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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

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 (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 (Covance, 2019) and regarded as a key study (Klimisch score of 1). The test item attained 97% biodegradation after 28 days. OECD Guideline No. 302B does not give any definitive pass levels for test items, however the “Revised Introduction to the OECD Guidelines for Testing of Chemicals, Section 3 (2006)” suggests that a figure of more than 20% biodegradation may be regarded as evidence for inherent, primary biodegradability. A figure of more than 70% mineralization may be regarded as evidence for ultimate inherent biodegradation. The test item can therefore be considered to have exhibited evidence of ultimate biodegradation under the experimental conditions employed in this study. It can therefore be concluded that based on the criteria mentioned above the substance is not persistent in the environment. The substance is concluded to be not P/vP.

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 -2.67 (Envigo, 2018), 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).

The toxicity assessment is based on the screening criteria in Annex XIII of the REACH Regulation. Based on an OECD 201 study (Envigo, 2018) it is concluded that the test item does not meet the Toxic (T) criteria since the EC50 and NOEC were >100 and 50 mg/L respectively. The test substance is not classified as carcinogenic (Cat. 1 or 2), as mutagenic (Cat. 1 or 2), or as reproductive toxicant (Cat. 1, 2, or 3), nor as STOT RE Cat. 1 or 2 according to the Regulation EC N° 1272/2008. Hence, it does not fulfill the criteria to be considered as Toxic (not T).

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