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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Amides, C12-C18 (even numbered), N-[3-(dimethylamino) propyl], Nā€™-oxides
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

An evaluation of the inherent properties of Amides, C12-18 (even numbered), N-[3-(dimethylamino) propyl], N'-oxides 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 (2008) were applied.

The available evidence on degradation is not sufficient for an assessment based on the Annex XIII criteria for persistence (P and vP). As the substance is concluded to be readily biodegradable and hydrolytically stable, the screening criteria for persistence are not fulfilled. Based on available evidence it is thus concluded that the substance is not P and not vP.

The available evidence on bioaccumulation potential for Amides, C12-18 (even numbered), N-[3-(dimethylamino) propyl], N'-oxides is not sufficient for an assessment based on the Annex XIII criteria for this endpoint. Following its relatively low log Kow, the screening criteria for bioaccumulative potential (B and vB) are not met.

The available evidence on the toxicity potential for Amides, C12-18 (even numbered), N-[3-(dimethylamino) propyl], N'-oxides is not sufficient for an assessment based on the Annex XIII criteria for this endpoint. Based on the available toxicity data, the substance does not fulfill Annex XIII or screening criteria for being considered as a toxic substance.

Based on the above, Amides, C12-18 (even numbered), N-[3-(dimethylamino) propyl], N'-oxides should not be considered as a PBT/vPvB substance.