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. Therefore, please 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 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. 

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