Registration Dossier

Administrative data

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:
other: GLP study conducted to current EU guideline
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
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. certificate)
Remarks:
Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
>= 51.9 - <= 53.9 other: % w/w
Temp.:
20 °C
pH:
>= 8.2 - <= 8.3

Any other information on results incl. tables

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.

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.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 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 deg C by visual assessment.
Executive summary:

The determination was carried out besed on the flask method, Method A6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

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.

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 oC by visual assessment.