Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Oct. 2010 to Nov. 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to standard guidelines and in compliance with GLP.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 12-hydroxystearic acid (CAS N° 106-14-9, EC N° 203-366-1)
- Physical state: Solid / white-yellowish
- Expiration date of the lot/batch: 09 April 2011
- Storage condition of test material: In original container, at room temperature (15 - 25°C), in the dark

Results and discussion

Water solubility
Water solubility:
0.976 mg/L
Temp.:
20 °C

Any other information on results incl. tables

Method:

The water solubility of the test item was determined using the column elution method. The saturation mass concentration of the test itemwas determined using a LC-MS/MS-method.

Result of the Preliminary Test (non-GLP):


The water solubility of the test item was estimated to be below 10 mg/L.

Result of the Main Test:

The saturation concentration of the test item was determined using LC-MS/MS method.

The linearity of the analytical method was proved in the concentration range from 0.05 to 1 mg test item/L. The regression coefficient (r²) was determined to be at least 0.9995.

Corresponding to the analysis the water solubility of the test item at 20 ± 1 °C was determined to be 0.976 mg/L.

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
Under the coditions of the study, the water solubility of the test material was 0.976 mg/L at 20 +/- 1°C.
Executive summary:

A study was conducted to determine the water solubility of 12 -hydroxystearic acid according to OECD Guideline 105.

Based on the results of a preliminary test, the column elution method was used.

Under the coditions of the study, the water solubility of the test material was 0.976 mg/L at 20 +/- 1°C.