Registration Dossier

Administrative data

Endpoint:
adsorption / desorption: screening
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

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))
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))
GLP compliance:
yes
Type of method:
HPLC estimation method
Media:
soil/sewage sludge

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Density: 0.895 g/cm3
Radiolabelling:
no

Study design

HPLC method

Details on study design: HPLC method:
The analysis was performed on an analytical column packed with a commercially available cyanopropyl solid phase containing lipophilic and polar moieties. A moderately polar stationary phase based on a silica matrix was used (EC 50/4.6 Nucleodur 100-5 CN-RP 150 x 4.6 mm; 5 µm). A mixture of 55% methanol / 45 % ultra-pure grade water was used as mobile phase and the column temperature was 25°C ± 1°C.

Results and discussion

Adsorption coefficient
Key result
Sample No.:
#1
Type:
log Koc
Value:
6.93
Temp.:
25 °C

Results: HPLC method

Details on results (HPLC method):
The study reports the following values: 6.55-7.20 of which the average is 6.93 (key value). The range of 6.55-7.20 is above the determination limit of the method (log KOC 5) and above the highest reference standard 5.63). The above values were hence extrapolated.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The study reports the following values: 6.55-7.20 of which the average is 6.93 (key value).
Executive summary:

The adsorption coefficient of the test item on solid and on sewage sludge (KOC) was determined by HPLC according to EC method C.19 (440/2008) and OECD guideline 121, under GLP. The analysis was performed on an analytical column packed with a commercially available cyanopropyl solid phase containing lipophilic and polar moieties. A moderately polar stationary phase based on a silica matrix was used (EC 50/4.6 Nucleodur 100-5 CN-RP 150 x 4.6 mm; 5µm). A mixture of 55% methanol / 45 % ultra-pure grade water was used as mobile phase and the column temperature was 25°C±1°C. The study reports the following values: 6.55-7.20 of which the average is 6.93 (key value). The range of 6.55-7.20 is above the determination limit of the method (log KOC5) and above the highest reference standard 5.63). The above values were hence extrapolated. The determined log KOCof two runs is within a range of±0.25 log units (absolute deviation). Hence the requirements of OECD guideline 121 concerning the quality criteria are fulfilled.