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Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Reference
Endpoint:
biodegradation in water and sediment: simulation testing, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20/10/2017 to 23/03/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guideline study, conducted to GLP and current methodology.
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment Systems)
Deviations:
yes
Remarks:
See "Any other information" for details
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
No further details specified in the study report.
Radiolabelling:
no
Oxygen conditions:
aerobic/anaerobic
Inoculum or test system:
natural water / sediment: freshwater
Details on source and properties of surface water:
Water/sediment system with sandy sediment
This surface water comes from the river “La Véore”. “La Véore” is a river in the south-east of France, a tributary of the Rhone on the left bank. It flows entirely in the department of Drôme, in region Auvergne-Rhône-Alpes.
The sampling was carried out on the commune of “Livron sur Rhone” (GPS coordinates 44.810454, 4.820417).
Water and sediment from the river “La Véore” were sampled on 16 October 2017. Water was sampled from the river. Oxygen content, pH and water temperature were measured at sampling. The water was clear and non-turbid.
Till arrival to the laboratory, the water and sediment (water-logged) were stored refrigerated under aerobic conditions (open lid) in the dark, prior to use.

Water/sediment system with silty sediment
This surface water comes from the lone “La Morte”, dead arm of the Rhone. “La Morte” is located in Saint-Benoit, a commune of the department of Ain, in France.
The sampling was carried out on the commune of Saint Benoit (GPS coordinates 45.701794, 5.553743).
Water and sediment from the river “La Morte” were sampled on 12 October 2017. Water was sampled from the river. Oxygen content, pH and water temperature were measured at sampling. The water was clear, non-turbid with a pale brown colour.
Till arrival to the laboratory, the water and sediment (water-logged) were stored refrigerated under aerobic conditions (open lid) in the dark, prior to use.
Till arrival to the laboratory, the water and sediment (water-logged) were stored refrigerated under anaerobic conditions (closed) in the dark, prior to use.
Details on source and properties of sediment:
Water/sediment system with sandy sediment
Four freshly sampled water/sediment systems were used in this study. Sediment samples were taken from the entire 5 to 10 cm upper layer of the sediment for aerobic test and under for the anaerobic test. Associated water was collected from the same location as the sediment.
Sediment sampling was performed by RRCo under non-GLP condition.
Sub-samples of the sediment of each system were shipped to La Drôme-Laboratoire, for the determination of particles size distribution and total organic carbon in the sediments.
The four sediments were significantly different based on the texture and percentage organic carbon of the sediment. The difference between the organic carbon contents of the two sediments was at least 2%. The difference in [clay + silt] content of the two sediments was at least 20%.
Concerning water, origin, temperature, pH and O2 concentration were recorded, and for sediment, origin, depth of layer and observation (colour/smell) were registered.
After collection, the sediments were separated from the water by filtration and the sediment wet-sieved to a 2 mm sieve using excess location water that were then discarded. Sediments and water were stored together, water-logged (6-10cm water layer), in the dark at 4°C ± 2 for a maximum of 4 weeks.
A period of acclimation for the water-sediment system took place prior to the beginning of the test, in order to reach stable physicochemical conditions. Therefore, incubation flasks (the same ones used for the test) were filled with a mix of sediment and water in the desired proportion. Water-sediment systems were acclimatized for 1 week under test conditions (darkness, 12°C ± 2). During equilibration, dissolved oxygen, pH, and conductivity were determined each day for each system. The temperature in the temperature controlled room was monitored continuously. Measurements made during this period are detailed in the result part of this report.
Prior to start of the incubation period, the sediment layer of 8 flasks of each system were shipped to SADEF Laboratory, for the determination of the microbial biomass using the fumigation-extraction method (non-GLP).
Water and sediment from the river “La Véore” were sampled on 16 October 2017.
The aerobic sediment was sampled from the top 5 cm and was brown. The sediment was then sieved with a 2 mm sieve mesh. The sediment was kept covered with water and bring to the laboratory on the sampling day.
Till arrival to the laboratory, the water and sediment (water-logged) were stored refrigerated under aerobic conditions (open lid) in the dark, prior to use.
The anaerobic sediment was sampled with a corer at a depth of 10 to 30 cm and was brown.
The sediment was then sieved with a 2 mm sieve mesh. The sediment was kept covered with water and bring to the laboratory on the sampling day.
Till arrival to the laboratory, the water and sediment (water-logged) were stored refrigerated under anaerobic conditions (closed) in the dark, prior to use.

