Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

The registered substance itself is not expected to be persistent based on primary degradation observed in a screening biodegradation assay. Neither is it expected to be B based on observed in vitro metabolism in trout S9 fractions and estimated BCFs. The substance is not T based on the long-term aquatic toxicity data available for algal inhibition and is not expected to be T based on acute aquatic EC50 values. Furthermore, based on available mammalian data the substance is not a CMR and there is no evidence of chronic toxicity or specific target organ toxicity.

The corresponding alcohol of Oxyoctaline formate was identified as the major primary biodegradation product. It is also the assumed hydrolysis product from the OECD117 study performed at pH 9 and was the major metabolite observed in the trout S9 study performed on the registered substance. This transformation product is not B/vB based on a measured log Kow of 4.2 and observed in vitro metabolism in trout S9 fractions. It is also not expected to be T to the aquatic environment. Given that the transformation product is neither B or T, no further assessment of the degradation product was performed.