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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 November 2017 to 05 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
27 July 1995
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D26-3-3-1
- Expiration date of the lot/batch: 01 December 2018
- Purity test date: 11 April 2017
- Stability under test conditions: Room temperature, in the dark
- Purity: 47.4 %
Key result
Water solubility:
548 g/L
Temp.:
20 °C
pH:
> 12.6 - < 13
Details on results:
All individual water solubility plateau results (Samples 3 to 5) were within ± 15% of the mean, thus satisfying the criteria specified in the guidelines.

On completion of the equilibration period, the samples were visually inspected. The results are shown in the following table:

Solution

Observation

Sample 1

A clear, pale yellow solution with no visible, excess test item

Sample 2

A clear, pale orange solution with a small amount of brown test item at the bottom of the vessel

Sample 3

A clear, light brown solution with a small amount of brown test item at the bottom of the vessel

Sample 4

A translucent, brown solution with a small amount of brown test item at the bottom of the vessel

Sample 5

A translucent, brown solution with a small amount of brown test item at the bottom of the vessel

The amount of solid present at the base of the vessels was approximately consistent. Therefore, it was considered that this was due to an insoluble impurity. Also, on standing, Sample 1 was noted to have some brown test item at the base of the vessels.

The solutions were decanted, avoiding excess test item prior to centrifugation. After centrifugation, the supernatants were taken for analysis. The supernatants were visually observed to be free from excess test item.

The concentration (g/L) of test item in the sample solutions is shown in the following table:

 

Sample Number

Time Shaken at

~ 30 ºC (hours)

Time Equilibrated at 20.0 ± 0.5 ºC

(hours)

Concentration (g/L)

 Solution pH

1

72

24

51.4

12.6

2

72

24

264

12.6

3

72

24

519

12.8

4

72

24

586

12.9

5

72

24

538

13.0

The mean concentration is 548 g/L at 20.0 +/-0.5°C (Samples 3 to 5)

The range is 519 to 586 g/L and the standard deviation is 34.9 g/L.

Conclusions:
The water solubility of the test item has been determined to be 548 g/L of solution at 20.0 ± 0.5 °C and pH 12.6-13.0.

Description of key information

The water solubility of the test item has been determined to be 548 g/L at 20.0 ± 0.5 °C and pH 12.6 -13.0 according to EU Method A.6 and OECD guideline 105 (K1, Covance, 2019).

Key value for chemical safety assessment

Water solubility:
548 g/L
at the temperature of:
20 °C

Additional information