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EC number: 249-120-7 | CAS number: 28645-51-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: "Microbial degradation test of chemical substances," specified in the notification concerning "Test Methods of New Chemical Substances etc."
- Version / remarks:
- (Notification No. 1121002 of Pharmaceutical and Food Safety Bureau, MHLW, dated on Nov. 21, 2003, Notification No. 2 of Manufacturing Industries Bureau, METI, dated on Nov. 13, 2003, and Notification No. 031121002 of Policy Planning Division, Environmental Health Department, Environmental Policy Bureau, MOE, finally revised on Nov. 20, 2006)
- Principles of method if other than guideline:
- Biodegradation study was conducted for 28 days for evaluating the percentage biodegradability of test chemical.
- GLP compliance:
- yes
- Oxygen conditions:
- not specified
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Sludge (surface water containing surface soils from rivers, lakes and marshes and inland seas and returned sludge from sewage treatment plants) was collected at 10 sites in Japan.
- Preparation of inoculum for exposure: The activated sludge was incubated in synthetic sewage (purified water containing glucose, peptone and potassium dihydrogen phosphate at a pH adjusted to 7.0±1.0) for 19 hrs.
- Concentration of sludge: 30 mg/l (as suspended solid concentration) - Duration of test (contact time):
- 28 d
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Parameter followed for biodegradation estimation:
- other: GC
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Three millilters of the solution in the composition A, B, C, or D specified in JIS K0102-2010 21 was added to purified water to make a solution of 1 L.
- Test temperature: 25±1°C
- pH: 7.0
- pH adjusted: yes, pH was adjusted to 7.0
- Suspended solids concentration: 30 mg/l
- Continuous darkness: Yes, test was performed under shaded condition.
- Other: Agitation method: revolutional agitation with stirrer.
TEST SYSTEM
- Culturing apparatus: culture bottle (300 ml) (improved culture bottle).
- Number of culture flasks/concentration: 6
- Measuring equipment: Closed-system oxygen consumption measuring apparatus.
- Details of trap for CO2 and volatile organics if used: Soda lime No.1 (Wako Pure Chemical Industries, Ltd. for absorption of carbon dioxide).
- Other: Tubes with stopcock were used for connection of the test containers and the measurement unit.
Constant temperature bath (equipped with measurement unit): AI-0001
CONTROL AND BLANK SYSTEM
- Inoculum blank: sludge blank system was used. - Reference substance:
- aniline
- Preliminary study:
- Yes, preliminary test was performed.
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 94
- Sampling time:
- 28 d
- Remarks on result:
- other: Other details not known
- Key result
- Parameter:
- other: GC
- Value:
- 100
- Sampling time:
- 28 d
- Remarks on result:
- other: Other details not known
- Details on results:
- Test chemical undergoes 94 and 100% degradation by oxygen consumption and GC parameter in 28 days.
- Results with reference substance:
- Reference substance aniline undergoes 77% degradation after 28 days.
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The average percentage degradation of test chemical was determined to be 94 and 100% by oxygen consumption and GC parameter in 28 days. The amount of DOC detected was less than 1 mgC, indicating that no water-soluble products were formed. Thus, based on percentage degradation, test chemical is considered to be readily biodegradable in water.
- Executive summary:
Biodegradation study of the test chemical was carried out with a total duration period of 28 days.The test chemical was considered to be 100% pure.Specific density of the test substance is 0.9520 (20/4ᵒC). Identity of test substance was confirmed by comparing the infrared absorption spectrum of the sample provided by the sponsor with that of the sample tested in the test facility. Activated sludge was used as a test inoculum obtained fromsludge (surface water containing surface soils from rivers, lakes and marshes and inland seas and returned sludge from sewage treatment plants) was collected at 10 sites in Japan. The activated sludge was incubated insynthetic sewage (purified water containing glucose, peptone and potassium dihydrogen phosphate at a pH adjusted to7.0±1.0) for 19 hrs. Conc. of inoculum used for the study is 30 mg/l and initial test substance conc. used for the study was 100 mg/l. The test substance was stored at room temperature in dark place. Aniline was used as a reference substance for the study.The suspended solid conc. was measured for determination of the activated sludge added. Measurement method used was according to JIS K0102-2010 14. After measurement, the suspended solid concentration of the activated sludge was determined to be 2660 mg/L.Sufficiently high activity of the activated sludge was confirmed by using aniline.Change in the BOD of the test solution was monitored continuously with a closed-system oxygen consumption measuring apparatus during the culture period. The temperature of the closed-system oxygen consumption measuring apparatus in the constant temperature bath was recorded every day. After the culture period, the test substance in the test solution was analyzed. From the preliminary test, it was found that the test substance is not soluble in the test solution. The dissolved organic carbon (DOC) in the test solutions of the (sludge + test substance) systems and the sludge blank system was analyzed for confirmation of whether there are water-soluble products generated. Analytical methods involve the pretreatment of the test solution of the (water + test substance) system was done to prepare a gas chromatography sample (GC) sample for analysis of the test substance. Pretreatment was also done of test solution of the (sludge + test substance) system and a sludge blank system to prepare total organic carbon analysis (TOC) samples for analysis of DOC (Dissolved Organic Carbon) and gas chromatography (GC) samples for analysis of the test substance. Quantification of the test substance was done by gas chromatography (GC).The average recovery rate of each test solution was 90% or more and the variability was within 5%.The test is carried at a temperature of 25±1°C with a duration period of 28 days. Reference substance aniline undergoes 77% degradation after 28 days. The average percentage degradation of test chemical was determined to be 94 and 100% by oxygen consumption and GC parameter in 28 days. The amount of DOC detected was less than 1 mgC, indicating that no water-soluble products were formed. Thus, based on percentage degradation, test chemical is considered to be readily biodegradable in nature.
