Registration Dossier

Environmental fate & pathways

Biodegradation in water: screening tests

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 August 2017 to 03 January 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Reliable experimental study following OECD 301 guidelines (1992) and EC No. 440/2008 Method C.4-C) adopted 2008, and US EPA Fate, Transport, and Transformation Test Guidelines OCSPP 835.3110 (Paragraph(m)) and GLP standards.

Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Deviations:
yes
Remarks:
The temperatures in a non-test vessel were recorded at 25.3 and 24.8 ˚C on days 18 and 20 of the test, respectively, outside the specified range of 22 ± 2 ˚C. This deviation did not affect study integrity since all validation criteria were met.
Qualifier:
according to
Guideline:
EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)
Version / remarks:
440/200
Deviations:
yes
Remarks:
The temperatures in a non-test vessel were recorded at 25.3 and 24.8 ˚C on days 18 and 20 of the test, respectively, outside the specified range of 22 ± 2 ˚C. This deviation did not affect study integrity since all validation criteria were met.
Qualifier:
according to
Guideline:
EPA OPPTS 835.3110 (Ready Biodegradability)
Version / remarks:
The guideline was identified as OCSPP 835/3110 in the study report.
Deviations:
yes
Remarks:
The temperatures in a non-test vessel were recorded at 25.3 and 24.8 ˚C on days 18 and 20 of the test, respectively, outside the specified range of 22 ± 2 ˚C. This deviation did not affect study integrity since all validation criteria were met.
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
The test substance is listed as DIPIP (1,3-Di-4-Piperidylpropane). The test substance consists of white flakes. The test substance was obtained from the Sponsor, Vertellus Holdings LLC and was stored at room temperature in the dark.
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic (adaptation not specified)
Details on inoculum:
A mixed population of activated sewage sludge micro-organisms was obtained on 4 December 2017 from the aeration stage of the Severn Trent Water Plc sewage treatment plant at Loughborough, Leicestershire, UK, which treats predominantly domestic sewage.
Duration of test (contact time):
28 d
Initial conc.:
13.5 mg/L
Based on:
test mat.
Initial conc.:
10 mg/L
Based on:
TOC
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
The amount of the test item was dispersed directly in mineral medium with the aid of ultrasonication (15 minutes) prior to dispersal in inoculated mineral medium. The volume was adjusted to 3 liters to give a final concentration of 13.5 mg/L, equivalent to 10 mg carbon/L.
Reference substance:
benzoic acid, sodium salt
Key result
Parameter:
% degradation (CO2 evolution)
Value:
5
Sampling time:
28 d
Validity criteria fulfilled:
yes
Remarks:
IC content <5% (protocol ≤ 5%); CO2 emitted by controls 30.38 mg/L (protocol <70 mg/L); difference replicates < 20% (protocol ≤20 %); degradation positive control 111% at 14 d (protocol pass ≤14 d); degradation toxicity d 14, 35% (protocol ≥25%).
Interpretation of results:
not readily biodegradable
Conclusions:
The test substance is considered as “not readily biodegradable”. The test substance reached 5% biodegradation after 28 d.

Description of key information

The key study was a CO2 evolution test conducted in accordance with OECD Guideline 301B. The substance was not found to be readily biodegradable in a test conducted in accordance with OECD Guideline 301B. The biodegradation was reported as 5% after 28 days. 

 

Key value for chemical safety assessment

Biodegradation in water:
under test conditions no biodegradation observed
Type of water:
freshwater

Additional information