Registration Dossier

Diss Factsheets

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 substance is hydrolytically unstable (half-life less than 12 hours)
the study does not need to be conducted because the analytical method is not sensitive enough
Justification for type of information:
After a testing time of 25 hours, the test-item concentration had increased significantly (i.e. 22% and 26%) at all pHs. Based on the monitored component, the test item did obviously not degrade hydrolytically. Accordingly Tier 2 testing was discontinued. The concentration of the investigated component may have increased as a higher-molecular-weight component degraded. It was, however, not possible to validate an analytical method for such a higher-molecular-weight component with sufficient sensitivity.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion