Registration Dossier

Administrative data

Endpoint:
dissociation constant
Type of information:
other: data waiving
Reliability:
other: applicable
Rationale for reliability incl. deficiencies:
other: Test was aborted
Data waiving:
study technically not feasible
Justification for data waiving:
other:

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 112 (Dissociation Constants in Water)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Any other information on results incl. tables

Prior to the preparation of a study plan, the investigations are aborted.

As shown in GLP final report 09 -16630 -7 / 10 -00403 -7 "Ethyl 2 -cyanoacrylate - Determination of Water solubility", the test item immediately reacts when getting in contact with water (spontaneous polymerization)

The concentration of the residual monomer ethyl 2 -cyanoacrylate after polymerization was shown to be 24µg/L, which is about 1.9 * 10 -7 M.

The determination of dissociation constants requires the preparation of aqueous dilutions with different concentrations of the test item. Due to the high reactivity of the test item and the small amount of residual monomer after polymerization, preparation of aqueous solutions with different concentrations of the test item is not possible.

Thus the investigation is aborted before preparing the study plan.

Applicant's summary and conclusion

Conclusions:
Prior to the preparation of a study plan, the investigations are aborted.
As shown in GLP final report 09 -16630 -7 / 10 -00403 -7 "Ethyl 2 -cyanoacrylate - Determination of Water solubility", the test item immediately reacts when getting in contact with water (spontaneous polymerization)
The concentration of the residual monomer ethyl 2 -cyanoacrylate after polymerization was shown to be 24µg/L, which is about 1.9 * 10 -7 M.
The determination of dissociation constants requires the preparation of aqueous dilutions with different concentrations of the test item. Due to the high reactivity of the test item and the small amount of residual monomer after polymerization, preparation of aqueous solutions with different concentrations of the test item is not possible.
Thus the investigation is aborted before preparing the study plan.