Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-09-21 - 2017-12-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Version / remarks:
OECD Guideline for Testing of Chemicals, Guideline No.117: ”Partition coefficient (n-octanol/water), High Performance Liquid Chromatography (HPLC) method”, adopted April 13, 2004
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient - HPLC Method)
Version / remarks:
Commission Regulation (EC) No.440/2008, Annex, Part A, Methods for the determination of physico-chemical properties, A.8 ”Partition coefficient”, 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7570 (Partition Coefficient, n-octanol / H2O, Estimation by Liquid Chromatography)
Version / remarks:
Product Properties Test Guideline of the United States Environment Protection Agency (EPA), OPPTS 830.7570, Partition Coefficient (n-Octanol/Water), Estimation By Liquid Chromatography, August 1996
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:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: sponsor

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At 20 °C ± 5 °C, in the dark

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
>= 5.7 - <= 5.8
Temp.:
25 °C
Remarks on result:
other: pH not determined

Applicant's summary and conclusion

Conclusions:
The logPow was determined acc. OECD TG 117 under GLP. The HPLC method was chosen based on initial estimates and considered . Hence, the results can be considered to be reliable. Two main signals were identified as test item. The logarithmic partition coefficient (n-octanol/water) of the test item was calculated at each signal. The results were determined to be log Pow between 5.7 and 5.8 using the HPLC method.
Executive summary:

The determination of the Partition Coefficient (n-Octanol/Water) of the test item was performed according to OECD 117 under GLP by High Performance Liquid Chromatography (HPLC). The partition coefficient was determined based on a calibration curve using 8 reference items. The test item showed three clear signals. To confirm the signals were related on the test item the intensity was compared at different wavelengths. Two main signals were identified as test item. The logarithmic partition coefficient (n-octanol/water) of the test item was calculated at each signal. The results were determined to be log Pow between 5.7 and 5.8 using the HPLC method.