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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study based on OECD Guidelines for Testing of Chemicals, Guideline No. 105, ’’Water Solubility”; adopted July, 1995 and EEC directive 92/69, Annex V, A6 “Water Solubility”, 1992

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
A suitable weighed amount of test item (0.1 to 0.5 g) will be dissolved in a suitable solvent, acetone preferably. Instead 50.4 mg of the test item were dissolved in 50 mL acetone. The amount is sufficient to saturate water at concentration >10mg/L.
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2-Ethylbutyl)cyclohexanecarbonitrile
EC Number:
619-573-9
Cas Number:
855425-38-6
Molecular formula:
C13H23N
IUPAC Name:
1-(2-Ethylbutyl)cyclohexanecarbonitrile
Details on test material:
Name: CAT-Nitril
Certificate of Analysis Date: June 27,2008
Aggregate State at Room
Temperature: Liquid
Colour: Colourless - light brown
Expiry Date: September 2009
Storage: In original container, at room temperature (10 degree C to 30 degree C), in the
dark

Results and discussion

Water solubility
Water solubility:
ca. 0.05 mg/L
Temp.:
20 °C

Any other information on results incl. tables

Method:

The water solubility of the test item was estimated using the column

elution method. The saturation mass concentration of the test item

wasdetermined using a GC method.

 

Result of the Main Test:

The saturation concentration of the test item was estimated using

GC method. The linearity of the analytical method was proved in the

concentration range from 0.01 to 0.1 mg test item / l. The mean

recovery rate of samples fortified at 0.05 mg / L was 64 %.

The regression coefficient was determined to be 0.9994.

The solubility was measured to be below the lowest

calibration concentration of 0.01 mg/L. Considering a mean

recovery rate of 64 % the solubility of the test item can be given to

be below 0.05 mg/L.

The recovery rate in the fortified samples was64% of the nominal

value. Even considering the determined recovery rate, the

concentration of the test item in water can be given to be lower than

0.05 mg/L.

 

Corresponding to the analysis the water solubility of the test item at

20 +/- 1 degree C was determined to be below 0.05 mg/L.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of the test item at 20 +/- 1 degree C was determined to be below 0.05 mglL.
Executive summary:

Title:

Determination of the Water Solubility of CAT-Nitril,

 

Guidelines/ Recommendations:

-OECD Guidelines for Testing of Chemicals, Guideline No. 105, “Water Solubility”; adopted July 27, 1995

-EEC directive 92/69, Annex V, Part A, Methods for the

determination of physico-chemicals properties, A6 “Water

Solubility”, 1992

 

Purpose:

The purpose of the study was to estimate the solubility of the test

item in water which is specified by the saturation mass

concentration of the test item in water at a specified temperature.

 

Results:

The water solubility of the test item was estimated to be smaller

than 0.01 g/L in a preliminary test (non-GLP). Therefore, the

column elution method was used in the main test.

The water solubility of the test item CAT-Nitril, was

determined to be < 0.05 mg/L using the column elution method for

the performance of the main test.