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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- Study performed

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guidline 112. Fat solubility of solid and liquid substances
Deviations:
no
Principles of method if other than guideline:
Organization for Economic Co-operation and Development, OECD Guideline for the Testing of Chemicals. Method # 112 (May 12, 1981 ).
Fat Solubility of Solid and Liquid Substances (Fiask Method).
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
OS Menthol Ester
IUPAC Name:
OS Menthol Ester
Constituent 2
Chemical structure
Reference substance name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
EC Number:
604-569-1
Cas Number:
147126-62-3
Molecular formula:
C14H24O4S
IUPAC Name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
Test material form:
solid: compact

Results and discussion

Solubility in organic solvents / fat solubility
Medium:
standard fat
Remarks:
coconut oil
Solubility:
47 g/kg solvent
Temp.:
37 °C
Remarks on result:
other: Average incubation temperature
Details on results:
The results showed that the samples pre-incubated at 30°C required Ionger to achieve a solubility plateau than samples treated with a 50°C
pre-incubation. lt was observed that by 22 hours, the 50°C pre-incubated samples had achieved a solubility. of 47.6 g/Kg, while the 30°C
pre-incubated samples displayed only 43.8 g/Kg. In view of this difference, the incubation was continued foranother 6 hours. After 28 hours, the 30°C pre-incubated samples reached the same Goncentration as the 50°C series. At this point, it was judged that the maximum solubility had
been reached. The fat solubility was calculated as the mean of the last time points in each series; giving a mean result of 47.0 ± 1.4 g/Kg.

Applicant's summary and conclusion

Conclusions:
We determined that the mean fat solubility of the test substance was 47.0 g/Kg. The results showed that the initial pre-incubation temperature
affected the rate at which the test substance dissolved in the standard fat. The material pre-incubated at the higher temperature achieved the
solubility plateau faster than when a lower pre-incubation temperature was used.