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:
other: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: Sa 163 / SAT-No. 080003
Batch-No.: Huc-Sa-9370-163
CAS-No.: 1001164-15-3
Molecular formula: C30H43NO2
Molecular weight: 449.7 g/mol
Purity: >99 % (NMR)
Homogeneity: not stated
Vapour pressure: at room temperature not volatile
Stability: in H2O, DMSO; EtOH, Aceton, Acetonitril unknown
Solubility: in H2O < 0.1 g/L, DMSO; EtOH, acetone, CH3CN unknown
Production date: 07. Aug. 2007
Expiry date: 07. Dec. 2009
Storage: room temperature 20 ± 5 °C, dark, dry

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
other: activated sludge from a biologic sewage treatment plant
Duration of test (contact time):
28 d
Initial test substance concentration
Initial conc.:
20 mg/L
Based on:
other: organic carbon (nominal)

Results and discussion

% Degradation
Parameter:
% degradation (CO2 evolution)
Value:
6
Sampling time:
28 d

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
under test conditions no biodegradation observed
Conclusions:
The test item Sa 163 / SAT-No. 080003 is considered as "not readily biodegradable". The degree of biodegradation reached 6 % after 28 days. No 10-day-window could be identified and the pass level of 60 % given in the OECD guideline was missed. No abiotic degradation was detected.
Executive summary:

The test item Sa 163 / SAT-No. 080003 is considered as "not readily biodegradable". The degree of biodegradation reached 6 % after 28 days. No 10-day-window could be identified and the pass level of 60 % given in the OECD guideline was missed. No abiotic degradation was detected.