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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:
From June 11, 1999 to December 14, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of method:
flask method
Water solubility:
35.5 g/L
Conc. based on:
act. ingr.
Temp.:
20 °C
pH:
>= 5.5 - <= 5.6
Details on results:
Water solubility of the test substance at a temperature of 20 °C (corrected for the purity of 51 % (w/w)): 35.5 g/L

Table 1. Water solubility of the test substance

Experiment

1

2

3

4

Amount of test substance (g)

26.0763

23.4368

23.4461

23.8622

Stirring time at 20 °C

4

4

4

4

pH at room temperature

5.5

5.6

5.5

5.5

Water solubility (g/L)

59.87

74.29

73.25

71.28

Average (experiments 1 to 4): 69.67 g/L

Standard deviation: 6.65 g/L

Relative standard deviation: 9.5 %

Conclusions:
Under the test conditions, the water solubility of the test substance was determined to be 35.5 g a.i./L at 20 °C
Executive summary:

A study was performed to determine the water solubility of test substance according to EU Method A.6.in compliance with GLP.

 

In the preliminary visual experiments the test substance showed the water solubility is between ca. 200 and 1000 g/L. Therefore the water solubility had to be determined by the "flask method".

 

Four weighed amounts of the test substance were added in portions to 50 mL distilled water and stirred at 20 °C for 4 h. Aliquots of the saturated aqueous phase were taken, centrifugatad (15 min, 5000 rpm) and filtered (Schleicher + Schull, 0.45 µm). One mL aliquot of the centrifugate was diluted with water and filled up to a volume of 100 mL. 1 mL of this solution was further diluted with water to a volume of 10 mL. The concentration of the test substance was determined by HPLC.

 

Under the test conditions, the water solubility of the test substance was determined to be 35.5 g/L at 20 °C

Description of key information

The water solubility of the test substance was determined to be 35.5 g/L at 20 °C

Key value for chemical safety assessment

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

Additional information

A study was performed to determine the water solubility of test substance according to EU Method A.6.

 

In the preliminary visual experiments the test substance showed the water solubility is between ca. 200 and 1000 g/L. Therefore the water solubility had to be determined by the "flask method".

 

Four weighed amounts of the test substance were added in portions to 50 mL distilled water and stirred at 20 °C for 4 h. Aliquots of the saturated aqueous phase were taken, centrifugatad (15 min, 5000 rpm) and filtered (Schleicher + Schull, 0.45 µm). One mL aliquot of the centrifugate was diluted with water and filled up to a volume of 100 mL. 1 mL of this solution was further diluted with water to a volume of 10 mL. The concentration of the test substance was determined by HPLC.

The water solubility of the test substance was determined to be 35.5 g/L at 20 °C (Mühlberger B, 1999)