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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:
17 March to 18 April 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognized method, and under GLP. No deviation was reported. Test substance is adequately specified with purity. Therefore full validation applies.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
UK GLP compliance programme (inspected on 05 July 2016 / signed on 28 October 2016)
Type of method:
flask method
Key result
Water solubility:
0.056 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
5 g/L
Incubation duration:
72 h
Temp.:
20 °C
pH:
>= 5.8 - <= 5.9

Preliminary Test

The preliminary estimate of water solubility was approximately 5 x 10-2 g/L (50 mg/L) at 20 °C.

 

Main Test

Table 4.8/2: Concentration (g/L) of test item in the sample solutions

 

Sample number

 

Time shaken at ~ 30 ºC (hours)

Time equilibrated at 20 ºC (hours)

Concentration (g/L)

 

Mean Concentration (g/L)

Solution pH

 

1A

24

24.25

5.75 x 10-2

4.91 x 10-2 (49.1 mg/L)

5.9

1B

24

24.25

4.07 x 10-2

2A

48

24.25

6.51 x 10-2

6.45 x 10-2 (64.5mg/L)

5.8

2B

48

24.25

6.39 x 10-2

3A

72

24.0

5.80 x 10-2

5.50 x 10-2 (55.0 mg/L)

5.9

3B

72

24.0

5.20 x 10-2

Mean concentration: 5.62 x 10-2 g/L at 20.0 ± 0.5 ºC

Range: 4.07 x 10-2 to 6.51 x 10-2 g/L

Relative Standard Deviation: 13.8 % (S.D.7.7 x 10-3 g/L)

 

Executive summary:

The water solubility of the test substance was measured under GLP according to OECD 105 / EU A6 guidelines, flask method. Three measurements were performed after 24, 48 and 72 h incubation at 20°C, with duplicate analysis by HPLC-UV. Equilibrium was found to be reached from 24 h, and the overall mean result was retained.

 

Mean concentration: 5.62 x 10-2 g/L at 20.0 ± 0.5 ºC

Range: 4.07 x 10-2 to 6.51 x 10-2 g/L

Relative Standard Deviation: 13.8 % (S.D.7.7 x 10-3 g/L)

 

The water solubility of the test item has been determined to be 56.2 mg/L of solution at 20.0°C, pH of saturated solution ca 5.9.

Description of key information

Slightly soluble, with equilibrium reached at 24h.

pH of saturated solution: ca 5.9

Key value for chemical safety assessment

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

Additional information

A fully reliable experimental study, conducted according to a recognized OECD/EC method and under GLP, is available. It is considered as a key study. The result is retained as key data for purpose of CSA.