Registration Dossier

Administrative data

Endpoint:
adsorption / desorption: screening
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 121 (Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC))
Deviations:
no
Principles of method if other than guideline:
HPLC is performed on analytical columns packed with a commercially available cyanopropyl solid phase containing lipophilic and polar moieties. A moderately polar stationary phase based on a silica matrix is used. While passing through the column along with the mobile phase the test substance interacts with the stationary phase. As a result of partitioning between mobile and stationary phases the test substance is retarded. The retention time of the test substance is evaluated by setting up a calibration plot for reference substances of known adsorption coefficient. By applying the regression equation of the calibration plot, the adsorption coefficient of the test substance can be calculated.

The adsorption coefficient Koc is defined as the ratio between the concentration of the substance in the soil/sludge and the concentration of the substance in the aqueous phase at adsorption equilibrium. The experimental method described in OECD Guideline 121 uses HPLC for the estimation of the adsorption coefficient in soil and sewage sludge.
GLP compliance:
yes (incl. QA statement)
Type of method:
HPLC estimation method
Media:
other: soil & sewage sludge

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Radiolabelling:
no

Study design

HPLC method

Details on study design: HPLC method:
HPLC is performed on analytical columns packed with a commercially available cyanopropyl solid phase containing lipophilic and polar moieties. A moderately polar stationary phase based on a silica matrix is used. While passing through the column along with the mobile phase the test substance interacts with the stationary phase. As a result of partitioning between mobile and stationary phases the test substance is retarded. The retention time of the test substance is evaluated by setting up a calibration plot for reference substances of known adsorption coefficient. By applying the regression equation of the calibration plot, the adsorption coefficient of the test substance can be calculated.

Batch equilibrium or other method

Analytical monitoring:
yes
Details on sampling:
Test ltem(s): E12MNA Oxazolidine (Sa 190)
Chemical Name: 1H,3H,5H-Oxazolo[3,4-c]oxazole, dihydro-3,5-bis(l­methyldecyl)-
CAS No: 1001161-63-2
Batch No.: 000006/24
Expiry Date: 2018-08-31
Appearance, Colour: cream coloured liquid
(deviation from study plan due to typo)

The identity and purity of the test item was determined under our LIMS reference 17-15163 (non-GLP).

Results and discussion

Adsorption coefficient
Key result
Type:
log Koc
Value:
> 4.09 dimensionless

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
A retention time of 4.040 min was determined for the test item. This is higher than the retention time for the reference item phenanthrene, thus, log Koc can be reported as:
log Koc > 4.09
Executive summary:

A retention time of 4.040 min was determined for the test item. This is higher than the retention time for the reference item phenanthrene, thus, log Koc can be reported as:

log Koc > 4.09