Registration Dossier

Environmental fate & pathways

Biodegradation in water: screening tests

Administrative data

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Qualifier:
according to
Guideline:
EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
brown color

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic (adaptation not specified)
Duration of test (contact time):
<= 28 d
Initial test substance concentration
Initial conc.:
<= 102.7 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
Noroxycodone was investigated for its ready biodegradability in a manometric respirometry test over a period of 28 days.
The reference item sodium benzoate (control) was tested simultaneously under the same conditions as the test item.
Other information: temperature at 22°C, darkness conditions, climatised chamber, pH of 7.6 (start test) and 7.5-7.7 (end test), vehicule composed of reconstituted water (pure water + salts)
Reference substance
Reference substance:
benzoic acid, sodium salt

Results and discussion

% Degradation
Key result
Parameter:
% degradation (O2 consumption)
Value:
<= 0
Sampling time:
28 d
Details on results:
The mean biodegradation at test end of the test after 28 days was 0% (THOD(NH4), ThOD(NO3)). Therefore, Noroxycodone is considered to be not readily biodegradable.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
not readily biodegradable
Conclusions:
Based on the experimental results, Noroxycodone is considered to be not readily biodegradable.