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:
21 May to 25 Jul 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Qualifier:
according to
Guideline:
EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)
GLP compliance:
yes (incl. certificate)
Remarks:
(Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,2-bi s[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate - Physical state: liquid- Analytical purity: 98 % (GC)- Lot/batch No.: CEL 2011-171- Expiration date of the lot/batch: 21 Jul n2016- Storage condition of test material: room temperature

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Details on inoculum:
- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Activated sludge from the ESN sewage treatment plant, NW-Lachen-Speyerdorf, Germany - Laboratory culture: no- Pretreatment: The sludge was filtrated, washed with tap water twice, then washed with and re-suspended in test medium. It was then aerated or >= 12 hours. The dry matter was determined with 4520 mg suspended solids/litre.
Duration of test (contact time):
60 d
Initial test substance concentrationopen allclose all
Initial conc.:
29.5 mg/L
Based on:
test mat.
Initial conc.:
28.4 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
TEST CONDITIONS- Composition of medium: according to the guildeline- Test temperature: 19.8 - 22.5 °C- pH adjusted: no- Continuous darkness: yesTEST SYSTEM- Culturing apparatus: 2000 mL SCHOTT flasks- Number of culture flasks/concentration: 2- Method used to create aerobic conditions: The test vessels were aerated with purified CO2-scrubbed, moistened air.- Measuring equipment: Carbon analyser TOC multi N/C 2100S, Analytik Jena- Details of trap for CO2 and volatile organics if used: The scrubbing of carbon dioxide was achieved by bubbling the purified air through a flask containing 1.5 m NaOH. To control the absence of CO2, the air was then led through a flask containing a solution of Ba(OH)2 before reaching the test vessels. The emitted CO2 was trapped in 0.25 m NaOH. Two scrubbers containing 100 mL each were connected in series to the test vessels. The initial IC value of the 0.25 m NaOH was separately determined in each flask.SAMPLING- Sampling frequency: rom each flask samples were taken on day 0, 2, 4, 7, 9, 11, 14, 18, 29, 35, 42, 49, 56 and 60- Sampling method: From each scrubber flask, fifteen samples were taken in order to determine the emitted CO2. The sample volume was 1 mL. The resulting change in the volume of the front flask was considered in the calculation of emitted CO2. On day 59, 5 mL HCL 2 m. were added to each flask in order to drive off dissolved CO2. On day 60, samples from both scrubber test flask were taken. CONTROL AND BLANK SYSTEM- Inoculum blank: yes, 2 replicates- Abiotic sterile control: yes, 1 bottle- Toxicity control: yes, 1 bottle- Positive control: yes, 2 replicates
Reference substance
Reference substance:
aniline
Remarks:
(nominal concentration: 2.1 g/L)

Results and discussion

% Degradation
Parameter:
% degradation (CO2 evolution)
Value:
6
Sampling time:
60 d
Details on results:
The test substance reached 6 % degradation after 60 d. Therefore, the test item was considered to be not ready biodegradable.

BOD5 / COD results

Results with reference substance:
Degradation: 84.8 % after 14 days, 60 % pass level was reached.

Any other information on results incl. tables

Degradation values:

Day

Positive Control 1

Positive Control 2

Positive Control Mean

Test 1

Test 2

Test Mean

Abiotic Control

Toxicity Control

2

2.0

-0.3

0.8

-0.4

0.9

0.2

-1.4

-0.1

4

17.8

25.7

21.7

0.0

1.0

0.5

-1.2

4.5

7

47.8

51.9

49.9

2.1

2.6

2.3

1.9

16.9

9

68.6

68.4

68.5

0.1

3.0

1.5

-0.5

23.3

11

78.6

72.3

75.4

1.4

4.2

2.8

-0.9

31.0

14

89.1

80.5

84.8

6.9

3.4

5.1

-1.7

34.3

18

81.7

80.5

81.1

1.3

2.9

2.1

-1.9

35.1

23

92.7

86.3

89.5

1.8

2.3

2.0

-1.8

41.5

29

91.3

83.6

87.4

1.4

2.8

2.1

-1.3

44.7

35

75.6

73.6

74.6

0.9

2.2

1.5

-2.6

39.8

42

81.7

77.2

79.4

3.8

4.9

4.4

-2.2

40.0

49

78.0

77.9

77.9

0.8

2.4

1.6

-3.6

39.8

56

79.0

77.4

78.2

2.1

3.8

3.0

-3.8

40.1

60

86.7

79.4

83.0

5.2

6.6

5.9

-4.1

41.2

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Interpretation of results:
under test conditions no biodegradation observed