Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient - HPLC Method)
GLP compliance:
yes
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Specific details on test material used for the study:
Batch number: 2016110462

Study design

Analytical method:
high-performance liquid chromatography
photometric method

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
1.64
Temp.:
22 °C
pH:
5.7

Any other information on results incl. tables

Results

 

Note. Data in the tables are rounded values taken from Excel spreadsheets which will be archived together with the raw data. The use of Excel spreadsheets for calculations produces more accurate endpoints. These endpoints may slightly differ from the values derived by replacing the rounded values in the formula given in the methods section.

The sentence “warning Chromatogram has been subjected to data manipulation” reported on chromatograms, is due to the conversion applied to the original file in order to obtain a format readable by Chrom-Card, software used to reprocess chromatograms generated from the different instruments.

 

The reference substance solutions and the test item solution were injected in duplicate.

 

Because the retention time of the test item under examination is in the range of the reference substances retention time, thePow value could be calculated by the linear regression analysis performed using the least squares method.

Table9 Partition Coefficient (n-octanol/water):
calculation of theP
ow value for the test item

 

Linear calibration curve parameters

Parameterm

(slope)

Parameterq

(intercept)

ParameterR2

(correlation)

2.999

3.075

0.95921

Test item

tr Mean(min)

k’

log k’

3.6

0.331

-0.4795

logPow

1.64

Pow

43.32

Applicant's summary and conclusion

Conclusions:
Partition Coefficient (n-octanol/water) of the substance is (log Pow) 1.64.