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EC number: 915-634-1 | 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:
- supporting study
- Study period:
- 16 June - 20 December 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Inoculum or test system:
- mixture of sewage, soil and natural water
- Details on inoculum:
- On-site sludge sampling was carried out at 10 locations in Japan (samples were from surface water and surface soil of rivers, lakes and inland sea, and return sludge from sewage plants). Activated sludge was prepared and was controlled in the CERI laboratory. The activated sludge which was cultivated for 21.3 hours after feeding with the synthetic sewage (glucose, peptone and potassium dihydrogenphosphate dissolved in purified in water at an adjusted pH 7.0±1.0) was used.
- Duration of test (contact time):
- 28 d
- Initial conc.:
- 100 mg/L
- Reference substance:
- aniline
- Parameter:
- % degradation (test mat. analysis)
- Value:
- 12
- Sampling time:
- 28 d
- Remarks on result:
- other: based on gc analysis of parent test item (sum of 3 peaks)
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 4
- Sampling time:
- 28 d
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- In a GLP study biodegradability of test item was evaluated according to OECD 301C "Ready Biodegradability: Modified MITI Test (l)". The average percentage ultimate biodegradation (measured as BOD) was 4% after 28 days. Thus, test item is regarded as not readily biodegradable according to this test.
- Executive summary:
In a GLP study biodegradability of test item was evaluated according to OECD 301C "Ready Biodegradability: Modified MITI Test (l)".
Test item was tested at the concentration of 100 mg/L along with the activated sludge (30 mg/L)at 25 ± 1°C for the duration of 28 days. Biochemical oxygen demand (BOD) was evaluated using a closed system oxygen consumption measuring apparatus and gas chromatography (GC). Percentage biodegradation by BOD (average) of test item was 4% and Percentage biodegradation of test item by GC (average) was 12 %. Validity criteria for the test were met.
Thus, test item is regarded as not readily biodegradable according to this test.
- Endpoint:
- biodegradation in water: inherent biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 23 October 2013 - 10 February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Not applicable
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 302 C (Inherent Biodegradability: Modified MITI Test (II))
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- GLP statement
- Inoculum or test system:
- natural water: freshwater
- Details on inoculum:
- Fresh activated sludge from a biological waste water treatment plant treating predominantly domestic sewage (Bois-de-Bay, Satigny, Switzerland) was used.
The sludge is collected in the morning, washed three times in the mineral medium (by centrifuging at 1000 g for 10 minutes, discarding the supernatant and resuspending in mineral medium) and kept aerobic until being used on the same day. - Duration of test (contact time):
- 69 d
- Initial conc.:
- 30 mg/L
- Parameter followed for biodegradation estimation:
- O2 consumption
- Reference substance:
- benzoic acid, sodium salt
- Remarks:
- purity: min. 99.0 %
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 4
- Sampling time:
- 69 d
- Remarks on result:
- other: replicate D1
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 35
- Sampling time:
- 69 d
- Remarks on result:
- other: replicate D2
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 20
- Sampling time:
- 69 d
- Remarks on result:
- other: mean of D1 and D2
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not inherently biodegradable
- Conclusions:
- The inherent Biodegradability of test item was determined by the Manometric Respirometry Test according to the OECD Guidelines for Testing of Chemicals, Method No. 302C. At the test concentration test item did not significantly inhibit the intrinsic respiration of the inoculum. Thus, test item should be regarded as not inherently biodegradable according to this test.
- Executive summary:
The inherent Biodegradability of test item was determined by the Manometric Respirometry Test according to the OECD Guidelines for Testing of Chemicals, Method No. 302C.
Based on biological oxygen demand, in the test conditions test item undergoes no biodegradation after 28 days (4% and 35% after 69 days on the two replicate flasks, respectively).
At the test concentration test item did not significantly inhibit the intrinsic respiration of the inoculum.
Thus, test item should be regarded as not inherently biodegradable according to this test.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 June - 03 October 2013
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.3110 (Ready Biodegradability)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- GLP statement
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic (adaptation not specified)
- Details on inoculum:
- The sludge is collected in the morning, washed three times in the mineral medium (by centrifuging at 1000 g for 10 minutes, discarding the supernatant and resuspending in mineral medium) and kept aerobic until being used on the same day.
