Registration Dossier

Administrative data

Endpoint:
hydrolysis
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water
Justification for type of information:
The test item is essentially insoluble in water. The water solubility testing produced a limit value for the water solubility based upon the lowest standard utilized within testing. Method C.7. states that the procedure is only applicable to water soluble
substances.

The water solubility samples did produce peaks, however were approximately equal in area to blank solutions run during testing. Therefore the water solubility is at a level that is approximately equal to the limit of quantification using a validated method. Therefore accurately quantifying the initial samples (half water solubility) would be inaccurate, determination of samples down to 10% of the initial would not be repeatable, even with concentration procedures applied.

As the test item is a reaction mixture, the monitoring of individual components (and these are not well defined) would be extremely difficult, in respect to concentration and reaction pathways.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion