JAUNE REACTIF 181

Solubility in organic solvents / fat solubility

Link to relevant study record(s)

Reference

Endpoint:

solubility in organic solvents / fat solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 October 1990 to 23 October 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: EU Method A.7

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Product designation: Monoazo Yellow BG 3247
Identification: FAT 40400/A BG 3247/TV 6

Medium:

standard fat

Remarks:

fat simulant HB 307, batch 27

Solubility:

< 0.05 mg/100 g solvent

Temp.:

37 °C

Test substance stable:

yes

 

Flasks	1	2	3	4	5	6	7	8
Weight of test substance in mg	1.47	1.76	1.82	1.99	1.52	1.98	1.49	1.54
weight of fat in g	25	25	25	25	25	25	25	25
Temperatures of agitation (°C)	30 /37		30 /37		50 /37		50 /37
Agitation duration	1h /1h		1h /1h		1h /1h		1h /1h
Equilibration duration at 37 °C	1 h		1 h		1 h		1 h
S'	<0.05	<0.05	<0.05	<0.05	<0.05	<0.05	<0.05	<0.05
S	<0.05	<0.05	<0.05	<0.05	<0.05	<0.05	<0.05	<0.05
mean value	<0.05 mg/100 g fat
standard deviation	-       mg/100 g fat
Fat solubility at 37 °C = <0.05 mg/100 g fat

S' = concentration of test substance in mg/100 g fat solution.

S = concentration of test substance in mg/100 g fat.

Conclusions:

The fat solubility of FAT 40400/A is lower than 0.05 mg/100 g fat at 37 °C.

Executive summary:

In a GLP-compliant study, performed according to EU method A.7, the fat solubility of the test substance was determined. The content of the test substance in fat simulant HB 307 was determined by spectrophotometry after extraction with water. The average fat solubility was determined from eight experiments to be lower than 0.05 mg/100 g fat at 37 °C.

Description of key information

In a GLP-compliant study, performed according to EU method A.7, the fat solubility of the test substance was determined (Ciba-Geigy 1990). The content of the test substance in fat simulant HB 307 was determined by spectrophotometry after extraction with water. The average fat solubility was determined from eight experiments to be lower than 0.05 mg/100 g fat at 37 °C.

Key value for chemical safety assessment

Solubility in mg/100g standard fat:

0.05

At the temperature of:

37 °C