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: EU guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2003-02-13
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
description: off-white powder
batch number: 0214400005
received: 13 October 2003
storage conditions: approximately 4°C in the dark

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficientopen allclose all
Type:
log Pow
Partition coefficient:
ca. 3.3
pH:
ca. 2
Remarks on result:
other: HPLC method
Type:
log Pow
Partition coefficient:
ca. -0.04
pH:
ca. 7
Remarks on result:
other: calculated

Applicant's summary and conclusion

Conclusions:
The partition coefficient of the test material has been determined to be 2.14/10^3, log 10 Pow 3.33at pH2, log10 Pow -0.04, calculated at pH 7.
Executive summary:

Partition coefficient.

2.14*10^3, log Pow 3.33 at pH 2, using the HPLC method, Method A8 od Comission Directive 92/69/EEC, log10 Pow -0.04, calculated at pH 7.