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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:
07 June 2018 to 10 July 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study was conducted in accordance with international guidelines and in accordance with GLP
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of Inspection: 18 July 2017 - 20 July 2017 Date on Certfiicate: 28 November 2017
Type of method:
flask method
Key result
Water solubility:
0.147 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.2
Details on results:
The preliminary estimate of the water solubility at 20.0 ± 0.5 °C was 0.165 g/L. The solution had a pH of 6.2.

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

Table 2

Solution

Mean peak area

Standard 101 mg/L

2.9799 x 107

Standard 100 mg/L

2.8745 x 107

Matrix Blank

None detected

Sample 1A

2.1085 x 107

Sample 1B

2.1125 x 107

Sample 2A

2.1487 x 107

Sample 2B

2.1456 x 107

Sample 3A

2.1412 x 107

Sample 3B

2.1354 x 107

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

Table 3

Sample number

Time shaken at ~ 30°C

Concentration (g/L)

Mean concentration (g/L)

Solution pH

1A

24

0.145

0.145

5.1

1B

24

0.146

2A

48

0.148

0.148

5.3

2B

48

0.148

3A

72

0.147

0.147

5.4

3B

72

0.147

Mean concentration: 0.147 g/L at 20.0 ±  0.5°C

Standard deviation: 1.32 x 10-3g/L

Validation

The linearity of the HPLC detector response with respect to concentration was assessed over the concentration range of 20.2 to 202 mg/L. The results were satisfactory with a correlation coefficient (r) of 1.000 being obtained.

Discussion

On completion of the equilibration period, the samples were translucent pale yellow liquids with excess test item present. The solutions were centrifuged and filtered leaving a clear pale yellow solution with no excess test item visible. A faint Tyndall beam effects was observed in each solution.

As the water solubility was determined during the preliminary test to be above 10-2 g/L, the flask shaking test was performed

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

Conclusions:
The water solubility of the test item has been determined to be 0.147 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:

The water solubility of the test item has been determined to be 0.147 g/L of solution at 20.0 ± 0.5 °C,

using the flask method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995 and Method 830.7840 of the OCSPP Guidelines.

Description of key information

The water solubility of the test item has been determined to be 0.147 g/L of solution at 20.0 ± 0.5 °C

Key value for chemical safety assessment

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

Additional information

The water solubility of the test item has been determined to be 0.147 g/L of solution of 20.0 ± 0.5 °C, using the flask method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995 and Method 830.7840 of the OCSPP Guidelines.