Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental start date 22 November 2018 Experimental completion date 11 January 2019
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Batch (Lot) Number: R18 14728
Expiry date: 08 October 2020 (expiry date)
Physical Description: Dark amber viscous liquid
Purity/Composition: UVCB
Storage Conditions: At room temperature
Specific details on test material used for the study:
Identity: T106D
Appearance: Viscous dark amber liquid
Batch number: R18 14728
Storage conditions: Room temperature (15 to 25°C)
Purity: UVCB 100%
Expiry date: 08 October 2020
Date received: 29 October 2018


Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
>= 4.3 - <= 7.2
Temp.:
25 °C
pH:
ca. 4

Any other information on results incl. tables

A calibration plot of log10k’ versus log10Powwas constructed for the reference standards
(Table 1, Figure 1 - Please see Attachment 1 of this Summary). The logarithm of the capacity factor for the test item was then calculated and the log10Powvalues determined by interpolation.

The test item,T106D, chromatographed as a cluster of peaks between approximately 3.5 and 15 minutes and was determined to have log10Powvalues ranging from 4.3 to 7.2 (equivalent to a Powrange of 21000 to 15000000), with a weight-averaged log10Powvalue of approximately 5.7 (Table 2 - Please see Attachment 2 of this Summary). Figures 2 to 4 present examples of chromatograms generated during this test (Please see these figures within Attachment 3 of this Summary).

Applicant's summary and conclusion

Conclusions:
T106D was determined to have log10Pow values ranging from 4.3 to 7.2 at 25°C, with a weight-averaged value of 5.7.
Executive summary:

The procedure outlined in this document has been designed to be compatible with the following guidelines and recommendations:

·          EC Method A.8

·          OECD Method 117

Conclusion

T106D was determined to have log10Powvalues ranging from 4.3 to 7.2 at 25°C, with a weight-averaged value of 5.7.