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Solubility in organic solvents / fat solubility

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Reference
Endpoint:
solubility in organic solvents / fat solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1992-07-14 to 1992-08-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
GLP study, but no internationally accepted guideline followed
Principles of method if other than guideline:
internal method: 2011-0340301-92D, SFC method
GLP compliance:
yes
Key result
Medium:
other: fat simulative medium HB 307 (NATEC)
Remarks on result:
other: 138.5 g per 1000 g fat
Test substance stable:
not determined
Details on results:
The fat solubility was determined using SFC method and an internal standard (peak area analysis).

Starting from under-saturation:

- 135.1 g per 1000 g fat (1 h at 30 °C)

- 144.2 g per 1000 g fat (3 h at 37 °C)

- 142.9 g per 1000 g fat (1 h at 30 °C)

- 135.1 g per 1000 g fat (24 h at 37 °C)

Starting from over-saturation:

- 141.6 g per 1000 g fat (1 h at 50 °C)

- 140.3 g per 1000 g fat (3 h at 37 °C)

- 135.1 g per 1000 g fat (1 h at 50 °C)

- 133.8 g per 1000 g fat (24 h at 37 °C)

Mean value: 138.5 g/ 1000 g fat (standard deviation: 4.2)

- Other: The system fat/test item is a system showing partial miscibility. At the mixing ration fat : test item = 1:1 and 1:10 (wt%) a complete miscibility was observed (in pre-tests). At the mixing ration fat : test item = 10:2 (wt%) two phases coexist. In this system the test item is in the fat phase having a concentration of 178 g/1000 g fat and a solubility of 138.5 g/1000g fat. This system (fat in excess) is therefore a system with a miscibility gap.

Conclusions:
The fat solubility of the test item was determined to be 138.5 g per 1000 g fat.
Executive summary:

The fat solubility of the test item was determined to be 138.5 g per 1000 g fat.

Description of key information

The fat solubility of the test item was determined to be 138.5 g per 1000 g fat.

Key value for chemical safety assessment

Solubility in mg/100g standard fat:
13 850
At the temperature of:
20 °C

Additional information

The fat solubility of the test item was determined to be 138.5 g per 1000 g fat.