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PBT assessment

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PBT assessment: overall result

Reference
Name:
T001036
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Related composition:
Composition 4
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

An evaluation of the inherent properties of T001036 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 readily biodegradability following the OECD 301B (Desmares-Koopmans, 2016), no significant biodegradation was observed for the substance. As the substance is concluded not to be readily biodegradable and appears to be hydrolytically stable, it should be considered potentially P and 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 2.2, 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 toxicity assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The test substance is classified as Mutagenic category 2 and STOT RE 2 according to the Regulation EC N° 1272/2008, hence fulfilling the criteria to be considered as T.

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