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PBT assessment

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PBT assessment: overall result

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

The Substance is assessed to be P/vP from a precautionary point of view.


In the provided studies, the Substance was not readily biodegradable. However, rapid degradation was observed after adaptation of the inoculum to the Substance. Nevertheless, the Substance should be considered as P/vP from a precautionary point of view.
The degradation products were assessed using the QSAR model CATALOGIC 301C v11.16 (OASIS Catalogic v5.14.1.5; see IUCLID Ch. 5.2.1). Only one metabolite was above the concentration for relevant degradation products (> 0.1%): 1-piperazinemethanol (CAS 90324-69-9). This substance is not readily biodegradable; however, the metabolite has a low log Kow (-2.05) which leads to the conclusion that it is not expected to bioaccumulate significantly in organisms. Therefore, the T status was not further assessed.


The Substance is not B/vB based on experimental data from a structurally similar substance as well as based on QSAR data for both substances.


 


A GLP BCF study conducted according to OECD 305 is available for the stucturally similar substance piperazine (CAS 110-85-0). The BCF value was determined to be < 3.9 L/kg (NITE, 1979). This experimental result is supported with the QSAR estimation of the BCF value for the 1-methylpiperazine and piperazine (3 – 9.5 L/kg, OASIS Catalogic v.5.14.1.5, BASF SE, 2020). Both substances are within the applicability domain of the model.


 


The Substance is T as it is classified as STOT RE 1.


 


In conclusion, the Substance is not a PBT/vPvB substance.