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Description of key information

Hydrolytically stable compound with a half-life > 1 year at 25 °C, OECD 111, EU Method C7, Provot 1996

Key value for chemical safety assessment

Additional information

The abiotic degradation of the test material was evaluated in the key study by Provot (1996). The preliminary hydrolysis study was performed under GLP conditions and in accordance with the standardised guidelines OECD 111 and EU Method C.7. Based on the principles for assessing data quality defined by Klimisch et al. (1997), the study was assigned a reliability score of 1.

The determination was undertaken at pH 4, 7 and 9 at 50.0 ± 0.5 °C, under sterile conditions at an initial test material concentration of between 8.78 and 9.22 g/L. Samples were collected in duplicate at 2.4 hours and on days 3 and 5; following a thirtyfold dilution in a buffer/acetonitrile solution 80:20 v/v they were submitted for analysis by HPLC-UV.

No significant variation of pH was observed for any solution at any sampling time. All test solutions were orange in colour throughout the study.

Less than 10 % of the test material was hydrolysed after five days at any of the tested pH levels. As a result of this, further testing was not required and the test material was considered to be a hydrolytically stable compound. Furthermore the half-life of the test material at 25 °C was considered to be greater than a year.