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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:
From 16 December 2011 to 3 September 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to internationally recognised guidelines, and under GLP. No deviation affected the quality of the study.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Remarks:
2011-08-31
Type of method:
flask method
Temp.:
20 °C
pH:
> 3.8 - < 5
Remarks on result:
other: Miscible in all proportions with water

Results:

The actual sample concentrations, observations recorded and solution pH values are shown in the following table:

Sample Number

Actual Concentration (%w/w)

Visual Assessment Following Equilibration at 20.0 ± 0.5°C

pH

1

5.04

Clear, colorless, homogeneous solution, free from any separated material or phases

4.5

2

24.9

Clear, colorless, homogeneous solution, free from any separated material or phases

5.0

3

49.8

Clear, colorless, homogeneous solution, free from any separated material or phases

3.9

4

74.8

Clear, colorless, homogeneous solution, free from any separated material or phases

3.8

5

95.0

Clear, colorless, homogeneous solution, free from any separated material or phases

4.7

Overall result: Miscible in all proportions with water at 20.0 ± 0.5°C

Discussion:

In the absence of any saturated solutions, it was not possible to apply the standard test method as detailed in the guidelines referenced. This was since the guidelines procedures require preparations of samples at five times the saturation concentration. Therefore miscibility was confirmed by visual assessment method. Again, in the absence of any saturated solutions, analysis of the samples was not considered relevant or necessary.

Conclusions:
The test item is miscible with water in all proportions at 20.0 ± 0.5°C.
Executive summary:

The determination was carried out using flask method according to Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 105 of the Guidelines for Testing of Chemicals, 27 July 1995 and according to GLP. No deviation from the guideline was observed during the test.


Increasing amounts of the test item are brought into contact with the solvent to give a range of concentrations. Successful dissolution of the test item is then determined by visual appraisal of the resulting solution.


In the absence of any saturated solutions, it was not possible to apply the standard test method as detailed in the guidelines referenced. This was since the guidelines procedures require preparations of samples at five times the saturation concentration. Therefore miscibility was confirmed by visual assessment method. Again, in the absence of any saturated solutions, analysis of the samples was not considered relevant or necessary.


The test item is miscible with water in all proportions at 20.0 ± 0.5°C.

Description of key information

Experimental water solubility of the test item at 20.0 ± 0.5°C : Miscible in all proportions with water.

Key value for chemical safety assessment

Water solubility:
100 000 mg/L
at the temperature of:
25 °C

Additional information

The determination was carried out using the flask method according to Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 105 of the Guidelines for Testing of Chemicals, 27 July 1995 and according to GLP. No deviation from the guideline was observed during the test.


In the absence of any saturated solutions, it was not possible to apply the standard test method as detailed in the guidelines referenced. This was since the guidelines procedures require preparations of samples at five times the saturation concentration.


The test item is miscible with water in all proportions at 20.0 ± 0.5°C.


For the risk assessment a surrogate water solubility value of 100,000 mg/L at 25° C has been included, as the substance is completely miscible with water and this is the maximum recommended water solubility for use in risk assessments.