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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:
05 March 1987 to 22 April 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: EEC directive 84/449 A.7
Deviations:
not specified
GLP compliance:
yes
Specific details on test material used for the study:
Product designation: Monoazo Yellow TZ 2382
Identification: FAT 40224/C
Vers. 10/86 Op. 1/86
Medium:
standard fat
Remarks:
Fat simulant
Solubility:
< 0.1 mg/100 g solvent
Temp.:
37 °C
Test substance stable:
yes
Details on results:
Only six individual results have been considered for the determination of the fat solubility because absorbances of test solution 7 and 8 are smaller than the intercept on the ordinate of the calibration curve and calculation is therefore not possible. The fat solubility determined is very small, approx. 0.03 +/- 0.01 mg / 100 g of fat. The actually fat solubility of Monoazo Yellow TZ 2382 is given as being lower than 0.1 mg / 100 g of fat.
Conclusions:
The fat solubility of FAT 40224/C is lower than 0.1 mg/100g fat at 37 °C.
Executive summary:

In a GLP-compliant study with FAT 40224/C, the fat solubility of the test substance was determined performed according to EU method A.7. The content of the test substance in fat simulant at the maximum solubility was determined by spectrophotometry after extraction with water. The average fat solubility was determined from six experiments. The fat solubility of the test substance is lower than 0.1 mg/100 g fat at 37 °C.

Description of key information

In a GLP-compliant study with FAT 40224/C, the fat solubility of the test substance was determined performed according to EU method A.7.The content of the test substance in fat simulant at the maximum solubility was determined by spectrophotometry after extraction with water. The average fat solubility was determined from six experiments. The fat solubility of the test substance is lower than 0.1 mg/100 g fat at 37 °C

Key value for chemical safety assessment

Solubility in mg/100g standard fat:
0.1
At the temperature of:
37 °C

Additional information