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EC number: 208-293-9 | CAS number: 520-45-6
- 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
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The source chemical is the sodium salt of the target. As such, both the source and the target are anticipated to behave similarly in aqueous systems.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: Dehydroacetic acid, sodium salt [EC 224-580-1; CAS 4418-26-2]. Composition provided in TMI.
Target: Dehydroacetic acid [EC 208-293-9; CAS 520-45-6]. Purity/impurity profile as described in Section 1.2
3. ANALOGUE APPROACH JUSTIFICATION
Screening studies available in the literature for the target chemical show that this substance is biodegradable (MITI test, OECD Screening test, Closed bottle test). These results support read-across to the source chemical which was found to be readily biodegradable meeting the 10 d-window (70% after 28 d, OECD 301 F).
4. DATA MATRIX: Refer to analogue justification provided in IUCLID section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Duration of test (contact time):
- 28 d
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 70
- Sampling time:
- 28 d
- Remarks on result:
- other: mean of replicates
- Results with reference substance:
- The pass level for ready biodegradation (> 60% degradation) was reached on Day 3. The validity criterion that the devgradation should by > 60% after 14 d was fulfilled.
Stages of Biodegradation: The adaptation phase changed to degradation phase within 2 d (degradation > 10%) and the biodegradation reached a maximum of 92% on Day 23. - Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- After a test period of 28 d, the test item is classified as readily biodegradable within the 10 d window and within the 28 d period of the study.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Oct - 22 Nov 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Version / remarks:
- 17 Jul 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Staatliches Gewerbeaufsichtsamt Hildesheim, Germany
- 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 (aeration with CO2-free air)
- Storage length: 6 d
- Preparation of inoculum for exposure: aqueous phase of non-adapted activated sludge
- 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 was maintained in aerobic conditions by aeration during 2.5 h. 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 d.
- Initial cell/biomass concentration of the inoculum: 1.18E+09 colony forming units/L (standard dilution plate count) - Duration of test (contact time):
- 28 d
- Initial conc.:
- 51.3 mg/L
- Based on:
- ThOD
- Initial conc.:
- 38 mg/L
- Based on:
- test mat.
- 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: 20.5 - 21.1°C
- pH: 7.68 - 7.78 (at test start), 7.66 - 8.07 (at test end)
- Colony forming units (CFU) in the test vessels: approximately 1.18E+07 CFU/L
- Continuous darkness: Yes, in an incubator.
- Other: Continuous stirring
TEST SYSTEM
- Culturing apparatus: brown glass bottles (500 mL)
- Number of culture flasks/concentration: 2
- Method used to create aerobic conditions: Aeration with CO2-free air.
- Measuring equipment: OxiTop measuring heads, WTW
- Test performed in open system: No, the bottles were closed with OxiTop measuring heads.
- Details of trap for CO2 and volatile organics if used: A rubber sleeve with soda lime was hung into the bottles to absorb evolved CO2.
- Other: Test volume: 250 mL
SAMPLING
- Sampling frequency: The oxygen consumption was determined in the incubation vessels by the OxiTop measuring system every 112 min during the 28 d incubation period (360 measuring points).
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 replicates containing mineral medium stock solutions, ultrapure water and inoculum.
- Functional control: 1 replicate containing reference item (45 mg/L = 75.2 mg O2/L) dissolved in mineral medium stock solutions, ultrapure water and inoculum.
- Toxicity control: 1 replicate containing the test item and reference item dissolved in mineral medium stock solutions, ultrapure water and inoculum.
- Other: Separate replicates of the test item and toxicity control were prepared for measurement of the pH-value at test start. - Reference substance:
- benzoic acid, sodium salt
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 70
- Sampling time:
- 28 d
- Remarks on result:
- other: mean of replicates
- Results with reference substance:
- The pass level for ready biodegradation (> 60% degradation) was reached on Day 3. The validity criterion that the devgradation should by > 60% after 14 d was fulfilled.
Stages of Biodegradation: The adaptation phase changed to degradation phase within 2 d (degradation > 10%) and the biodegradation reached a maximum of 92% on Day 23. - Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- After a test period of 28 d, the test item is classified as readily biodegradable within the 10 d window and within the 28 d period of the study.
