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Physical & Chemical properties

Water solubility

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Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 11 feb 2010 to 25 may 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study and conducted according to standardised guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
Specimen quantification of the batch C. As the flask 10-024 C1 was broken during the centrifugation, only one weighing (10-024 C2) was taken instead of two
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Water solubility:
9.31 g/L
Temp.:
20 °C
pH:
6.7
Details on results:
Preliminary test
Through the serial volume addition of water to the test item, it was shown that the water solubility of the test item was estimated between 1 and 10 g/L at 20°C.
Therefore the flask method was chosen to determine the hydrosolubility.

Main test

 The following concentrations were obtained in the solutions prepared for the hydrosolubility determination.

 

Test solution

Guetol mean concentration

(g/L)

After 24 h

B1 (pH = 6.47)*

B2 (pH = 6.48)*

 

9.32

After 48 h

C2 (pH = 6.82)*

 

9.17

After 72 h

D1 (pH = 6.89)*

D2 (pH = 6.86)*

 

9.44

*The pH of the solutions was taken after centrifugation.

 

Mean value of the concentrations:         9.31g/L

 

Relative Standard Deviation (RSD):        1.45%

 

           As the RSD is lower than 15%, the result is acceptable.

 

Conclusions:
Soluble (1000-10000 mg/L)
As the Relative Standard Deviation (RSD) of 1.45% is lower than 15%, highest deviation accepted in the EC A6 method, the result can be considered as valid.
The solubility of GUETOL in water is equal to 9.31 g/L (RSD = 1.45%) at 20°C and pH 6.70.
Executive summary:

In a study (Defitraces, 2010), the solubility of the test item Guetol was determined according to the OECD 105 guideline, using the shake flask method.

After determination of the regression curve obtained with the test item, the concentration of GUETOL in the samples issued from the EC A6 method test are experimentally defined.

The solubility of GUETOL in water is equal to 9.31 g/L (RSD = 1.45%) at 20°C and pH 6.70.

Description of key information

The water solubility of Guetol was 9.31 g/L at 20°C and pH 6.70 according to OECD 105 study using shake flask method.

Key value for chemical safety assessment

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

Additional information

Only one study was available (Defitraces, 2010) and was selected as key study with reliability 1 (OECD 105 guideline and GLP).