Registration Dossier
Registration Dossier
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EC number: 947-251-0 | CAS number: -
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- not specified
- Analytical monitoring:
- yes
- Transformation products:
- not specified
- Key result
- Remarks on result:
- not determinable
- Remarks:
- Due to the lack of a specific analytical method capable of quantifying the test material, the determination of the hydrolysis as a function of pH by OECD 111 was not possible.
- Details on results:
- Due to the lack of a specific analytical method capable of quantifying the test material, the determination of the hydrolysis as a function of pH by OECD 111 was not possible.
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Due to the lack of a specific analytical method capable of quantifying the test material, the determination of the hydrolysis as a function of pH by OECD 111 was not possible. For this reason, a waiver from OECD 111 testing is requested.
- Executive summary:
The test material is a pale yellow solid. During preliminary evaluation of solvent solubility, the test material was found to be insoluble in water and most common organic solvents, with the exception of chloroform and tetrahydrofuran.
OECD 111 requires a specific analytical method for the quantification of the test material as well as potential hydrolysis products in aqueous solution. However, despite the test material having a maximum absorbance at 243 nm, an HPLC method could not be developed as the test material could not be detected using an HPLC-UV system under a variety of conditions.
A method based on LCMSMS was therefore attempted, however not all of the components of the test material could be detected. Additionally, the detected components of the test material separated during chromatography analysis. Due to the lack of precise concentrations of each component in the test material and without the ability to detect each component, an analytical method based on LCMSMS could not be developed.
Due to the lack of a specific analytical method capable of quantifying the test material, a waiver from OECD 111 testing is requested.
Reference
Description of key information
Due to the lack of a specific analytical method capable of quantifying the test material, the determination of the hydrolysis as a function of pH by OECD 111 was not possible.
Key value for chemical safety assessment
Additional information
The test material is a pale yellow solid. During preliminary evaluation of solvent solubility, the test material was found to be insoluble in water and most common organic solvents, with the exception of chloroform and tetrahydrofuran.
OECD 111 requires a specific analytical method for the quantification of the test material as well as potential hydrolysis products in aqueous solution. However, despite the test material having a maximum absorbance at 243 nm, an HPLC method could not be developed as the test material could not be detected using an HPLC-UV system under a variety of conditions.
A method based on LCMSMS was therefore attempted, however not all of the components of the test material could be detected. Additionally, the detected components of the test material separated during chromatography analysis. Due to the lack of precise concentrations of each component in the test material and without the ability to detect each component, an analytical method based on LCMSMS could not be developed.
Due to the lack of a specific analytical method capable of quantifying the test material, a waiver from OECD 111 testing is requested.
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