Registration Dossier

Administrative data

Endpoint:
dissociation constant
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is insoluble
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

The study does not need to be conducted because of its low solubility. In addition, the substance does not contain relevant functional groups for which an assessment of the dissociation behaviour would provide information for risk assessment purposes. Therefore, the determination of a dissociation constant is not considered to be required (Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance, section R.7.1.17.1).

Study waived in accordance with Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance, section R.7.1.17.1, on the basis of intrinsic chemistry.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion