Registration Dossier
Registration Dossier
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EC number: 939-579-8 | CAS number: -
Hydrolysis
Administrative data
Link to relevant study record(s)
Description of key information
OECD Guideline 111, GLP, key study, validity 1:
Less than 10% of the applied test item were hydrolysed after 120h (5 days) at each of the three pH values (4, 7 and 9).
No further testing was deemed necessary.
Half-life estimated to be > 1 year.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
Additional information
One key study is available to assess the hydrolysis potential of Chimexane HB. This study was performed, according to OECD-Guideline No.111 (2004) with GLP statement, with test item concentrations of 1 mg/L in buffer solutions at pH 4, 7 and 9 at a test temperature of 50°C (preliminary test).
Samples were taken at test start (0h), 2, 4h and test end (120h) and analysed via UPLC-MS/MS on a reversed phase column using an external standard. Buffer solutions were analysed at test start and test end with no interference with the test item. The analytical method for determination of the test item CHIMEXANE HB (lyophilised) was validated and tested with satisfactory results in regard to linearity, repeatability of injections, accuracy , precision and specificity.
Degradation was calculated as the percentage loss of the test item over the time. In the preliminary test, the test item was found to be stable at pH 4, 7 and 9, respectively. No further testing was deemed necessary as less than 10% of the applied test item were hydrolysed after 120h (5 days) at each of the three pH values. Reaction rate constants and half lives could not be calculated due to the fact that the test item undergoes no significant hydrolysis. With reference to the guideline a half life of > 1 year could be assumed.
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