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PBT assessment

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PBT assessment: overall result

Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Related composition:
Composition 0
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB

An evaluation of the inherent properties of T001159 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. In a guideline study on ready biodegradability following the OECD 301B (Desmares-Koopmans, 2016), no significant biodegradation was observed for the substance. It can therefore be concluded that based on the criteria mentioned above the substance is persistent in the environment. The substance hence fulfills the cirteria to be considered as 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 2.7 at neutral pH, a low BCF can be estimated. Since the log Pow of the substance is < 4.5 (Reingruber, 2016), the screening criteria for bioaccumulation are not fulfilled and the substance is concluded not to have a bioaccumulative potential. Hence, the substance is considered as not B/vB.

The toxicity assessment is based on the screening criteria in Annex XIII of the REACH Regulation.The available evidence on the toxicity potential for the substance is sufficient for an assessment based on the Annex XIII criteria for this endpoint. The substance is classified as Repro tox category 2 and STOT RE category 2 according to Regulation EC No 1272/2008. Taking into account the available data and the criteria of the CLP regulation, the substance does fulfill the screening criterium for being considered as T.

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