2019 GA meeting May 8 in Madrid

2018 GA MEETING

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

Prenatal Developmental Toxicity Study in the Han Wistar Rat/MnCl2/OECD 414/Inhalation/GLP

The purpose of this study was to detect effects on the pregnant rat, development of the embryo and fetus consequent to exposure of the pregnant female via inhalation route (by nose-only, flow-past exposure) for risk assessment purposes and for gathering data necessary for modeling work safety scenarios.

A recovery group of non-mated females in all dose groups and the control group were observed for reversibility, persistence or delayed occurrence of systemic toxic effects in the lung- information necessary for establishing workplace task rotation strategies.

Four groups of 22 mated females (main study animals) and 6 non-mated females (recovery animals) were treated with manganese dichloride once daily, for 6 hours per day. Mated females were treated from day 6 post coitum (implantation) to day 20 post coitum (the day prior to Caesarean section) and recovery animals from day 1 to 15 of a concurrent treatment period at target dose levels of:

Group 1:               0 µg/L air (control group)

Group 2:               5 µg/L air

Group 3:             15 µg/L air

Group 4:             25 µg/L air

All mated females were sacrificed on day 21 post coitum and the fetuses were removed by Caesarean section. For the recovery animals, three females per group were sacrificed after four weeks and three females per group were sacrificed after eight weeks of the recovery period.

Conclusion

Based on these results, the NOAEL (No Observed Adverse Effect Level) as well as the NOEL (No Observed Effect Level) for the toxicity in pregnant females were considered to be 5 µg/L air.

In non-pregnant females, the NOEL for systemic toxicity was established at 15 µg/L air, whereas the NOAEL was established at 25 µg/L air.

Although the fetal thyroids increased in size were found at the dose level of 25 µg/L air, which caused adverse maternal toxicity, the causal correlation for these observations was unclear. Also, the outcome of the fetal finding for the postnatal live could not be conclusively established based on the results of this study. Therefore, the NOEL as well as NOAEL for prenatal developmental toxicity was considered to be 15 µg/L air.

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