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EC number: 812-962-6 | CAS number: 34354-88-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2017-08-31 to 2017-09-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Version / remarks:
- adopted 1992-07-17
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ceramide IIIB
- IUPAC Name:
- Ceramide IIIB
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- The test item was weighed out for each replicate and directly transferred into the test vessels with 250 mL of the inoculated test medium, using a 250 mL measuring flask.
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): Municipal sewage treatment plant, 31137 Hildesheim, Germany
- Receipt: 2017-08-24
- Pretreatment: The activated sludge was washed twice with chlorine free tap water. After the second washing the settled sludge was re-suspended in mineral salts medium and was maintained in an aerobic condition by aeration for 2 hours. Thereafter the sludge was homogenized with a blender. After sedimentation the supernatant was decanted and maintained in an aerobic condition by aeration with CO2-free air for 6 days. 10 mL/L were used to initiate inoculation.
- Colony forming units in the test vessels: approximately 1.00E+07 – 1.00E+08 CFU/L - Duration of test (contact time):
- 28 d
Initial test substance concentrationopen allclose all
- Initial conc.:
- 18 mg/L
- Based on:
- test mat.
- Remarks:
- ThOD: 2.80 mg O2/mg; ThOD NO3: 2.91 mg/ O2/mg
- Initial conc.:
- 50.4 g/L
- Based on:
- ThOD
Parameter followed for biodegradation estimation
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Mineral salts medium according to OECD 301 F
- Test temperature: 20.0 - 20.3 °C
- pH: start: 7.73, end: 7.67 - 7.93
- pH adjusted: no
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: dark brown bottles, 250ml
- Number of culture flasks/concentration:
two for the inoculum control (C1, C2)
one for the functional control (R1)
two for the test item (P1, P2)
one for the toxicity control (T1)
- Method used to create aerobic conditions: aeration 6 days
- Measuring equipment:
OxiTop OC110 controller with software Achat OC, WTW
OxiTop measuring heads, WTW
Climatic exposure test cabinet, RUMED Rubarth Apparate GmbH
pH-Meter, Multi 350i, WTW
Datalogger 174 T, Testo
Analytical balance, Sartorius
Balance, Kern
Multipette X-Stream, eppendorf
Spectralphotometer NANOCOLOR® UV/VIS, Macherey-Nagel
Test Kits: Nitrat 50, Nitrit 4, Nitrit 2, all by Macherey-Nagel
Various pipettes
CONTROL AND BLANK SYSTEM
- Inoculum blank: Inoculum Control: Test medium without test and / or reference item, 2 vessels
- Abiotic sterile control: functional control one vessel
- Toxicity control: one vessel
For further details on test system, please see section “any other information on materials and methods incl. tables”.
Reference substance
- Reference substance:
- benzoic acid, sodium salt
- Remarks:
- 45 mg/L
Results and discussion
% Degradation
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 62
- Sampling time:
- 28 d
- Remarks on result:
- other: biodegradation rate as % BOD
- Details on results:
- For a detailed description of results, please see section "any other information on results incl. tables".
BOD5 / COD results
- Results with reference substance:
- The percentage degradation of the reference substance sodium benzoate reached the pass level of 60 % within 3 days.
Any other information on results incl. tables
Results
Theoretical Oxygen Demand
The biodegradation in % was calculated based on the ThODNO3 of 2.91 mg O2/mg test item.
Colony Forming Units of the Inoculum
Colony forming units (CFU) of the inoculum were determined prior to test start by standard dilution plate count: 1.67E+09 CFU/L. The CFU concentration of the inoculum corresponds to approx. 1.67E+07 CFU/L in the final test solution.
Results of the Functional Control
The pass level for ready biodegradation (≥ 60 % degradation) was reached within 3 days. The validity criterion that the degradation should be ≥ 60 % after 14 d was fulfilled. Stages of Biodegradation: The adaptation phase changed to degradation phase within 2 days (degradation > 10 %) and the biodegradation came to a maximum of 100 % on day 19.
Results of the Toxicity Control
In the toxicity control the biodegradation achieved 69 % after 14 days. After 28 days the biodegradation came to 83 %. The validity criterion that the test item should not inhibit the biodegradation of the reference item was fulfilled.