Water/sediment system with silty sediment
This surface water comes from the lone “La Morte”, dead arm of the Rhone. “La Morte” is located in Saint-Benoit, a commune of the department of Ain, in France.
The sampling was carried out on the commune of Saint Benoit (GPS coordinates 45.701794, 5.553743).
Water and sediment from the river “La Morte” were sampled on 12 October 2017. Water was sampled from the river. Oxygen content, pH and water temperature were measured at sampling. The water was clear, non-turbid with a pale brown colour.
The aerobic sediment was sampled from the top 5 cm and was light brown. The sediment was then sieved with a 2 mm sieve mesh. The sediment was kept covered with water and shipped to the laboratory on the sampling day.
Till arrival to the laboratory, the water and sediment (water-logged) were stored refrigerated under aerobic conditions (open lid) in the dark, prior to use.
The anaerobic sediment was sampled with a corer at a depth of 10 to 30 cm and was brown.
The sediment was then sieved with a 2 mm sieve mesh. The sediment was kept covered with water and bring to the laboratory on the sampling day.
Till arrival to the laboratory, the water and sediment (water-logged) were stored refrigerated under anaerobic conditions (closed) in the dark, prior to use.
Details on inoculum:
Not required
Duration of test (contact time):
100 d
Initial conc.:
10 µg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
test mat. analysis
Details on study design:
The test was performed in incubators containing the water-sediment system with a volume ratio from 3:1 to 4:1. For the sandy system, about 170 g of wet sediments and 300 ml of water and for the silt system about 150 g of wet sediments and 300 ml of water were weighed into 500 ml amber glass jars. Approximately 2 cm of sediment and a water layer of approximately 6 cm were obtained at the end of equilibration.
A stock solution of the test item (C.I. Yellow 124) was prepared in acetone at a concentration of 1 g.L-1 and mixed with glass beads. The solvent was eliminated with rotary evaporator and the glass beads were rinsed with water. Then, the test solution was prepared by agitation of the glass beads in water during 24 hours. This solution was analysed and according to the measured concentration, the test system was spiked with this solution to obtain a test item quantity of approximately 10 μg in the test system.
Two flasks with test item and one control were prepared, for each sampling time (i.e. 14 flasks containing the test item and 7 control flasks).
The test item was applied as an aqueous solution into the water phase of the incubation flasks, previously acclimatised. The aqueous phase was gently mixed in order to ensure homogeneity, disturbing the sediment as little as possible. An abiotic control was performed with water system sterilized.
The frequency of atmospheric air renewal of the headspace of the flasks in the aerobic test was to two times a week in order to compensate the oxygen consumption by the biomass. The ingoing air was allowed to bubble gently through the upper part of the water layer – in order to not disturb the sediment layer – before leaving the metabolism flasks.
A trap with ethylene glycol was used for the trapping of volatile products.
The test was performed under the darkness and at 12°C ± 2.
7 samplings have been performed during the test (0, 3, 7, 14, 23, 51 days and final time). For each sampling, two flasks containing the test item and a control flask were sacrificed. Abiotic control were sampled three times (14 days, 51 days and at final time).
At the final time, the sediment of 4 dedicated flasks were shipped to SADEF laboratory for the determination of microbial biomass.
The test item and identifiable transformation product (with known analytical standards) were measured for each sampling in the aqueous phase and in the sediments.
Mineralization and mass balance have not been performed because the molecules were not radiolabelled.
The water layer was carefully separated from the sediment. Dissolved oxygen, pH, and redox potential were determined at each sampling interval.
The sediment layer was mixed. Approximately 5 g of the sediment layer was weighed for determination of pH and redox potential. About 3.5 g of the “La Veore” sediment and 7 g of the “La morte” Sediment were weighed for determination of test item and transformation products in each sediment.
The water and sediment layer were analysed for the presence of C.I. Yellow 124 at each sampling interval.
Reference substance:
other: Solvent Yellow 124; CAS No. 34432-92-3
Test performance:
Measurements of microbial biomass were performed by Sadef laboratory.
At the beginning of the incubation period, microbial biomass was determined to be 33.2 mg C/kg dry sample for “La Véore” aerobic system, 15.0 mg C/kg dry sample for “La Véore” anaerobic system, 49,8 mg C/kg dry sample for “La Morte” aerobic system and 49,8 mg C/kg dry sample for “La Morte” anaerobic system.
The results indicate sufficiently viable conditions for both water/sediment systems.
Key result
Remarks on result:
other: No degradation compounds was detected
Key result
Compartment:
natural water / sediment: freshwater
DT50:
11 d
Type:
(pseudo-)first order (= half-life)
Temp.:
12.9 °C
Remarks on result:
other: "La Véore" aerobic
Key result
Compartment:
natural water / sediment: freshwater
DT50:
4.1 d
Type:
(pseudo-)first order (= half-life)
Temp.:
12.9 °C
Remarks on result:
other: "La Morte" aerobic
Key result
Compartment:
natural water / sediment: freshwater
DT50:
28.4 d
Type:
(pseudo-)first order (= half-life)
Temp.:
12.9 °C
Remarks on result:
other: "La Véore" anaerobic
Key result
Compartment:
natural water / sediment: freshwater
DT50:
2.8 d
Type:
(pseudo-)first order (= half-life)
Temp.:
12.9 °C
Remarks on result:
other: "La Morte" anaerobic
Transformation products:
not measured
Volatile metabolites:
no
Details on results:
Parameters measured during incubation period
Temperature
During the incubation period, the temperature was within the range 11.4 – 14.4°C.

