Registration Dossier

Administrative data

Endpoint:
partition coefficient
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 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7570 (Partition Coefficient, n-octanol / H2O, Estimation by Liquid Chromatography)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes (incl. certificate)
Type of method:
HPLC method
Partition coefficient type:
octanol-water

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)
- Substance type: Fatty acid
- 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

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
5.7

Any other information on results incl. tables

The partition coefficient was calculated based on a calibration curve using 6 regerence items. The difference between the three measurements of the reference mixture was less than the given 0.1 log units. Therefore, the study was considered valid.

Applicant's summary and conclusion

Conclusions:
The logarithmic partition coefficient (n-octanol/water) of the test substance was determined to be 5.7 using the HPLC method.
Executive summary:

A study was conducted to determine the n-octanol/water partition coefficient of 12 -hydroxystearic acid according to OECD Guideline 117 using the HPLC method.

The partition coefficient was calculated based on a calibration curve using 6 reference items.

The logarithmic partition coefficient (n-octanol/water) of the test substance was determined to be 5.7.