Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov 8, 2007 - Dec 13, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an internationally recognised method, and under GLP. No deviation was reported. The substance is adequately characterised. Therefore full validation applies.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2007
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
See Annex 6 of the full report
Type of method:
shake-flask method to: flask method
Partition coefficient type:
octanol-water

Test material

Constituent 1
Reference substance name:
NOREENAL
IUPAC Name:
NOREENAL
Test material form:
other: Liquid
Details on test material:
colourless translucent liquid.
The batch number was reported as 862036
It was stored at room temperature protected from direct sun light.

Study design

Analytical method:
gas chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
ca. 3.87
Temp.:
20 °C
Remarks on result:
other: Mean Log Pow and observed interval = 3.87 [3.78 – 3.99]. The six LogPow values fell within a range of ± 0.3 units.
Details on results:
40 mL of pre-saturated water and 4 mL of pre-saturated n-octanol were mixed with 0.4 mL of a 10 g/L stock solution. The tubes were continuously rotated for 15 min and then centrifuged for 10 min at 3500 tr/min and 20°C.
The test was reproduced using half and twice, respectively, the above volume ratio.

Mean Log Pow and observed interval = 3.87 [3.78 – 3.99]
The validity criteria were fulfilled: The six LogPow values fell within a range of ± 0.3 units.

Any other information on results incl. tables

n-octanol:water

Ratio 1:10

Ratio 2:10

Ratio 1:20

Replicate tube

1

2

1

2

1

2

Volumes

n-octanol

4.0 mL

4.0 mL

8.0 mL

8.0 mL

2.0 mL

2.0 mL

 

Water

40.0 mL

40.0 mL

40.0 mL

40.0 mL

40.0 mL

40.0 mL

 

Stock solution

0.4 mL

0.4 mL

0.8 mL

0.8 mL

0.2 mL

0.2 mL

Nominal added amounts mg

3.91

3.91

7.82

7.82

1.96

1.96

Measured

Dilution

200

200

200

200

200

200

concentrations in the

Area

113337

112052

111379

108295

110894

112669

n-octanol phase

mg/L(1)

895.95

885.31

879.74

854.25

875.73

890.42

Measured

Dilution

0.4

0.4

0.4

0.4

0.4

0.4

concentrations in the

Area

7278

6602

7797

10018

9356

9990

water phase

mg/L(1)

0.10

0.09

0.11

0.14

0.13

0.14

Measured

In n-octanol

3.942

3.895

7.742

7.517

1.927

1.959

Amounts (mg)

In water

0.004

0.004

0.004

0.006

0.005

0.006

 

Total

3.946

3.899

7.746

7.523

1.932

1.965

 

% nominal value

100.9

99.7

99.0

96.2

98.8

100.5

Calculated Log Pow

 

3.95

3.99

3.91

3.78

3.82

3.80

Applicant's summary and conclusion

Conclusions:
Mean Log Pow and observed interval = 3.87 [3.78 – 3.99]
Executive summary:

 

Phytosafe study number

07-42-050-ES

Title

GLP analysis of NOREENAL: octanol/water partition

Test item

NOREENAL

Code A45756, batch n°862036

Test dates

Initiation : November 8, 2007

Completion : December 13, 2007

 

Results

 

Partition coefficient

Shake flask method

(EEC A8)

n-octanol:watervolume ratio              Log Pow = 3.95 and 3.99

n-octanol:watervolume ratio              Log Pow = 3.91 and 3.78

n-octanol:watervolume ratio              Log Pow = 3.82 and 3.80

Measured partition coefficient and observed interval

NOREENAL                                                     Log Pow = 3.87 [3.78-3.99]

Validity criteria were fulfilled: The six LogPow values fell within a range of ± 0.3 units.