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Physical & Chemical properties

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:
2 October 1991 - 16 January 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
according to
Guideline:
OECD Guideline 116 (Fat Solubility of Solid and Liquid Substances)
Deviations:
no
Qualifier:
according to
Guideline:
other: EEC Method A.7
Deviations:
no
GLP compliance:
yes
Medium:
standard fat
Solubility:
0.32 mg/100 g solvent
Temp.:
37 °C

Table 1 Measurements of solubility in standard fat HB 307 at 37 °C

Sample Treatment

Solute Concentration (mg/kg) after two periods at 37 °C

2 Hours

24 Hours

Initially 72 hours at 30 °C

(1 g test material in 22 g fat)

3.8, 4.4

2.2, 3.7

Initially 72 hours at 50 °C

(1 g test material in 22 g fat)

1.5, 2.2

5.4, 2.2

 

Overall (pooled) mean = 3.2 ± 1.35* = 0.32 ± 0.135 mg/100 g fat (C. of V. = 43 %)

 

*the large standard deviation is attributed to the proximity of the measured concentrations to the limit of assay (1.5 mg/kg)

Conclusions:
The solubility of the test material in standard fat was determined to be 0.32 mg/100 g of fat at 37 °C.
Executive summary:

The solubility of the test material in fat was determined in accordance with the standardised guidelines OECD 116 and EC Method A.7.

The solubility of the test material in HB 307 standard fat simulant was determined to be 0.32 mg/100 g of fat at 37 °C.

Description of key information

The solubility of the test material in  standard fat simulant was determined to be 0.32 mg/100 g of fat at 37 °C.

Key value for chemical safety assessment

Solubility in mg/100g standard fat:
0.32
At the temperature of:
20 °C

Additional information

In the key study, the solubility of the test material in fat was determined in accordance with GLP and the standardised guidelines OECD 116 and EC Method A.7.

The solubility of the test material in HB 307 standard fat simulant was determined to be 0.32 mg/100 g of fat at 37 °C.

Supporting information is provided in the form of a second study that investigated the solubility of the test material in fat that was carried out in accordance with GLP and the standardised guideline EU Method A.7.

The solubility of the test material in HB 307 standard fat simulant was determined to be 0.823 mg/100 g of fat at 37 °C.