Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02/12/2008 to 17/02/2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with recognised guideline, but involving an estimation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
(see below)
Principles of method if other than guideline:
The standard A6 Method was not applicable to this test material due to highly viscous samples being produced at high concentration levels. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. Thus, the water solubility was estimated on visual inspection.
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
20.1 - 22 other: % w/w
Temp.:
20 °C
pH:
7.2 - 7.3
Details on results:
It is evident from the information obtained in the hydrolysis study and data relating to the pH of the test material in water that negligible hydrolysis of the sample solution occurred during the course of the water solubility test.

The standard A6 Method was not applicable to this test material due to highly viscous samples being produced at high concentration levels. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. Thus, the water solubility was estimated based on visual inspection.
The small dots of material noted in some samples were considered to be due to impurities, as increasing the test material concentration did not significantly affect the appearance of the samples.

Any other information on results incl. tables

The water solubility of the test material has been determined to be in the range 20.1 to 22.0 % w/w of solution at 20.0 ± 0.5°C.

Observations, concentrations and pH's relating to the samples are shown in the following table:

Sample

Concentration

(% w/w)

Observations

pH

1

16.1

Dark blue solution. Small dots of undissolved test material on the

bottom and sides of the vessel.

7.2

2

18.6

Dark blue solution. Small dots of undissolved test material on the

bottom and sides of the vessel.

7.2

3

20.1

Dark blue solution. Small dots of undissolved test material on the

bottom and sides of the vessel.

7.2

4

22.0

Dark blue solution with excess test material. Sample is more viscous

than Samples 1 to 3.

7.2

5

24.0

Dark blue solution with excess test material. Sample is more viscous

than Samples 1 to 3.

7.2

6

26.0

Dark blue solution with excess test material. Sample is more viscous

than Samples 1 to 3.

7.3

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The water solubility of the test material has been determined to be in the range 20.1 to 22.0 % w/w of solution at 20.0 ± 0.5°C.
It is evident from the information obtained in the hydrolysis study and data relating to the pH of the test material in water that negligible hydrolysis of the sample solution occurred during the course of the water solubility test.
The standard A6 Method was not applicable to this test material due to highly viscous samples being produced at high concentration levels. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. Thus, the water solubility was estimated based on visual inspection.
The small dots of material noted in some samples were considered to be due to impurities, as increasing the test material concentration did not significantly affect the appearance of the samples.
Executive summary:

In a determination of general physico-chemical properties study (Harlan project number: 0959/0224) the test material has been determined to be in the range 20.1 to 22.0 % w/w of solution at 20.0 ± 0.5°C.

The determination was carried out using a procedure based on the flask method, Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008.

It is evident from the information obtained in the hydrolysis study and data relating to the pH of the test material in water that negligible hydrolysis of the sample solution occurred during the course of the water solubility test.

The standard A6 Method was not applicable to this test material due to highly viscous samples being produced at high concentration levels. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. Thus, the water solubility was estimated based on visual inspection.

The small dots of material noted in some samples were considered to be due to impurities, as increasing the test material concentration did not significantly affect the appearance of the samples.