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The hydrolysis of the test material was investigated in accordance with the standardised guideline OECD 111, under GLP conditions.
The preliminary test was performed at pH 4, 7 and 9 at 50 °C for five days. The test material was hydrolytically stable at pH 4 and 7. Tier 2 was required at pH 9.
Tier 2 was conducted at three temperatures (25 °C, 37.5 °C and 50 °C) and one pH (pH 9). The test material was composed of several peaks ranging from 0.9 min to 13 minutes. The profile of the test material in pH 9 buffer did not change over the course of the experiment. There was a size reduction is some of the peaks but it was considered insignificant when compared to the overall profile. The experiment was conducted over a 21-day period. As there was no hydrolysis at pH 9 / 50 °C, the test was also stopped at 37.5 °C and 25 °C after 21 days.
Under the conditions of this study, the test material is hydrolytically stable at pH 9 at 25, 37.5 and 50 °C in OECD Test No. 111 Tier 2. Based on OECD Test No. 111, the test material is hydrolytically stable at pH 4, 7 and 9.
Under the conditions of the study, the test material is hydrolytically stable at pH 9 at 25, 37.5 and 50 °C in OECD Test No. 111 Tier 2. Based on OECD Test No. 111, the test material is hydrolytically stable at pH 4, 7 and 9.
The hydrolysis of the test material was investigated in accordance with the standardised guideline OECD 111, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
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