Distribution of C.I. Yellow 124
“La Véore” aerobic system
At the start of incubation, 8.3-7.6 μg (corresponding to 80% of the applied dose) of the 10 μg the nominally applied of C.I. Yellow 124 were recovered in the layer of water in both systems. After 3 days of incubation, the amount of C.I. Yellow 124 decreased to 3.7-3.1 μg (corresponding to 34% of the applied dose) in the water layer and increased to 4.9-6.4 μg (corresponding to 57% of the applied dose) in the sediment layer. Subsequently, C.I. Yellow 124 further decreased in the water layer to approximately 0 μg (LOQ < 0.2 μg of C.I. Yellow 124 / L) and decreased in the sediment layer to approximately 0.2 μg (0.18 – 0.19 μg (corresponding to 2 % of the applied dose) at the end of the incubation period.
In both total systems, the initial amount of detected C.I. Yellow 124 was 9.2 – 8.9 μg (corresponding to 91% of the applied dose). During the whole incubation period a decrease of approximately 9 μg was observed.

“La Morte” aerobic system
At the start of incubation, 5.5-12.1 μg (corresponding to 88% of the applied dose) of the 10 μg the nominally applied of C.I. Yellow 124 were recovered in the layer of water in both systems. After 3 days of incubation, the amount of C.I. Yellow 124 decreased to 1.9-1.7 μg (corresponding to 18% of the applied dose) in the water layer and increased to 3.8-4.1 μg (corresponding to 39% of the applied dose) in the sediment layer. Subsequently, C.I. Yellow 124 further decreased in the water layer to approximately 0 μg (LOQ < 0.2 μg of C.I. Yellow 124 / L) and decreased in the sediment layer to approximately 0.3 μg (0.33 – 0.19 μg (corresponding to 3 % of the applied dose) at the end of the incubation period.
In both total systems, the initial amount of detected C.I. Yellow 124 was 7.3 – 14.3 μg (corresponding to 108% of the applied dose). During the whole incubation period a decrease of approximately 10 μg was observed.

“La Veore” anaerobic system
At the start of incubation, 6.2-6.1 μg (corresponding to 62% of the applied dose) of the 10 μg the nominally applied of C.I. Yellow 124 were recovered in the layer of water in both systems. After 7 days of incubation, the amount of C.I. Yellow 124 decreased to 0.9-1.2 μg (corresponding to 10% of the applied dose) in the water layer and increased to 3.4-2.5 μg (corresponding to 40% of the applied dose) in the sediment layer. Subsequently, C.I. Yellow 124 further decreased in the water layer to approximately 0 μg (LOQ < 0.2 μg of C.I. Yellow 124 / L) and decreased in the sediment layer to approximately 0.2 μg (0.22 – 0.25 μg (corresponding to 2 % of the applied dose) at the end of the incubation period.
In both total systems, the initial amount of detected C.I. Yellow 124 was 7.0 – 8.6 μg (corresponding to 78% of the applied dose). During the whole incubation period a decrease of approximately 7.5 μg was observed.

“La Morte” anaerobic system
At the start of incubation, 8.6-4.8 μg (corresponding to 67% of the applied dose) of the 10 μg the nominally applied of C.I. Yellow 124 were recovered in the layer of water in both systems. After 3 days of incubation, the amount of C.I. Yellow 124 decreased to 0.9-1.0 μg (corresponding to 9% of the applied dose) in the water layer and increased to 4.0-2.7 μg (corresponding to 34% of the applied dose) in the sediment layer. Subsequently, C.I. Yellow 124 further decreased in the water layer to approximately 0 μg (LOQ < 0.2 μg of C.I. Yellow 124 / L) and decreased in the sediment layer to approximately 0 μg at the end of the incubation period.
In both total systems, the initial amount of detected C.I. Yellow 124 was 10.9 – 5.5 μg (corresponding to 82% of the applied dose). During the whole incubation period a decrease of approximately 8.2 μg was observed.

Carbon in NaOH traps
In carbon traps, 493 mg.L-1 of inorganic carbon was found in the control, 489 and 499 mg.L-1 in the both samples of “La Véore” system. For “La Morte” system, 507 mg.L-1 of inorganic carbon was found in the control, 517 mg.L-1 in the test 1 and 513.5 mg.L-1 in the test 2. No significant production of inorganic carbon was highlighted in test system compared to the control.

Analysis of metabolites in Q-TOF
Sediment and aqueous phase samples were analysed for the presence of metabolites using a high resolution LC-MS.
A visual examination of data was firstly done by overlaying control and test samples. Then a subtraction chromatogram was generated using Metabolite Detect software from Bruker by the subtraction of control to test sample.
No metabolite was highlighted.
Finally, a list of expected metabolite structures was created using literature or Metabolite Predict software from Bruker with phase I metabolism pathways and were screened in the samples.
No expected metabolite was highlighted.

