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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

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 (2017) 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.  Based on the available experimental data the substance fulfills the P/vP criteria.


The bioaccumulation potential of the substance was evaluated based on the Annex XIII criteria. An assessment of the aquatic bioaccumulation of ionisable organic chemicals was carried out based on existing scientific literature, and concluded that the substance does not meet the regulatory criterion for B/vB properties. Additionally, a QSAR analysis (using the BCFBAF model) was carried out and the resulting BCF value was predicted to be 3.16 L/kg, which further confirmed the low bioaccumulation potential of the substance. Based on the above, 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.


In conclusion, taking into account that the substance is P/vP, not B/vB and not T, the substance should not be considered as a PBT/vPvB substance. 


In addition, the EAWAG-BBD PPS tool was used to predict biotransformation products likely or very likely to be formed through aerobic microbial degradation. The 41 degradation products that were identified were subsequently assessed for potential PBT/vPvB properties using appropriate QSAR models. The biodegradability, BCF values and acute ecotoxicity of the modelled degradation products were predicted using the relevant models available in the EPI Suite software.


Of the 41 degradation products, 27 were predicted to be readily biodegradable (and not P/vP), while 14 were predicted to be not readily biodegradable (and potentially P/vP). All of the 41 biodegradation products had an estimated BCF value below the cut-off value of 2000 L/kg, indicating that they are not B/vB. Their acute aquatic toxicity was also very low.


Based on the available data, it can be concluded that none of the predicted degradation products are likely to be PBT/vPvB. As none of the degradation products is a potential PBT/vPvB substance, this further supports the conclusion that the substance should not be considered a PBT/vPvB substance.