Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 November 2010 - 4 November 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
HPLC 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
Type:
log Pow
Partition coefficient:
> 6.5
Temp.:
25 °C
Remarks on result:
other: Test pH not reported.
Details on results:
Test pH not reported.

The accurate log Pow for the test material could not be calculated, because the measured retention times are out of the calibrated range.
The extrapolated values were calculated for 6 components of the test material.

Retention times measured for the test material (51 - 135 min) are significantly higher than that of the last eluting standard, DDT (6.2 min). This result shows that log Pow of the test material is significantly higher than the calibrated range. Therefore extrapolated values were determined. Since the test material is a mixture of homologues, the weighted average log Pow was calculated for the five main components, which contribute a peak area of 5 % or more.

Any other information on results incl. tables

Table 1: Measured and calulated data of the components of the test iem above 5%.

Constituent

Retention time

(min)

log k’

Log POW

Calculated

Extrapolated

Component 2

(area %: 8.6)

49.63

1.559

14.25

50.37

1.566

14.30

51.79

1.578

14.40

52.20

1.581

14.42

50.64

1.568

14.32

50.19

1.564

14.29

Mean

50.80

1.569

14.3

CV %

2

-

-

Component 3

(area %: 19.2)

63.61

1.669

15.09

64.67

1.677

15.15

66.61

1.690

15.25

67.21

1.694

15.28

64.96

1.679

15.16

64.29

1.674

15.13

Mean

64.23

1.680

15.2

CV %

2

-

-

Component 4

(area %: 28.5)

81.25

1.778

15.91

82.77

1.786

15.98

85.36

1.799

16.08

86.03

1.803

16.11

82.99

1.787

15.99

82.16

1.783

15.95

Mean

83.43

1.789

16.0

CV %

2

-

-

Component 5

(area %: 26.5)

103.47

1.884

16.72

105.28

1.892

16.78

109.04

1.907

16.90

110.21

1.912

16.94

105.52

1.893

16.79

104.32

1.888

16.75

Mean

106.31

1.896

16.8

CV %

3

-

-

Component 6

(area %: 14.1)

131.65

1.990

17.53

134.45

1.999

17.60

138.77

2.013

17.70

140.45

2.018

17.74

133.63

1.997

17.58

132.75

1.994

17.56

Mean

135.28

2.002

17.6

CV %

3

-

-

Weighted average of the extrapolated log POWvalues             16

Applicant's summary and conclusion

Conclusions:
The estimated log Pow of the test material is higher than 6.5.
The weighted average of the extrapolated log Pow values of the five main components is 16.
Executive summary:

In a partition coefficient study (10/095-346AN), the log partition coefficient (log Pow) was estimated to be greater than 6.5 according to EU Test method A.8.