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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:

PBT assessment (summary)

Persistence:

Based on available studies, no biotic or abiotic degradation observed. Screening assignment (v)P.

Bioaccumulation:

Based on BCFWIN computational results for the three major components of 1.37, 2.99, and 2.82, which can be considered as worst case results (see justification given in endpoint summary for bioaccumulation), the estimated log BCF values all are below the cut-off value of 3.3 for B criterion. BCF computations based on the more relevant pH-dependent log D values reveal log BCF results of 0.36, 1.9, and 1.94, respectively, which all are well below the regulatory cut-off value for the B criterion of 3.3. Substance not to be considered as (v)B.

Toxicity:

Based on 28-day oral repeated dose toxicity study, the substance is to be classified as R48/22. T criterion applies.

Conclusion:

With the evidence provided it safely can be assumed that the substance is not fulfilling the B criterion, and that the submission item therefore shall not be considered as a PBT or vPvB substance.