Disodium {sulfonylbis[4,1-phenylenediazene-2,1-diyl(1-ethyl-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridine-5,3-diyl)]}dimethanesulfonate

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12-Oct-2010 to 25-Feb-2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted 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. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Remarks:

EXAMPLE: The determination was carried out using the flask method, Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008.

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow RN 2903

IUPAC Name:

Acid Yellow RN 2903

Details on test material:

Identification: Acid Yellow RN 2903
Batch Number: Vers. Kilo 6, 26.05.2009
Purity: 65.7 %
Expiry Date: August 01, 2015
Storage Conditions: At room temperature at about 20 °C

Results and discussion

Water solubility

Water solubility:

6 392.1 mg/L

Temp.:

20 °C

pH:

7.9

Details on results:

Please see section Remarks on results including tables and figures.

Any other information on results incl. tables

The saturation concentration of Acid Yellow RN 2903 at room temperature was estimated by a simplified flask method in the preliminary test to be higher than 10^-2g/L. Therefore, the flask shaking test was performed.

 

After a shaking time of 24 hours, 48 hours and 72 hours, respectively, at 30 °C, the samples were equilibrated for another 24 hours at 20 °C. Afterwards, the samples were centrifuged, filtrated, diluted and analyzed by HPLC.The water solubility of Acid Yellow RN 2903 at 20 °C was determined to be 6392.1 mg/L. The standard deviation of the measured results differ by less than 15%.Therefore, the study is considered to be valid.The results of the individual measurements of the main test are summarized inTable 2. The tabulated values represent rounded results, which were obtained by calculation using the exact raw data.

 

A typical chromatogram of a standard solution is given in the attached Figure 1. A typical chromatogram of a sample solution after 72 hours of incubation is shown in the attached Figure 2. The calibration curve and data are shown in the attached Figure 3 and in Table 3. The r² fit was 0.9996 (optimum 1.0000). This reflects the linearity of the HPLC-system within the calibration range of 0.5412 µg/mL to 10.824 µg/mL of the test item.

Table1       Data of the Performance of the Water Solubility Test

Sample Solution No.		Weighed sample of the test item [mg]		Added volume of water [mL]		Agitation time at 30 °C [hours]		Equili-bration time at 20 °C [hours]		pH value of test item solution		Dilution factor before quanti-fication
1		145.7		10		72		24		7.98		1000
2		143.3		10		72		24		7.90		1000
3		144.0		10		72		24		7.92		1000
4		140.4		10		48		24		7.88		1000
5		139.7		10		48		24		7.86		1000
6		142.1		10		48		24		7.78		1000
7		146.5		10		24		24		7.95		1000
8		147.6		10		24		24		7.82		1000
9		144.9		10		24		24		7.70		1000

 

 

Table 2       Results of the Water Solubility of Acid Yellow RN 2903

Sample No.	Shakingtime at30 °C	Concentration analyzed	Concentration calculated	Water solubility calculated (rounded)
		[mg/L]	[mg/L]	[mg/L]
1	72	5.680	5678.48	6392.1 SD = 615.2
2		5.620	5621.86
3		5.720	5722.40
4	48	7.030	7028.48
5		7.190	7191.73
6		7.030	7027.57
7	24	6.290	6289.85
8		6.510	6512.07
9		6.460	6456.27

The saturation mass concentration is calculated from the bold values

 

SD = standard deviation

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): soluble (1000-10000 mg/L)
During this study the water solubility of Acid Yellow RN 2903 was determined and found to be 6392.1 mg/L at 20 °C and a pH of 7.9 using the flask shaking method.

Executive summary:

During this study the water solubility of Acid Yellow RN 2903 was determined. Vessels containing water and test item were shaken for 24 hours, 48 hours and 72 hours, respectively, at 30 °C. Afterwards the samples were equilibrated for another 24 hours at 20.0 °C. After dilution with water the concentrations in the aqueous solutions were determined by a HPLC-method.

 

The water solubility of Acid Yellow RN 2903 was determined to be

 

6392.1 mg/L at 20.0 °C and a pH of 7.9

 

using the flask shaking method.