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PBT assessment

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PBT assessment: overall result

Reference
Name:
T000749
Type of composition:
legal entity composition of the substance
State / form:
liquid
Related composition:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

An evaluation of the inherent properties of T000749 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 OECD 301D study (Desmares-Koopmans, 2016). The results reveal that the test substance degrades and the substance is considered to be readily biodegradable. 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. A measured Log Kow of 3.3 and 1.5 have been determined in an OECD 106 study (Reingruber, 2017) for the main component and main degradation product of the test item. Since the measured log Kow of the parent compound is below the criterium of log Kow < 4.5 no further assessment on bioaccumulation is needed. The test substance is concluded to be not B/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.

Based on an OECD 201 study, the ErC10 and NOErC values were higher than the cut-off value of 0.01 mg/L (34 mg/L and < 8.1 mg/L respectively). The test substance is not classified as carcinogenic or as a reproductive toxicant. It is classified as mutagenic Cat. 2 but not as a mutagenic Cat. 1A or 1B. However based on the available data and according to the criteria of the CLP Regulation, the test item should be classified as STOT RE category 2. Therefore it is concluded that the test item meets the Toxic (T) criteria.

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