Registration Dossier

Administrative data

Endpoint:
dissociation constant
Data waiving:
study technically not feasible
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
Based on the low water solubility, It is not possible to conduct the study so as to detect any changes in the substance identity.
Executive summary:

The study is only possible if there is sufficient solubility in water at a range of pH levels to allow chemical analysis to detect changes in the substance identity caused by dissociation. Dissociation will not occur with this substance and although it is possible to predict this in terms of making an assessment of properties, the substance meets the criteria for a waiver to be requested.