ECHA reviews extended one-generation reproductive toxicity studies and recommends good practices

In a review of 55 extended one-generation reproductive toxicity (EOGRT) studies, ECHA confirms their effectiveness in identifying substances of concern.

Helsinki, 28 March 2023 – Since their implementation as a REACH information requirement in 2015, EOGRT studies have proven effective in identifying substances of concern. The studies help to clarify if a substance has adverse effects on sexual function, fertility, and development. The results can be used for classifying substances or supporting identification of endocrine disruptors and to protect parents and their offspring against the unwanted effects of these chemicals.

To optimise the design, conduct, analysis, and reporting of future EOGRT studies, ECHA has provided several recommendations of good practices for test laboratories and registrants. These include the need to describe the testing methodology in sufficient detail and to choose a test laboratory that is equipped to carry out the tests.

The review found that in 20% of evaluated EOGRT studies, dose levels for testing were too low, leading to difficulties in identifying hazards and the need for repeated testing. To address this issue which is common in different types of toxicity studies, ECHA has published advice for registrants on how to set appropriate dose levels.  

To support test laboratories and registrants in conducting EOGRT testing, ECHA will organise a workshop later this spring. 

Background

The extended one-generation reproductive toxicity study (EU B.56, OECD TG 443) is requested to provide information mainly on the sexual function and fertility, but it may also provide information on developmental toxicity and endocrine activity as well as effects on or through lactation and other toxicity.