2020 GA Meeting May 6th Postponed to November 4th due to COVID 19

2019 GA MEETING

The 2019 GA meeting which took place on Wednesday 8 May 2019 in Madrid, Spain was a resounding success. Hosted by FerroGlobe, the meeting which lasted 4 hours saw several deliberations related to the consortium governace, dossier updates and classification & labelling. Some key decisions taken by way of vote are as follows:

Some highlights:

  • Executive Committee: A new Chairmanand  a new 2nd Vice Chairman were appointed, meanwhile the 1st Vice Chiarman was maintained to enure continuity
  • Dossier updates: Reveal changes in classification and labelling if compared to the 2010 submitted dossiers
  • Approval of the 2018 workplan and budget
  • Brexit and data: Mara will continue to support REACH registration inside and outside the EU (UK REACH inclusive) but at a charge yet to be determined

Prenatal Developmental toxicity study in the rabbit/FeMn slag/OECD 414/oral/GLP - New Classification

A final decision from ECHA to conduct a Prenatal developmental study on a second specie  (Rabbit, OECD 414) and submit a registration update by June 4th 2020, prompted further investigations related to developmental toxicity for this UVCB substance. After evaluating this parameter with data - as per below, it is clear that FeMn slag will be classified as a developmental toxicant - Catergory 2 - H361d. Update your eSDS's accordingly.

Data:

1) Ferromanganese Slag: Study for Effects on Embryo-Fetal Development in the Rat by Oral Gavage Administration/OECD 414/Envigo Labs

2) Ferromanganese Slag: Study for Effects on Embryo-Fetal Development in the Rabbit by Oral Gavage Administration/OECD 414/Envigo Labs

Evaluation of Data

The  guideline and GLP compliant prenatal development toxicity study in RATS  identified no effects of FeMn slag on the pregnancy or on survival or development of foetuses after dosing up to the limit dose of 1000 mg/kg/day.

Contrary to the rat,  in the rabbit prenatal development study, adverse foetal effects (increased overall incidence of major visceral abnormalities) were observed at all dose levels (100, 300 or 800 mg/kg/day), with minor skeletal ossification delays also apparent at 300 or 800 mg/kg/day.  In view of the nature and incidence of major fetal abnormalities detected in all treated groups, a NOAEL for embryo-fetal development was not established. However, it should be noted that the morphological changes in foetuses were disparate and without a clear dose-response when the individual incidences of anomalies were considered on a litter or foetal basis. With regard to maternal toxicity, effects were largely comparable to controls at all dose levels, however, clear vehicle tolerability issues were apparent at all dose levels, demonstrated by 5 premature deaths (23 %) in the vehicle (Corn oil; 2 mL/kg dose volume) control group due to gastro-intestinal disturbance, inappetence and embryo-foetal deaths, abortions and/or litter resorptions. Though maternal clinical signs, body weight gains and food intake were comparable to controls in all groups, poor diet consumption reflecting GI disturbance in all groups, including controls, reduces the reliability of these data. Whilst post-implantation loss was marginally increased in dose’s given 800 mg/kg/day, the higher incidence of deaths in the controls which also had marked embryo-foetal deaths has biased these data as the premature decedent data are excluded from means.  

In the absence of clear evidence of an adverse effect on development to warrant Category 1b, it is considered plausible to consider a classification of Category 2 (H361) for developmental toxicity. Moreso,  with adverse effects only observed in one species with confounding vehicle effects and no maternal or developmental effects of prenatal exposure to FeMn slag in the other species, this proposed classifcation is considered by the Mn Consortium as adequate, although the regulators could argue otherwise.

For more information contact: reach@manganese.org 

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