The Extended One-Generation Reproductive Toxicity Study was adopted as an OECD Test Guideline in 2011 in the section 400 for human health effects. This Test Guideline is designed to provide an evaluation of reproductive and developmental effects that may occur as a result of pre- and postnatal chemical exposure as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. The Test Guideline has been used quite extensively in Europe for the REACH regulation and experience gained and data analysed from more than 100 studies.
First commenting round on the draft updated Test Guideline on the Extended One-Generation reproduction Toxicity Study (EOGRTS)
- Submission period
- 25 July - 31 December 2024
Background public consultation
Project description
Data from about 120 studies were analysed to evaluate the performance of the test and provide a basis to revise specific sections of the Test Guideline and the associated Guidance Document 151. In this consultation, only the draft updated TG 443 is open for comments. In particular, the evaluation of developmental immunotoxicity (mostly paragraph 57), reproductive endpoints such as anogenital distance and nipple retention (mostly paragraph 46), and re-alignment across the test Guideline are proposed to be updated. The consultation is limited to the specific text edits proposed.
How to contribute
The draft updated TG 443 is currently under a commenting round by the Working Party of the National Coordinators of the Test Guidelines Programmes and open for comments from the public at the same time. Interested parties are invited to contact their National Coordinators at least a week before 31 December 2024.
