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Two Dossiers have been successfully updated: Manganese Chloride : EC 233-828-8 AND Manganese Dinitrate: EC 231-868-6


The concerns raised by the ECHA ARN’s report triggered a thorough overview of the MnCl2 and the Mn(NO3)2  dossiers which were submitted and accepted by the ECHA  this month – June 2025.

 

The List below is a brief outline of the sections updated within the dossier.

  • General overall update of all sections to improve the consistency of information reporting across the solubles datasets and to align information reporting with the latest version of IUCLID.
  • Data selection has been more closely focused on key data with the removal of less accurate and disregarded data.
  • Endpoint summaries have been substantiated so that overall conclusions are more clearly reported. Where summary documents on an endpoint are available (such as the new neurotoxicity and endocrine disruption reports) these have been included. Particular attention has been paid to endpoints of relevance to the ARN on Mn, namely: repeated dose toxicity, neurotoxicity, reproductive and developmental toxicity, endocrine disruption (HH), and aquatic (eco)toxicity.
  • Re-calculation of the chronic environmental reference value (for use in environmental hazard classification of the consortium registered substances) following the species sensitivity distribution (SSD) approach.
  • Re-assessment of the environmental PNECs.
  • Update of RAAF report
  • Revising DNELs
  • Exposure assessments
  • Risk characterization.
  • Inclusion of new ED studies

 

Addressing the above has involved a considerable amount of work given the very large volume of data that are available and also given the technical complexity of the data.

Given that the regulatory focus is on the hazards of the Mn substances – this has been the focus of the review/update work. Specifically, to enable the regulators to base their assessments on the revised hazard datasets.

If you are in good financial standing, please request the updated Exposure scenarios, IUCLID file, CSR’s  and CLP notification documents from reach@manganese.org.

However, if you are NOT in good financial standing please complete the request form by clicking on the link https://docs.google.com/forms/d/e/1FAIpQLSfDitHDJyEhmQFzDqta88P-B6FQOuEtTrizkUCz3MnKvlgv_Q/viewform