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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 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 (2014) were applied.

The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in a biodegradability study according to OECD Guideline No. 302B (Envigo, 2018) and regarded as a key study (Klimisch score of 1).

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 (2014), >= 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. Indeed, as specified in the ECHA guidance on information requirements Chapter R.7b, Section R7.9.4.1 (to which the PBT assessment guidance refers), > 20% biodegradation in an OECD 302 B study provides evidence for inherent, primary biodegradation and suggests that stable degradation products are likely to be formed. Therefore, no conclusion can be drawn based on the available data and the substance is therefore to be considered as potentially P or vP until additional information would become available allowing to draw a definitive conclusion on whether the substance is to be considered as P/vP or not.

 

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation. 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 log Pow of -0.0386 (Harlan, 2015), a low BCF can be estimated. Since the log Pow of the substance is far below the threshold of 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).

 

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".

 

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