Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-25 - 2008-07-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The GLP study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
< 0
Temp.:
20 °C
pH:
7

Applicant's summary and conclusion

Conclusions:
The partition coefficient of the test substance (Weikoform) was determined. The procedure was performed according to EU Method A.8, Partition coefficient, Directive 92/69/EEC, published in OJ No L 383 A, 1992. With respect to the character of the test substance (a mixture of compounds) and to the results of QSAR estimations of Log Pow of main components it was concluded that the partition coefficient of Weikoform could be evaluated only by means of a calculation method. The partition coefficients of all main components of the test substance were calculated. For the confirmation of calculated values of the partition coefficients, an HPLC experiment was performed, the results of which were in accordance with calculation (except for Methenamin, where HPLC method is still inapplicable).
Executive summary:

The partition coefficient of the test substance (Weikoform) was determined. The procedure was performed according to EU Method A.8, Partition coefficient, Directive 92/69/EEC, published in OJ No L 383 A, 1992. With respect to the character of the test substance (a mixture of compounds) and to the results of QSAR estimations of Log Pow of main components it was concluded that the partition coefficient of Weikoform could be evaluated only by means of a calculation method. The partition coefficients of all main components of the test substance were calculated. For the confirmation of calculated values of the partition coefficients, an HPLC experiment was performed, the results of which were in accordance with calculation (except for Methenamin, where HPLC method is still inapplicable).