Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Reliability:
1 (reliable without restriction)
Data waiving:
study technically not feasible
Justification for data waiving:
other:

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No experimental determination possible because test substance is insoluble in water. Therefore estimation based on hydrolysis data for structurally similar substance.
GLP compliance:
no

Test material

Radiolabelling:
no

Study design

Analytical monitoring:
no

Results and discussion

Transformation products:
not measured

Applicant's summary and conclusion

Executive summary:

On the basis of the structural similarity of the test substance ZK 137314 with ZK 90346

hydrolytic stability is to be expected at pH 7. Below and above pH 7 hydrolytic degradation will

occur.

The rate of hydrolysis of ZK 90346 was determined at pH 4, 7 and 9 (see Schering report

No. A11337). The half-lives of ZK 90346 at 25 °C are: pH 4: 17 d, pH 7: stable, pH 9: 1.2 a.

Similar rates of hydrolysis are to be expected for the test substance at pH 4 and 7. Due to the

bromine atom present in ZK 137314, the test substance may be more instable in the alkaline pH

region. However, the rate of hydrolysis of ZK 137314 cannot be experimentally determined

because the test substance is insoluble in water. The water solubility at 25 to 30 °C was

determined to be smaller than 1.5 E-03 g/L (see Schering report A01788).