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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 test substance is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2017) were applied.


The persistence assessment is based on the PBT screening criteria. As the substance is concluded not to be readily biodegradable and hydrolytically stable, the screening criteria for persistence are fulfilled. Based on available evidence it is thus concluded that the substance is P and potentially 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). 


The available evidence on the toxicity potential for the test substance is sufficient for an assessment based on the Annex XIII criteria for this endpoint. Chronic toxicity data are available for algae; the 72h-NOEC was determined to be 12.5 mg/L which is above the critical value of 0.01 mg/L for chronic aquatic studies. 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".


Taking into account all available data, it can be concluded that the substance does not fulfil the PBT/vPvB criteria.


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 39 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 39 degradation products, 26 were considered to be potentially P/vP (while the remaining 13 were predicted to be readily biodegradable and considered to be not P/vP). All of the 39 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 "ZR50_biodeg_products_PBT_Assessment". 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).