Registration Dossier

Administrative data

Endpoint:
adsorption / desorption: screening
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 121 (Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
HPLC estimation method
Media:
soil/sewage sludge

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): LCE08116
- Physical state: Colourless to slightly colored limpid liquid
- Analytical purity: 30,3% dry extract
- Purity test date: 2008-11-07
- Lot/batch No.: 0824800002
- Expiration date of the lot/batch: 04 September 2011
- Storage condition of test material: In darkness at room temperature
Radiolabelling:
no

Study design

Test temperature:
The temperature during the analytical phase was around 22°C.

HPLC method

Details on study design: HPLC method:
Preparation of the test item solution:
A quantity of about 100 mg of LCE08116 was accurately weighed into a 100-mL volumetric flask and the volume was made with methanol. The
solution was treated with ultrasounds for 5 minutes and left to cool. The solution was diluted 10 times in methanol and a vial was prepared for
analysis.

Instrumental analysis
The experimental conditions used for the determination of the retention times of the analytical reference items and of the test item by high
pressure liquid chromatography equipped with an ultraviolet detector are as following:

Column
Column Supelco Length (cm) 25
Particle size (μm) 5.0 Internal diameter (mm) 4.6
Stationary phase Supelcosil LC-CN
Mobile phase Methanol / water 45/55 v/v
Flow rate (mL/min) 0.9
Injected volume (μL) 40 Wave length analysis (nm) 210

Injection sequence:
Mixture of the analytical reference items, test item, mixture of the analytical reference items, test item, mixture of the analytical reference items,
individual analytical reference items.

Results and discussion

Adsorption coefficient
Type:
log Koc
Value:
< 1.25
Temp.:
22 °C

Results: HPLC method

Details on results (HPLC method):
Variation in the retention times of the reference items are very small. Therefore a stable configuration of the HPLC column can be assumed.
The correlation logk’/ log koc is accurate as calibration gave a coefficient of correlation near r2 = 0.965.
Under the normal chromatographic conditions, the test item peak showed nearly no retention on the column and no reference item with lower retention time was available.
Therefore, the log koc of the test item peak must be stated as < 1.25 (lowest value of calibration).

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
The adsorption / desorption coefficient of LCE08116 is lower then 1.25.
Executive summary:

The objective of this study was to estimate the adsorption/desorption coefficient on soil and on sewage sludge using (HPLC) High Performance Liquid Chromatography following the test method (OECD Guideline No. 121, 2001). Using this procedure, it was shown that the adsorption / desorption coefficient of LCE08116 is lower then 1.25.