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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:
23 March 2018 to 19 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method
Specific details on test material used for the study:
Batch/Lot Number: 150205
Appearance: Blue powder
Purity: As a UVCB purity is considered as 100%
Key result
Water solubility:
< 0.17 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 5.9 - <= 6.5
Details on results:
Preliminary test: The investigation was performed at 20 °C to get a rough information of the water solubility. Portions of the test item were added to distilled water and were stirred for at least 48 hours in a water bath at 20°C. Measuring the content of copper in the filtered solutions outside GLP showed a water solubility far below 10 mg /L. Therefore the column elution method at one temperature (20 °C) was carried out according to the guidelines.
Main test: The results of the solubility of "B440" in water at 20 °C are listed in Table 1 to Table 2. The temperature of the water bath was 20 °C at run A and B. The pH of the solutions was 5.9 to 6.5 for run A and B. The mean water solubility of "B440" in water at 20 °C was < 0.17 mg / L, 5 replicates, at a flow of 25.0 ml / h and < 0.17 mg / L, 5 replicates, at a flow of 12.5 ml / h. The mean water solubility of "B440" in water at 20 °C was < 0.17 mg/L, 2 replicates. In each replicate run the water solubility of the test substance was less than the limit of quantification (0.17 mg / L) of the analytical method.

Table 1

description
(sample)

date / time

flow

(mL/h)

total bed volume

pH

copper content in water
(mg / L)

test item concentration in water
(mg / L)

deviation from the mean concentration
(%)

Start

2018-04-18 09:55

25

0

--

--

--

--

1

2018-04-18 10:55

25

10

6.4

< 0.017

< 0.17

--

2

2018-04-18 12:10

25

22

6.0

< 0.017

< 0.17

--

3

2018-04-18 13:20

25

34

5.9

< 0.017

< 0.17

--

4

2018-04-18 14:35

25

46

5.9

< 0.017

< 0.17

--

5

2018-04-18 15:50

25

59

5.9

< 0.017

< 0.17

--

 

 

 

Mean

6.0

< 0.017

< 0.17

 

Table 2

description
(sample)

date / time

flow

(mL/h)

total bed volume

pH

copper content in water
(mg / L)

test item concentration in water
(mg / L)

deviation from the mean concentration
(%)

Start

2018-04-18 09:55

12.5

0

--

--

--

--

1

2018-04-18 12:00

12.5

10

6.5

< 0.017

< 0.17

--

2

2018-04-18 14:30

12.5

22

6.1

< 0.017

< 0.17

--

3

2018-04-19 08:00

12.5

110

5.9

< 0.017

< 0.17

--

4

2018-04-19 10:25

12.5

122

5.9

< 0.017

< 0.17

--

5

2018-04-19 12:50

12.5

134

5.9

< 0.017

< 0.17

--

 

 

 

Mean

6.1

< 0.017

< 0.17

 

Conclusions:
The mean water solubility of "B440" in water at 20 °C was < 0.17 mg/L, 2 replicates. In each replicate run the water solubility of the test substance was less than the limit of quantification (0.17 mg / L) of the analytical method.
Due to the low water solubility the temperature coefficient of the solubility of the test substance cannot be determined, therefore no further tests at other temperatures were performed, in agreement with the guideline.

Description of key information

Mean water solubility was found to be less than 0.17 mg/L at 20°C.

Key value for chemical safety assessment

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

Additional information

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