Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 15, 2010 - December 21, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
maximum difference between the 24, 48 and 72 hours stirred samples was 17% due to a slightly higher result for the 24 hours stirred sample; this result however was considered to be within the spread of the analytical method
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
maximum difference between the 24, 48 and 72 hours stirred samples was 17% due to a slightly higher result for the 24 hours stirred sample; this result however was considered to be within the spread of the analytical method
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2-ethylbutyl)cyclohexane-1-carboxylic acid
EC Number:
619-508-4
Cas Number:
381209-09-2
Molecular formula:
C13 H24 O2
IUPAC Name:
1-(2-ethylbutyl)cyclohexane-1-carboxylic acid
Details on test material:
- Name of test material (as cited in study report): CAT-Acid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark

Results and discussion

Water solubility
Water solubility:
11.1 mg/L
Temp.:
20 °C
pH:
>= 4.8 - <= 4.9
Details on results:
- Preliminary test: the content of test substance dissolved in the water sample was 12 mg/L
- No test substance was detected in the pretreated samples from the blank water mixture
- Maximum difference between the 48 and 72 hours stirred samples was 10%
- Maximum difference between the 24, 48 and 72 hours stirred samples was 17% due to a slightly higher result for the 24 hours stirred sample. This result however was considered to be within the spread of the analytical method and not to be due to not having reached equilibrium. Based on this, it was decided to calculate water solubility as the average of all three values.

Any other information on results incl. tables

Stirring time (hrs)

Analysed concentration (mg/L)

Mean (mg/L)

Maximum Difference (%)

 pH

24

12.0

11.1

17

4.9

48

10.1

4.8

72

11.2

4.9

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The flask method was applied for the determination of the water solubility of the substance. The water solubility of the test substance at 20°C was 11.1 mg/L. The pH of the aqueous samples was 4.8 – 4.9.