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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:
27 February to 3 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
GLP compliance:
yes (incl. certificate)
Remarks:
Swiss Federal Office of Public Health, Bern, Switzerland
Type of method:
flask method
Key result
Water solubility:
453 mg/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
ca. 7.1

The R² fit of the calibration curve used was 0.9993. This reflects the linearity of the analytical system within the calibration range of 30.0 to 120 mg test item /L. The calibration was verified by a 2nd weighing of the test item and dilution of this stock solution into the calibration curve at levels of 41.7, 62.5 and 104 mg/L. Analysis of these quality control solutions and evaluation against the calibration curve yielded recoveries of 104%, 102% and 102% compared to the nominal values. These data show the correct preparation of the calibration standards.

 

The following table summarizes the results of the water solubility test. The tabulated values represent rounded results, obtained by calculation using the exact raw data.

 

Sample No.

Shaking time at 30 °C

Determined concentration

Water Solubility Mean Value

Overall Mean ± Std. Dev.

Rel. Std. Dev.

 

[hours]

[mg/L]

[mg/L]

[mg/L]

[%]

72-7

72

440

447

453 ± 6

1

72-8

72

453

48-7

48

452

453

48-8

48

454

24-7

24

459

460

24-8

24

460

 

According to the test guideline, the results for three assays should not differ by more than 15% for three assays. The acceptance criterium was fulfilled. Thus, the study is valid.

 

The test item showed to be stable during the performance of the test.

 

A mean pH value of 7.1 was measured for the used solutions.

 

The water solubility of the test substance was found to be 453 ± 6 mg/L.

Conclusions:
A water solubility value of 453 ± 6 mg/L (at 20 °C, pH ca. 7.1) was determined for the test substance according to OECD 105.

Description of key information

Water solubility: 453 ± 6 mg/L at 20 °C, pH ca. 7.1 (OECD Guideline 106, flask method)

Key value for chemical safety assessment

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

Additional information