- Duration of test (contact time):
- 28 d
- Initial conc.:
- 30 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Reference substance:
- benzoic acid, sodium salt
- Remarks:
- 99% purity
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 7
- Sampling time:
- 28 d
- Results with reference substance:
- Degradation of sodium benzoate exceeded 40% after 7 days and 65% after 14 days: the activity of the inoculum was thus verified (validity criterion).
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- Ethyl Safranate undergoes 7% biodegradation after 28 days in the test conditions.
Ethyl Safranate did not inhibit the intrinsic respiration of the inoculum at the test concentration and was therefore considered to be non-toxic to the inoculum at the test concentration.
Thus, Ethyl Safranate should be regarded as not readily biodegradable according to this test. - Executive summary:
The Ready Biodegradability of Ethyl Safranate was determined by the Manometric Respirometry Test. Ethyl Safranate undergoes 7% biodegradation after 28 days in the test conditions.
Ethyl Safranate did not inhibit the intrinsic respiration of the inoculum at the test concentration and was therefore considered to be non-toxic to the inoculum at the test concentration.
Thus, Ethyl Safranate should be regarded as not readily biodegradable according to this test.
Referenceopen allclose all
After the end of the incubation, pH of the test solutions was not measured because the test item seemed to be volatile. At the start and end of experiment the test item was found to be insoluble and test solution appears to be colourless.
Table 5.2.1/1: Biodegradability of test item after 28 days
|
Water + Test item |
Sludge + Test item |
Average |
||
Vessel No. 1 |
Vessel No. 2 |
Vessel No. 3 |
Vessel No. 4 |
||
BOD* (mg) |
0.9 |
0.9 |
3.6 |
4.8 |
- |
Residual amount of test item (mg) |
28.1 |
27.3 |
24.9 |
22.0 |
- |
% Biodegradation by BOD |
- |
1 |
5 |
6 |
4 |
% Biodegradation by GC |
- |
3 |
11 |
22 |
12 |
Oxygen uptakes, as read on the Oxitop meters, are corrected to account for the small differences between actual and nominal concentrations of test and reference substances.
Degradation of sodium benzoate exceeded 40 % after 7 days and 65 % after 14 days: the activity of the inoculum was thus verified (validity criterion).
Table 5.2.1/2: Biodegradability of test substance
Theoretical Oxygen Demand (ThOD): 2.55 mg O2/ mg
Days |
7 |
14 |
21 |
28 |
35 |
42 |
69 |
|
O2uptake of sludge (inoculum blank) |
23 B1100 |
54.0 |
71.4 |
81.1 |
86.8 |
94.6 |
98.4 |
106.0 |
24 B2100 |
52.0 |
69.3 |
78.9 |
86.6 |
92.4 |
96.2 |
108.0 |
|
Mean B100 |
53.0 |
70.4 |
80.0 |
86.7 |
93.5 |
97.3 |
107.0 |
|
O2uptake of substance + sludge |
21 C1 |
48.4 |
63.9 |
75.5 |
81.3 |
91.0 |
96.8 |
110.0 |
22 C2 |
50.6 |
68.1 |
75.8 |
85.6 |
103.0 |
111.0 |
134.1 |
|
O2uptake of substance |
C1-B100 |
-4.6 |
-6.5 |
-4.5 |
-5.4 |
-2.5 |
-0.5 |
3.0 |
C2-B100 |
-2.4 |
-2.3 |
-4.2 |
-1.1 |
9.5 |
13.7 |
27.1 |
|
% biodegradation of test substance |
D1 |
-6 |
-8 |
-6 |
-7 |
-3 |
-1 |
4 |
D2 |
-3 |
-3 |
-6 |
-1 |
12 |
18 |
35 |
|
Mean D |
-5 |
-6 |
-6 |
-4 |
5 |
9 |
20 |
Calculations
B1100, B2100-C1 C2 experimental O2uptake values
B1100= (B1100+ B2100)
D1 = 100 (C1 - B1100)/ ThOD * [S]
D1 = 100 (C2 - B1100)/ ThOD * [S]
D = (D1 + D2)/2
