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Physical & Chemical properties

Solubility in organic solvents / fat solubility

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 116 (Fat Solubility of Solid and Liquid Substances)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Results and discussion

Solubility in organic solvents / fat solubility
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.

Applicant's summary and conclusion

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.