RSS-4, DRY SUBSTANCE

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18/08/2008-17/10/2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

yes

Remarks:

Please check field "principles of method..."

Principles of method if other than guideline:

The standard A6 Method was not applicable to this test material due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

GLP compliance:

yes (incl. QA statement)

Remarks:

Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)

Type of method:

flask method

Water solubility:

>= 51.9 - <= 53.9 other: % w/w

Temp.:

20 °C

pH:

>= 8.2 - <= 8.3

Water solubility:

> 1 000 g/L

Temp.:

20 °C

pH:

>= 8.2 - <= 8.3

The standard A.6 Method was not applicable to this test material due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

Preliminary test

The sample concentration, observations and solution pH, on completion of the 20 °C equilibration period, are shown in the following table:

Sample Number	Concentration % (w/w)	Observations	Solution pH
1	20.1	Clear, colourless solution with no visible excess test material	7.3
2	30.0	Clear, colourless solution with no visible excess test material	8.1
3	39.9	Clear, colourless, slightly viscous solution with no visible excess test material	8.2
4	50.0	Clear, colourless, viscous solution with no visible excess test material	8.2
5	60.2	Cloudy solution with excess test material visble	8.2
6	69.8	Cloudy paste-like solution with excess test material visible	8.0
7	79.8	No liquid phase, excess test material visible	-

Result: solubility in the range 50.0 to 60.2 % (w/w) of solution at 20.0 ± 0.5 °C

Definitive test

The sample concentration, observation and solution pH, on completion of the 20 °C equilibration period are shown in the following table:

Sample Number		Concentration % (w/w)		Observations		Solution pH
1		49.9		Clear, colourless solution with no visible excess test material		8.3
2		51.9		Clear, colourless solution with no visible excess test material		8.2
3		53.9		Slightly cloudy solution with excess test material visible		8.3
4		56.0		Cloudy solution with excess test material visible		8.2
5		57.9		Cloudy solution with excess test material visible		8.2
6		59.9		Cloudy solution with excess test material visible		8.2

Result: solubility in the range 51.9 to 53.9% (w/w) of solution at 20.0 ± 0.5 °C.

Conclusions:

Interpretation of results (migrated information): very soluble (> 10000 mg/L) 51.9 to 53.9 % (w/w)
The water solubility of the test material was determined to be in the range 51.9 to 53.9 % (w/w) of solution at 20.0 ± 0.5 °C by visual assessment.

Executive summary:

The determination was carried out besed on the flask method, Method A.6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The standard A.6 Method was not applicable to this test material due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

Under the conditions of the test the substance was found to have a solubility range of 51.9 to 53.9 % (w/w) of solution at 20.0 ± 0.5 °C by visual assessment.

Description of key information

The water solubility of the substance was determined to be > 1 kg/L.

Key value for chemical safety assessment

Water solubility:

1 000 g/L

at the temperature of:

20 °C

Additional information

The water solubility of the substance was determined based on visual inspection.