REAKTIV-GELB F-68 072 FW

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:

supporting study

Study period:

24 March 1993 to 29 April 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: EU Directive 84/449/EEC Part A7

Deviations:

no

GLP compliance:

yes

Key result

Medium:

standard fat

Remarks:

HB 307

Solubility:

< 0.005 mg/100 g solvent

Temp.:

37 °C

Remarks on result:

not determinable because of methodological limitations

Details on results:

The extinction at 415 nm of the each extract was less than that of the calibration standard with the lowest concentration (0.21 mg/L test material; detection limit). Thus the ratio test substance per 100 g fat was calculated from the detection limit.

For evaluation of the result one has to take into account that the spectrophotometric measurements only include organic components showing absorption at the quantification wavelength. A correction with the purity of the test substance in the test material yields the fat solubility of Reaktiv-Gelb F-68072.

Experiment No.	Pre-saturation		Stirring time at 37⁰C (h)	Mass ration test sub./fat mg/100g
	Stirring time (h)	Temp (⁰C)
1 / 2	5	30	2	<0.001
3 / 4	5	30	25	<0.001
5 / 6	5	50	2	<0.001
7 / 8	5	50	25	<0.001

 

Conclusions:

Fat solubility of Reaktiv-Gelb F-68072 in the test substance: < 0.005 mg/100 g fat (37 °C)

Executive summary:

The objective of this, study was the determination of the fat solubility of the test substance according to 84/449/EEC Part A.7. Fat Solubility, study performed in compliance with GLP.

 

Mixtures containing circa 200 mg test substance and circa 75 g fat were stirred at 30 °C or 50 °C for 5 hours and at 37 °C (test temperature) for 2 or 25 hours.

 

The saturated liquid phase is separated from undissolved test substance by centrifugation at 37 °C and by filtration through a filter (0.45 µm) at 37 °C. Ca. 60 g of the liquid phase are dissolved in 100 ml n-hexane and extracted 3 times with 7 ml water. The extracts are combined, filled up to a volume of 25 ml, filtrated, and subjected to spectro-photometric analysis.

 

In a pretest, performed analogously to the above described procedure, a fat solubility of < 0.01 mg/100 g fat based on test material was found.

 

Fat solubility of Reaktiv-Gelb F-68072 in the test substance:< 0.005 mg/100 g fat (37 °C) based on active ingredient.

 

Description of key information

Fat solubility of Reaktiv-Gelb F-68072 in the test substance: < 0.005 mg/100 g fat (37 °C).

Key value for chemical safety assessment

Solubility in mg/100g standard fat:

0.005

At the temperature of:

37 °C

Additional information

The objective of this, study was the determination of the fat solubility of the test substance according to 84/449/EEC Part A.7. Fat Solubility, study performed in compliance with GLP.

 

Mixtures containing circa 200 mg test substance and circa 75 g fat were stirred at 30 °C or 50 °C for 5 hours and at 37 °C (test temperature) for 2 or 25 hours.

 

The saturated liquid phase is separated from undissolved test substance by centrifugation at 37 °C and by filtration through a filter (0.45 µm) at 37 °C. Ca. 60 g of the liquid phase are dissolved in 100 ml n-hexane and extracted 3 times with 7 ml water. The extracts are combined, filled up to a volume of 25 ml, filtrated, and subjected to spectro-photometric analysis.

 

In a pretest, performed analogously to the above described procedure, a fat solubility of < 0.01 mg/100 g fat based on test material was found.

 

Fat solubility of Reaktiv-Gelb F-68072 in the test substance:< 0.005 mg/100 g fat (37 °C) based on active ingredient.