Registration Dossier

Administrative data

Endpoint:
adsorption / desorption: screening
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-10-02 to 2007-03-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD Guideline 121 (Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC)) without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

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
Remarks:
The testing facility indicated that the protocol was followed without deviation.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
Department of Health of the Government of the United Kingdom
Type of method:
HPLC estimation method
Media:
soil

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): VRT-126016
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: no data
- Physical state: white to off-white powder
- Analytical purity: 99.8 area% by High Performance Liquid Chromatography (HPLC)
- Impurities: chloride: <0.1%
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: 2006-02-02
- Lot/batch No.: 25719
- Expiration date of the lot/batch: February 2008
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
- Other: no data
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable
Radiolabelling:
no

Study design

Test temperature:
25 deg C

HPLC method

Details on study design: HPLC method:
EQUIPMENT
- Apparatus: Hewlett Packard 1050 Liquid Chromatograph
- Type: not applicable
- Type, material and dimension of analytical (guard) column: Hypersil CPS (25 cm x 4.6 mm i.d.)
- Detection system: UV set at 210 nm


MOBILE PHASES
- Type: Acetonitrile buffer solution (55:45 v:v) where phosphate and borate buffer solutions were employed for the pH 2.5 and pH 9 tests respectively
- Experiments with additives carried out on separate columns: not applicable
- pH: 2.5 and 9
- Solutes for dissolving test and reference substances: no, test substance was dissolved in HPLC mobile phase


DETERMINATION OF DEAD TIME
- Method: Formamide with no retenetion on the HPLC column was used to determine the deadtime of the HPLC system


REFERENCE SUBSTANCES
- Identity: Internal deadtime standard, Acetanilide, Nitrobenzene, Napthalene, 2-Methylnapththalene, Anthracene, DDT


DETERMINATION OF RETENTION TIMES
- Quantity of test substance introduced in the column: 0.302 ug
- Quantity of reference substances: 1-2 ug
- Intervals of calibration: no data


REPETITIONS
- Number of determinations: The test substance solution was prepared and chromatographed in duplicate, bracketed by samples of the reference mixture.


EVALUATION
- Calculation of capacity factors k': (t(r)-t0)/t0, where t(r) is the retention time of the sample or reference, and t0 is the retention time of IDS
- Calculation of retention times: true retention time = measured time - deadtime
- Determination of the log Koc value: 4.97 logk + 4.41

Batch equilibrium or other method

Analytical monitoring:
no
Details on sampling:
Not applicable
Details on matrix:
Not applicable
Details on test conditions:
Not applicable
Computational methods:
Not applicable

Results and discussion

Results: HPLC method

Details on results (HPLC method):
- Retention times of reference substances used for calibration: 3.571-7.837 min
- Details of fitted regression line (log k' vs. log Koc): log Koc = 4.97 log K + 4.41
- Graph of regression line attached : no
- Average retention data for test substance: 4.25 min

Results: Batch equilibrium or other method

Adsorption and desorption constants:
Not applicable
Recovery of test material:
Not applicable
Concentration of test substance at end of adsorption equilibration period:
Not applicable
Concentration of test substance at end of desorption equilibration period:
Not applicable
Details on results (Batch equilibrium method):
Not applicable
Statistics:
Not applicable

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
The test substance was found to have logKoc values of 2.6 and < 1.3 at pH 2.5 and pH 9 respectively.
Executive summary:

Not applicable