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Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

GLP study according to EU testing guideline C.7.
Analytical Development Physical Chemistry, Schering AG, Berlin. Study report No. A05755 (ADP 2001_201), dated 2001-12-20.
Result: The test compound is hydrolytically stable at pH 4, exhibits 9 % decay after 35d at pH 7 and hydrolyses with a half-life of 7.9d at pH9 (at 25°C).

Key value for chemical safety assessment

Additional information

The rate of hydrolysis in aqueous solutions buffered to pH values of 4, 7 and 9 was studied according to EU testing guideline C.7.

No hydrolytic degradation was observed within 5 days at pH 4 at 50 ± 0.1 °C (pretest). Therefore no further testing was required and the compound can be considered to be hydrolytically stable at pH 4 and 25 °C.

At pH 7 a dacay of approx. 9 % was observed after 35d. However, no half-life could be extrapolated due to the low degradation during the observation time.

At pH 9 a half-life of hydrolysis of 7.9d (95% confidence limits 7.7d to 8.1d) was determined.