Sodium 4-[4-[[2-methyl-4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo]anilino]-3-nitrobenzenesulphonate

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October from 24th to 29th, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

adopted July 27

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Water solubility:

0.33 g/L

Temp.:

20 °C

pH:

8.84 - 9.41

Remarks on result:

other: 95 % confidence interval

Details on results:

The repeatability of the determination was < 15 % and thus within the range required by the guidelines.

Results of determination of water solubility

Sampling time	Measured concentration of test item, g/l		Measured pH
	Test vessels	Mean
After 24 hrs	0.35	0.32	9.13
	0.3		9.33
	0.31		9.41
After 48 hrs	0.32	0.32	9.07
	0.3		8.84
	0.32		9.25
After 72 hrs	* 0.21	0.35	9.11
	0.36		9.06
	0.34		9.09
Mean with confidence interval (95 %)	0.33± 0.05		9.14
RSD %	6		-

Conclusions:

0.33 ± 0.05 g/l at 20 ± 0.5 °C and pH 8.84 - 9.414

Executive summary:

Water solubility test was tested, according to the OECD guideline 105; flask method was used. A preliminary test was carried out to determine the suitable method to be used in the main test. In this preliminary test the solubility of the test item was higher than 10 mg/l. Therefore, the flask method was used in the main test. ca. 0.3 g of test item was weighed into 100 ml stoppered Erlenmeyer flasks (three parallel). After the addition of ultrapure water, the flasks were agitated at 30 °C. After one and two days, another three samples were prepared and added to shaker, respectively.

After the pre-incubation time had elapsed the nine test vessels were removed and re-equilibrated at 20 °C for 24 hours. The concentration in the clear solvent phase was determined by HPLC. The pH of each sample was recorded. The repeatability of the determination was < 15 % and thus within the range required by the guidelines.

Conclusion

The water solubility was determined to be 0.33 ± 0.05 g/l (95 % confidence interval) at 20 ± 0.5 °C using the flask method for the performance of the main test.

Description of key information

0.33 ± 0.05 g/l at 20 ± 0.5 °C and pH 8.84 - 9.414

Key value for chemical safety assessment

Water solubility:

0.33 g/L

at the temperature of:

20 °C

Additional information

OECD 105 - Flask method