Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 7th - June 3rd 2020
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
GLP compliance:
yes
Type of method:
flask method
Partition coefficient type:
octanol-water

Test material

1
Chemical structure
Reference substance name:
4-(2-hydroxyethyl)benzene-1,2-diol
EC Number:
600-704-3
Cas Number:
10597-60-1
Molecular formula:
C8H10O3
IUPAC Name:
4-(2-hydroxyethyl)benzene-1,2-diol
Specific details on test material used for the study:
Batch 17092019

Manufacturing date September 17th, 2019

Expiry date September 17th, 2020

Storage 5±3°C, protected from light

Receiving number P-LV-2020052-ADS

Receiving date February 21st, 2020
#ID LV-MAT-FOV7-20-059-0770:a

Study design

Analytical method:
other: HPLC-DAD

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
0.05
Temp.:
23 °C
Remarks on result:
other: pH value not reported

Applicant's summary and conclusion

Conclusions:
The aim of the study was to determine the partition coefficient (n-octanol/water) Pow of the test item “HYDROXYTYROSOL’ according to OECD 107.

The partition coefficient (POW) is defined as the ratio of the equilibrium concentrations of a dissolved substance in a two-phase system of two immiscible solvents (n-octanol and water) and serves as an indicator of the bioaccumulation potential.
Pow = C n-octanol/C water

The partition coefficient, being the quotient of two concentrations, is dimensionless and is usually
given in the form of its logarithm to base ten (logPow).

Test vessels containing the two-phase system were manually shaken at the set temperature. After a set mixing time and the phase separation, the test substance concentrations were determined in both phases and the total quantity of test substance present was calculated and compared to the amount initially added.

The test for the determination of Pow was carried out a room temperature in a range of 23+1°C. Two test for each volume ratio of the 2 phases were performed.

A HPLC-DAD method, validated during this study, was applied to quantify the active substance HYDROXYTIROSOLin the aqueous and the octanol phase.

All the determinations have been performed in saturated 1-octanol and saturated HP water.
Under the chromatographic conditions specified in “HPLC-DAD METHOD” and according to OECD 107 guidelines, the log Pow of the test item at 23°C+1°C proved to be 0.050.