Registration Dossier
Registration Dossier
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EC number: 258-416-5 | CAS number: 53179-11-6
Biodegradation in water: screening tests
Administrative data
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 26 to June 24, 2015
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Loperamide
- EC Number:
- 258-416-5
- EC Name:
- Loperamide
- Cas Number:
- 53179-11-6
- Molecular formula:
- C29H33ClN2O2
- IUPAC Name:
- 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide
- Details on test material:
- Name Loperamide base (CAS 53179-11-6)
Batch no. 02742200215
Appearance White solid
Purity 99.5 %
Homogeneity Homogeneous
Expiry date 20. Aug. 2015
Constituent 1
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic (adaptation not specified)
- Details on inoculum:
- Activated sludge from a biologic sewage treatment plant was used. The chosen plant is treating mostly domestic sewage.
- Duration of test (contact time):
- 28 d
- Details on study design:
- Flask volume 1500 mL
Apparatus blanks 2, containing mineral medium only
Blank Controls 2, containing mineral medium and inoculum
Positive control flasks 2, containing positive control, mineral medium and inoculum
Test flasks 2, containing test item, mineral medium and inoculum
Abiotic control 1, containing test item, mineral medium and HgCl2
Toxicity control 1, containing test item, positive control. mineral medium and
inoculum
Inoculum concentration: 25.0 mg/L
Temperature 19.5 – 24.1 °C
Duration 28 days
The test was performed with a nominal start concentration of 20 mg organic carbon/L.
Reference substance
- Reference substance:
- aniline
Results and discussion
% Degradation
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 0
- Sampling time:
- 28 d
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- under test conditions no biodegradation observed
- Conclusions:
- Regardless of the 10-day-window. Loperamide base (CAS 53179-11-6) is not readily biodegradable following OECD 301B/EU C.4-C.
No biodegradation could be observed after 28 days. The 10-day-window could not been detected.
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