Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
T002907
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Related composition:
Composition 2
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

An evaluation of the inherent properties of T002907 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 301F study (Grutzner, 2007). The results reveal that the test substance does not degrade (3% degradation observed under conditions of the test) and hence, the substance is considered to be not 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. A measured Log Kow of -0.4 has been determined in an OECD 107 study (Weissenfeld, 2006). 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. Taking into account the available data and the criteria of the CLP regulation (REGULATION (EC) N° 1272/2008), the substance does not fulfill the screening criterium for being considered as T.

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