Reference
Table: Calculation table for percentage biodegradation by BOD.
Study No.15581
Duration of cultivation:28 days
Vessel no. |
28thday |
Mean |
|
BOD (mg) |
Deg. (%) |
Deg. (%) |
|
6 |
77.1 |
77 |
- |
5 |
7.8 |
- |
- |
2 |
86.5 |
94 |
94 |
3 |
85.3 |
93 |
|
4 |
88.0 |
96 |
|
1 |
0.7 |
- |
- |
Deg.:Percentage biodegradation
Vessel no. 6 : Sludge + aniline
Vessel no. 5 : Control blank (B)
Vessel no. 2, 3, 4: Sludge + test item
Vessel no. 1 : Water + test item
Formula:
Deg. (%) = [BOD-B]/ [TOD] × 100%
Where,
TOD of test item = 83.7 mg
TOD of aniline = 90.3 gm
Table: Analytical results of test solutions.
|
(Water + test substance) system |
(Sludge + test substance) system |
Theoretical amount |
|||
1 |
2 |
3 |
4 |
|||
BOD*1 |
mg |
0.7 |
78.7 |
77.5 |
80.2 |
83.7 |
Amount of DOC detected and detection rate*1*2 |
mgC |
- |
0.4 |
0.5 |
0.8 |
22.8 |
% |
- |
2 |
2 |
4 |
- |
|
Test substance residual amount and residual rate (GC) |
mg |
29.1 |
0 |
0 |
0 |
30.0 |
% |
97 |
0 |
0 |
0 |
- |
Note: *1 The value of the (sludge + test substance) system was shown, as it is subtracted by the value of the sludge blank system.
*2 The (sludge + test substance) systems and the sludge blank system were analyzed to examine whether there was water-soluble products generated.
Table: Percentage degradability by BOD and GC.
|
(Sludge + test substance) system |
||||
2 |
3 |
4 |
Average |
||
BOD degradability |
% |
94 |
93 |
96 |
94 |
Test substance degradability (GC) |
% |
100 |
100 |
100 |
100 |
Table: Calculation table for percentage biodegradation by BOD
Study No. 15581
Duration of cultivation: 28 days
Vessel no. |
7thday |
14thday |
21stday |
28thday |
Mean |
||||
BOD (mg) |
Deg. (%) |
BOD (mg) |
Deg. (%) |
BOD (mg) |
Deg. (%) |
BOD (mg) |
Deg. (%) |
Deg. (%) |
|
6 |
60.9 |
65 |
72.5 |
75 |
75.1 |
76 |
77.1 |
77 |
- |
5 |
2.3 |
- |
5.1 |
- |
6.5 |
- |
7.8 |
- |
- |
2 |
40.8 |
46 |
64.4 |
71 |
80.8 |
89 |
86.5 |
94 |
94 |
3 |
22.4 |
24 |
48.5 |
52 |
73.2 |
80 |
85.3 |
93 |
|
4 |
43.2 |
49 |
63.2 |
69 |
79.7 |
87 |
88.0 |
96 |
|
1 |
0.0 |
- |
0.0 |
- |
0.0 |
- |
0.7 |
- |
- |
Deg.: Percentage biodegradation
Vessel no. 6 : Sludge + aniline
Vessel no. 5 : Control blank (B)
Vessel no. 2, 3, 4 : Sludge + test item
Vessel no. 1 : Water + test item
Test item of 30 mg was added
Deg. = [BOD-B]/ [TOD] × 100%
TOD of test item: 83.7 (mg)
C16H28O2+ 22O2 → 16O2+ 14H2O
22O2/ C16H28O2= 703.97/252.39 = 2.79
TOD = 30 × 2.79 = 83.7 (mg)
TOD of aniline: 90.3 (mg)
C6H7N + 8.75O2→ 6CO2+ 3.5H2O + NO2
8.75O2/ C6H7N = 279.99/93.13 = 3.01
TOD = 30 × 3.01 = 90.3 (mg)
Table: Calculation table for percentage detection of DOC
Study No. 15581
Sample description |
A |
D |
E |
F |
Water blank |
n.d |
|
|
|
(2) Sludge + test item |
2.6 |
0.4 |
2 |
|
(3) Sludge + test item |
3.0 |
0.5 |
2 |
2 |
(4) Sludge + test item |
4.1 |
0.8 |
4 |
|
(5) Control blank |
1.4 |
|
|
|
Amount of test item added: 30 mg
Theoretical amount of carbon: 22.8 mgC 30 × 16C/ C16H28O2
A: Measured value (mgC/L)
B: Final volume: 40 mL
C: Ratio of portion used for analysis: 40/300
D: Detection amount of DOC
Ds= ( A(Sludge + test item) – A(Control blank) ) × (B/C) / 1000 (mgC)
E: Percentage detection (%)
E= D/ (Theoretical amount of carbon) × 100
F: Average percentage detection (%)
Table: Calculation table for percentage biodegradation of test item
Study No. 15581
Sample description |
A |
E |
F |
G |
H |
Standard solution 300 mg/l |
403027 |
|
|
|
|
(1)Water + test item |
380751 |
29.1 |
97 |
|
|
(2)Sludge + test item |
n.d. |
0 |
0 |
100 |
|
(3)Sludge + test item |
n.d. |
0 |
0 |
100 |
100 |
(4)Sludge + test item |
n.d. |
0 |
0 |
100 |
|
(5)Control blank |
n.d. |
|
|
|
|
Amount of test item added: 30 mg
A: Peak area (fA sec)
B: Final volume: 100 ml
C: Ratio of portion used for anaylsis: 300/300
D: Recovery rate: 97.4 % (water + test item)
96.7 % (sludge + test item)
E: Residual amount of test item (mg)
Ew= I × ( A(water + test item) / A(standard) × (B/C) / (D /100) / 1000
Es= I × [ A(sludge + test item) – A(Control blank) / A(Standard)] × (B/C) / (D /100) / 1000
F: Percentage residue (%)
F= E / 30 mg × 100
G: Percentage biodegradation (%),
G= [ (E(water + test item) - E(sludge + test item) ) / E(water + test item) ] × 100
H: Average percentage biodegradation (%)
I: Concentration of standard solution: 300 mg/l
Description of key information
