Reaction mass of 2-hydroxy-N-(2-(2-hydroxyethoxy)ethyl)-N-(2-hydroxyethyl)-N-methylethan-1-amininium hydroxide and 2-hydroxy-N,N-bis(2-hydroxyethyl)-N-methylethanaminium hydroxide

Water solubility

Link to relevant study record(s)

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