DT50 and DT90 determination
The DT50 and DT90 calculations for the decrease of C.I. Yellow 124 in the test systems are based on the individual quantities measured.
The half-life calculated for the water layer is not a degradation DT50 but a dissipation half-life because transfer from water to sediment is included in the dissipation process.
For the sediment, degradation was assessed from the maximum onwards at a time ( 3 days for “La morte” anaerobic sediment, 7 days for “la morte” aerobic sediment, 14 days for “La veore” aerobic and anaerobic sediment) where C.I. Yellow 124 is present in the water layer at a concentration less than 10% of applied quantity so that transfer from water to sediment is reduced.
The SFO model fitted for water, sediment and total system for both test systems. The DFOP model, FOMC model and HS model fitted for several conditions.
Considering the c2 for the different models, the results with the “best” model were used in the exposure/persistence assessments.

Distribution of C.I. Yellow 124

 

La Véore” aerobic system

Water samples:

 

Date

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

 

Concentration (ug/L)

Water volume (mL)

Quantity (µg)

Mean quantity (µg)

Initial time

12/12/2017

0

<LOQ

26.821

25.453

309.580

309.710

299.330

<LOQ

8.31

7.62

7.96

Sampling 1

15/12/2017

3

<LOQ

12.421

10.463

307.800

299.950

299.890

<LOQ

3.73

3.14

3.43

Sampling 2

19/12/2017

7

0.042

4.632

5.116

302.200

302.840

304.170

<LOQ

1.40

1.56

1.48

Sampling 3

26/12/2017

14

<LOQ

1.937

1.789

298.650

297.540

297.680

<LOQ

0.58

0.53

0.55

Sampling 4

04/01/2018

23

<LOQ

0.926

0.800

301.570

296.450

300.080

<LOQ

0.27

0.24

0.26

Sampling 5

01/02/2018

51

<LOQ

0.021

0.063

304.290

308.190

296.520

<LOQ

0.01

0.02

0.01

Sampling 6

22/03/2018

100

<LOQ

0.042

0.021

304.450

298.640

302.520

<LOQ

0.01

0.01

0.01

Abiotique (Sampling 4)

26/12/2017

14

0.168

299.22

0.05

0.05

Abiotique (Sampling 5)

01/02/2018

51

0.105

282.260

0.03

0.03

Abiotique (Sampling 6)

22/03/2018

100

0.147

281.600

0.04

0.04

Sediment samples

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Sample weighing (g)

Quantity (ug)

sediment weight (g)

Quantity in sediment (µg)

Mean quantity (µg)

0

3.6

3.6

3.5

< LOQ

0.0204

0.031

152.3

150.4

149.5

< LOQ

0.87

1.31

1.09

3

3.5

3.5

3.6

< LOQ

0.1156

0.1502

150.0

151.7

153.7

< LOQ

4.92

6.42

5.67

7

3.5

3.5

3.5

< LOQ

0.1372

0.0978

151.9

151.6

153.6

< LOQ

5.93

4.24

5.09

14

3.6

3.7

3.7

< LOQ

0.054

0.0716

151.7

153.8

160.3

< LOQ

2.31

2.98

2.65

23

3.5

3.5

3.5

< LOQ

0.054

0.0408

157.3

154.7

153.3

< LOQ

2.44

1.78

2.11

51

3.5

3.5

3.6

< LOQ

0.0154

0.0164

154.7

151.7

153.9

< LOQ

0.68

0.70

0.69

100

3.6

3.5

3.6

< LOQ

0.004

0.004

159.4

150.8

158.1

< LOQ

0.18

0.19

0.18

14

3.6

0.0944

153.6

4.05

4.05

51

3.6

0.0778

162.3

3.56

3.56

100

3.6

0.0874

153.3

3.74

3.74

Total system:

Water

Sediment

Total system

Date

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Test 1

Test 2

Quantity in water (µg)

Quantity in sediment (µg)

Quantity (µg)

Mean quantity (µg)

Initial time

12/12/2017

0

<LOQ

8.31

7.62

< LOQ

0.87

1.31

9.18

8.93

9.05

Sampling 1

15/12/2017

3

<LOQ

3.73

3.14

< LOQ

4.92

6.42

8.65

9.56

9.10

Sampling 2

19/12/2017

7

<LOQ

1.40

1.56

< LOQ

5.93

4.24

7.33

5.80

6.57

Sampling 3

26/12/2017

14

<LOQ

0.58

0.53

< LOQ

2.31

2.98

2.88

3.52

3.20

Sampling 4

04/01/2018

23

<LOQ

0.27

0.24

< LOQ

2.44

1.78

2.71

2.02

2.37

Sampling 5

01/02/2018

51

<LOQ

0.01

0.02

< LOQ

0.68

0.70

0.69

0.72

0.71

Sampling 6

22/03/2018

100

<LOQ

0.01

0.01

< LOQ

0.18

0.19

0.19

0.19

0.19

Abiotique (Sampling 4)

