Registration Dossier

Diss Factsheets

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
Study period:
April 2013 - Nov 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Qualifier:
according to guideline
Guideline:
EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
Principles of method if other than guideline:
The abiotic sterile control was prepared with deionised water and not with medium.
This procedure, according to standard operating procedures, is chosen to reduce
the possibility of any microbial activity. It was wrongly indicated in the study plan.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(3S,5R,8aS)-3-phenyl-3,5,6,7,8,8a-hexahydro-2H-oxazolo[3,2-a]pyridine-5-carbonitrile
EC Number:
634-598-5
Cas Number:
106565-71-3
Molecular formula:
C14H16N2O1
IUPAC Name:
(3S,5R,8aS)-3-phenyl-3,5,6,7,8,8a-hexahydro-2H-oxazolo[3,2-a]pyridine-5-carbonitrile
Test material form:
solid: crystalline
Details on test material:

Identification PAM-Oxazolopiperidine
Chemical name (3S,5R,8aS)-(+)Hexahydro-3-phenyl-5H-
oxazolo[3,2a]pyridine-5-carbonitrile
Batch no BS12010625
CAS no. 106565-71-3
Molecular formula C14H16N2O
BMG sample no. M1302-00843-01
Physical form Solid
Purity 99.7% (w/w)
Theoretical oxygen demand 2.803 mg O2/mg (calculated according to chapter
5.2 assuming nitrification)
Test substance storage At room temperature, protected from light
Stability Stable under storage conditions
Expiry date 8 November 2013

additional analytical information is provided in section 1.4

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Duration of test (contact time):
ca. 28 d
Initial test substance concentration
Initial conc.:
ca. 100 mg/L
Based on:
ThOD/L
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
O2 consumption

Results and discussion

% Degradation
Parameter:
% degradation (O2 consumption)
Value:
ca. 23
Sampling time:
28 d
Details on results:
Based on the data of the individual O2 determinations, the mean
biodegradability in the Manometric Respirometry Test of PAM-Oxazolopiperidine
was calculated to be 23% after 28 days as compared to the theoretical oxygen
demand (ThOD).

BOD5 / COD results

Results with reference substance:
The procedure control sodium benzoate reached 80% biodegradation after 14 days,
thus confirming suitability of inoculum and test conditions.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
under test conditions no biodegradation observed
Conclusions:
PAM-Oxazolopiperidine is not biodegradable in the Manometric Respirometry Test.
Executive summary:

The biodegradability of PAM-Oxazolopiperidine exposed to microorganisms derived from activated sludge of a municipal sewage treatment plant was investigated under aerobic static exposure conditions. (Manometric Respirometry Test, OECD 301F)

A biodegradability of 23% of PAM-Oxazolopiperidine based on O2 consumption was observed during 28 days as compared to the theoretical oxygen demand (ThOD).

The procedure control sodium benzoate reached 80% biodegradation after 14 days, thus confirming suitability of inoculum and test conditions.

The calculated biodegradation based on DOC measurements reached 48% for PAM-Oxazolopiperidine and 99% for sodium benzoate, respectively. The data show that the consumed O2 was used for partial mineralization of the test compound, since the determined degradation values based on BOD were lower as compared to those based on DOC.

PAM-Oxazolopiperidine did not reach the pass level of 60% for ready biodegradability in the Manometric Respirometry Test within the 10-d window as well as after 28 days and, therefore, cannot be termed as readily biodegradable.

PAM-Oxazolopiperidine is not biodegradable in the Manometric Respirometry Test.

Categories Display