Benzenesulfonic acid, 2-[2-[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]diazenyl]-4-[[4-chloro-6-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-, sodium salt (1:2)

Solubility in organic solvents / fat solubility

Administrative data

Endpoint:

solubility in organic solvents / fat solubility

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

24 March 1993 to 27 May 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to EU tes guidance in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EU Directive 84/449/EEC Part A7

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

See below

Results and discussion

Solubility in organic solvents / fat solubility

Medium:

standard fat

Solubility:

< 0.003 mg/100 g solvent

Temp.:

37 °C

Test substance stable:

not determined

Details on results:

The extinction at 425 nm of the each extract was lower than that of the calibration standard with the lowest concentration (0.15 mg/l (not com); 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 54 % (w/w) yields the fat solubility of Reaktiv-Gelb F-66923.

Any other information on results incl. tables

Experiment No.	Pre-saturation		Stirring time a 37⁰C (h)	Mass ration test sub./fat mg/100g
	Stirring time (h)	Temp (⁰C)
1 / 2	3	30	3	<0.006
3 / 4	3	30	27	<0.006
5 / 6	3	50	3	<0.006
7 / 8	3	50	27	<0.006

 

Applicant's summary and conclusion

Conclusions:

Fat solubility of Reaktiv-Gelb F-66923 in the test substance:
(Reaktiv-Gelb F-66923) < 0.003 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 EU test guidance 84/449/EEC, A.7. in compliance with GLP.

Mixtures containing circa 200 mg test substance and circa 80 g fat were stirred at 30 °C or 50 °C for 3 hours and at 37 °C (test temperature) for 3 or 27 hours.

 

The saturated liquid phase is separated from undissolved test substance by centrifugation at 37 °C and by filtration through a filter at 37 °C. Ca. 60 g of the liquid phase are dissolved in 100 ml n-hexane and extracted 3 times with 7 ml H2O. The extract is filled up to a volume of 25 ml, filtrated, and subjected to spectrophotometric analysis.

 

A pretest according to the above prescribed procedure resulted in a fat solubility less than 0.01 mg/100 g fat (not corr.).

 

Fat solubility of Reaktiv-Gelb F-66923 in the test substance:

 

(Reaktiv-Gelb F-66923) < 0.003 mg/100 g fat (37°C)