26/12/2017

14

0.05

4.05

4.10

4.10

Abiotique (Sampling 5)

01/02/2018

51

0.03

3.56

3.59

3.59

Abiotique (Sampling 6)

22/03/2018

100

0.04

3.74

3.78

3.78

 

Time (days)

% of applied quantity of test item

water

sediment

Water + sediment

0

80%

11%

91%

3

34%

57%

91%

7

15%

51%

66%

14

6%

26%

32%

23

3%

21%

24%

51

0%

7%

7%

100

0%

2%

2%

 

“La Morte” aerobic system

Water samples:

Date

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Concentration (ug/L)

Water volume (mL)

Quantity (µg)

Mean quantity (µg)

Initial time

12/12/2017

0

<LOQ

17.621

39.032

308.600

314.880

308.840

<LOQ

5.55

12.05

8.80

Sampling 1

15/12/2017

3

<LOQ

6.000

5.811

299.730

308.400

298.720

<LOQ

1.85

1.74

1.79

Sampling 2

19/12/2017

7

0.042

2.084

2.653

305.170

296.530

304.460

<LOQ

0.62

0.81

0.71

Sampling 3

26/12/2017

14

<LOQ

0.463

0.800

301.300

300.500

300.620

<LOQ

0.14

0.24

0.19

Sampling 4

04/01/2018

23

<LOQ

0.232

0.189

301.870

292.510

297.070

<LOQ

0.07

0.06

0.06

Sampling 5

01/02/2018

51

<LOQ

0.000

0.000

276.190

273.580

274.440

<LOQ

0.00

0.00

0.00

Sampling 6

22/03/2018

100

<LOQ

0.042

0.021

279.030

258.230

259.440

<LOQ

0.01

0.01

0.01

Abiotique (Sampling 4)

26/12/2017

14

0.021

263.400

0.01

< LOQ

Abiotique (Sampling 5)

01/02/2018

51

0.021

276.990

0.01

< LOQ

Abiotique (Sampling 6)

22/03/2018

100

0.021

263.500

0.01

< LOQ

Sediment samples:

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Sample weighing (g)

Concentration (ug/L)

sediment weight (g)

Quantity in sediment (µg)

Mean quantity (µg)

0

7.0

7.0

7.0

< LOQ

0.0732

0.0868

168.9

176.4

173.8

< LOQ

1.78

2.20

1.99

3

7.0

6.9

7.0

< LOQ

0.1458

0.1652

181.3

172.1

178.1

< LOQ

3.78

4.10

3.94

7

7.0

6.9

7.0

< LOQ

0.0928

0.2144

178.4

176.0

181.1

< LOQ

2.36

5.44

3.90

14

7.0

7.2

6.9

< LOQ

0.0844

0.0764

185.7

181.0

171.7

< LOQ

2.23

1.92

2.08

23

7.0

7.0

6.9

< LOQ

0.0554

0.0774

183.1

182.6

178.9

< LOQ

1.45

2.03

1.74

51

6.9

7.0

7.0

< LOQ

0.0242

0.033

200.8

205.7

198.9

< LOQ

0.70

0.97

0.84

100

7.0

7.0

7.0

< LOQ

0.011

0.006

205.8

214.1

209.0

< LOQ

0.32

0.18

0.25

14

7.0

0.0144

189.5

0.39

0.39

51

7.0

0.0072

177.1

0.18

0.18

100

7.0

0.0098

186.6

0.26

0.26

Total system:

Water

Sediment

Total system

Date

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Test 1

Test 2

Quantity in water (µg)

Quantity in sediment (µg)

Quantity (µg)

Mean quantity (µg)

Initial time

12/12/2017

0

<LOQ

5.55

12.05

< LOQ

1.78

2.20

7.32

14.25

10.79

Sampling 1

15/12/2017

3

<LOQ

1.85

1.74

< LOQ

3.78

4.10

5.64

5.83

5.73

Sampling 2

19/12/2017

7

<LOQ

0.62

0.81

< LOQ

2.36

5.44

2.98

6.24

4.61

Sampling 3

26/12/2017

14

<LOQ

0.14

0.24

< LOQ

2.23

1.92

2.37

2.16

2.27

Sampling 4

04/01/2018

23

<LOQ

0.07

0.06

< LOQ

1.45

2.03

1.52

2.09

1.80

Sampling 5

01/02/2018

51

<LOQ

0.00

0.00

< LOQ

0.70

0.97

0.70

0.97

0.84

Sampling 6

22/03/2018

100

<LOQ

0.01

0.01

< LOQ

0.32

0.18

0.33

0.19

0.26

Abiotique (Sampling 4)

26/12/2017

14

0.01

0.39

0.40

0.40

Abiotique (Sampling 5)

01/02/2018

51

0.01

0.18

0.19

0.19

Abiotique (Sampling 6)

22/03/2018

100

0.01

0.26

0.27

0.27

 

Time (days)

