Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
03.12.1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: None GLP guideline study. However, the test could not be performed as the water solubility of the test substance is lower than 1 x 10E-4 g/L.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EEC, A.6
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable.
Radiolabelling:
no

Study design

Analytical monitoring:
no
Details on sampling:
Not applicable.

Results and discussion

Details on results:
The hydrolysis test could not be performed.

Any other information on results incl. tables

The hydrolysis test could not be performed due to following reasons:

The water solubility of the test substance is lower than 1 x 10E-4 g/L. The detection limit of the analytical method must be at least 40 times lower and the factor of 40 is due to the fact that:

- The initial concentration for the hydrolysis test must not exceed half the saturation concentration.

- the accuracy of the analytical method should be better than 5% of the initial concentration (e.g. to determine a 10% decomposition during the preliminary test).

For this reasons and because only the upper limit of the water solubility was experimentally determinable, the hydrolysis test could not be performed.

Applicant's summary and conclusion