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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
T000824- LE
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
T000824- LE
PBT status:
the substance is not PBT / vPvB
Justification:

An evaluation of the inherent properties of T000824 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 guideline study on ready biodegradability following the OECD OECD 301F and EU C.4 Method (GLP study) (2016). The results reveal that the test substance does not degrade and hence the substance is considered not to be readily biodegradable. It can therefore be concluded that based on the criteria mentioned above the substance is persistent in the environment. The substance is concluded to be 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 2.56 at neutral pH, a low BCF can be estimated. Since the log Pow of the substance is < 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 available evidence on the toxicity potential for the substance is sufficient for an assessment based on the Annex XIII criteria for this endpoint. Taking into account the available data and the criteria of the CLP regulation (REGULATION (EC) N° 1272/2008), wherein the substance is meeting the criteria for classification as reproductive toxicant category 2 and as a repeated dose toxicant (STOT RE 2), the substance does fulfill the screening criterium for being considered as T.

As a conclusion, taking into account 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.