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Classification & Labelling & PBT assessment

PBT assessment

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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 “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2014).

 

Persistency assessment
One experimental study is available investigating the biodegradability of the test substance. The study was performed according to OECD 310 (GLP). After 28 d the substance was degraded to 62% (mean; CO2 evolution, 10 -day window not applicable) indicating that the substance is readily biodegradable. Thus, the substance is not considered to be P/vP based on the screening criteria.

Bioaccumulation
The substance has a log Kow of 4.4 (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 LC50 (96 h): 8.43 mg/L). Moreover, the substance is not classified as carcinogenic, mutagenic or toxic to reproduction (CMR). Since the P/vP and B/vB criteria are not met a further assessment is not necessary in accordance with ECHA Guidance R.11.