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:
JUSTIFICATION FOR DATA WAIVING
The Physico-chemical properties of ZBEC and its lack of toxic effects observed in both tox and ecotox studies suggest that ZBEC cannot pass biological membranes and, therefore, will not be taken up by organisms. Furthermore, a structurally similar substance, albeit smaller and with more favourable Physico-chemical properties for uptake, did not bioaccumulate in fish (BCF 20 L/kg). Therefore, ZBEC can be considered to have a low bioaccumulation potential, and the performance of an OECD 305 study is not considered necessary. This is also in line with Article 13 and 25 of REACH, indicating that animal testing should be avoided and should be undertaken only as a last resort. Further details can be found in the attached document 'ZBEC_Bioaccumulation justification'.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion