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Hydrolysis

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Description of key information

In a GLP study according to EPA Guideline Subdivision N 161 -1 (Hydrolysis), the test substance was not hydrolysed. 

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Additional information

The objectives of the study according to EPA Guideline Subdivision N 161-1 (Hydrolysis) under GLP, which was considered to be reliable, were to determine the rate of hydrolysis of the test substance and its degradation pattern in aqueous buffer solutions at target pH-values of 5, 7 and 9. Therefore, radiolabelled test substance was incubated at concentrations of 0.79 - 0.81 µg/ml in aqueous solutions under sterile conditions during 30 days at a temperature of 25 °C. The amounts of radioactivity were almost completely recovered. Balances within 30 days amounted, on average, to 96.5 ± 2.6 %, 95.1 ± 2.0 % and 93.8 ± 1.9 % of the radioactivity initially applied for pH 5, 7 and 9, respectively. Based on TLC- and HPLC-analyses, almost exclusively the parent compound was found at all time intervals and pH-values. During incubation, metabolite fractions M2 and M3 were detected in negligible amounts. Metabolite fraction M2 was found at all pH-values, ranging from 1.3 to 3.3 % of the radioactivity initially applied. Metabolite fraction M3 was only found at pH 5 and pH 7 (maximally 1.5 %).

In conclusion, the test substance was hydrolysed to negligible extent at pH 5, 7 and pH 9 at 25 °C within 30 days.