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 has no ionic structure
the study does not need to be conducted because the substance is insoluble

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
In accordance with section 1 of REACH Annex XI, the dissociation constant study specified under information requirement 7.16 of Annex IX does not need to be conducted as it is not scientifically relevant. Section R.7.1.17.1 of Chapter R.7a: Endpoint specific guidance states that the dissociation constant endpoint is not intended to cover the dissolution of salts from their crystal lattice into individual ions. As the substance is a mixed metal oxide salt, it is therefore considered that that the dissociation constant study is not required.