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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:
Sep - Oct 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes
Type of method:
column elution method
Key result
Water solubility:
10.7 mg/L
Conc. based on:
test mat. (dissolved fraction)
Temp.:
20 °C
pH:
3.8
Details on results:
The saturation concentration of CGP 48933 Step 9 was determined to be 11.3 mg/I± 0.6 mg/I standard deviation in the first experiment and 10.2 mg/I± 0.3 mg/I standard deviation in the second experiment.
The relativ standard... deviation of each 7 consecutive samples was calculated to be 3 - 5 % during the experiments. 1'he variation between the water solubilities as determined during the low flow rate (first experiment) and the high flow rate was calculated to be< 10 %. According to the guidelines, the criteria of< 30 % were met and therefore the test was considered to be valid.
The linearity of the analytical method was proved in the concentration range from 1.45 μg/ml to 14.5 μg/ml.

Solvent

Temp (°C)

Resulting pH

Solubility (g/L)

water

25

3.8

0.18

0.2 M NaCl

25

3.8

0.18

0.1 N HCl

22

1.12

0.084

0.01 M glycine buffer, pH = 3

22

3.05

0.104

0.067 M phosphate buffer, pH = 5.2

22

4.41

0.64

0.067 M phosphate buffer, pH = 6.0

22

4.90

2.82

0.067 M phosphate buffer, pH = 7.4

22

5.26

14.4

0.067 M phosphate buffer, pH = 8.0

22

5.29

16.8

water

37

3.8

0.21

0.01 N HCl

37

1.0

0.10

Conclusions:
The water solubility of CGP 48933 Step 9 was determined to be on avarage 10.7 mg/I at 20.0 °C ± 0.5 °C using the column elution method.

Description of key information

The water solubility of CGP 48933 Step 9 was determined to be on avarage 10.7 mg/L at 20.0 °C ± 0.5 °C using the column elution method.

Key value for chemical safety assessment

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

Additional information