Registration Dossier

Administrative data

Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Reason / purpose:
reference to other study

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

This test material does not contain a hydrolyzable function groups, apart from the sulfonic acid moiety which could be neutralized at pH>2..
Executive summary:


Hydrolysis as a Function of pH

Justification For data Waiving (ECHA TGD ref



From the compositional description and the structural formula given, and the fact that the substance 272-473-3 (EINECS) is highly insoluble in water, it can be concluded that hydrolysis of the principal active ingredient, at any pH, will not be evident (will not be degraded by hydrolytic means in either strong aqueous acid or strong base). However, this substance is also comprised of a sulfonic acid functional group, which will significantly dissociate in the presence of aqueous media if that media exhibits a pH>2, wherein the sulfonic acid moiety is essentially neutralized.  Apart from this consideration, there are no functional groups or other structural alerts present in the active organic ingredient that would indicate that this substance would otherwise decompose by hydrolysis and thus should not be classified as dangerous according to the criteria for hydrolysis as a function of pH. Furthermore, this is confirmed by long term handling experience.






Dr. Thomas F. Buckley III