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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:
19 March 2011 to 14 April 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method
Key result
Water solubility:
< 0.01 mg/L
Conc. based on:
test mat.
Incubation duration:
>= 64 - <= 114 h
Temp.:
20 °C
pH:
>= 7.01 - <= 7.25
Details on results:
CALIBRATION
- Concentrations of the calibration samples were 0.1, 0.2, 0.5, 2, 5, 10 and 20 μg/mL. The calibration graph was calculated applying weighted linear regression using 1/concentration as weighting factor.

ANALYSIS OF THE TEST MATERIAL SAMPLES
- Measured concentrations of the test material on the two parallel columns using two different flow rates were recorded.
- Most of the measured values were below the quantitation limit; therefore calculation of the mean value is not feasible.
- Based on the measured data water solubility of the test material was considered to be less than 0.01 μg/mL (corresponds to the quantitation limit of the analytical method corrected with the tenfold concentration factor) at 20 ± 1°C.

Table 1: Results of the determination of the test material concentrations

Analytical occasion/ Time period (hours)

Flow rate (mL/hour)

Measured concentration of the test material (mg/L)

Concentration

pH

Concentration

pH

11 April 2011 / 64

~25

*

7.07

*

7.01

11 April 2011 / 72

*

7.10

*

7.10

12 April 2011 / 88

*

7.12

*

7.15

12 April 2011 / 96

*

7.09

*

7.11

13 April 2011 / 112

*

7.13

*

7.09

28 March 2011 / 66

~12.5

*

7.18

*

7.22

28 March 2011 / 74

*

7.21

*

7.23

29 March 2011 / 90

*

7.18

*

7.23

29 March 2011 / 98

*

7.25

*

7.21

30 March 2011 / 114

*

7.22

*

7.20

* below the quantitation limit

Conclusions:
Under the conditions of this study, the water solubility of the test material was considered to be less than 0.01 μg/mL (corresponds to the quantitation limit of the analytical method corrected with the tenfold concentration factor) at 20 ± 1°C.
Executive summary:

The water solubility of the test material was investigated in accordance with the standardised guidelines OECD 105 and EU Method A.6, under GLP conditions.

The column elution method was applied and samples were analysed with high performance liquid chromatography (HPLC). Two parallel tests were performed.

Measured concentrations of the test material on the two parallel columns using two different flow rates were recorded. Most of the measured values were below the quantitation limit; therefore calculation of the mean value was not feasible.

Under the conditions of this study, the water solubility of the test material is considered to be less than 0.01 μg/mL (corresponds to the quantitation limit of the analytical method corrected with the tenfold concentration factor) at 20 ± 1°C.

Description of key information

Under the conditions of the study, the water solubility of the test material was considered to be less than 0.01 μg/mL (corresponds to the quantitation limit of the analytical method corrected with the tenfold concentration factor) at 20 ± 1°C.

Key value for chemical safety assessment

Additional information

The water solubility of the test material was investigated in accordance with the standardised guidelines OECD 105 and EU Method A.6, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The column elution method was applied and samples were analysed with high performance liquid chromatography (HPLC). Two parallel tests were performed.

Measured concentrations of the test material on the two parallel columns using two different flow rates were recorded. Most of the measured values were below the quantitation limit; therefore calculation of the mean value was not feasible.

Under the conditions of the study, the water solubility of the test material was considered to be less than 0.01 μg/mL (corresponds to the quantitation limit of the analytical method corrected with the tenfold concentration factor) at 20 ± 1°C.