This news update regarding the one-generation reproductive toxicity study is brought to you by ECHA.



The REACH annexes VIII, IX and X have been amended with the inclusion of the extended one-generation reproductive toxicity study (EOGRTS, EU B.56, OECD TG 443).


EOGRTS will now be the information requirement for reproductive toxicity in REACH instead of the two-generation reproductive toxicity study (EU B.35, OECD TG 416). The updated annexes will enter into force 13 March 2015. ECHA is updating its guidance on reproductive toxicity to reflect the regulatory changes and aims to finalise it by July 2015. A draft is already available on ECHA’s website.



For more information please visit the EHCA link above. Please contact Nexreg for regulatory services.