Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 10, 2007 - June 18, 2007
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Version / remarks:
, 2004
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Version / remarks:
, 1992
Deviations:
no
Principles of method if other than guideline:
NaNO3 instead of an organic substance was used for the determination the dead time, because NaNO3 as a small inorganic molecule has less interaction on a reversed phase chromatographic column than organic substances. This was confirmed by our experience with this method. Due to technical reasons, standards were injected separately instead of simultaneously.
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2006-06-01
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Symrose
- Substance type: technical product
- Physical state: colourless, liquid
- Storage condition of test material: ambient air, dark and dry

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
4.49
Temp.:
24 °C
pH:
6
Details on results:
The test temperature was within the range of 23.8 – 24.5 °C. The HPLC dead time (t0) was determined by threefold injection of a solution of 1 mg/L sodium nitrate and was determined to 0.526 min (mean).

Any other information on results incl. tables

Table1: Retention times, Capacity factors and estimated Partition Coefficient of Symrose

 Test item

Retention time (min)

Capacity factor

log (capacity factor)

log POW

Symrose

5.430

9.323

0.970

4.49

5.420

9.304

0.969

4.49

5.402

9.270

0.967

4.48

5.395

9.257

0.966

4.48

Mean

4.49

Applicant's summary and conclusion

Conclusions:
The logPow of the test item Symrose was calculated at 4.49 at pH 6