Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with GLP. A full study report is available which includes a GLP compliance statement.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Version / remarks:
84/449/EEC
Deviations:
no
GLP compliance:
yes
Type of method:
shake-flask method to: flask method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: White powder
- Analytical purity: Not stated
- Lot/batch No.: C-7672
- Expiration date of the lot/batch: Not stated
- Stability under test conditions: Considered stable
- Storage condition of test material: Brown screw capped bottle at room temperature
- Other:

Study design

Analytical method:
other: UV-Visible spectrophotometry

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
2.32
Temp.:
18 °C
Details on results:
The mean concentration of test substance in n-octanol test solution before partition was determined to be 2810.5 μg/ml
The test substance was not detected spectrophotometrically in either the aqueous or organic blank solutions
The average value of the partition coefficient from all determinations was
P = 210.3
log P = 2.32

The standard deviation from the mean of the individual P values was 26.15. The range of log P values obtained were within the repeatability criteria of ±0.3 log units

Any other information on results incl. tables

The study report is attached to provide full details and the various spectrophotometrical charts.

Applicant's summary and conclusion

Conclusions:
The log Pow is determined to be 2.32 at 18C
Executive summary:

A known mass of test sample was dissolved in a 50ml sample of water saturated n-octanol. The test volume and an equal volume of n-octanol were shaken for 100 rotations in a 1L flask and each phase analyses by UV-visible spectrophotometetry. The concentration of test sample in each phase was compared to show the proportion of test sample in the organic phase to the concentration in the aqueous phase. The log Pow is determined to be 2.32 at 18C.