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Description of key information

Based on the results of the preliminary test the test item was found to be stable in buffer solution of pH 4, of pH 7 and of pH 9 after 5 days at 50 °C. No further test are needed.

Key value for chemical safety assessment

Additional information

In the course of this study the hydrolysis of the test item in different pH buffer solutions was determined at 50 °C ± 0.5 °C.

The content of test item in the different pH buffer samples was determined at the beginning and the end of the test period. Five samples were analysed at the start of the study. The samples were measured after dilution(two hundred andfifty-fold) with ultra-pure water. Two samples were taken from each of three separate tubes of the hydrolysis test after 5 days storage period and analysed by HPLC. Samples were diluted (two hundred andfifty-fold) with ultra-pure water before analysis. Three samples were taken from the control at the start and at the end of the storage and these were measured in the same way as the test samples.

Based on the results obtained, test substance can be considered as hydrolytically stable at pH 4, pH 7 and pH 9 under the conditions investigated.