The ECHA published a draft decision on the testing proposal in May 2022 - for the OECD 414 study, second species.

This study looks at the prenatal developmental toxicity potential of MnCO3 in Rabbits - a more sensitive specie. In view of all the reproductive toxicity concerns raised by ECHA in its restriction road map and risk assessment needs report - it is important that this study is conducted to the highest standard, with minimal deviations and with accurate analysis and conclusions. 

The study is quoted at ca. €300 000 and the cost will be shared accordingly as per the data-sharing regulation via our LoA top-up fees model.

It is anticipated that the study will start next year after the final decision has been published and the results are predicted to be available by 2024. 

Upon the finalisation of this study – a dossier update will be triggered and the CSR will be updated. We will be requesting real exposure data from co-registrants to enable us develop an accurate risk assessment which is representative of your activities with the EU.