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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:

An evaluation of the inherent properties of the substance is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2008) were applied.

 

In two guideline studies on readily biodegradability following the OECD 301B (Desmares-Koopmans, 2002) and OECD 301C guidelines (Mori, 2016), no significant biodegradation was observed for the substance. Four out of 18 degradation products were predicted to be not readily biodegradable using the BIOWIN tool (v 4.10). Due to the available experimental data the substance may fulfill the P or vP criteria.

 

The available evidence on the bioaccumulation potential for the substance indicates that the screening criteria for bioaccumulation potential (B and vB) are not met. Based on a measured log Kow of 0.0931, a low BCF can be estimated. Since the log Kow of the substance and the predicted log Kow (BIOWIN, v 4.10) values of the degradation products are clearly < 4.5, the screening criteria for bioaccumulation are not fulfilled and the substance is concluded not to have a bioaccumulative potential (not B / not vB). 

 

The available evidence on the toxicity potential for the substance is sufficient for an assessment based on the Annex XIII criteria for this endpoint. Taking into account the available data and the criteria of the CLP regulation (REGULATION (EC) N° 1272/2008), the screening criteria for toxicity potential (T) are not met.

 

Based on the above, the substance should not be considered as a PBT/vPvB substance.

 

Reference:

[3] CRAFT, DEVELOPED BY MOLECULAR NETWORKS ON BEHALF OF THE EUROPEAN COMMISSION’S JOINT RESEARCH CENTRE, ITALY, 2008; SOFTWARE AVAILABLE AT http://www.molecular-networks.com/products/craft