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: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch: Huc-Sa-9370-163

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
> 5.7
Temp.:
20 °C
pH:
7

Applicant's summary and conclusion

Conclusions:
The test item Sa 163 elutes after 6.2 minutes, the reference item triphenylamine after 3.5 minutes.
Due to the principle of the HPLC method, reference items will elute the later, the higher the log Pow value is. In conclusion, the test item
exhibits a log POW value significantly higher than the reference item.
The reference item triphenylamine is listed in the EU test procedure with the second highest log Pow value (5.7). Furthermore, the test
procedure is only applicable within log Pow values from - 2 to +6.
Thus, based on the preliminary tests, the following result can be reported:
Log Pow(Sa 163) > 5.7