Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24th July 2017 to the 20th November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient - HPLC Method)
Qualifier:
according to
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
GLP compliance:
yes (incl. certificate)
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Test material form:
solid: crystalline
Details on test material:
Expiry date:01 February 2021
Storage conditions: Room temperature in the dark
Batch 21-16131
Specific details on test material used for the study:
Identification:
2,5-diphenyloxazole
Appearance/Physical state:
White crystalline powder
Batch:
21-16131
Purity:
99.9%
Expiry date:
01 February 2021
Storage conditions:
Room temperature, in the dark

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
ca. 4.1
Temp.:
30 °C
pH:
ca. 5.6
Details on results:
Mean log10 Pow: 4.10
Partition coefficient: 1.25 x 10^4

Applicant's summary and conclusion

Conclusions:
The substance, 2,5-diphenyloxazole, partition coefficient was studied in accordance with EC Method A.8 and OECD Method 117 via a GLP-certified laboratory. The study used the reverse HPLC method and determined that the substance partition coefficient (n-ocanol/water) to be 1.25 x 10^4, log10 Pow 4.10.
Executive summary:

The substance, 2,5-diphenyloxazole, partition coefficient was studied in accordance with EC Method A.8 and OECD Method 117 via a GLP-certified laboratory. The study used the reverse HPLC method with a very low percentage of polar groups was used and the mobile phase contained at least 25% aqueous phase. The resultant time to pass through the coloumn was compared to 6 different reference substances and then extrapulated for the true-value prior to substance dilution.

The study determined that the substance partition coefficient (n-ocanol/water) to be 1.25 x 10^4, log10 Pow 4.10.