Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Based on comparison to the screening criteria, EDTA-Mn(NH4)2 is not B or vB. Based on comparison to the criteria in Annex XIII, the substance is also not T.

EDTA (acid form) and its salts are not readily biodegradable according to OECD criteria. It was shown that under special conditions like adaptation or slightly alkaline pH, which is realistic under environmental surfacewater conditions, the biodegradability of EDTA is considerably enhanced. Exchange between metal ions will transform less biodegradable into (well)biodegradable complex species. Therefore all metal-EDTA complexes are to be considered inherently and ultimately degradable and not persistent, but not readily biodegradable.

In acidic soils EDTA is expected to be oxidized by Mn(III/IV) hydroxides because the rate is greatly enhanced under acidic conditions. Therefore it

can be concluded that EDTA is ultimately biodegradable under such environmental conditions. In addition, due to high water solubility and low adsorption, EDTA will eventually leach to ground- and surface waters and not accumulate in soil. Due to pH fluctuations in surface water, moderate substitution rates and the combined photodegradation and biodegradation, all EDTA salts will eventually disappear from surface water.

EDTA-Mn(NH4)2 is not considered a PBT or vPvB substance.