Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
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

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.