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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for the substance is based on the criteria set out in the “Echa -Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment”.

 

Persistency assessment
One experimental study is available investigating the biodegradability of the substance. The study was performed according to OECD 301D (GLP). After 28 d the substance was degraded to 0% (O2 consumption) indicating that the substance is not readily biodegradable according to the OECD criteria. Thus, the substance is considered to meet the P/vP criteria based on the available data.

Bioaccumulation
The substance has a log Kow of 2.23 (OECD 117). In accordance with the ECHA Guidance R.11 substances with a log Kow of <4.5 are not considered to be B/vB. Thus, the substance is not considered to be B/vB based on the screening criteria.

Toxicity
Aquatic studies are available for three trophic levels. All acute effect concentrations were clearly >0.1 mg/L (lowest EC10 (72 h): 68.7 mg/L). Moreover, the substance is not classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and the screening criterion for bioaccumulation is not met. Thus, in accordance with ECHA Guidance R.11 no further assessment is necessary.

In conclusion the substance is not PBT/vPvB.