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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 June 2006 to 05 July 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
other: Column elution and Flask method
Key result
Water solubility:
0.001 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.4

Preliminary Test

The preliminary estimate of water solubility was 1.30 x 10^-3 g/L.

Column Elution Test

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

Solution

Mean Peak Area

Standard 1.01 mg/L

32.893

Standard1.00 mg/L

33.534

Sample A1

4.077

Sample B1

3.849

Standard 1.00 mg/L

33.453

Standard1.00 mg/L

33.97

Sample A2

3.327

Sample B2

2.953

Standard 1.01 mg/L

33.809

Standard 1.00 mg/L

33.849

Sample A3

3.022

Sample B3

2.678

Standard1.00 mg/L

33.643

Standard 1.00 mg/L

33.797

Sample A4

2.553

Sample B4

2.571

Standard 0.99 mg/L

33.414

Standard1.11 mg/L

38.117

Sample A5

1.271

Sample B5

0.646

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

Sample number

Sampling time (hour)

Concentration (g/L)

Solution pH

Determination A

Determination B

Determination A

Determination B

Determination A

Determination B

1

66.25

33.75

2.47 x 10-4

2.33 x 10-4

6.8

7.1

2

91

71.25

1.98 x 10-4

1.76 x 10-4

7.0

7.0

3

115

115.25

1.80 x 10-4

1.59 x 10-4

6.8

6.9

4

139

139.25

1.51 x 10-4

1.52 x 10-4

7.1

7.0

5

235

235.25

7.45 x 10-5

3.78 x 10-5

6.8

7.0

 

Flask Test

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

Solution

Mean Peak Area

Standard 5.03 mg/L

145.587

Standard 5.03 mg/L

145.359

Sample1A

11.081

Sample1B

9.870

Sample 2A

10.537

Sample 2B

10.451

Sample 3A

10.761

Sample 3B

10.688

 

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

Sample number

Time shaken at 30 °C (hours)

Time equilibrated at 20 °C (hours)

Concentration (g/L)

Solution pH

1

1

1

7.22 x 10-4

6.3

2

2

1

7.23 x 10-4

6.5

3

3

1

7.39 x 10-4

6.5

 

Mean concentration:  7.28 x 10-4 g/L at 20.0 ± 0.5 °C

Conclusions:
Under the conditions of the study the water solubility of the test material was determined to be 7.28 x 10^-4 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:

The water solubility of the test material was investigated in a study which was conducted in accordance with the standardised guideline EU Method A.6, under GLP conditions.

The determination was carried out using both the column elution method with a recirculating pump and the flask method.

Under the conditions of the study the water solubility of the test material was determined to be 7.28 x 10^-4 g/L of solution at 20.0 ± 0.5 °C.

Description of key information

Under the conditions of the study the water solubility of the test material was determined to be 7.28 x 10^-4 g/L of solution at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

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

Additional information

The water solubility of the test material was investigated in a study which was conducted in accordance with the standardised guideline EU Method A.6, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The determination was carried out using both the column elution method with a recirculating pump and the flask method.

Under the conditions of the study the water solubility of the test material was determined to be 7.28 x 10^-4 g/L of solution at 20.0 ± 0.5 °C.