Biodegradation study of the test chemical was carried out with a total duration period of 28 days (Experimental study report, 2011).The test chemical was considered to be 100% pure.Specific density of the test substance is 0.9520 (20/4ᵒC). Identity of test substance was confirmed by comparing the infrared absorption spectrum of the sample provided by the sponsor with that of the sample tested in the test facility. Activated sludge was used as a test inoculum obtained fromsludge (surface water containing surface soils from rivers, lakes and marshes and inland seas and returned sludge from sewage treatment plants) was collected at 10 sites in Japan. The activated sludge was incubated insynthetic sewage (purified water containing glucose, peptone and potassium dihydrogen phosphate at a pH adjusted to7.0±1.0) for 19 hrs. Conc. of inoculum used for the study is 30 mg/l and initial test substance conc. used for the study was 100 mg/l. The test substance wasstored at room temperature in dark place.Aniline was used as a reference substance for the study.The suspended solid conc. was measured for determination of the activated sludge added. Measurement method used was according to JIS K0102-2010 14. After measurement, the suspended solid concentration of the activated sludge was determined to be 2660 mg/L.Sufficiently high activity of the activated sludge was confirmed by using aniline.Change in the BOD of the test solution was monitored continuously with a closed-system oxygen consumption measuring apparatus during the culture period. The temperature of the closed-system oxygen consumption measuring apparatus in the constant temperature bath was recorded every day.After the culture period, the test substance in the test solution was analyzed. From the preliminary test, it was found that the test substance is not soluble in the test solution. The dissolved organic carbon (DOC) in the test solutions of the (sludge + test substance) systems and the sludge blank system was analyzed for confirmation of whether there are water-soluble products generated. Analytical methods involve thepretreatment of the test solution of the (water + test substance) system was done to prepare a gas chromatography sample (GC) sample for analysis of the test substance. Pretreatment was also done of test solution of the (sludge + test substance) system and a sludge blank system to prepare total organic carbon analysis (TOC) samples for analysis of DOC (Dissolved Organic Carbon) and gas chromatography (GC) samples for analysis of the test substance. Quantification of the test substance was done by gas chromatography (GC).The average recovery rate of each test solution was 90% or more and the variability was within 5%.The test is carried at a temperature of25±1°C with a duration period of 28 days.Reference substance aniline undergoes 77% degradation after 28 days. The average percentage degradation of test chemical was determined to be 94 and 100% by oxygen consumption and GC parameter in 28 days. The amount of DOC detected was less than 1 mgC, indicating that no water-soluble products were formed. Thus, based on percentage degradation, test chemical is considered to be readily biodegradable in nature.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
Various experimental key and supporting studies of the test chemical were reviewed for the biodegradation end point which are summarized as below:
In an experimental key study from study report (2011),biodegradation study of the test chemical was carried out with a total duration period of 28 days. The test chemical was considered to be 100% pure. Specific density of the test substance is 0.9520 (20/4ᵒC). Identity of test substance was confirmed by comparing the infrared absorption spectrum of the sample provided by the sponsor with that of the sample tested in the test facility. Activated sludge was used as a test inoculum obtained from sludge (surface water containing surface soils from rivers, lakes and marshes and inland seas and returned sludge from sewage treatment plants) was collected at 10 sites in Japan. The activated sludge was incubated in synthetic sewage (purified water containing glucose, peptone and potassium dihydrogen phosphate at a pH adjusted to7.0±1.0) for 19 hrs. Conc. of inoculum used for the study is 30 mg/l and initial test substance conc. used for the study was 100 mg/l. The test substance was stored at room temperature in dark place. Aniline was used as a reference substance for the study. The suspended