Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to the recommended guidelines and GLP, and without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
GLP compliance:
yes (incl. certificate)
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
>= 4.4 - <= 4.6
Temp.:
22 °C
pH:
7

Applicant's summary and conclusion

Conclusions:
The Pow and log Pow values of the test substance are at neutral pH:
Pow: 2.8 -4.1 x 104 - Log Pow: 4.4 - 4.6

Impurities with a peak area percentage of > 1% of the total peak area were not observed.

There were no deviations from the guideline; validity criteria have been fulfilled.