- Endpoint:
- biodegradation in water: screening test, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- A number of different tests were included in this study: The coupled units test, Zahn-Wellens test, Japanese MITI test, Modified OECD screening test, closed bottle test.
- GLP compliance:
- no
- Parameter:
- % degradation (DOC removal)
- Value:
- 99
- Remarks on result:
- other: Coupled units test
- Parameter:
- % degradation (DOC removal)
- Value:
- 96
- Sampling time:
- 6 d
- Remarks on result:
- other: Zahn-Wellens test
- Parameter:
- % degradation (DOC removal)
- Value:
- 91
- Sampling time:
- 14 d
- Remarks on result:
- other: MITI test
- Parameter:
- % degradation (O2 consumption)
- Value:
- 77
- Sampling time:
- 14 d
- Remarks on result:
- other: MITI test
- Parameter:
- % degradation (DOC removal)
- Value:
- 98
- Sampling time:
- 19 d
- Remarks on result:
- other: OECD Screening test
- Parameter:
- % degradation (O2 consumption)
- Value:
- 81
- Sampling time:
- 30 d
- Remarks on result:
- other: Closed bottle test
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test item was found to be biodegradable in all the tests employed.
Referenceopen allclose all
Both test item replicates reached the 10% level (beginning of biodegradation) on Day 6. The mean of replicates reached the 60% pass level on Day 13. The mean biodegradation on Day 28 was 70%.
In the toxicity control the biodegradation achieved 84% after 14 d and 92% after 28 d. The validity criterion that the test item should not inhibit the biodegradation of the reference item was fulfilled.
Table 1. Biodegradation [%] of the Test Item in Comparison to the Functional Control and Toxicity Control.
Date |
|
Functional Control
|
Biodegradation [%] |
|
Toxicity Control: Test Item + Reference Item |
|
[d] |
R1 |
P1 |
P2 |
T1 |
2016-10-26 |
1 |
7 |
0 |
0 |
5 |
2016-10-27 |
2 |
52 |
0 |
3 |
36 |
2016-10-28 |
3 |
65 |
0 |
4 |
42 |
2016-10-29 |
4 |
75 |
0 |
6 |
49 |
2016-10-30 |
5 |
79 |
4 |
7 |
51 |
2016-10-31 |
6 |
81 |
32 |
21 |
53 |
2016-11-01 |
7 |
83 |
47 |
46 |
61 |
2016-11-02 |
8 |
84 |
52 |
52 |
73 |
2016-11-03 |
9 |
86 |
54 |
54 |
77 |
2016-11-04 |
10 |
86 |
56 |
57 |
79 |
2016-11-05 |
11 |
87 |
57 |
59 |
81 |
2016-11-06 |
12 |
88 |
59 |
60 |
82 |
2016-11-07 |
13 |
88 |
61 |
62 |
83 |
2016-11-08 |
14 |
89 |
61 |
63 |
84 |
2016-11-09 |
15 |
90 |
64 |
65 |
86 |
2016-11-10 |
16 |
86 |
60 |
62 |
84 |
2016-11-11 |
17 |
87 |
60 |
61 |
85 |
2016-11-12 |
18 |
89 |
60 |
62 |
86 |
2016-11-13 |
19 |
88 |
63 |
63 |
87 |
2016-11-14 |
20 |
87 |
64 |
64 |
87 |
2016-11-15 |
21 |
89 |
63 |
65 |
87 |
2016-11-16 |
22 |
88 |
63 |
67 |
88 |
2016-11-17 |
23 |
92 |
67 |
70 |
91 |
2016-11-18 |
24 |
92 |
68 |
71 |
92 |
2016-11-19 |
25 |
91 |
68 |
71 |
91 |
2016-11-20 |
26 |
90 |
67 |
70 |
91 |
2016-11-21 |
27 |
91 |
67 |
72 |
92 |
2016-11-22 |
28 |
91 |
67 |
72 |
92 |
Both test item replicates reached the 10% level (beginning of biodegradation) on Day 6. The mean of replicates reached the 60% pass level on Day 13. The mean biodegradation on Day 28 was 70%.