% of applied quantity of test item

water

sediment

Water + sediment

0

88%

20%

108%

3

18%

39%

57%

7

7%

39%

46%

14

2%

21%

23%

23

1%

17%

18%

51

0%

8%

8%

100

0%

3%

3%

 

“La Veore” anaerobic system

Water samples:

Date

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Concentration (ug/L)

Water volume (mL)

Quantity (µg)

Mean quantity (µg)

Initial time

12/12/2017

0

<LOQ

20.126

20.400

291.650

307.070

300.590

<LOQ

6.18

6.13

6.16

Sampling 1

15/12/2017

3

<LOQ

5.768

16.968

292.320

301.520

304.540

<LOQ

1.74

5.17

3.45

Sampling 2

19/12/2017

7

0.042

2.947

3.768

296.720

305.870

310.380

<LOQ

0.90

1.17

1.04

Sampling 3

26/12/2017

14

<LOQ

1.137

1.516

306.760

308.710

301.430

<LOQ

0.35

0.46

0.40

Sampling 4

04/01/2018

23

<LOQ

1.600

1.200

297.010

311.760

314.050

<LOQ

0.50

0.38

0.44

Sampling 5

01/02/2018

51

<LOQ

0.126

0.063

302.540

303.450

297.970

<LOQ

0.04

0.02

0.03

Sampling 6

22/03/2018

100

<LOQ

0.126

0.063

298.740

304.790

307.660

<LOQ

0.04

0.02

0.03

Abiotique (Sampling 4)

26/12/2017

14

0.211

326.880

0.07

0.07

Abiotique (Sampling 5)

01/02/2018

51

0.126

243.460

0.03

0.03

Abiotique (Sampling 6)

22/03/2018

100

0.147

307.890

0.05

0.05

Sediment samples:

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Sample weighing (g)

Concentration (ug/L)

sediment weight (g)

Quantity in sediment (µg)

Mean quantity (µg)

0

3.5

3.5

3.5

< LOQ

0.019

0.057

155.3

154.3

152.3

< LOQ

0.84

2.50

1.67

3

3.5

3.5

3.5

< LOQ

0.0844

0.3056

154.4

151.7

156.0

< LOQ

3.69

13.15

8.42

7

3.5

3.5

3.5

< LOQ

0.0786

0.0572

152.0

154.5

152.4

< LOQ

3.39

2.51

2.95

14

4.0

4.1

4.1

< LOQ

0.1468

0.1674

153.9

155.3

151.2

< LOQ

5.63

6.42

6.03

23

3.6

3.5

3.5

< LOQ

0.0948

0.1134

156.9

147.8

152.7

< LOQ

4.17

4.77

4.47

51

3.5

3.5

3.5

< LOQ

0.0394

0.0202

153.8

153.1

153.6

< LOQ

1.71

0.87

1.29

100

3.6

3.6

3.6

< LOQ

0.004

0.005

154.3

155.1

151.7

< LOQ

0.18

0.23

0.21

14

3.6

0.06

154.5

2.55

2.55

51

3.5

0.051

161.1

2.33

2.33

100

3.6

0.0328

159.4

1.46

1.46

Total system:

Water

Sediment

Total system

Date

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Test 1

Test 2

Quantity in water (µg)

Quantity in sediment (µg)

Quantity (µg)

Mean quantity (µg)

Initial time

12/12/2017

0

<LOQ

6.18

6.13

< LOQ

0.84

2.50

7.02

8.63

7.82

Sampling 1

15/12/2017

3

<LOQ

1.74

5.17

< LOQ

3.69

13.15

5.43

18.32

11.87

Sampling 2

19/12/2017

7

<LOQ

0.90

1.17

< LOQ

3.39

2.51

4.30

3.68

3.99

Sampling 3

26/12/2017

14

<LOQ

0.35

0.46

< LOQ

5.63

6.42

5.98

6.88

6.43

Sampling 4

04/01/2018

23

<LOQ

0.50

0.38

< LOQ

4.17

4.77

4.67

5.14

4.91

Sampling 5

01/02/2018

51

<LOQ

0.04

0.02

< LOQ

1.71

0.87

1.75

0.89

1.32

Sampling 6

22/03/2018

100

<LOQ

0.04

0.02

< LOQ

0.18

0.23

0.22

0.25

0.24

Abiotique (Sampling 4)

26/12/2017

14

0.07

2.55

2.62

2.62

Abiotique (Sampling 5)

01/02/2018

51

0.03

2.33

2.36

2.36

Abiotique (Sampling 6)

22/03/2018

100

0.05

1.46

1.51

1.51

 

Time (days)

% of applied quantity of test item

water

sediment

Water + sediment

0

62%

17%

78%

3

35%

84%

119%

7

10%

30%

40%

14

4%

60%

64%

23

4%

45%

49%

51

0%

13%

13%

100

0%

2%

2%

 

“La Morte” anaerobic system

Water samples:

Date

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Concentration (ug/L)

Water volume (mL)

Quantity (µg)

Mean quantity (µg)