[S] = Initial test substance concentration (mg/L)
Table 5.2.1/2: Biodegradability of Reference substance
Theoretical Oxygen Demand (ThOD): 1.67 mg O2/ mg
Days |
5 |
7 |
14 |
21 |
28 |
69 |
|
O2uptake of sludge (inoculum blank) |
3 B130 |
16.8 |
18.9 |
25.2 |
27.4 |
27.4 |
33.7 |
4 B230 |
17.1 |
19.3 |
25.7 |
27.9 |
27.9 |
34.3 |
|
Mean B30 |
17.0 |
19.1 |
25.5 |
27.7 |
27.7 |
34.0 |
|
O2uptake of substance + sludge |
1 A1 |
129.0 |
141.0 |
162.0 |
169.0 |
173.0 |
190.0 |
2 A2 |
126.0 |
134.0 |
156.0 |
166.0 |
173.0 |
185.0 |
|
O2uptake of substance |
A1-B30 |
112.1 |
121.9 |
136.6 |
141.4 |
145.4 |
156.0 |
A2-B30 |
109.1 |
114.9 |
130.6 |
138.4 |
145.4 |
151.0 |
|
% biodegradation of test substance |
D1 |
67 |
73 |
82 |
85 |
87 |
94 |
D2 |
65 |
69 |
78 |
83 |
87 |
91 |
|
Mean D |
66 |
71 |
80 |
84 |
87 |
92 |
Calculations
B130, B230-A1 A2 experimental O2uptake values
B130= (B130+ B230)
D1 = 100 (C1 - B130)/ ThOD * [S]
D1 = 100 (C2 - B130)/ ThOD * [S]
D = (D1 + D2)/2
[S] = Initial test substance concentration (mg/L)
Oxygen uptakes, as read on the Oxitop meters, are corrected to account for the small differences between actual and nominal concentrations of test and reference substances.
Degradation of sodium benzoate exceeded 40 % after 7 days and 65 % after 14 days: the activity of the inoculum was thus verified (validity criterion). The repeatability validity criterion (not more than 20% difference between replicates) is fulfilled for the flasks containing test substance. Therefore, the test is considered valid.
Table 5.2.1/2: Biodegradability of test substance
Theoretical Oxygen Demand (ThOD): 2.55 mg O2/ mg
Days |
5 |
7 |
14 |
21 |
28 |
58 |
|
O2uptake of sludge (inoculum blank) |
3 B1 |
21.0 |
23.1 |
29.5 |
29.5 |
31.6 |
33.7 |
4 B2 |
15.0 |
17.1 |
23.6 |
23.6 |
25.7 |
30.0 |
|
Mean B |
18.0 |
20.1 |
26.6 |
26.6 |
28.7 |
31.9 |
|
O2uptake of substance + sludge |
11 C1 |
21.4 |
23.6 |
27.9 |
32.1 |
34.3 |
34.3 |
12 C2 |
24.8 |
24.8 |
28.9 |
33.0 |
33.0 |
37.2 |
|
O2uptake of substance |
C1-B |
3.4 |
3.5 |
1.4 |
5.6 |
5.7 |
2.5 |
C2-B |
6.8 |
4.7 |
2.3 |
6.4 |
4.3 |
5.3 |
|
% biodegradation of test substance |
D1 |
4 |
5 |
2 |
7 |
7 |
3 |
D2 |
9 |
6 |
3 |
8 |
6 |
7 |
|
Mean D |
7 |
5 |
2 |
8 |
7 |
5 |
Calculations
B1, B2, C1, C2, A1, A2, E1 experimental O2uptake values
B1= (B1 + B2)
D1 = 100 (C1 - B)/ ThOD * [S]
D1 = 100 (C2 - B)/ ThOD * [S]
D = (D1 + D2)/2
[S] = Initial test substance concentration (mg/L)
Table 5.2.1/2: Biodegradability of Reference substance
Theoretical Oxygen Demand (ThOD): 1.67 mg O2/ mg
Days |
5 |
7 |
14 |
21 |
28 |
55 |
|
O2uptake of sludge (inoculum blank) |
3 B1 |
21.0 |
23.1 |
29.5 |
29.5 |
31.6 |
33.7 |
4 B2 |
15.0 |
17.1 |
23.6 |
23.6 |
25.7 |
30.0 |
|
Mean B |
18.0 |
20.1 |
26.6 |
26.6 |
28.7 |
31.9 |
|
O2uptake of substance + sludge |
1 A1 |
131.0 |
141.0 |
162.0 |
171.0 |
177.0 |
188.0 |
2 A2 |
132.0 |
143.0 |
162.0 |
170.0 |
175.0 |
185.0 |
|
O2uptake of substance |
A1-B |
113.0 |
120.9 |
135.5 |
144.5 |
148.4 |
156.2 |
A2-B |
114.0 |
122.9 |
135.5 |
143.5 |
146.4 |
153.2 |
|
% biodegradation of test substance |
D1 |
68 |
73 |
81 |
87 |
89 |
94 |
D2 |
68 |
74 |
81 |
86 |
88 |
92 |
|
Mean D |
68 |
73 |
81 |
86 |
88 |
93 |
Calculations
B1, B2, C1, C2, A1, A2, E1 experimental O2uptake values
B1= (B1 + B2)
D1 = 100 (A1 - B)/ ThOD * [S]