Course and Stages of Biodegradation of Functional Control and Test Item
The biodegradation of the test item is shown in Table 1 and graphically presented 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) on day 5 and the 60 % pass level on day 27. The pass level of the 10-day-window was not fulfilled (< 40 % on Day 15). The mean biodegradation on day 28 was 62 %. For the calculation of the biodegradation, the ThODNO3 of 52.4 mg O2/L (i.e. with nitrification) was considered, since the concentration of nitrate increased during the test.
After a test period of 28 days, the test item is classified as readily biodegradable within the 28 day period of the study.
Table1: Biodegradation [%] of the Test Itemin Comparison to the Functional Control and Toxicity Control
|
Biodegradation [%] |
||||
|
Study Day [d] |
||||
|
Replicate |
7 |
14 |
21 |
28 |
Test Item |
1 |
18 |
36 |
51 |
64 |
2 |
17 |
34 |
46 |
60 |
|
Functional Control |
|
85 |
96 |
100 |
100 |
Toxicity Control |
|
56 |
69 |
77 |
83 |
Table2: Biological Oxygen Demand (BOD) of Inoculum Control, Functional Control and Toxicity Control
|
|
BOD |
||||||||
Date |
[d] |
Inoculum |
Functional |
Test Item |
Toxicity Control |
|||||
|
|
|
R1 |
P1 |
P2 |
T1 |
||||
|
|
mean |
gross |
net |
gross |
net |
gross |
net |
gross |
net |
2017-09-01 |
1 |
2.5 |
8.7 |
6.2 |
4.2 |
1.7 |
3.3 |
0.9 |
11.8 |
9.3 |
2017-09-02 |
2 |
3.0 |
45.8 |
42.9 |
5.3 |
2.3 |
4.4 |
1.5 |
48.8 |
45.8 |
2017-09-03 |
3 |
3.1 |
56.6 |
53.5 |
6.5 |
3.4 |
5.4 |
2.3 |
59.3 |
56.2 |
2017-09-04 |
4 |
3.0 |
61.4 |
58.4 |
8.1 |
5.1 |
7.6 |
4.6 |
66.0 |
62.9 |
2017-09-05 |
5 |
3.3 |
64.4 |
61.0 |
9.8 |
6.5 |
9.1 |
5.8 |
68.8 |
65.5 |
2017-09-06 |
6 |
3.2 |
65.7 |
62.5 |
11.3 |
8.1 |
10.5 |
7.4 |
71.4 |
68.3 |
2017-09-07 |
7 |
3.3 |
67.5 |
64.2 |
12.9 |
9.6 |
12.1 |
8.7 |
74.7 |
71.4 |
2017-09-08 |
8 |
4.3 |
70.6 |
66.3 |
15.1 |
10.8 |
14.6 |
10.3 |
78.8 |
74.5 |
2017-09-09 |
9 |
4.5 |
71.3 |
66.9 |
15.6 |
11.1 |
15.6 |
11.1 |
80.8 |
76.4 |
2017-09-10 |
10 |
3.6 |
71.0 |
67.4 |
16.1 |
12.5 |
16.0 |
12.4 |
82.6 |
79.0 |
2017-09-11 |
11 |
4.6 |
73.3 |
68.8 |
18.7 |
14.1 |
18.7 |
14.1 |
86.3 |
81.8 |
2017-09-12 |
12 |
4.5 |
74.6 |
70.1 |
20.3 |
15.8 |
20.5 |
15.9 |
89.3 |
84.8 |
2017-09-13 |
13 |
4.6 |
75.1 |
70.5 |
22.3 |
17.7 |
21.2 |
16.6 |
90.6 |
86.0 |
2017-09-14 |
14 |
5.3 |
77.2 |
71.9 |
24.2 |
18.9 |
23.1 |
17.8 |
93.6 |
88.4 |
2017-09-15 |
15 |
4.7 |
77.5 |
72.8 |
25.2 |
20.4 |
24.0 |
19.2 |
96.0 |
91.3 |
2017-09-16 |
