Registration Dossier

Administrative data

Endpoint:
dissociation constant
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the analytical method is not sensitive enough
the study does not need to be conducted because the substance is insoluble
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

According to the guideline, the titration method is not suitable for low solubility compounds and the spectrophotometric method, suitable for low solubility, is only applicable to compound having different UV/Vis-absorption spectra for the dissociated and undissociated forms.
However, the substance is insoluble in water and the dissociated forms has the same UV/Vis-absorption spectra than the non-dissociated forms.
Therefore the test is technically not feasible

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion