The Manganese Consortium would like to draw your attention to an approved testing proposal submitted by an opt out co-registratint for a genetic toxicity end point –Invivo mammalian erythrocyte micronucleus OECD TG 474.
ECHA confirms that, that co-registrant submitted this proposal via opt-out because they disagreed with the Lead registrants’ conclusions of no classification for genetic toxicity. Considering that the lead dossier complies with ALL genetic toxicity end points via read cross ECHA dimmed it necessary to accept this testing proposal which will be on the substance itself – MnO2.
The new study is expected to be finalise by Q1 2023.
WARNING: In real terms what does this mean?
That the Consortium will have to buy this study from the co-registrant and update the lead dossier without undue delay as stipulated in the regulation
The outcome of this study could be positive for genetic toxicity – in which case a new/updated risk assessment will be required, and you will all need to update your SDS’s
In the event of a positive result, MnO2 will be considered under the CMR umbrella with a potential to be in the substance of very high
All work triggered by this testing will be reinvoiced to co-registrants by Q4 2023 via the LoA top-up fees under the data-sharing regulation.
For the dossier to be representative of actual manufacture/use, we will need accurate information on exposure therefore, we will need to hear from all co-registrants and their down stream users. Therefore, expect a questionnaire to this effect before the next dossier update scheduled for Q3 2023.