Registration Dossier

Environmental fate & pathways

Biodegradation in water: screening tests

Administrative data

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

Data source

Reference Type:
study report
Report date:

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
(2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate)
Cas Number:
Molecular formula:
(2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate)
Test material form:
Light yellow solid (powder)

Study design

Oxygen conditions:
Inoculum or test system:
activated sludge, domestic, adapted
Details on inoculum:
The test item Chiguard GA403 was tested using a concentration of nominal 49 mg test item/L nominal (equivalent to a theoretical oxygen demand of 99.75 mg O2/L). Activated sludge was used as inoculum.
Duration of test (contact time):
ca. 28 d

Results and discussion

% Degradation
% degradation (O2 consumption)
ca. 0
Sampling time:
28 d
Details on results:
The degree of biodegradation reached 0 % after 28 days.
The 10-day-window was not detected.
The degradation phase is defined as interval between the end of the lag phase and the reaching of 90 %. No degradation within the test duration of 28 days was observed and therefore no evaluation of the degradation phase was possible.

Therefore, when applying the 10-day-window, the test item Chiguard GA403 is not readi-ly biodegradable following OECD 301F/EU C.4-D. As degradation missed 60 % in the course of the test, Chiguard GA403 is considered as not ultimately biodegradable, with-in 28 days as well.

Any other information on results incl. tables

All validity criteria were met.

Oxygen consumption in the blank controls and in the positive controls was normal, indicating that the test system has worked properly.

The ThOD of the test item was calculated and based on molecular formula of the test item, given by the sponsor as C39H46N2O12. The 10-day-window was not detected and at the end of the test duration no degradation could be observed.

Since qualitative analysis of nitrate and nitrite gave negative results, no nitrification had taken place.

Therefore, when applying the 10-day-window, the test itemChiguard GA403is considered asnotreadily biodegradablefollowing OECD 301F/EU C.4-D.

As degradation missed 60 % in the course of the test,Chiguard GA403is considered asnot ultimately biodegradable,within 28 days as well.

No observations were made which might cause doubts concerning the validity of the study outcome.

The result of the test can be considered valid.

Applicant's summary and conclusion

Validity criteria fulfilled:
Interpretation of results:
not readily biodegradable
When applying the 10-day-window, the test item Chiguard GA403 is not readily biode-gradable following OECD 301F/EU C.4-D