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Diss Factsheets

Physical & Chemical properties

Solubility in organic solvents / fat solubility

Administrative data

Endpoint:
solubility in organic solvents / fat solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 21 - March 24, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to guideline under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 116 (Fat Solubility of Solid and Liquid Substances)
GLP compliance:
yes

Test material

Results and discussion

Solubility in organic solvents / fat solubility
Medium:
standard fat
Solubility:
0.047 other: mg/kg
Temp.:
37 °C
Test substance stable:
not determined
Details on results:
- For data see Table [1].

Any other information on results incl. tables

The results of the individual measurements of the main study are summarized in Table 1:

Table 1. Solubility (mg/kg) in Standard Fat HB307 at 37 C

Shaking time (hours)

Group 1 (undersaturation)

Group 2 (oversaturation)

3

0.0455

0.0463

3

0.0415

0.0457

24

0.0489

0.0485

24

0.0494

0.0480

Applicant's summary and conclusion

Conclusions:
The solubility of the test material in standard fat HB307, as determined by OECD 116, is 0.0467 mg/kg at 37 degrees C.
Executive summary:

Following OECD 116, the solubility of the test material in a standard fat was measured. The standard fat, HB 307, used for the study was a synthetic mixture of saturated triglycerides with a fatty acid and triglyceride distribution similar to that found in coconut fat..

Following stirring times of 3 hours and 24 hours at 37 C, the concentration of the test material solubilized in the fat was measured by UV-Vis spectrophotometry. No significant differences were observed in the fat solubility with different equilibration/stirring times.

The mean fat solubility was determined to be 0.0467 mg/kg standard fat.