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Biodegradation in water: screening tests

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Reference
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)
Version / remarks:
(04 April 1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
Version / remarks:
(17 July 1992)
Deviations:
no
GLP compliance:
not specified
Oxygen conditions:
aerobic
Inoculum or test system:
not specified
Details on inoculum:
- no data
Duration of test (contact time):
28 d
Initial conc.:
6 mg/L
Based on:
test mat.
Initial conc.:
1.14 other: mg O2/mg
Based on:
ThOD/L
Initial conc.:
3 other: mg/L, toxicity control
Based on:
test mat.
Initial conc.:
1.35 other: mg O2/mg, toxicity control
Based on:
ThOD/L
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
TEST SYSTEM
- Number of culture flasks/concentration: 3 (test substance); 2 (inoculum blank, toxicity control, reference substance)
- Test performed in closed vessels due to significant volatility of test substance: closed bottle test

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes; medium + inoculum
- Abiotic sterile control: no
- Toxicity control: yes; medium + inoculum + test item (3 mg/L) + reference substance (2 mg/L)
- Reference substance: medium + inoculum + reference substance (4 mg/L)
Reference substance:
benzoic acid, sodium salt
Parameter:
% degradation (O2 consumption)
Value:
51.2
Sampling time:
7 d
Parameter:
% degradation (O2 consumption)
Value:
53.7
Sampling time:
14 d
Parameter:
% degradation (O2 consumption)
Value:
54.4
Sampling time:
21 d
Parameter:
% degradation (O2 consumption)
Value:
53.7
Sampling time:
28 d
Details on results:
The biodegradation reached app. 52% 10 days after the beginning of biodegradation (10-d window). After 21 d a plateau was reached at app. 54.4% degradation.
The biodegradation in the toxicity control reached 68.2 (day 7) to 73.3% (day 28). The test substance showed no inhibitory effects to microorganisms.
Results with reference substance:
The reference substance degraded normally under the test conditions (80.1% after 14 d).

Biodegradation [%]

0 d

7 d

14 d

21 d

28 d

test substance

0

51.2

 

53.7

 

54.4

53.7

toxicity control

0

68.2

 

72.1

 

70.5

73.3

reference substance

0

79.4

80.1

75.3

77.5

Validity criteria fulfilled:
yes
Interpretation of results:
inherently biodegradable
Conclusions:
The ready biodegradability of TFMEA was studied according to OECD Guideline 301 D and EU method C.4-E (closed bottle test). After 28 d 53.7% biodegradation was observed. The pass level of 60% was not reached within the 10-d window as well as after 28 days of incubation and, therefore, the test substance cannot be termed as readily biodegradable. According to the Guidance on information requirements and chemical safety assessment, Chapter R.7b, version 1.1, May 2008, the test substance can be termed as inherently biodegradable.
The test item showed no inhibitory effects to microorganisms.
Executive summary:

The ready biodegradation of TFMEA was investigated in a study conducted according to OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test), adopted 17 July 1992 and EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test), over a period of 28 days. The type of inoculum was not specified in the study report. The biodegradation rate was determined by measurement of O2 consumption. Inoculum blank and procedural/functional control with the reference substance sodium benzoate were performed.

The functional control reached the pass level >60% after 7 d. The biodegradation of the test substance reached 52% 10 days after the beginning of biodegradation (10 d window). After 21 d, a plateau was reached at 54.4% degradation. The pass level of 60% was not reached within the test period.

According to the Guidance on information requirements and chemical safety assessment, Chapter R.7b, version 1.1, May 2008, the test substance can be termed as inherently biodegradable, as the pass level was almost reached.

 

The biodegradation in the toxicity control reached 68.2 (day 7) to 73.3% (day 28). The test substance showed no inhibitory effects to microorganisms.

Description of key information

Inherently biodegradable; OECD Guideline 301 D/EU method C.4-E (closed bottle);
Not inhibitory to microorganisms

Key value for chemical safety assessment

Biodegradation in water:
inherently biodegradable

Additional information

One reliable (RL=2), relevant and adequate study on the biodegradation of TFMEA is available:

The ready biodegradation of TFMEA was investigated in a study conducted according to OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test), adopted 17 July 1992 and EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test), over a period of 28 days. The type of inoculum was not specified in the study report. The biodegradation rate was determined by measurement of O2 consumption. Inoculum blank and procedural/functional control with the reference substance sodium benzoate were performed.

The functional control reached the pass level >60% after 7 d. The biodegradation of the test substance reached 52% 10 days after the beginning of biodegradation (10 d window). After 21 d, a plateau was reached at 54.4% degradation. The pass level of 60% was not reached within the test period.

According to the Guidance on information requirements and chemical safety assessment, Chapter R.7b, version 1.1, May 2008, the test substance can be termed as inherently biodegradable, as the pass level was almost reached.

The biodegradation in the toxicity control reached 68.2 (day 7) to 73.3% (day 28). The test substance showed no inhibitory effects to microorganisms.