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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Type of composition:
legal entity composition of the substance
State / form:
Reference substance:
PBT status:
the substance is not PBT / vPvB

An evaluation of the inherent properties of the test 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.


The persistency assessment is based on the screening the PBT screening criteria. The ready biodegradation potential of the substance was assessed with a QSAR analysis (using the BIOWIN model). The results indicated that the substance is considered to be not readily biodegradable.

The inherent biodegradation of the substance was determined according to OECD 302 B. The test item attained 36% biodegradation after 28 days. According to the screening criteria as laid down in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2017), >= 70% mineralisation should be obtained in an OECD 302 B biodegradation study in order to conclude that the test substance is not P or vP. If < 70% mineralisation is observed the substance should be considered as potentially P or vP.

Based on the available data, the substance is considered as potentially P/vP.


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). 


Long-term or chronic toxicity data are available for algae only, which were most sensitive in the acute toxicity studies. The 72-h NOEC was determined to be 2.9 mg/L and is above the critical value of 0.01 mg/L for chronic aquatic studies. In addition, the substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2), and is not classified for specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to the CLP Regulation. Therefore, the substance can be concluded not to fulfil the Annex XIII criteria for "T".


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 53 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 53 degradation products, 20 were predicted to be readily biodegradable (and not P/vP), while 33 were predicted to be not readily biodegradable (and potentially P/vP). All of the 53 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.


The PBT assessment of the degradation products is further detailed in the attached file "LE30_degradation_products_PBT". All supporting documents relating to QSAR modelling of the degradation products are also included under the "Additional information". These are listed following the model used according to the EPI Suite package (BCFBAF, BIOWIN, ECOSAR, KOWWIN).