12-hydroxystearic acid

Water solubility

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

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

Test material information

Constituent 1

Reference substance name:

12-hydroxystearic acid

EC Number:

203-366-1

EC Name:

12-hydroxystearic acid

Cas Number:

106-14-9

Molecular formula:

C18H36O3

IUPAC Name:

12-hydroxyoctadecanoic acid

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.