16 |
4.9 |
77.9 |
73.0 |
26.0 |
21.1 |
24.4 |
19.5 |
95.9 |
91.0 |
2017-09-17 |
17 |
6.1 |
80.8 |
74.8 |
29.2 |
23.1 |
27.7 |
21.6 |
100.3 |
94.2 |
2017-09-18 |
18 |
5.5 |
80.1 |
74.5 |
29.5 |
23.9 |
27.3 |
21.7 |
99.6 |
94.1 |
2017-09-19 |
19 |
6.1 |
81.4 |
75.2 |
31.0 |
24.9 |
29.2 |
23.0 |
102.7 |
96.6 |
2017-09-20 |
20 |
6.0 |
81.9 |
75.9 |
32.1 |
26.1 |
29.7 |
23.7 |
103.7 |
97.7 |
2017-09-21 |
21 |
5.8 |
81.7 |
75.9 |
32.4 |
26.6 |
30.0 |
24.2 |
104.1 |
98.3 |
2017-09-22 |
22 |
6.1 |
82.6 |
76.4 |
34.0 |
27.9 |
32.0 |
25.8 |
106.2 |
100.1 |
2017-09-23 |
23 |
9.1 |
84.8 |
75.7 |
37.2 |
28.1 |
34.8 |
25.7 |
109.2 |
100.1 |
2017-09-24 |
24 |
6.4 |
83.2 |
76.8 |
36.1 |
29.6 |
33.8 |
27.4 |
108.7 |
102.3 |
2017-09-25 |
25 |
6.6 |
84.2 |
77.6 |
37.5 |
30.9 |
35.2 |
28.6 |
110.0 |
103.4 |
2017-09-26 |
26 |
7.1 |
84.8 |
77.6 |
38.9 |
31.8 |
36.5 |
29.4 |
111.6 |
104.5 |
2017-09-27 |
27 |
6.9 |
84.9 |
78.0 |
39.4 |
32.5 |
37.6 |
30.7 |
112.6 |
105.8 |
2017-09-28 |
28 |
7.5 |
85.4 |
78.0 |
41.1 |
33.6 |
39.1 |
31.7 |
113.8 |
106.3 |
Table3: Biodegradation [%] of the Test Itemin Comparison to the Functional Control and Toxicity Control
|
|
Biodegradation [%] |
|||
Date |
[d] |
Functional |
Test Item |
Toxicity Control |
|
|
|
R1 |
P1 |
P2 |
T1 |
2017-09-01 |
1 |
8 |
3 |
2 |
7 |
2017-09-02 |
2 |
57 |
4 |
3 |
36 |
2017-09-03 |
3 |
71 |
6 |
4 |
44 |
2017-09-04 |
4 |
78 |
10 |
9 |
49 |
2017-09-05 |
5 |
81 |
12 |
11 |
51 |
2017-09-06 |
6 |
83 |
16 |
14 |
53 |
2017-09-07 |
7 |
85 |
18 |
17 |
56 |
2017-09-08 |
8 |
88 |
21 |
20 |
58 |
2017-09-09 |
9 |
89 |
21 |
21 |
60 |
2017-09-10 |
10 |
90 |
24 |
24 |
62 |
2017-09-11 |
11 |
91 |
27 |
27 |
64 |
2017-09-12 |
12 |
93 |
30 |
30 |
66 |
2017-09-13 |
13 |
94 |
34 |
32 |
67 |
2017-09-14 |
14 |
96 |
36 |
34 |
69 |
2017-09-15 |
15 |
97 |
39 |
37 |
72 |
2017-09-16 |
16 |
97 |
40 |
37 |
71 |
2017-09-17 |
17 |
99 |
44 |
41 |
74 |
2017-09-18 |
18 |
99 |
46 |
41 |
74 |
2017-09-19 |
19 |
100 |
47 |
44 |
76 |
2017-09-20 |
20 |
100 |
50 |
45 |
77 |
2017-09-21 |
21 |
100 |
51 |
46 |
77 |
2017-09-22 |
22 |
100 |
53 |
49 |
78 |
2017-09-23 |
23 |
100 |
54 |
49 |
78 |
2017-09-24 |
24 |
100 |
57 |
52 |
80 |
2017-09-25 |
25 |
100 |
59 |
55 |
81 |
2017-09-26 |
26 |
100 |
61 |
56 |
82 |
2017-09-27 |
27 |
100 |
62 |
59 |
83 |
2017-09-28 |
28 |
100 |
64 |
60 |
83 |
pH-Values at Test Start and Test End
The pH-values of the samples were measured at test start and test end (day 28). The results are given inTable 4.
