Manganese Sulphate(EC: 232-089-9) Dossier Successfully Update

The submitted dossier was accepted by the ECHA in April 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 on aspects highlighted in the ERN report have been substantiated so that overall conclusions are more clearly reported.

• Where new 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 substances, 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 was successfully completed.
• Ensured consistency of data used for the PNEC calculation.
• Updated DNEL’s and PNECs
• Updated CSR

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.

It may also be worth noting that given that the regulatory focus is on the hazards of the Mn substances– this has been our focus for the review/update work. Specifically, to enable the regulators to base their assessments on the revised hazard datasets.