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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:
14th January 1993 to 18th May 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 116 (Fat Solubility of Solid and Liquid Substances)
Deviations:
no
Qualifier:
according to
Guideline:
other: EU Method A.7
Deviations:
not applicable
GLP compliance:
yes
Medium:
standard fat
Temp.:
37 °C
Remarks on result:
not determinable
Remarks:
The test material was miscible in standard fat in all proportions tested (between 2.2 and 3180 g/100 g fat)
Test substance stable:
yes

Table 1: Results from run 1, with 9.64 g of standard fat

Test material added

(g)

Test material concentration

(g/100 g fat)

Observations

0.21

2.18

Miscible

0.49

5.08

Miscible

0.87

9.02

Miscible

2.72

28.2

Miscible

3.69

38.3

Miscible

4.53

47.0

Miscible

5.96

61.8

Miscible

7.07

73.3

Miscible

7.99

82.9

Miscible

10.39

108

Miscible

13.38

139

Miscible

The test substance was shown to be miscible with standard fat between 2.2 and 139 g/100 g.

 

Table 2: Results from run 2, with 10.18 g of test material

Standard Fat Added

(g)

Test material concentration

(g/100 g fat)

Observations

0.21

2.18

Miscible

0.49

5.08

Miscible

0.87

9.02

Miscible

2.72

28.2

Miscible

3.69

38.3

Miscible

4.53

47.0

Miscible

5.96

61.8

Miscible

7.07

73.3

Miscible

7.99

82.9

Miscible

10.39

108

Miscible

13.38

139

Miscible

The test substance was shown to be miscible with standard fat between 82.5 and 3180 g/100 g fat.
The overall range over which the test substance was shown to be miscible with standard fat was therefore 2.2 to 3180 g/100 g fat.

 

 

Conclusions:
Under the conditions of the tes, the test material was found to be miscible with standard fat in all proportions tested (between 2.2 and 3180 g/100 g fat).
Executive summary:

The solubility of the test material in standard fat was determined in a study conducted in accordance with OECD 116 and EU Method A.7. The test material was mixed with standard fat at 37 °C to attempt to produce a saturated solution. This did not occur, and a further study showed that the test material was miscible with standard fat in all proportions tested (between 2.2 and 3180 g/100 g fat).

Description of key information

The solubility of the test material in standard fat was determined in a study conducted in accordance with OECD 116 and EU Method A.7. The test material was mixed with standard fat at 37 °C to attempt to produce a saturated solution. This did not occur, and a further study showed that the test material was miscible with standard fat in all proportions tested (between 2.2 and 3180 g/100 g fat).

Key value for chemical safety assessment

Additional information