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Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March from the 10th to the 14th, 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Reason / purpose for cross-reference:

reference to other study

Remarks:

validated analytical method

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

adopted July 27, 1995

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7840 (Water Solubility)

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Water solubility:

13.24 g/L

Conc. based on:

test mat.

Incubation duration:

24 - 72 h

Temp.:

20 °C

pH:

5.69 - 5.8

Details on results:

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

Results of the determination of water solubility of test item

Sampling time	Measured concentration of test item, g/l		Measured pH
	Test vessels	Mean
After 24h	15.44	13.55	5.76
	12.41		5.7
	12.22		5.77
After 48h	15.18	14.77	5.72
	14.19		5.75
	14.96		5.69
After 72h	10.9	11.59	5.76
	12.08		5.8
	11.8		5.81
Mean with confidence interval (95 %)		13.24 ± 3.96	5.75
RSD %		12

Conclusions:

Water solubility: 13.24 ± 3.96 g/l at 20 °C and pH 5.69 - 5.80

Executive summary:

Solubility was performed following the recommendations of the OECD method 105, by flask method.

A weight of ca. 4.1 g test item was weighed into 300 ml stoppered Erlenmeyer flasks (nine parallel). After the addition of 100 ml ultra pure water, the flasks were agitated at 30 °C. After one day, three of the vessels were removed and re-equilibrated at 20 ± 0.5 °C for 24 hours. The concentration in the clear solvent phase was determined by HPLC. The other flasks were treated similarly after initial equilibration at 30 °C for two and three days, respectively.

The water solubility of test item 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. The repeatability of the determination was < 15 %, thus within the range required by the guidelines

Conclusion

Water solubility: 13.24 ± 3.96 g/l at 20 °C and pH 5.69 - 5.80

Description of key information

13.24 ± 3.96 g/l at 20 °C and pH 5.69 - 5.80

Key value for chemical safety assessment

Water solubility:

13.24 g/L

at the temperature of:

20 °C

Additional information

Flask method - OECD 105