Manganese carbonate (EC: 209-942-9; Cas 598-62-9)
Annex VI, 4.1
The lead dossier was submitted in 2010 with no testing proposals. In 2013 a compliance check was initiated, requesting more details with regard to the following information requirements/updates:
- Annex VI, 2.3.7 ( description of the analytical methods for the identification of the substance)
- Annex IX, 8.6.2 (Sub-chronic study - 90days, Oral route, OECD 408)
- Annex IX 8.7.2 (pre-natal developmental study, oral route, OECD 414)
- Annex X, 8.7.3 (two-generation reproductive toxicity study, oral route, OECD 416 or an extended one generation reproductive toxicity study, OECD 443)
- Annex VI, 4.1 & 4.2 (hazard classification and resulting hazard label for chronic aquatic toxicity)
By Q4 2013 the consortium secretariat on behalf of the lead registrant had responded to the ECHA’s draft decision concerns, highlighting the lack of need for such animal-intensive studies for this substance and the importance of using available literature and readacross. More information was provided in the updated dossier using available literature to comply with the OECD 408 and using studies from MnCl2 - a more soluble salt as a worse-case analysis to comply with the OECD 416 studies. The chronic environmental classification was revised.
After a second correspondence between ECHA and the lead registrant, the third conrrespondence was the compliance check final decision concluding that the following studies should be conducted:
- Pre-natal developmental toxicity study (Annex IX, 8.7.2.; test method: EU B.31/OECD 414) in rats or rabbits, oral route
In Q4 2017, the dossier was updated and submited with the OECD 414 study from MnCl2.
ECHA's request to update this dossier in January 22, 2018 http://consortium.manganese.org/news/article/four-manganese-substances-short-listed-by-the-echa-as-substances-of-potenti encouraged a review of the 2017 version of the lead dossier with specific attention to reproductive toxicity endpoints. The consortium concluded that the 2017 submitted dossier addressed ECHA's concerns appropriately hence there was no need for another spontaneous update.
Note: Post 2018, the consortium will no longer invoice co-registrants for ECHA requested studies retrospectively. All compliance check related work will require co-registrants to contribute their share before any dossier update work can begin.