Table4: pH-Values at Test Start and Test End. 1), 2) = First, second replicate
|
pH-Value |
|
Start |
End |
|
Inoculum Control |
7.73 |
1) 7.67 |
2) 7.66 |
||
Functional Control |
7.74 |
7.83 |
Test Item |
7.75 |
1) 7.69 |
2) 7.65 |
||
Toxicity Control |
7.74 |
7.93 |
Determination of oxidized Nitrogen Species at Test End
At
test end, the concentration of nitrite and nitrate was determined by
photometric measurement from aliquots of the control and test item
replicates (Table
5).
The corresponding oxygen consumption was calculated with the factors
3.43 for nitrite and 4.57 for nitrate, as given in
OECD 301F. The increase of the nitrate concentration indicates
nitrification. Therefore, the values of the biodegradation were
calculated based upon the ThODNO3.
Table5: Nitrite and Nitrate Concentrations at Test End
Nitrite- |
Nitrate-N |
corresponding Oxygen |
Biodegradation |
Biodegradation |
|
|
[mg/L] |
[mg/L] |
[mg/L] |
[%] |
[%] |
Inoculum Control C1 |
0 |
0 |
0 |
- |
- |
Inoculum Control C2 |
0.003 |
0 |
0 |
- |
- |
Test item repl. P1 |
0 |
0.9 |
4.1 |
67 |
64 |
Test item repl. P2 |
0 |
0.8 |
3.7 |
63 |
60 |
Validity Criteria
The study was performed according to OECD Guideline 301 F and GLP principles. The validity criteria were fulfilled according to the guideline:
· The
percentage degradation of the functional control reached the pass level
of 60 %
within 3 days (validity criterion: 60 % after 14 days).
· The
mean oxygen depletion in the inoculum control was 7.5 mg oxygen/L on day
28
(validity criterion: < 60 mg oxygen/L).
· The pH-value of all test replicates was in the range of 6.0 - 8.5 at the end of the test.
· The difference of extremes of replicate values of removal of the test item at the end of the test was less than 20 % (4% difference on day 28).
· The
percentage degradation of the toxicity control reached the pass level of
25 % within
2 days (validity criterion: 25 % after 14 days).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable, but failing 10-day window
- Conclusions:
- After a test period of 28 days, the test item was classified as readily biodegradable within the 28 day period of the study but failed the 10-day window.
- Executive summary:
The ready biodegradability of Ceramide IIIB was determined with non-adapted activated sludge in the Manometric Respirometry Test for a period of 28 days. The study was conducted according to OECD guideline 301 F. The concentration of Ceramide IIIB selected as appropriate was 18 mg/L, corresponding to a ThOD of 50.4 mg O2/L (52.4 mg O2/L with nitrification) per test vessel. The oxygen was depleted by the respiration of bacteria and the degradation was followed by measuring the oxygen concentration. The biodegradation rate is therefore expressed as the percentage BOD (biological oxygen demand) and was calculated for each study day.
The mean oxygen depletion in the inoculum control was 7.5 mg O2/L on day 28.
Sodium benzoate was used as functional control. The pass level > 60 % was reached within 3 days. The biodegradation reached a maximum of 100 % degradation on day 19.
In the toxicity control containing both test and reference item 69 % degradation occurred within 14 days. After 28 days the biodegradation came to 83 %. The degradation of the reference item was not inhibited by Ceramide IIIB.
The mean of replicates reached the 10 % level (beginning of biodegradation) on day 5 and the 60 % pass level on day 27. The mean biodegradation on day 28 was 62 %. For the calculation of the biodegradation, the ThODNO3 of 52.4 mg O2/L (i.e. with nitrification) was considered, since the concentration of nitrate increased during the test.
The validity criteria of the guideline are fulfilled.
Ceramide IIIB is classified as readily biodegradable within the 28 day period of the study, but failing the 10-day window.
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