Yellow LF 6881

Water solubility

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 guideline

Test guideline 1

Qualifier:

according to

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

Test guideline 2

Qualifier:

according to

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Test guideline 3

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.