOGRTS were evaluated. The main findings highlighted issues related to identifying effect levels and reproductive toxicants/endocrine disruptors, using the F2 generation, selecting adequate dose levels, methodological aspects, reporting issues, and proficiency for conducting investigations. While the EOGRTS was found to be generally effective in identifying substances of concern and the F2 generation was deemed useful, some methodological issues were identified. The selection of inadequate dose levels was regularly observed, and the developmental immunotoxicity (DIT) and developmental neurotoxicity (DNT) cohorts were particularly challenging in terms of test laboratory proficiency. This report also includes two sections on recommendations to support test laboratories and sponsors to improve the design, conduct, analysis, and reporting of future EOGRTS.
- Published:
- Corporate author(s): European Chemicals Agency (EU body or agency)
- Personal author(s): Bichlmaier, Ingo ; Sihvola, Virve ; Simanainen, Ulla
- Themes: Scientific and technical research , Chemical industry
- Subject: analytical chemistry , births , chemical product , chemicals legislation , endocrine disruptor , regulation (EU) , report , testing , toxic substance
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| ISSN | ISBN 978-92-9468-262-8 | DOI 10.2823/92503 | Catalogue number ED-05-23-079-EN-N |
- Released on EU Publications:
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