2023 Mn REACH Conference September 26-28th Thon Hotel, City Centre, Brussels

Register Now

MARA's 2023 Mn REACH Conference is scheduled to take place on September 26-28 at the Thon Hotel City Centre, Brussels.

Speakers from the Manganese Industry, other Metal Consortia, European Metal Associations and Regulatory Experts will enlighten you on the short-term risks/threats on your businesses as well as your responsibilities under the Evaluation aspect of EU REACH


Register now!



Manganese carbonate (EC: 209-942-9; Cas 598-62-9)- Testing Proposal

In 2018 - 2019: Review of available data on reproductive and developmetal toxicity and conerns highlighted from ECHA regarding the Japanese GHS classification for these endpoints. 

Outcome of reveiw - in summary

Developmental toxicity data  and the two generation reproductive toxicity data in the rat on the read-across substance manganese dichloride resulted in no classification. Although readacross is acceptable, there was no second species data for these endpoints on any inorganic Mn- based substance. A pilot study was therefore initated in the rabbit. Although the total number of rabbits used was very small, it identified  that exposure up to the limit dose of 1000 mg/kg/day in non-pregnant rabbits was generally well tolerated for 14 days. However, this was not the case for pregnant rabbits. Embryo-foetal toxicity  was observed at dose levels ≥ 150 mg/kg/day (decreased embryo-foetal survival) but only in the presence of overt, excessive maternal toxicity which manifested as premature mortality, with an associated decline in clinical condition, body weight loss and inappetence (150 mg/kg/day was associated with maternal mortality of 50 %). ECHA CLP guidance1 (Annex I: defines that “maternal mortality greater than 10 % is considered excessive and the data from that dose level shall not normally be considered further for evaluation”.

Hence, it is justified to consider that although identifying findings of concern in a limited data set, the preliminary study does not provide sufficient data for basis of classification owing to the excessive maternal toxicity apparent at all dose levels where embryo-foetal effects are apparent.

In order to clarify this concern it is recommended that a full OECD Guideline 414 study is conducted in the rabbit - based on this, an appriorpiate testing proporsal will be submitted in the next dossier update - Q4 2020


For more information contact: reach@manganese.org

« Back to news

About cookies on our website

Following a revised EU directive on website cookies, each company based, or doing business, in the EU is required to notify users about the cookies used on their website.

Our site uses cookies to improve your experience of certain areas of the site and to allow the use of specific functionality like social media page sharing. You may delete and block all cookies from this site, but as a result parts of the site may not work as intended.

To find out more about what cookies are, which cookies we use on this website and how to delete and block cookies, please see our Which cookies we use page.

Click on the button below to accept the use of cookies on this website (this will prevent the dialogue box from appearing on future visits)