Registration Dossier
Registration Dossier
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EC number: 919-697-6 | CAS number: -
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2011-01-14 till 2011-02-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Principles of method if other than guideline:
- No hydrolysis test according to OECD TG 111 (2004) could be performed because no suitable analytical method could be developed to observe a hydrolysis test.
- GLP compliance:
- yes (incl. QA statement)
- Preliminary study:
- Preliminary tests for defining the analytical parameters which should be applied for the hydrolysis tests revealed that the test item was not sufficiently soluble in buffer solutions.
- Remarks on result:
- not determinable because of methodological limitations
- Conclusions:
- Due to low solubility in buffer solutions no suitable analytical method could be developed to observe hydrolysis.
- Executive summary:
A water solubility of 0.0058 g/L of the substance was determined.
Preliminary tests for defining the analytical parameters which should be applied for the hydrolysis tests revealed that the test item was not sufficiently soluble in buffer solutions.
The test item precipitates at a concentration of approximately 2 mg/L in buffer pH 7 as well as in buffer pH 7 with 1 % tetrahydrofuran as organic solubilizer. By increasing the concentration of the organic solubilizer up to 30 %, a solution with streak formations was observed. After adding this solution to the HPLC mobile phase, a precipitation was observed immediately. Additionally no suitable analytical method could be developed to observe a hydrolysis test.
Therefore no hydrolysis test according to OECD TG 111 (2004) could be performed.
Reference
A water solubility of 0.0058 g/L of the substance was determined under study number 2010/0087/07.
Preliminary tests to define the analytical parameters which should be applied for the hydrolysis tests revealed that the test item was not sufficiently soluble in buffer solutions.
The test item precipitates at a concentration of approximately 2 mg/L in buffer pH 7 as well as in buffer pH 7 with 1 % tetrahydrofuran as organic solubilizer.
By increasing the concentration of the organic solubilizer up to 30 %, a solution with streak formations was observed. After adding this solution to the HPLC mobile phase, a precipitation was observed immediately.
Additionally no suitable analytical method could be developed to observe a hydrolysis test.
Therefore no hydrolysis test according to OECD TG 111 (2004) could be performed.
Description of key information
Due to low solubility in buffer solutions no suitable analytical method could be developed to observe hydrolysis.
Key value for chemical safety assessment
Additional information
A water solubility of 0.0058 g/L of the substance was determined.
Preliminary tests for defining the analytical parameters which should be applied for the hydrolysis tests revealed that the test item was not sufficiently soluble in buffer solutions.
The test item precipitates at a concentration of approximately 2 mg/L in buffer pH 7 as well as in buffer pH 7 with 1 % tetrahydrofuran as organic solubilizer. By increasing the concentration of the organic solubilizer up to 30 %, a solution with streak formations was observed. After adding this solution to the HPLC mobile phase, a precipitation was observed immediately. Additionally no suitable analytical method could be developed to observe a hydrolysis test.
Therefore no hydrolysis test according to OECD TG 111 (2004) could be performed.
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