Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10-14 March 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern guideline conform study performed in GLP certified laboratory

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch No. RW 2013-10-22
Expiry date 22 October 2018

Results and discussion

Water solubility
Water solubility:
> 9.28 - < 17.2 g/L
Temp.:
20 °C
pH:
> 5.69 - < 5.8
Details on results:
The water solubility of Yellow LF 6881 was determined to be 13.24  3.96 g/L (95% confidence interval) at 20 °C ± 0.5 °C using the flask method for the performance of the main test.

Any other information on results incl. tables

The calibration solutions were prepared on each analytical occasion.Thecalibration sampleswere analysed by HPLC with three parallel injections from each.

The test item concentrations were calculated with the help of the calibration equations given in Table 1.

One exemplary calibration curve is given in Figure 1.

Representative chromatograms can be seen in the Appendix 3.

 

Table 1. Regression data

Analytical occasion

Constant

X Coefficient

R. Squared

12 March 2014

4061

76041

1.000

13 March 2014

976

75958

1.000

14 March 2014

734

78645

1.000

 

Measured concentrations of Yellow LF 6881 are summarised in Table 2. The repeatability of the determination was < 15 % and thus within the range required by the guidelines.

 

Table 2. Results of the determination of water solubility of Yellow LF 6881

Sampling time

Measured concentrationoftest item,g/L

Measured pH

Test vessels

Mean

After 24h

15.44

13.35

5.76

12.41

5.70

12.22

5.77

After 48h

15.18

14.77

5.72

14.19

5.75

14.96

5.69

After 72h

10.90

11.59

5.76

12.08

5.80

11.80

5.81

Mean with confidence interval (95 %)

13.24 ± 3.96

5.75

RSD %

12

-

Applicant's summary and conclusion

Conclusions:
In conclusion the water solubility of Yellow LF 6881 was determined to be 13.24 +/- 3.96 g/L (95% confidence interval) at 20 °C ± 0.5 °C using the flask method for the performance of the main test.
Executive summary:

The water solubility of Yellow LF 6881 was determined to be13.24 ± 3.96 g/L(95% confidence interval) at 20 °C ± 0.5 °C using the flask method for the performance of the main test.