solid conc. was measured for determination of the activated sludge added. Measurement method used was according to JIS K0102-2010 14. After measurement, the suspended solid concentration of the activated sludge was determined to be 2660 mg/L. Sufficiently high activity of the activated sludge was confirmed by using aniline. Change in the BOD of the test solution was monitored continuously with a closed-system oxygen consumption measuring apparatus during the culture period. The temperature of the closed-system oxygen consumption measuring apparatus in the constant temperature bath was recorded every day. After the culture period, the test substance in the test solution was analyzed. From the preliminary test, it was found that the test substance is not soluble in the test solution. The dissolved organic carbon (DOC) in the test solutions of the (sludge + test substance) systems and the sludge blank system was analyzed for confirmation of whether there are water-soluble products generated. Analytical methods involve the pretreatment of the test solution of the (water + test substance) system was done to prepare a gas chromatography sample (GC) sample for analysis of the test substance. Pretreatment was also done of test solution of the (sludge + test substance) system and a sludge blank system to prepare total organic carbon analysis (TOC) samples for analysis of DOC (Dissolved Organic Carbon) and gas chromatography (GC) samples for analysis of the test substance. Quantification of the test substance was done by gas chromatography (GC).The average recovery rate of each test solution was 90% or more and the variability was within 5%.The test is carried at a temperature of 25±1°C with a duration period of 28 days. Reference substance aniline undergoes 77% degradation after 28 days. The average percentage degradation of test chemical was determined to be 94 and 100% by oxygen consumption and GC parameter in 28 days. The amount of DOC detected was less than 1 mgC, indicating that no water-soluble products were formed. Thus, based on percentage degradation, test chemical is considered to be readily biodegradable in nature.
For the test chemical, 28-days Closed Bottle test following the OECD guideline 301 D to determine the ready biodegradability of the test chemical (Experimental study report, 2017). The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used for this study. 1 polyseed capsule were added in 500 ml D.I water and then stirred for 1 hour for proper mixing and functioning of inoculum. This gave the bacterial count as 10E7 to 10E8 CFU/ml. At the regular interval microbial plating was also performed on agar to confirm the vitality and CFU count of microorganism. The concentration of test and reference chemical (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. OECD mineral medium was used for the study. ThOD (Theoretical oxygen demand) of test and reference item was determined by calculation. % degradation was calculated using the values of BOD and ThOD for test chemical and reference chemical. The % degradation of procedure control (reference item) was also calculated using BOD & ThOD and was determined to be 73.49% at 20 ± 1°C. Degradation of Sodium Benzoate exceeds 43.37% on 7th days & 58.43% on 14th day. The activity of the inoculum was thus verified and the test can be considered as valid.The BOD28 value of test chemical was observed to be 1.17 mgO2/mg. ThOD was calculated as 2.78 mgO2/mg. Accordingly, the % degradation of the test item after 28 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 42.08%. Based on the results, the test item, under the test conditions, was considered to be ultimate inherently biodegradable in nature.
In a supporting study from peer reviewed journal (Daniel Salvito et. al., 2011),biodegradation experiment was conducted for 28 days for evaluating the percentage biodegradability of test chemical. The study was performed according to OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test).The percentage degradation of test chemical was determined to be 84% by O2 consumption parameter in 28 days. Thus, based on percentage degradation, test chemical is considered to be readily biodegradable in nature.
On the basis of above overall results for test chemical, it can be concluded that the test chemical is considered to be readily biodegradable in water.
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