Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 26 March 2007 and 05 May 2007.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification: C-Y9
Description: yellow powder
Lot number: MB-l
Date received: 06 March 2007
Storage conditions: room temperature, in the dark, over silica gel

Results and discussion

Water solubility
Water solubility:
32 - 33.9 other: % w/w of solution
Temp.:
20 °C
pH:
8.1

Any other information on results incl. tables

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

20.0

Dark orange solution containing no excess, undissolved test material

8.1

2

30.7

Dark orange solution with excess, undissolved test material

8.0

3

40.0

Dark orange solution with excess, undissolved test material

7.9

 

4

50.0

Dark orange solution with excess, undissolved test material

7.9

Result: Solubility in the range 20.0 to 30.7% w/w of solution at 20.0 ± 0.5°C.

Definitive 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

19.9

Dark orange solution containing no excess, undissolved test material

8..1

2

21.9

Dark orange solution containing no excess, undissolved test material

8.1

3

23.9

Dark orange solution containing no excess, undissolved test material

8.1

4

25.9

Dark orange solution containing no excess, undissolved test material

8.0

5

27.8

Dark orange solution containing no excess, undissolved test material

8.1

6

29.9

Dark orange solution containing no excess, undissolved test material

8.1

7

32.0

Dark orange solution containing no excess, undissolved test material

8.1

8

33.9

Dark orange solution with excess, undissolved test material

8.1

9

35.9

Dark orange solution with excess, undissolved test material

8.1

10

38.0

Dark orange solution with excess, undissolved test material

8.1

11

39.9

Dark orange solution with excess, undissolved test material

8.1

12

41.9

Dark orange solution with excess, undissolved test material

Insufficient solution volume to measure pH

Result: Solubility in the range 32.0 to 33.9% w/w of solution at 20.0 ± 0.5°C.

Discussion:

The standard EEC A6 Method/OECD Method 105 were not applicable due to the extremely high water solubility of the test material. It was therefore not possible to prepare samples at five times saturation level as specified in the guideline. Therefore a number of individual samples were prepared at increasing nominal concentrations and the solubility determined by visual assessment of the resulting solutions.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: extremely high water solubility
The water solubility of the test material was determined to be in the range 32.0 to 33.9% w/w of solution at 20.0 ± 0.5°C by visual assessment.
Executive summary:

Water Solubility.

In the range 32.0 to 33.9 % w/w of solution at 20.0 ± 0.5°C, by visual assessment using a flask method, based on Method A6 of Commission Directive 92/69/EEC and Method 105 of the DECD Guidelines for Testing of Chemicals, 27 July 1995.