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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 criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are used as information to decide whether the test substance may potentially fulfil the PBT or vPvB criteria.

 

Persistence Assessment

Based on the available data, the test substance is not readily biodegradable. Thus, the substance may potentially fulfil the P/vP criteria.

 

Bioaccumulation Assessment

The bioaccumulation potential of the test substance is expected to be low based on the log Pow of 1.76 at 22.8 °C (EU Method A.8, HPLC method). Since the log Pow does not exceed the trigger value of 4.5 the substance is not considered to be B or vB.

 

Toxicity Assessment

Aquatic acute toxicity data are available for all three trophic levels and the E(L)C50 values are > 100 mg/L (nominal). Aquatic chronic data can be taken from the algae study. No effects on growth were recorded. The corresponding ErC10 (72 h) was derived to be > 100 mg/L (nominal). In conclusion all available experimental data do not indicate any effects on aquatic organisms. However, the substance is classified as Repr. 2 (H361f) according to the consolidated Regulation (EC) No 1272/2008 (CLP). Thus, the criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are met and the test substance is considered to meet the T criterion.