Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental starting date: 05 July 2017. Experimental completion date: 23 August 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
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.8 (Partition Coefficient - HPLC Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Identification: Beta-Menadione
CAS No: 58-27-5
Description: light yellow powder
Batch number: J16090701
Purity: 99.2%
Expiry date: 06 September 2017
Storage conditions: room temperature, in the dark

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
2.43
Temp.:
30 °C
pH:
6.2
Details on results:
Preliminary Estimate
The log10 Pow estimate was calculated to be 2.21.

Discussion
The result from the preliminary estimate indicated that the HPLC method was suitable for determination of partition coefficient for this test item.
Several peaks were detected with a retention time between 2 and 6 minutes but were not considered to be the main component of the test item and were therefore not reported.

Any other information on results incl. tables

Partition coefficient of sample

The retention times, capacity factor and log10 Pow value determined for the sample are shown in the following table:

Injection Retention Time Capacity factor (k') Log10 k' Log10 Pow Mean Log10 Pow
1 8.285 3.44 0.537 2.43 2.43
2 8.287 3.44 0.537 2.43

Mean log10 Pow: 2.43

Mean partition coefficient: 269

Applicant's summary and conclusion

Conclusions:
The partition coefficient of the test item has been determined to be 269, log10 Pow of 2.43.
Executive summary:

Partition Coefficient. 269, log10 Pow 2.43, using the HPLC method, designed to be compatible with Method A.8 Partition Coefficient of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 117 of the OECD Guidelines for Testing of Chemicals, 13 April 2004.