Registration Dossier

Administrative data

Endpoint:
adsorption / desorption: screening
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Start of experiment: 04 November 2009 End of experiment: 04 November 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which did not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
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))
Qualifier:
according to guideline
Guideline:
EU Method C.19 (Estimation of the Adsorption Coefficient (KOC) on Soil and Sewage Sludge Using High Performance Liquid Chromatography (HPLC))
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 13th to the 22nd of October 2008 (GLP certificate is valid for 2 years)
Type of method:
HPLC estimation method
Media:
soil/sewage sludge

Test material

Constituent 1
Reference substance name:
Pellicer
IUPAC Name:
Pellicer
Details on test material:
Name: Pellicer
Lot No.: 01-09-17
Chemical name: L-Lysine,N2,N6-bis[N-(1-oxododecyl)-L-α(or γ)-glutamyl]-, sodium salt (1;?)
Appearance: White powder
Storage condition: Room temperature (15-25 °C), in the dark and protected from humidity (with desiccant)
Manufacture date: 17 January 2009
Expiry Date: 17 January 2011
Safety precautions: Routine safety and hygienic procedures sufficient to ensure personnel health and safety

Study design

Test temperature:
25 degrees

HPLC method

Details on study design: HPLC method:
EQUIPMENT
- Apparatus: HPLC
- Type:Merck-Hitachi LaChrom HPLC system:
Mobil Phase: Methanol : Water (55 : 45)
Flow: 1.0 ml/min.
Injection volume: 5 μl
Detector: UV at 200 nm
Column temperature: 25 °C
- Type, material and dimension of analytical (guard) column: not stated
- Detection system: UV

MOBILE PHASES
- Type: Methanol : Water (55 : 45)
- Experiments with additives carried out on separate columns: no
- pH: not stated
- Solutes for dissolving test and reference substances: Reference substances were dissolved in methanol

DETERMINATION OF DEAD TIME
Dead time, t0 was determined by the injection of sodium nitrate solution. Concentration of these stock solutions was about 1 mg/ml. Pellicer was also dissolved in methanol. The concentration of this solution was 1 mg/ml. This stock solution was diluted with mobile phase (1 to 10 dilution).

REFERENCE SUBSTANCES
Chemical name CAS Number log Koc Purity, Supplier Batch No.
Sodium nitrate 7631-99-4 t0 ≥99.5 % Merck KGaA A980637
Acetanilide 103-84-4 1.25 99.9 % Merck KGaA S4715244
Methyl benzoate 93-58-3 1.80 99.9 % Merck KGaA S4748230
Isoproturon 34123-59-6 1.86 99.8 %, Sigma Aldrich 3209X
Linuron 330-55-2 2.59 99.7 %, Sigma Aldrich 5320X
Naphthalene 91-20-3 2.75 99.9 % Merck KGaA 4767446
Fenthion 55-38-9 3.31 97.8 %, Sigma Aldrich 6193X
Phenantrene 85-01-8 4.09 99.4 %, Sigma Aldrich 1176479

DETERMINATION OF RETENTION TIMES
- Quantity of test substance introduced in the column: 1 mg/ml.

REPETITIONS
- Number of determinations: not stated

EVALUATION
- Calculation of capacity factors k':
The capacity factors, k’ were calculated from the retention times (tR) of the selected reference substances and the dead time (t0):
k' = tR - t0 / t0
- Calculation of retention times:
- Determination of the log Koc value: see attachment 1

Results and discussion

Adsorption coefficientopen allclose all
Type:
log Koc
Value:
< 1.25
Temp.:
25 °C
Type:
Koc
Value:
< 20
Temp.:
25 °C

Results: HPLC method

Details on results (HPLC method):
- Retention times of reference substances used for calibration: Please see table 2 in the attachments section
- Details of fitted regression line (log k' vs. log Koc): Please see attachment 1
- Graph of regression line attached: Please see attachment 1

Any other information on results incl. tables

Data measured for the reference substances are given in Table 2 (please see attachments section). The equation of the line fitted to the calibration points is as follows: log k' = 0.2104 * log Koc - 0.0767 (Rsq = 0.978) Log Koc for Pellicer could not be calculated, because the measured retention time is close to the dead time and out of the calibrated range. (see Table 2). However, the log Koc is clearly significantly lower than 1.25 (regulatory guideline does not allow extrapolation, so only a “lower than” value can be provided).

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Conclusions:
Retention time of Pellicer (1.26 min) is close to the dead time and this is significantly lower than that of the first eluting standard, Acetanilide (3.17 min). This result shows that log Koc of Pellicer is significantly lower than the calibrated range. Therefore no accurate value of log Koc can be estimated. The estimated log Koc is lower than 1.25
Executive summary:

This study was carried out according to OECD guideline 121 and the EU Method C19. Retention time of Pellicer (1.26 min) is close to the dead time and this is significantly lower than that of the first eluting standard, Acetanilide (3.17 min). This result shows that log Koc of Pellicer is significantly lower than the calibrated range. Therefore no accurate value of log Koc can be estimated (this is because the regulatory guideline does not allow extrapolation, so only a “lower than” value can be provided). The estimated log Koc is lower than 1.25

.