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EC number: - | CAS number: -
- 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
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Feb - 04 Jul 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)
- Version / remarks:
- March 2006
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Staatliches Gewerbeaufsichtsamt Hildesheim, Germany (03.01.2017)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge: Municipal sewage treatment plant, Hildesheim, Germany
- Storage conditions: Aerobic conditions (aeration with CO2-free air)
- Storage length: 7 d
- Pretreatment: The activated sludge was washed twice with chlorine free tap water. After the second washing, the settled sludge was resuspended in mineral salts medium and maintained for 2 h in aerobic conditions. Then, the sludge was homogenized with a blender. After sedimentation the supernatant was decanted and maintained in aerobic conditions by aeration with CO2-free air for 7 d (1st definitive study)/5 d (second definitive study) until test start.
- Initial cell/biomass concentration (in test vessel): 1.73E07 CFU/L (1st study); 1.55E07 CFU/L (2nd study) - Duration of test (contact time):
- 28 d
- Initial conc.:
- 26.4 mg/L
- Based on:
- test mat.
- Initial conc.:
- 19.8 mg/L
- Based on:
- other: Carbon content: mg C/L
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Remarks:
- TIC analysis
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Mineral salts medium according to OECD 310
- Test temperature: 19.0 °C - 21.0 °C (1st study); 19.0 - 20.2 °C (2nd study)
- Continuous darkness: No, low light conditions
- Agitation: Shaker (150 - 200 rpm)
TEST SYSTEM
- Culturing apparatus: 120 mL headspace flasks
- Number of culture flasks/concentration: Triplicates and 5 replicates at test end
- Measuring equipment: Carbon analyser, Multi N/C 3100, Analytik Jena
- Test performed in closed vessels due to significant volatility of test substance: Yes
- Other: Headspace to liquid ratio = 1:2
SAMPLING
- Sampling frequency: 1st study; Day 1, 4, 7, 11, 14, 21, and 28; 2nd study: Day 1, 3, 7, 10, 14, 21, and 28
- Other: The TIC of the sodium hydroxide solution (blind value) was determined at each sampling time.
CONTROL AND BLANK SYSTEM
- Functional control: 30 mg/L reference item (17.5 mg C/L) + inoculum (triplicates and 5 replicates at test end)
- Inoculum blank: Mineral salts medium + inoculum (triplicates and 5 replicates at test end)
- Toxicity control: Test item + 30 mg/L reference item + inoculum (triplicates and 5 replicates at test end) - Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 46
- Sampling time:
- 28 d
- Remarks on result:
- other: 95% confidence interval: 39 - 53%
- Remarks:
- 1st study
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 48
- Sampling time:
- 28 d
- Remarks on result:
- other: 95% confidence interval: 44 - 52%
- Remarks:
- 2nd study
- Details on results:
- FIRST DEFINITIVE STUDY
Test item
The biodegradation of the test item reached the 10% level (beginning of biodegradation) within 4 d. After 28 d biodegradation reached 46%. The 95% confidence interval on Day 28 was 39 - 53%.
Toxicity control
The toxicity control reached 59% biodegradation after 14 d and 37% after 28 d. Therefore, the biodegradation of the reference item was not inhibited by the test item. The 95% confidence interval on Day 28 was 27 - 46%.
SECOND DEFINITIVE STUDY
Test item
The 10% pass level was reached within 3 d. After 28 d biodegradation was 48%. The 95% confidence interval on Day 28 was 44 - 52%.
Toxicity control
Biodegradtion reached 55% on Day 14 and 62% on Day 28. Therefore, the test item did not inhibit the biodegradation of the reference item. The 95% confidence interval on Day 28 was 59 - 64%. - Results with reference substance:
- FIRST STUDY
The functional control reached the degradation phase (≥ 10% level) within 4 d. The course of the degradation phase was rapid and the pass level of 60% was reached within 7 d. Biodegradation peaked after 7 d at 67%. Therefore, the validity criterion of > 60% was fulfilled. The 95% confidence interval on Day 28 was 22 - 65%.
SECOND STUDY
The functional control reached the 10% pass level within 3 d. The degradation phase was rapid and reached the pass level of 60% within 3 d. Biodegradation peaked at 81% on Day 21. Therefore, the validity criterion of > 60% after 14 d was fulfilled. The 95% confidence interval on Day 28 was 78 - 81%. - Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The substance is not readily biodegradable according to the OECD 310 guideline criteria (48% within 28 d).
Reference
VALIDITY CRITERIA
Both definitive tests fulfilled the validity criteria defined by the guideline (Tables 1 and 2).