Initial time

12/12/2017

0

<LOQ

28.505

16.463

294.640

303.910

291.180

<LOQ

8.66

4.79

6.73

Sampling 1

15/12/2017

3

<LOQ

3.137

3.116

289.870

301.220

304.300

<LOQ

0.94

0.95

0.95

Sampling 2

19/12/2017

7

0.042

1.853

1.768

291.850

306.750

300.200

<LOQ

0.57

0.53

0.55

Sampling 3

26/12/2017

14

<LOQ

0.168

0.463

306.140

306.730

305.580

<LOQ

0.05

0.14

0.10

Sampling 4

04/01/2018

23

<LOQ

0.021

0.021

305.820

302.270

307.010

<LOQ

0.01

0.01

0.01

Sampling 5

01/02/2018

51

<LOQ

0.000

0.000

295.220

301.510

305.000

<LOQ

0.00

0.00

0.00

Sampling 6

22/03/2018

100

<LOQ

0.126

0.063

298.580

304.050

306.560

<LOQ

0.04

0.02

0.03

Abiotique (Sampling 4)

26/12/2017

14

0.063

315.740

0.02

< LOQ

Abiotique (Sampling 5)

01/02/2018

51

0.021

245.720

0.01

< LOQ

Abiotique (Sampling 6)

22/03/2018

100

0.042

307.780

0.01

< LOQ

Sediment samples:

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Control

Test 1

Test 2

Sample weighing (g)

Concentration (ug/L)

sediment weight (g)

Quantity in sediment (µg)

Mean quantity (µg)

0

7.0

7.0

7.0

< LOQ

0.0878

0.0276

178.2

174.9

176.7

< LOQ

2.25

0.69

1.47

3

6.9

7.0

7.0

< LOQ

0.149

0.1124

186.1

168.4

175.2

< LOQ

3.99

2.72

3.36

7

7.0

7.0

7.0

< LOQ

0.0276

0.0222

179.3

175.4

177.8

< LOQ

0.71

0.56

0.63

14

7.4

7.4

7.3

< LOQ

0.0218

0.0784

176.4

176.6

177.5

< LOQ

0.52

1.87

1.19

23

7.0

6.9

6.9

< LOQ

0.0092

0.0016

170.5

182.6

173.6

< LOQ

0.23

0.04

0.13

51

7.0

7.0

7.0

< LOQ

0.001

0.0012

181.2

177.9

177.1

< LOQ

0.03

0.03

0.03

100

7.0

7.0

6.9

< LOQ

0.000

0.000

180.1

172.8

171.9

< LOQ

0.00

0.00

0.00

14

7.4

0.06

169.5

1.38

1.38

51

6.9

0.0132

187.4

0.36

0.36

100

7.0

0.0358

170.0

0.88

0.88

Total system:

Water

Sediment

Total system

Date

Time (days)

Control

Test 1

Test 2

Control

Test 1

Test 2

Test 1

Test 2

Quantity in water (µg)

Quantity in sediment (µg)

Quantity (µg)

Mean quantity (µg)

Initial time

12/12/2017

0

<LOQ

8.66

4.79

< LOQ

2.25

0.69

10.91

5.49

8.20

Sampling 1

15/12/2017

3

<LOQ

0.94

0.95

< LOQ

3.99

2.72

4.93

3.67

4.30

Sampling 2

19/12/2017

7

<LOQ

0.57

0.53

< LOQ

0.71

0.56

1.28

1.09

1.18

Sampling 3

26/12/2017

14

<LOQ

0.05

0.14

< LOQ

0.52

1.87

0.57

2.01

1.29

Sampling 4

04/01/2018

23

<LOQ

0.01

0.01

< LOQ

0.23

0.04

0.23

0.05

0.14

Sampling 5

01/02/2018

51

<LOQ

0.00

0.00

< LOQ

0.03

0.03

0.03

0.03

0.03

Sampling 6

22/03/2018

100

<LOQ

0.04

0.02

< LOQ

0.00

0.00

0.04

0.02

0.03

Abiotique (Sampling 4)

26/12/2017

14

0.02

1.38

1.40

1.40

Abiotique (Sampling 5)

01/02/2018

51

0.01

0.36

0.36

0.36

Abiotique (Sampling 6)

22/03/2018

100

0.01

0.88

0.89

0.89

 

Time (days)

% of applied quantity of test item

water

sediment

Water + sediment

0

62%

17%

78%

3

35%

84%

119%

7

10%

30%

40%

14

4%

60%

64%

23

4%

45%

49%

51

0%

13%

13%

100

0%

2%

2%

 

“La véore” aerobic system

Test system

Compartment

Kinetics

Visual fit

c2

DT50

(days)

DT90

(days)

« La Véore »

water

SFO

moderate

7.49

2.8

9.1

FOMC

good

1.17

2.4

11.2

DFOP

good

1.01

2.5

11.2

sediment

SFO

moderate

4.61

20.6

68.3

Total system

SFO

moderate

10.6

11.0

36.5

HS

moderate

12.27

10.8

38.7

 

