Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 October 2013 - 13 December 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Qualifier:
according to
Guideline:
OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
GLP compliance:
yes
Remarks:
OECD Principles on Good Laboratory Practice (revised 1997, ENV/MC/CHEM(98)17)
Type of method:
shake-flask method to: flask method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
off-white powder

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficientopen allclose all
Type:
log Pow
Partition coefficient:
2.47
Temp.:
21.6 °C
Remarks on result:
other: ± 0.1°C
Type:
Pow
Partition coefficient:
295
Temp.:
21.6 °C
Remarks on result:
other: ± 0.1°C

Any other information on results incl. tables

 Sample nr Organic/Aqueous Volume Ratio   Partition Coefficient  Log10 Pow  Mean Partition Coefficient
 1  1:1     285  2.45     285
 2  285  2.45
 3 1:2      285  2.45     279
 4  274  2.44
 5 2:1      336  2.53     322
 6  307  2.49

Applicant's summary and conclusion

Conclusions:
The partition coefficient of the test item has been determined to be 295 at 21.6 ±1.0°C, log10 Pow 2.47.