Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Data waiving:
study technically not feasible
Justification for data waiving:
other:

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. QA statement)

Test material

Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
NA
Radiolabelling:
no

Results and discussion

Details on results:
The test on the abiotic degradation was not performed.
Reason:
The determination of the hydrolysis rate as a function of the pH-value according to the guideline was not possible, because the described method is only suitable for soluble substances. In order to analyse the hydrolysis rate the solubility of the test item in water has to be much higher than the detection limit of the analytical method (HPLC).
The water solubility of the test item was determined to be lower than 50 µg/L which corresponds to the detection limit of the analytical method (HPLC). Therefore the study of the hydrolysis does not need to be conducted.

Applicant's summary and conclusion

Conclusions:
The solubility of the test item in water is extremely low. The water solubility of the test item was determined to be lower than 50 µg/L. Therefore, an experimental determination of the hydrolysis was not possible, as the described method (OECD guideline 111 and European Commission Regulation (EC) No. 440/2008, C.7.) is only suitable for water soluble substances.