Analysis of available literature for the purposes of the evaluation of Neurotoxicity Potential of 3 inorganic Mn-based salts.

The publication of the ECHA Assessment of Regulatory Needs Report and the European Commission’s Restriction Road Map Report, triggered a thorough investigation on the Neurotoxicity potential of 3 Mn-Based salts -MnCl2, MnSO4 and Mn(NO3)2.

Four Manganese Scientist (Prof David Dorman; Prof Michael Aschner; Prof Len Levy and Dr Doreen McGough), developed a robust methodology to retrieve published literature and defined strict inclusion and exclusion criteria.

This is the largest literature review there has been on this endpoint since the REACH 2010 registration deadline. The search yielded 609, 33 and 33 unique citations for each chemical form - chloride, sulfate, and nitrate forms respectively.

The retrieved data was analysed this task force vis-à-vis the REACH regulation and the EU Classification and labelling regulation, taking into account the essentiality aspect of manganese and its toxicology.

The experts concluded thatoral or inhalation exposure for the sulfate and chloride with lead to STOT RE 2 (Specific Target Organ Toxicity, Repeated Exposure Category 2) with the brain as the target organ. Data on the nitrate was limited possibly due to its corrosivity potential. However, based on read across principles and data available from other Mn(II) salts a similar classification as the other soluble salts was proposed.

The report was finalised in August 2024 and the REACH dossiers for all 3 Mn salts are being updated accordingly.