Registration Dossier

Administrative data

Endpoint:
adsorption / desorption: screening
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 February 2011 – 27 April 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and EC guidelines and in compliance with GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
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))
Version / remarks:
(2001)
Deviations:
no
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))
Version / remarks:
(Official Journal of the European Union no. L142, May 31, 2008)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
HPLC estimation method
Media:
soil/sewage sludge

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): E-C104
- Description: Blue powder
- Batch: MB-1
- Test substance storage: At room temperature protected from light
- Stability under storage conditions: Stable
- Expiry date: 23 December 2015
Radiolabelling:
no

Study design

Test temperature:
35°C +/- 1°C

HPLC method

Details on study design: HPLC method:
Analytical conditions
Instrument: Alliance Separation Module 2695 (Waters, Milford, MA, USA)
Detector: Dual λ Absorbance Detector 2487 (Waters)
Column: Hypersil BDS-CN, 150 mm x 4.6 mm i.d., dp = 5 μm (Thermo Fisher Scientific, Waltham, MA, USA)
Column temperature: 35°C +/- 1°
Mobile phase: 55/45 (v/v) methanol/water
Flow: 1 ml/min
Injection volume: 10 μl
UV detection: 210 nm

E-C104 is a complex mixture of a range of poly substituted organic salt compounds. Therefore, the test was performed at neutral pH.

Results and discussion

Adsorption coefficientopen allclose all
Type:
Koc
Value:
< 18
Temp.:
35 °C
Remarks on result:
other: HPLC estimation method
Type:
log Koc
Value:
< 1.3
Temp.:
35 °C
Remarks on result:
other: HPLC estimation method

Results: HPLC method

Details on results (HPLC method):
In the chromatogram of the test substance solution, one peak with a retention time of 1.11 minutes was observed. Under the same analytical conditions, the retention time of acetanilide (log Koc = 1.26) was 2.28 minutes. Hence, it was concluded that the log Koc of test substance was < 1.3 (Koc < 18).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The HPLC method using soil-adsorption-reference data was applied for the determination of the adsorption coefficient (Koc) of E-C104.
The Koc and log Koc values of the test substance at neutral pH were < 18 and < 1.3, respectively.