D1 = 100 (A2 - B)/ ThOD * [S]
D = (D1 + D2)/2
[S] = Initial test substance concentration (mg/L)
Description of key information
The ready biodegradability of Ethyl Safranate has been investigated using two standard ready screening methods, the OECD 301F Manometric Respirometry Test (Givaudan 13 -E097, key study) and the OECD 301C modified MITI test (CERI 2016, supporting study). The test guideline 301C specifies use of activated sludge precultured with synthetic sewage containing glucose and peptone. This pre-treatment may seriously lower the diversity and biodegradation capacity of the microbes. In contrast the 301F study uses activated sludge directly from wastewater treatment plants. For this reason the 301F study is considered to be the key study and the 301C study as supporting. The average level of biodegradation (measured as BOD) was respectively 7% and 4% after 28 days. Thus, Ethyl Safranate is regarded as not readily biodegradable according to both tests.
Specific chemical analysis is obligatory in the MITI method and can be used to assess primary degradation of the test substance. The average percentage primary degradation of the test item (by GC, total peak area) after 28 days was 12% (based on 3 replicates; 3, 11 and 22%). A day 28 extract was subsequently analysed under the conditions of the OECD117 HPLC Partition Coefficient method. The log Pow determined for the converted products varied between 1.3 and 2.5, demonstrating them to be significantly more polar than the parent (log Pow 3.4). Based on LC-MS analysis, some of the converted products were tentatively identified as di- and tri-hydroxylated derivatives of the test item.
In an inherent study 302C study (Givaudan 13 -E169), Ethyl Safranate achieved no biodegradation after 28 days but after 69 days the level of biodegradation (measured as BOD) in the two replicate flasks was 4 and 35% respectively. When assessing inherent biodegradability it is not necessary to define limits on test duration. Biodegradation above 20% may be regarded as evidence of inherent, primary biodegradation. Thus, the results of one replicate indicate that Ethyl Safranate is inherently primarily biodegradable. The different behaviour between the two replicate flasks is probably due to some heterogeneity in the inoculum leading to different microorganism population growth and diversity (i.e. one or more competent microorganism(s) required for the biodegradation to continue were either not introduced into the first flask or had not established themselves to a sufficient concentration for metabolism to be observed). In environmental waters there will be greater homogeneity and biodiversity of the microbes present. Thus under more environmentally realistic test conditions, all replicates would be expected to show some degradation.
Based on the above information, the registered substance is regarded as not readily biodegradable for the purposes of classification and labelling and the conclusion for the exposure assessment is that no biodegradation was observed. However, the indication of primary degradation is taken into consideration for the purposes of the PBT assessment.
Key value for chemical safety assessment
- Biodegradation in water:
- not biodegradable
- Type of water:
- freshwater
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.