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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:
15 September 2010 - 25 September 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, conducted to current guidelines.
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method
Key result
Water solubility:
< 0.02 mg/L
Temp.:
20 °C
pH:
7.45
Remarks on result:
other: Average pH.
Details on results:
Concentrations of the calibration samples were 0.1, 0.2, 0.5, 2, 5, 10, 20 and 50 µg/ml. The calibration graph was calculated applying linear regression.
The Kronitex TXP concentrations were calculated with the help of the calibration equations given in Table 2, below.

Analysis of the samples gave measured concentrations of Kronitex TXP on the two parallel columns using two different flow rates as detailed in Table 3 below.

Table 2. Regression data

Analytical occasion

Constant

X Coefficient

R. Squared

16 September 2010

1414

26814

1.000

17 September 2010

189

28093

1.000

20 September 2010

799

26869

1.000

21 September 2010

915

27519

1.000

24 September 2010

-350

27747

1.000

25 September 2010

294

27679

1.000

 

Table 3. Results of the determination ofKronitex TXPconcentrations

Analytical occasion / Time Period

Flow rate (ml / hour)

Measured concentration ofKronitex TXP(mg/l)

Column 1.

Column 2.

16 September 2010 / 18 hours

~ 25

*

pH = 7.39

*

pH = 7.61

16 September 2010 / 26 hours

0.010*

pH = 7.46

0.005*

pH = 7.52

17 September 2010 / 42 hours

0.015*

pH = 7.47

0.016*

pH = 7.58

20 September 2010 / 114 hours

0.017*

pH = 7.43

0.002*

pH = 7.50

20 September 2010 / 119 hours

0.015*

pH = 7.45

0.010

pH = 7.48

21 September 2010 / 17 hours

~ 12.5

0.012*

pH = 7.37

0.003*

pH = 7.44

21 September 2010 / 25 hours

0.004*

pH = 7.39

0.003*

pH = 7.44

23 September 2010 / 73 hours

0.019*

pH = 7.39

*

pH = 7.44

24 September 2010 / 89 hours

0.020*

pH = 7.42

0.012*

pH = 7.48

25 September 2010 / 113 hours

0.015*

pH = 7.41

0.005*

pH = 7.48

* below the quantitation limit

Conclusions:
Interpretation of results: insoluble (< 0.1 mg/L)
Most of the measured values are below the quantitation limit; therefore calculation of the mean value is not feasible.
Considering the tenfold concentration of the samples before the analysis, the above results correspond to a water solubility of less than 2x10-5 g/l at 20 °C ± 1°C applying the column elution method.
Executive summary:

Considering the tenfold concentration of the samples before the analysis, the above results correspond to a water solubility of less than 2x10-5g/lat 20 °C ± 1°C applying the column elution method. The substance is considered as insoluble in water.

Description of key information

Water solubility

Key value for chemical safety assessment

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

Additional information

A single GLP compliant gives the water solubility as <0.02 mg/l at 20 °C