Registration Dossier

Physical & Chemical properties

Water solubility

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental starting date: 11 August 2012. Experimental completion date: 10 October 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Water solubility:
16.4 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
3.7
Remarks on result:
other: Preliminary test result
Key result
Water solubility:
19.3 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 4.4 - <= 6.1
Remarks on result:
other: Definitive test result
Details on results:
Validation
The linearity of the detector response with respect to concentration was assessed over the concentration range of 100 to 2.50 x 103 mg/L. This was satisfactory with a correlation coefficient (r^2) of 0.996 being obtained.

Discussion
On completion of the equilibration period, the samples were clear, colourless liquids containing excess test item; whereas, after centrifugation and filtration, the samples were free from excess test item.

All individual water solubility results were within ± 15 % of the mean, thus satisfying the criteria specified in the guideline(s).

The mean peak areas relating to the standard and sample solutions are shown in the following table:

Solution

Mean peak area

Standard 1.01 x 103mg/L

2.6038 x 107

Standard 1.02 x 103mg/L

2.6040 x 107

Sample 1A

4.9492 x 107

Sample 1B

5.0449 x 107

Sample 2A

4.9633 x 107

Sample 2B

4.8877 x 107

Sample 3A

4.9753 x 107

Sample 3B

4.9715 x 107

 

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

Sample number

Time shaken at ~ 30°C (h)

Time equilibrated at 20 °C (h)

Concentration (g/L)

Solution pH

1

24

24

19.4

4.4

2

48

24

19.1

5.2

3

72

24

19.3

6.1

 

Mean concentration: 19.3 g/L at 20.0 ± 0.5 °C

Range: 19.1 to 19.4 g/L

Conclusions:
The water solubility of the test material was assessed according to OECD guideline 105 and determined to be 19.3 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:

The water solubility of the test material was determined to be 19.3 g/L of solution at 20.0 ± 0.5 °C, using the flask method, designed to be compatible with Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.

Description of key information

The water solubility of the test material was assessed according to OECD guideline 105 and determined to be 19.3 g/L of solution at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

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

Additional information

The water solubility of the test material was determined to be 19.3 g/L of solution at 20.0 ± 0.5 °C, using the flask method, designed to be compatible with Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.