Carbonic acid disodium salt, reaction products with aniline, 4-nitrobenzenamine, p-phenylenediamine, sodium sulfide, sulfur and p-toluidine

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 03 - May 03, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

July 27, 1995

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Version / remarks:

March 2014

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7840 (Water Solubility)

Version / remarks:

March 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Key result

Water solubility:

2.81 mg/L

Conc. based on:

test mat.

Loading of aqueous phase:

3.33 g/L

Incubation duration:

>= 24 - <= 72 h

Temp.:

20 °C

pH:

>= 6.71 - <= 6.84

Remarks on result:

other:

Remarks:

the water solubility of Yellow 22 was determined to be 2.81 +/- 0.16 mg/L

Details on results:

Result of Water Solubility Test
Results of the test and measured concentrations of Yellow 22 are presented in the following table. The measured concentrations are constant within ± 15 % and thus within the range required by the guidelines. The water solubility of Yellow 22 was determined to be 2.81 +/- 0.16 mg/L (95% confidence interval) at 20 °C ± 1 °C using the shake-flask method for the performance.

Validation Results

Yellow 22 in water was analysed by the previously validated spectrophotometric method.

Results of the Method Validation

Measurement repeatability

(8 parallels)       CV% < 1 %

Repeatability of the Preparation (n=5)       ~ 4 %

Linear range       0.1 - 20 µg/mL

Correlation coefficients       > 0.999

Limit of Quantification       0.1 µg/mL

Limit of Detection       0.1 µg/mL

Recovery from ISO medium       92 %

Recovery from 20X AAP medium       104 %

Recovery from ultra-pure water       100 %

Accuracy       ≤ 6 %

Precision       ≤ 6 %

(16 % at LOQ)

Stability of the test item in ISO medium at the temperature 18-22°C for 2 days       83 % at the test conditions

Stability of the test item in 20X AAP medium at the temperature 22-26°C for 7 days       50 % at the test conditions

Stock solution stability (1 mg/ml) , after dissolution, dye complexation and  color development       for at least 3 days at 5 +/- 3 °C

Results of the determination of Yellow 22 concentrations

Sampling time	Measured concentrationofYellow 22(mg/L )		Measured pH
	Test vessels	Mean withthe 95% confidence intervals
After 24h	2.55	2.65 ± 0.22	6.84
	2.72		6.84
	2.69		6.84
After 48h	2.87	2.83 ± 0.67	6.81
	3.08		6.79
	2.55		6.75

Results of the determination of Yellow 22 concentrations (continued)

Sampling time	Measured concentrationofYellow 22(mg/L )				Measured pH
	Test vessels		Mean withthe 95% confidence intervals
After 72h	2.79		2.95 ± 0.37		6.72
	3.08				6.72
	2.97				6.71
Solubility ofthe test item (mg/L)	2.81 ± 0.16	-
RSD%	7	-
Ultra-pure water			< LOQ	6.53

Conclusions:

The water solubility of the test item was determined to be 2.81 ± 0.16 mg/L (95% confidence interval) at 20 °C ± 1 °C using the shake-flask method for the performance.

Executive summary:

The water solubility of the test item was dertermined at 20 ± 1 °C

according to OECD TG 105 using the shake-flask method. The water solubility is 2.81 ± 0.16 mg/L (95% confidence interval).

Description of key information

The water solubility of Yellow 22 was determined to be 2.81 ± 0.16 mg/L (95% confidence interval)  at 20 °C ± 1 °C using the shake-flask method.  

Key value for chemical safety assessment

Water solubility:

2.81 mg/L

at the temperature of:

20 °C