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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

The PBT Assessment for UMA 121 is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2014).

Persistence

UMA 121 is not considered to be inherently biodegradable based on a study conducted according to OECD 302C (14.8 - 16.6% based on O2 consumption in 28 days). Persistency can therefore not be excluded, and the test substance needs to be considered as very persistent (vP).

Bioaccumulation

The exposure of aquatic organisms to UMA 121 is expected to be minimal, due to the low solubility and high adsorption potential of the substance. In the unlikely event of exposure, uptake of UMA 121 by organisms is considered unlikely, based on the high molecular weight of the UMA homologues (> 500 mg/L). The HPMA constituent is expected to have low bioaccumulation potential, due to its low log Kow value. Based on the available information, UMA 121 is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

Toxicity

A long-term study with Daphnia magna conducted with HPMA, the only potentially bioavailable constituent of UMA 121, resulted to a NOEC (21 d) of 45.2 mg/L. Moreover, UMA 121 is not classified as carcinogenic, mutagenic, or toxic for reproduction according to Regulation (EC) No. 1272/2008 or as T, R48, or Xn, R48 according to Directive 67/548/EEC. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance is not considered to meet the T criterion.