Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conducted between 26 May 2015 and 25 September 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

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 (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

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
> 6.5
Temp.:
30 °C
pH:
ca. 1.9

Any other information on results incl. tables

Preliminary Estimate

Estimated log10Pow: 6.00

Main Test

Partition coefficient of the sample

The retention times, capacity factor and log Powvalue determined for the sample are shown in the following table:

 

Injection

Retention Time (min)

Capacity Factor (k')

Log10k'

Log10Pow

1

40.975

24.4

1.39

>6.5

2

40.975

24.4

1.39

>6.5

 

Overall log10Pow:      >6.5

Partition coefficient: >3.16 x 106

Applicant's summary and conclusion

Conclusions:
The partition coefficient of the test item as logPow has been determined to be greater than greater than 6.5.
Executive summary:

The partition coefficient of the test item has been determined to be greater than 3.16 x 106,
log10Powgreater than 6.5.