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: Guideline study, to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
impurity
Test material form:
other: liquid, may crystalize to white solid
Specific details on test material used for the study:
Details on Test Material
- Name of test material (as cited in study report): Pivacyclene
- Physical state: Colourless to pale yellow liquid, may crystalize.
- Analytical purity: >=92.0 %
- Lot/batch No.: SC00004118
- Expiration date of the lot/batch: 17 July 2014.
- Stability under test conditions: Stable.
- Storage condition of test material: Protect from light. Refrigerated at 2 to 8 °C

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
5.55
Temp.:
25 °C
pH:
7
Details on results:
Note: Testing was performed at 25°C (column temperature), however the values can be considered to represent the values at an unspecified, probably ambient temperature since no mention is made in the guidelines of the temperature at which the tabulated reference substances log Kow values were determined. Partition coefficients of the test and reference substances are assumed to vary with temperature in the same way.

Applicant's summary and conclusion

Conclusions:
The log Pow of Pivacyclene according to the HPLC method is 5.55.
Executive summary:

In an OECD guideline study (TG 117), conducted according to GLP, the partition co-efficient (n-octanol/water, log Pow), determined by the HPLC method, was 5.55.