Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 January 2012- 19 March 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and EC guidelines and according to the principles of GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- Version / remarks:
- (2004)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
Test material
- Details on test material:
- - Physical state: Clear colourless/slightly yellow, sticky resin
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature protected from light
-Stability at higher temperatures: Maximum 1 month at 50°C
- General information: Avoid heat, direct sunlight, acid and base
Constituent 1
Study design
- Analytical method:
- high-performance liquid chromatography
Results and discussion
Partition coefficientopen allclose all
- Type:
- log Pow
- Partition coefficient:
- 1.4
- Temp.:
- 35 °C
- Remarks on result:
- other: Not buffered. Peak 3 (area of 49%).
- Type:
- log Pow
- Partition coefficient:
- 3.9
- Temp.:
- 35 °C
- Remarks on result:
- other: Not buffered. Peak 7 (area of 30%).
- Type:
- log Pow
- Partition coefficient:
- <= 0.3
- Temp.:
- 35 °C
- Remarks on result:
- other: Not buffered. Peak 1 (area 0.90%)
- Type:
- log Pow
- Partition coefficient:
- >= 0.6 - 6.2
- Temp.:
- 35 °C
- Remarks on result:
- other: Not buffered. Peaks 2 to 13 (included), without peaks 1, 3 and 7. Peak areas ranging from 0.55% to 5.9% (included).
- Details on results:
- In the HPLC chromatogram of the test solution, 13 different peaks were observed. Individual results: see table below. The equation of the regression line was: log k` = 0.305 x log Pow – 0.707 (r = 0.98; n=12). Chromatograms and regression line: see attachment.
Any other information on results incl. tables
Table: Powof the test substance
Substance |
tr,1 |
tr,2 |
mean tr |
log Pow |
Pow |
Area |
|
|
|
|
|
|
|
Formamide (t0) |
1.141 |
1.136 |
1.139 |
|
|
|
|
|
|
|
|
|
|
Ethylmethylketone |
1.352 |
1.351 |
|
0.3 |
|
|
Toluene |
3.029 |
3.020 |
|
2.7 |
|
|
1,4-Dichlorobenzene |
3.919 |
3.905 |
|
3.4 |
|
|
Dibenzyl |
7.878 |
7.813 |
|
4.8 |
|
|
Fluoranthene |
10.930 |
10.799 |
|
5.1 |
|
|
4,4’-DDT |
16.807 |
16.645 |
|
6.5 |
|
|
|
|
|
|
|
|
|
NS203602 Peak1 |
1.398 |
1.397 |
1.398 |
<0.3 |
<2.0 |
0.90 |
NS203602 Peak2 |
1.483 |
1.483 |
1.483 |
0.6 |
4.1 |
2.0 |
NS203602 Peak3 |
1.723 |
1.724 |
1.724 |
1.4 |
2.3 x 101 |
49 |
NS203602 Peak4 |
2.310 |
2.316 |
2.313 |
2.4 |
2.3 x 102 |
2.3 |
NS203602 Peak5 |
3.017 |
3.022 |
3.020 |
3.0 |
1.1 x 103 |
1.8 |
NS203602 Peak6 |
3.461 |
3.482 |
3.472 |
3.3 |
2.2 x 103 |
0.83 |
NS203602 Peak7 |
4.710 |
4.740 |
4.725 |
3.9 |
8.9 x 103 |
30 |
NS203602 Peak8 |
5.450 |
5.474 |
5.462 |
4.2 |
1.6 x 104 |
0.71 |
NS203602 Peak9 |
6.110 |
6.146 |
6.128 |
4.4 |
2.6 x 104 |
0.55 |
NS203602 Peak10 |
7.341 |
7.387 |
7.364 |
4.7 |
5.4 x 104 |
5.2 |
NS203602 Peak11 |
11.179 |
11.201 |
11.190 |
5.4 |
2.6 x 105 |
0.67 |
NS203602 Peak12 |
11.529 |
11.742 |
11.636 |
5.5 |
3.0 x 105 |
0.70 |
NS203602 Peak13 |
18.531 |
18.525 |
18.528 |
6.2 |
1.6 x 106 |
5.9 |
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Conclusions:
- The log Pow of the test substance components ranges from ≤ 0.3 to 6.2 (13 peaks in total).
Log Pow values for the two major peaks (49% and 30% peak area) were 1.4 and 3.9, respectively.
Log Pow values for two other large peaks (5.2% and 5.9% peak area) were 4.7 and 6.2 respectively.
The log Pow values for the 9 smaller peaks (areas from0.55 to 2.3%) ranges from ≤ 0.3 to 5.5.
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