Table 1. Validity criteria (first study)
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The percentage degradation of the reference item must exceed the pass level of 60% by Day 14. |
Biodegradation of the functional control peaked at 67% after 7 d. |
Yes |
The mean amount of TIC present in the inoculum controls at the end of the test is < 3 mg C/L. |
The mean amount of TIC present in the inoculum controls on Day 28 is 1.77 mg C/L. |
Yes |
Table 2. Validity criteria (second study)
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The percentage degradation of the reference item must exceed the pass level of 60% by Day 14. |
Biodegradation of the functional control was 61% after 3 d. |
Yes |
The mean amount of TIC present in the inoculum controls at the end of the test is < 3 mg C/L. |
The mean amount of TIC present in the inoculum controls on Day 28 is 1.51 mg C/L. |
Yes |
RESULTS OF THE FIRST DEFINITIVE STUDY
Table 3. CO2 Production and Biodegradation in the test item samples of the first study.
|
CO2 production [mg C/L] |
|||||||
Day |
P1 |
P2 |
P3 |
P4 |
P5 |
MP |
Net MP |
Degr. [%] |
0 |
1.49 |
1.98 |
1.46 |
- |
- |
0.01 |
- |
- |
1 |
2.74 |
2.11 |
2.25 |
- |
- |
0.46 |
0.28 |
1 |
4 |
12.33 |
11.54 |
11.67 |
- |
- |
10.20 |
9.37 |
47 |
7 |
12.93 |
11.39 |
12.32 |
- |
- |
10.54 |
9.74 |
49 |
11 |
14.01 |
14.40 |
13.07 |
- |
- |
11.84 |
11.05 |
56 |
14 |
13.03 |
14.96 |
11.39 |
- |
- |
11.42 |
10.23 |
52 |
21 |
13.65 |
9.65 |
13.77 |
- |
- |
10.59 |
9.01 |
46 |
28 |
12.56 |
12.48 |
14.58 |
11.78 |
12.03 |
10.87 |
9.13 |
46 |
MP = mean values (NaOH corrected)
Net MP = netto mean production (corrected for inoculum control values)
Degr. = degradation
Table 4. Biodegradation and Confidence interval of the test item in comparison to the function control and the toxicity control of the first study
Replicates |
Biodegradation [%] on Day 28 |
Confidence interval on Day 28 |
||||
1 |
2 |
3 |
4 |
5 |
P = 95% |
|
Test item |
45 |
45 |
56 |
42 |
43 |
39 – 53 |
Function control |
66 |
25 |
56 |
30 |
41 |
22 – 65 |
Toxicity control |
26 |
35 |
39 |
47 |
37 |
27 - 46 |
RESULTS OF THE SECOND DEFINITIVE STUDY
Table 5. CO2 production and biodegradation in the test item samples of the second study.
|
CO2 production [mg C/L] |
|||||||
Day |
P1 |
P2 |
P3 |
P4 |
P5 |
MP |
Net MP |
Degr. [%] |
0 |
1.74 |
1.72 |
1.74 |
- |
- |
0.72 |
- |
- |
1 |
1.85 |
1.80 |
1.78 |
- |
- |
0.38 |
0.00 |
0 |
4 |
7.84 |
7.85 |
7.25 |
- |
- |
6.96 |
5.30 |
27 |
7 |
10.14 |
10.49 |
9.64 |
- |
- |
8.59 |
7.55 |
38 |
11 |
10.70 |
11.22 |
9.86 |
- |
- |
9.11 |
7.98 |
40 |
14 |
11.91 |
11.49 |
10.72 |
- |
- |
9.97 |
8.55 |
43 |
21 |
12.15 |
10.95 |
12.05 |
- |
- |
10.08 |
8.53 |
43 |
28 |
12.84 |
13.09 |
13.61 |
11.90 |
12.60 |
11.15 |
9.57 |
48 |
MP = mean values (NaOH corrected)
Net MP = netto mean production (corrected for inoculum control values)
Degr. = degradation
Table 6. Biodegradation and Confidence interval of the test item in comparison to the function control and the toxicity control of the second study
Replicates |
Biodegradation [%] on Day 28 |
Confidence interval on Day 28 |
||||
1 |
2 |
3 |
4 |
5 |
P = 95% |
|
Test item |
48 |
50 |
52 |
44 |
47 |
44 – 52 |
Function control |
78 |
81 |
79 |
79 |
79 |
78 – 81 |
Toxicity control |
64 |
59 |
61 |
62 |
62 |
59 - 64 |
Description of key information
Not readily biodegradable (48% within 28 d, OECD 310)
Key value for chemical safety assessment
- Biodegradation in water:
- inherently biodegradable
Additional information
There is one study available, in which the ready biodegradability of the substance was investigated according to OECD guideline 310 and GLP.
In the available study, two definitive studies were conducted due to the high confidence intervals measured in the replicates at the end of the (formally valid) first test. The second study confirmed the results of the first study and showed smaller confidence intervals, which is why it is considered more reliable.
In the conducted Headspace Test with a headspace to liquid ratio of 1:2, a nominal concentration of 26.4 mg/L test item (corresponding to a carbon content of 19.8 mg C/L) was inoculated with domestic activated sludge (1.73 E07 CFU/L) for 28 d. A functional, inoculum and toxicity control were run in parallel. The quantity of CO2 produced by the respiration of bacteria was followed by periodic analysis of total inorganic carbon (TIC).
After 28 d, biodegradation reached 46% in the first test and 48% in the second test. The functional controls in both tests confirmed the suitability of the inocula. Thus, it was concluded that the test item is not readily biodegradable according to guideline criteria. The toxicity controls in both studies showed that the test item did not inhibit the biodegradation of the test item at the tested concentrations.
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