The 2018 GA meeting which took place on Thursday 3 May 2018 in Brugge, Belgium saw an increase in attendance from 2017. Hosted by Prince-Erachem, the meeting which lasted 5 hours saw several deliberations related to the last REACH deadline and its consequences thereafter including the possible re-structuring of the consortium. Some key decisions taken by way of vote are as follows:
Some highlights:
- Future structure of Mara: A more streamline structure to be established if the organisation is to continue functioning infinitely or in the event of a complete closure its mandate and members to be incorporated within the Mn trade association –The IMnI. Discussions are still on-going
- Collaboration: A clearly defined pathway for collaboration between Mara and the IMnI was established
- Data-sharing Regulation: Approval of the reimbursement structure (to be executed in phases) in accordance with regulation 2016/9
- Approval of the 2018 workplan and budget
13-Week Inhalation Toxicity Study in the Wistar Rat /Mn metal/OECD 413/GLP/
In this 13 - week inhalation toxicity study Mn Metal Powder was administered 6 hours daily for 5 days/week to rats by nose-only, flow-past inhalation exposure. The reversibility or progression of any test item related effects or any delayed toxicity was assessed during a 4 - week treatment free recovery period following the treatment period. The study comprised four groups containing 25 male and 25 female rats in group 1 and 31 male and 31 female rats in groups 2 to 4. The rats of the control group (group 1) were exposed to air only. Groups 2 to 4 were exposed to target concentrations of 0.5, 5 and 20 µg/L Mn Metal Powder, respectively.
Throughout the study all animals were observed for viability and clinical signs. In addition body weights and food consumption were recorded. Detailed clinical signs and functional observation battery were performed. Ophthalmoscopic examinations were performed and blood and urine samples were taken for clinical laboratory investigations. Blood, brain and lungs were taken for measurements of Mn levels in different blood compartments as well as brain areas. Following completion of the treatment and recovery period, a detailed necropsy was performed on all animals and
Conclusion
In accordance to the findings above the lung was considered to be the target organ for the exposure to Mn Metal Powder mainly because it was the port of entry. There was indication of reversibility of the findings, however, the 4 week duration of the recovery period was considered insufficient to demonstrate full reversal of all findings.
Based on the histopathological findings in this study a No-Observed-Adverse-Effect-Level (NOAEL) was established at 0.5 µg/L Mn Metal Powder.
selected organs were weighed. Various tissues and organs were placed in fixative, processed and examined microscopically. Neuropathology was performed in selected animals.