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:
11.12.2017 - 08.01.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Fraunhofer Institute for Molecular Biology and Applied Ecology (IME), Auf dem Aberg 1, D-57392 Schmallenberg, Germany

Test material

Constituent 1
Reference substance name:
L-Threonine, N-coco acyl derivs., monosodium salts
Cas Number:
90583-79-2
Molecular formula:
n/a
IUPAC Name:
L-Threonine, N-coco acyl derivs., monosodium salts
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Ajinomoto Co., Inc., 15-1 Kyobashi 1-Chome, Chuo-Ku, Tokyo 104-8315 Japan/Batch No.: 160329
- Expiration date of the lot/batch: 29.03.2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dark and cool place, protected from light

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no

FORM AS APPLIED IN THE TEST (if different from that of starting material): solid

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
sewage, predominantly domestic, non-adapted
Details on inoculum:
- Source of inoculum/activated sludge: withdrawn from the sewage treatment plant Ruhrverband Kläranlage, Schmallenberg, Germany. The sewage treatment plant was mainly fed with municipal wastewater
- Method of cultivation: samples were not washed with mineral medium after the arrival at the laboratory but kept aerobic until use
- Initial cell/biomass concentration: 29.6 mg dry mass/L
Duration of test (contact time):
28 d
Initial test substance concentrationopen allclose all
Initial conc.:
100 mg/L
Based on:
test mat.
Initial conc.:
226 mg/L
Based on:
ThOD/L
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
TEST CONDITIONS
- Composition of medium: according to guideline
- Additional substrate: no
- Solubilising agent (type and concentration if used): no
- Test temperature: 22 °C ± 1°C
- pH: test start: 7.4± 0.2, test end: 7.2-7.8 (in all test vessels)
- pH adjusted: yes
- Aeration of dilution water: not reported
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus: respirometer
- Number of culture flasks/concentration: 2
- Method used to create aerobic conditions: aeration during the test
- Measuring equipment: Sapromat

SAMPLING
- Sampling frequency: oxygen demand measured continuously via Sapromat respirometer

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Abiotic sterile control: yes (sterilized with HgCl2)
- Toxicity control: yes
- Other: Procedural control using sodium benzoate was performed

Reference substance
Reference substance:
benzoic acid, sodium salt
Remarks:
100 mg/L

Results and discussion

% Degradationopen allclose all
Key result
Parameter:
% degradation (O2 consumption)
Value:
74.2
St. dev.:
1
Sampling time:
14 d
Remarks on result:
other: mean of 2 determinations
Key result
Parameter:
% degradation (O2 consumption)
Value:
81.7
St. dev.:
0.3
Sampling time:
28 d
Remarks on result:
other: mean of 2 determinations

BOD5 / COD results

Results with reference substance:
The reference item sodium benzoate was degraded to 86 % within the first 14 days thus fulfilling the guideline requirements.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
According to the guideline, the test item TH-CS-11-T can be considered as being readily biodegradable.
Executive summary:

The ready biodegradation of the test material was investigated in a study conducted according to OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test) and EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test) over a period of 28 days and using non-adapted activated sludge as inoculum. The biodegradation rate was determined by measurement of oxygen consumption. Inoculum blank, procedural/functional control with reference substance sodium benzoate and toxicity control using 100 mg/L test item and 100 mg/L reference compound were performed.

 

This study is regarded as reliable without restriction and satisfies the guideline requirements for ready biodegradation.

The test item proved to be readily biodegradable (82% biodegradation after 28d incubation) and fulfilling the 10-d-window criterion (71% biodegradation within 10 d-window). In the toxicity control containing both test and reference item, 80% biodegradation was measured within 14 d thus indicating that the test item was non-toxic to the inoculum at the concentration tested.

Categories Display