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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:
6 Oct - 6 Nov 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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
Type of method:
column elution method
Water solubility:
>= 1 - <= 21 mg/L
Temp.:
20 °C
pH:
6.2

Preliminary test:

Experiment

Water [mL]

Test Item [mg]

Result

A

2.0

129.02

Very hazy mixture

B

2.0

8.87

Hazy mixture

C

8.0

3.80

Hazy mixture

D

25

4.69

Hazy mixture

E

100

0.66

Slight hazy mixture

Based on these results, the column elution method was considered suitable for the determination of the water solubility of the test item.

Main test results

The concentrations of the test item in different test solutions were calculated automatically using the equation of the calibration curve. The results are shown in the following table (pH = 6.2):

Flow rate (ml/h)

Fraction No. (combined aliquots)

Concentration of test item [µg/L], using marker

pH value

Peak 1

Peak 2

Peak 3

Peak 4

25.0

1 (1-2)

21200

6700

3300

2625

6.2

 

2 (3-4)

17400

5050

1725

925

6.2

 

3 (5-6)

19075

5150

1825

775

6.2

 

4 (7-8)

14275

4150

1450

750

6.2

 

5 (9-10)

17475

5700

1575

725

6.2

 

6 (11-12)

18825

5575

1500

650

6.2

 

7 (13-14)

16400

5250

1425

700

6.2

 

8 (15-16)

14875

4300

1250

500

6.2

 

 

 

 

 

 

 

12.5

1 (1-2)

21425

8325

6500

5625

6.2

 

2 (3-4)

23425

6850

5250

4375

6.2

 

3 (5-6)

22200

7650

4550

3825

6.2

 

4 (7-1)

22975

6750

4250

3550

6.2

 

5 (9-10)

20150

7550

3700

2725

6.2

 

6 (11-12)

20150

6200

3500

3025

6.2

 

7 (13-14)

20100

6375

3325

2600

6.2

 

8 (15-16)

20350

6400

3225

2525

6.2

Summary results:

Flow rate

Value

Peak 1

Peak 2

Peak 3

Peak 4

25.0 mL/h (fractions 4-8)

Mean

16.4 mg/L

5.0 mg/L

14.4 mg/L

0.7 mg/L

Rel. SD

11.4%

14.5%

8.4%

14.9%

12.5 mL/h (fractions 4-8)

Mean

20.7 mg/L

6.7 mg/L

3.6 mg/L

2.9 mg/L

Rel. SD

6.0%

8.1%

11.3%

14.9%

OECD 105 states, that at least five successive fractions should not deviate by more than 30% to demonstrate a concentration plateau. This is achieved by the fractions 4-8 in both runs.

There are variations for the determined values (0.7 to 20.7 mg/L) depending on the marker signal and the flow rate of the pump. Since the test item is a complex mixture of components with different solubilities, these variations are expected and acceptable.

The overall water solubility of the test item is hence given as the range between 1 and 21 mg/L.

Description of key information

1 - 21 mg/L at 20 °C, pH 6.2 (OECD 105, column elution method)

Key value for chemical safety assessment

Water solubility:
21 mg/L
at the temperature of:
20 °C

Additional information