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

Dissociating properties:
not determined

Applicant's summary and conclusion

Conclusions:
Test not technically feasible, no dissociation constant can be determined.
Executive summary:

The OECD 112 test guideline presents three testing options for determination of the dissociation constant of a test substance in water. The three tests are identified and described in the test guideline as the titration, spectrophotometric and conductometric methods. Significant effort was expended in two of these three methods to try and determine this parameter for the material however this proved to be not technically feasible within the boundaries of the tests. The third test was not considered by the Sponsor to be likely to succeed based on the low water solubility and the results of the other two tests. Agreement was therefore reached with the laboratory that the dissociation constant could not be established for this material. An expert statement by the laboratory is attached to this ESR.