Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
GLP compliance:
no
Type of method:
flask 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
Key result
Type:
log Pow
Partition coefficient:
2.312
Temp.:
22.5 °C
Remarks on result:
other: pH of aqueous phase adjusted to 2.28 (pH of stock solution = 5.31); mean value of 8 samples tested

Applicant's summary and conclusion

Conclusions:
logPow = 2.31 (at 22.5 °C)
Executive summary:

The partition coefficient of the test material was determined in a non-GLP test according to EU Method A.8, whereby the concentration of the test material in the sample solutions was determined by high performance liquid chromatography (HPLC). Eight different samples were tested. The overall Pow of the test material was determinded to be 261.23 at a temperature of 22.5 °C (pH of aqueous phase adjusted to 2.28, pH of stock solution was 5.31), resulting in a mean logPow of 2.3121.