Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23/02/2017 – 28/02/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient - Shake Flask Method)
Version / remarks:
EU Regulation (EC) 440/2008, Annex Part A test A8
Qualifier:
according to
Guideline:
OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
GLP compliance:
yes (incl. certificate)
Other quality assurance:
other: QA SOP 010
Remarks:
The procedure of the determination of whether the study live phase is audited by the QA unit is set out in QA SOP 010 and is determined at the time the QA unit receives study notification.
Type of method:
flask method
Remarks:
shake flask method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Test material form:
solid
Details on test material:
- Stabilisation: stable
- Safety precautions: The routine hygienic procedures were sufficient to assure personnel health and safety
- Colour: brownish red
- Storage conditions: room temperature

Results and discussion

Partition coefficient
Key result
Type:
Pow
Partition coefficient:
1 739
Temp.:
20 °C
pH:
> 8.2 - <= 8.73
Details on results:
Mean partition coefficient result (Log Pow): 1.739

Applicant's summary and conclusion

Conclusions:
Mean partition coefficient result (Log Pow): 1.739