Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
This information will be submitted later based on ECHA communication/decision number TPE-D-2114519518-44-01/F.
The Bioconcentration study is still ongoing. The start of the experimental phase of the study has been delayed because the synthesis of the test substance has taken longer than previously expected. The interim results showed that the steady state was not reached after 28 days. The bioconcentration factor will be determined by using the kinetic BCF and this value is not available before the deadline of this decision. The interim results revealed that the substance most likely has bioaccummulative properties. When the final report is available and the outcome of the study indicates that the substance is bioaccumulative, the assumption that the substance is P based on the persistence properties of the starting material MDA (See current PBT assessment) will be re-evaluated.
The final report is expected to be available by the end of March, therefore the expected submission of section 5.3.1 of the dossier will be within a month after the final report.

The CSR and the PBT assessment will be prepared when all the data are available and updated within six months after the final report date of the bioconcentration study.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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