Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2017-12-05 to 2017-12-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Version / remarks:
2004
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient - HPLC Method)
Version / remarks:
2008
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:
solid: particulate/powder
Details on test material:
- Appearance: solid yellow powder

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
2.91
Temp.:
20 °C
Remarks on result:
other: Mean of two independent runs
Details on results:
The two measurements made under identical conditions and using the same set of reference items fall within a range of ±0.1 log units. The requirements of OECD guideline 117 concerning the quality criteria are fulfilled.

Any other information on results incl. tables

Retention time and log Pow of test item (mean of two runs):

 

Mean retention

time

[min]

Mean retention time of two runs [min]

Absolute deviation [min]

Mean log Pow

Mean log Pow of two runs

Absolute deviation of log Pow

1st run

10.381

10.39

0.01

2.90

2.91

0.01

2nd run

10.391

2.91

Applicant's summary and conclusion

Conclusions:
The log Pow of test item at 20 °C was determined to be 2.91.
Executive summary:

The aim of this study was the determination of the n-octanol/water partition coefficient of test item by high performance liquid chromatography (HPLC) method according to EC method A.8 and OECD guideline 117.

The analysis was performed on an analytical column packed with a solid phase containing long hydrocarbon chains chemically bound onto silica (Luna 5µ C18(2) 100A 250 x 3.0 mm). A mixture of 60 % methanol and 40 % ultrapure water was used as mobile phase and the column temperature was 20°C±1°C.

The log Pow of test item was determined to be 2.91 (mean of two runs).

The two measurements made under identical conditions and using the same set of reference items fall within a range of±0.1 log units. The requirements of OECD guideline 117 concerning the quality criteria are fulfilled.