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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:
19 March 2016 - 27 May 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
The study plan indicated that the water solubility main test sample vessels would be incubated (at approximately 30 °C) for 24 hours, 48 hours and 72 hours, respectively; whereas, the vessels were incubated (at approximately 30 °C) for 25 hours, 48 hours and 72 hours, respectively.
Deviations:
yes
Remarks:
The impact of this issue on the results of the water solubility test and, therefore, the validity of the study was considered to be negligible.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
The study plan indicated that the water solubility main test sample vessels would be incubated (at approximately 30 °C) for 24 hours, 48 hours and 72 hours, respectively; whereas, the vessels were incubated (at approximately 30 °C) for 25 hours, 48 hours and 72 hours, respectively.
Deviations:
no
Remarks:
The impact of this issue on the results of the water solubility test and, therefore, the validity of the study was considered to be negligible.
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
Appearance/Physical state: Brown liquid
Lot: 15B26 Purity: 81.7%
Expiry date: 01 August 2016
Storage conditions: Room temperature, in the dark, under nitrogen
Key result
Water solubility:
>= 27.2 - <= 27.6 g/L
Conc. based on:
test mat.
Incubation duration:
>= 25 - <= 72 h
Temp.:
20 °C
pH:
>= 12.9 - <= 13.1
Details on results:
See Table 2.
Mean concentration : 27.4 g/L at 20.0 ± 0.5 ºC
Range : 27.2 to 27.6 g/L
Standard Deviation : 0.175 g/L
All individual water solubility results were within ± 15% of the mean, thus satisfying the criteria specified in the guidelines.

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 250 to 2.0 x 103 mg/L. The results were satisfactory with a correlation coefficient (r) of 1.000 being obtained.

Table 2: Results

 

Samplenumber

Timeshakenat

~30ºC(hours)

Timeequilibratedat20ºC(hours)

Concentration(g/L)

 

SolutionpH

1

25

24

27.2

13.0

2

48

24

27.6

12.9

3

72

24

27.4

13.1

Conclusions:
The water solubility of the test item has been determined to be 27.4 g/L of solution at 20.0 ± 0.5 °C.

Description of key information

The water solubility of the test item has been determined to be 27.4 g/L of solution at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

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

Additional information

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