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
Study period:
2019-08-01 to 2019-10-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
anhydro-D-glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
EC Number:
839-734-9
Cas Number:
2290526-77-9
Molecular formula:
C15H29NO5 C17H33NO5
IUPAC Name:
anhydro-D-glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
Test material form:
liquid: viscous

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Duration of test (contact time):
28 d
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
CO2 evolution

Results and discussion

% Degradation
Parameter:
% degradation (CO2 evolution)
Value:
63
Sampling time:
28 d

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable, but failing 10-day window
Conclusions:
The biodegradation of the test item is shown graphically in Figure 1 in comparison to the readily
degradable functional control and the toxicity control. The mean of replicates reached the 10 %
level (beginning of biodegradation) within 6 days. The mean of test item replicates did reach the
60 % pass level within 28 days. The mean biodegradation on day 28 was 63%.
Executive summary:

The ready biodegradability of the test item cyclic Glucamide C8-C10 (batch no.: BP 1c (reactor

mix)) was determined with a non-adapted activated sludge over a test period of 28 days in the

Modified Sturm Test. The study was conducted according to OECD 301 B from 2019-08-01 to

2019-10-18, with a definitive exposure phase from 2019-09-19 to 2019-10-18 at the test facility.

The test item was tested at a concentration of 20 mg/L with 2 replicates corresponding to a carbon

content (TOC) of 10.1 mg C/L. The test vessels were incubated at low light conditions and at a

temperature of 22 ± 2 °C.

The biodegradation of the test item was followed by titrimetric analysis of the quantity of CO2

produced by the respiration of bacteria. The degradation was stopped on day 28 by acidification

of the test solutions. The last titration was made on day 29 after residual CO2 had been purged

from the test solutions over a period of 24 hours. The percentage CO2 production was calculated

in relation to the theoretical CO2 production (ThCO2) of the test item. The biodegradation was

calculated for each titration time.

To check the activity of the test system sodium benzoate was used as functional control. The

percentage degradation of the functional control reached the pass level of 60 % within 6 days. A

maximum biodegradation of 88 % was achieved on day 28.

In the toxicity control containing both test and reference item a biodegradation of 68 % was

determined within 15 days, with 80 % after 28 days. The biodegradation of the reference item

was not inhibited by the test item in the toxicity control.

The biodegradation of the test item is shown graphically in Figure 1 in comparison to the readily

degradable functional control and the toxicity control. The mean of replicates reached the 10 %

level (beginning of biodegradation) within 6 days. The mean of test item replicates did reach the

60 % pass level within 28 days. The mean biodegradation on day 28 was 63%.