Registration Dossier
Registration Dossier
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EC number: 947-251-0 | CAS number: -
Solubility in organic solvents / fat solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- solubility in organic solvents / fat solubility
- 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 116 (Fat Solubility of Solid and Liquid Substances)
- Deviations:
- no
- GLP compliance:
- 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 fat solubility by OECD 116 was not possible.
- Test substance stable:
- not determined
- Details on results:
- Due to the lack of a specific analytical method capable of quantifying the test material, the determination of the fat solubility by OECD 116 was not possible.
- Conclusions:
- Due to the lack of a specific analytical method capable of quantifying the test material, the determination of the fat solubility by OECD 116 will not be possible. For this reason, a waiver from OECD 116 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 116 requires a specific analytical method for the quantification of the test material in a liquid "standard fat". 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 116 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 fat solubility by OECD 116 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 116 requires a specific analytical method for the quantification of the test material in a liquid "standard fat". 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 116 testing is requested.
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