In the toxicity control the biodegradation achieved 84% after 14 d and 92% after 28 d. The validity criterion that the test item should not inhibit the biodegradation of the reference item was fulfilled.
Table 1. Biodegradation [%] of the Test Item in Comparison to the Functional Control and Toxicity Control.
Date |
|
Functional Control
|
Biodegradation [%] |
|
Toxicity Control: Test Item + Reference Item |
|
[d] |
R1 |
P1 |
P2 |
T1 |
2016-10-26 |
1 |
7 |
0 |
0 |
5 |
2016-10-27 |
2 |
52 |
0 |
3 |
36 |
2016-10-28 |
3 |
65 |
0 |
4 |
42 |
2016-10-29 |
4 |
75 |
0 |
6 |
49 |
2016-10-30 |
5 |
79 |
4 |
7 |
51 |
2016-10-31 |
6 |
81 |
32 |
21 |
53 |
2016-11-01 |
7 |
83 |
47 |
46 |
61 |
2016-11-02 |
8 |
84 |
52 |
52 |
73 |
2016-11-03 |
9 |
86 |
54 |
54 |
77 |
2016-11-04 |
10 |
86 |
56 |
57 |
79 |
2016-11-05 |
11 |
87 |
57 |
59 |
81 |
2016-11-06 |
12 |
88 |
59 |
60 |
82 |
2016-11-07 |
13 |
88 |
61 |
62 |
83 |
2016-11-08 |
14 |
89 |
61 |
63 |
84 |
2016-11-09 |
15 |
90 |
64 |
65 |
86 |
2016-11-10 |
16 |
86 |
60 |
62 |
84 |
2016-11-11 |
17 |
87 |
60 |
61 |
85 |
2016-11-12 |
18 |
89 |
60 |
62 |
86 |
2016-11-13 |
19 |
88 |
63 |
63 |
87 |
2016-11-14 |
20 |
87 |
64 |
64 |
87 |
2016-11-15 |
21 |
89 |
63 |
65 |
87 |
2016-11-16 |
22 |
88 |
63 |
67 |
88 |
2016-11-17 |
23 |
92 |
67 |
70 |
91 |
2016-11-18 |
24 |
92 |
68 |
71 |
92 |
2016-11-19 |
25 |
91 |
68 |
71 |
91 |
2016-11-20 |
26 |
90 |
67 |
70 |
91 |
2016-11-21 |
27 |
91 |
67 |
72 |
92 |
2016-11-22 |
28 |
91 |
67 |
72 |
92 |
Description of key information
Readily biodegradable within the 10 d-window (70% after 28 d, OECD 301 F, RA-A CAS 4418-26-2)
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
There is no study available investigating the ready biodegradability of the substance to modern guidelines. However, data is available from a GLP study on a structural analogue (DHA-Na, CAS 4418-26-2, source substance), which was conducted according to the OECD guideline 301 F. Due to the high chemical and structural similarity of the two substances as well as the higher water solubility of the source substance (worst-case), the results of this study are considered a justified estimate of the biodegradability of the target substance.
In the Manometric Respirometry Test, a nominal concentration of 38 mg/L source substance (equivalent to 51.3 mg ThO2/L) was inoculated with 1.18 1E7 colony forming units/L non-adapted, activated sludge over a period of 28 d. Degradation was followed by continuously measuring oxygen concentration in the test bottles. Inoculum, functional and toxicity controls were run in parallel. The percentage biodegradation was expressed in terms of biological oxygen demand.
On Day 28 the mean biodegradation of the test item was 70%. Both test item replicates reached the 10% level on Day 6 and the 60% pass level on Day13, thereby fulfilling the 10-d window. The toxicity control achieved 84% degradation within 14 d indicating no inhibitory effect of the test item on the metabolic activity of the inoculum. Therefore, the test item is classified as readily biodegradable.
This conclusion is supported by a screening study available in the literature in which the biodegradability of the substance was tested in a range of methods - the coupled units test, the Zahn-Wallens test, the Japanese MITI test, the modified OECD screening test and the closed bottle test. High levels of biodegradability were reported for each test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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