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Description of key information

< 10% hydrolysis observed after 5 days at 50 °C at pH 4, 7 and 9. Therefore the test material was determined to be hydrolytically stable; OECD 111, EU Method C.7, Sárvári (2013).

Key value for chemical safety assessment

Additional information

In the key study (Sárvári, 2013) hydrolysis of the test material was assessed under GLP conditions and in line with the standardised guidelines OECD 111 and EU Method C.7. Hydrolysis was assessed in a preliminary study at three difference pH levels, 4, 7 and 9. Sterile aqueous buffer solutions of the different pH values are treated with the test material and incubated in the dark for 120 hours at 50.0 ± 0.5 °C. Concentrations of the test material were determined at the start and at the end of incubation using HPLC.

During the course of the preliminary test the observed hydrolysis of the test material was less than 10 percent after 120 hours at pH 4, 7 and 9. Therefore the test material is considered to be hydrolytically stable under these circumstances and additional testing is considered unnecessary.