Registration Dossier

Administrative data

Endpoint:
adsorption / desorption: screening
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06-12-2011 to 18-01-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.19 (Estimation of the Adsorption Coefficient (KOC) on Soil and Sewage Sludge Using High Performance Liquid Chromatography (HPLC))
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))
GLP compliance:
yes
Type of method:
HPLC estimation method
Media:
other:

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Amber coloured viscous liquid
- Physical state: Liquid
- Expiration date of the lot/batch: 15 August 2013
- Storage condition of test material: Room temperature in the dark
Radiolabelling:
no

Study design

Test temperature:
30°C

HPLC method

Details on study design: HPLC method:
EQUIPMENT
- Apparatus: Agilent Technologies 1100
- Type, material and dimension of analytical (guard) column: Luna 5µ CN 100Å (150 x 4.6 mm id), flow rate: 1.0 mL/min
- Detection system: UV detection (210 nm)

MOBILE PHASES
- Type: Methanol:water (55:45 v/v)
- pH: 6.8 adjusted with 0.1M sodium hydroxide
- Solutes for dissolving test and reference substances: methanol

DETERMINATION OF DEAD TIME
- Method: measurement of retention time of formaide (purity 99.94%, 688 mg/L solution in mobile phase)

REFERENCE SUBSTANCES
- Identity: See Appendix I attached.

DETERMINATION OF RETENTION TIMES
- Quantity of test substance introduced in the column: 0.9733 g in 100 mL, injection volume: 10µL
- Quantity of reference substances: See Appendix I attached.

REPETITIONS
- Number of determinations: 2

EVALUATION
- Calculation of capacity factors k': using equation k = tr - t0 / t0 and Log Koc where
k = capacity factor
tr = retention time (min)
t0 = dead time (min)

- Calculation of retention times: calibration curve constructed from retention time data of deadtime and reference standard solutions
- Determination of the log Koc value: Log10 Koc = Log10 k-A / B where:
Koc = adsorption coeffcient
k = capacity factor
A = intercept of the calibration curve
B = slope of calibration curve.

Results and discussion

Adsorption coefficient
Type:
log Koc
Value:
> 5.63
Temp.:
30 °C
Remarks on result:
other: % organic carbon not determined for HPLC method

Results: HPLC method

Details on results (HPLC method):
See Appendix 4: calibration curve and Appendix 5: retion times and Koc derivation attached.
The test was performed at neutral pH as the test item contained no dissociation constants within the environmental pH range or scope of the test.
It was observed that the sample chromatography contained 3 peaks between 5 and 10 minutes. These were investigated by immediately injecting a sample after preparation at 10 g/L in methanol using the same method parameters. The chromatogram of the fresh sample showed no evidence of the initial 3 peaks and had a greater peak height for a corresponding concentration therefore confirming that test item degrades in a relatively short period of time in methanol. The definitive test result was taken just from the peaks eluted by the methanol gradient.

Any other information on results incl. tables

See appendices attached.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The absorption coefficient of the test item has been determined to be > 4.27 E05, Log Koc => 5.63.
Executive summary:

Test Guidance

OECD Guideline No. 121 and EC Method C19

Method and material

The determination was carried out using the HPLC screening method.

Results

The absorption coefficient of the test item has been determined to be > 4.27 E05, Log Koc => 5.63.

Conclusion

The test substance has low mobility in soil.