Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10Oct1998 to 09Dec1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
See individual study reports for purity information and CofA where applicable
Specific details on test material used for the study:
Batch: CGF-F020088/0010
Purity: 98%
Appearance: Solid
Expiration date: April 14, 2000
Storage: At room temperature at about 20 °C

Results and discussion

Water solubility
Key result
Water solubility:
ca. 27.5 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
248 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
ca. 7

Applicant's summary and conclusion

Conclusions:
The saturation concentration of the test item at room temperature was estimated by a simplified flask method in the preliminary test to be higher than 10-2 g/1. Therefore the flask shaking method was used in the main test.

In the main test the concentrations determined after 24 hours, 48 hours and 72 hours differ by less than 15 %. Therefore the study is considered to be valid.

In conclusion, the water solubility of the test item at 20 °C ± 1.0 °C was determined to be 27.5 g/L (standard deviation 0.83 %).
Executive summary:

The saturation concentration of the test item at room temperature was estimated by a simplified flask method in the preliminary test to be higher than 10-2g/1. Therefore the flask shaking method was used in the main test.

 

In the main test the concentrations determined after 24 hours, 48 hours and 72 hours differ by less than 15 %. Therefore the study is considered to be valid.

 

In conclusion, the water solubility of the test item at 20 °C ± 1.0 °C was determined to be 27.5 g/L (standard deviation 0.83 %).