“La Morte” aerobic system

Test system

Compartment

Kinetics

Visual fit

c2

DT50

(days)

DT90

(days)

« La Morte »

water

SFO

moderate

9.5

1.4

4.6

FOMC

good

1.94

1.0

5.7

sediment

SFO

moderate

14.99

14.9

49.4

FOMC

moderate

8.27

10.0

107.3

Total system

SFO

moderate

16.85

6.1

20.3

FOMC

moderate

7.18

4.1

40.9

DFOP

moderate

8.34

3.7

30.9

HS

moderate

8.37

3.3

30.1

 

“La Veore” anaerobic system

Test system

Compartment

Kinetics

Visual fit

c2

DT50

(days)

DT90

(days)

« La Morte »

water

SFO

moderate

10.39

3.2

10.5

HS

moderate

9.15

3.1

10.3

sediment

SFO

good

3.29

17.6

58.4

Total system

SFO

moderate

21.03

28.4

94.2

 

“La Morte” anaerobic system

Test system

Compartment

Kinetics

Visual fit

c2

DT50

(days)

DT90

(days)

« La Morte »

water

SFO

moderate

9.5

1.4

4.6

FOMC

good

1.94

1.0

5.7

sediment

SFO

moderate

38.12

2.7

7.9

Total system

SFO

moderate

15

3.1

10.3

FOMC

moderate

14.55

2.8

12.4

Validity criteria fulfilled:
yes
Conclusions:
At the start of incubation, 6.2 - 8.8 μg (corresponding to 62 – 88 % of the applied dose) of the 10 μg the nominally applied of C.I. Yellow 124 were recovered in the layer of water in both systems.
Between 3 and 14 days of incubation, the amount of C.I. Yellow 124 decreased in the water layer and increased in the sediment layer.
Subsequently, C.I. Yellow 124 further decreased in the water layer to approximately 0 μg (LOQ < 0.021 μg of C.I. Yellow 124 / L) and decreased in the sediment layer to approximately 0.2 μg at the end of the incubation period.
In both total systems, the initial amount of detected C.I. Yellow 124 was 7.8-10.8 μg (corresponding to 78 – 108 % of the applied dose). During the whole incubation period a decrease of 7.6 – 10.6 μg was observed.
No metabolite was identified through this test. The decrease of C.I. Yellow 124 measured concentration could be due to mineralization (CO2 production) or important adsorption on sediment (Non-extractable (bound) residues.
Executive summary:

The objective of this study was to assess the aerobic transformation rate of the test item in aquatic sediment and the measurement of the distribution of the test substance and its transformation products between the two phases according to OECD guideline 308.

 

The test was performed in the dark in a water-sediment system. The test item was applied as an aqueous solution into the water phase of the test system. Concentration of the test item and the transformation products was measured regularly in samples taken from the water phase and the sediment. This allowed the measurement of the transformation rate of the test item in the sediment and in a water-sediment system, as well as its distribution between these two phases. The identification of transformation products was based on comparison with control.

 

The test was performed on two aerobic and anaerobic aquatic sediment for 100 days at the most.

 

Upon addition to the water layer, C.I. Yellow 124 partitioned between the water and sediment.

At the start of incubation, 6.2 - 8.8 μg (corresponding to 62 – 88 % of the applied dose) of the 10 μg the nominally applied of C.I. Yellow 124 were recovered in the layer of water in both systems.

Between 3 and 14 days of incubation, the amount of C.I. Yellow 124 decreased in the water layer and increased in the sediment layer.

Subsequently, C.I. Yellow 124 further decreased in the water layer to approximately 0 μg (LOQ < 0.021 μg of C.I. Yellow 124 / L) and decreased in the sediment layer to approximately 0.2 μg at the end of the incubation period.

In both total systems, the initial amount of detected C.I. Yellow 124 was 7.8-10.8 μg (corresponding to 78 – 108 % of the applied dose). During the whole incubation period a decrease of 7.6 – 10.6 μg was observed.

 

No metabolite was identified through this test. The decrease of C.I. Yellow 124 measured concentration could be due to mineralization (CO2 production) or important adsorption on sediment (Non-extractable (bound) residues).

 

The DT50and DT90 values of C.I. Yellow 124 in both water/sediment systems are shown in the table below.

Test system

Compartment

Kinetics

Visual fit

ꭓ2

DT50(days)

DT90(days)

“La Véore” aerobic

Water

DFOP

Good

1.01

2.5

11.2

Sediment

SFO

Moderate

4.61

20.6

68.3

Total system

SFO

Moderate

10.6

11.0

36.5

“La Morte” aerobic

Water

FOMC

Good

1.94

1.0

5.7

Sediment

FOMC

Moderate

8.27

10.0

107.3

Total system

FOMC

Moderate

7.18

4.1

40.9

“La Véore” anaerobic

Water

HS

Moderate

9.15

3.1

10.3

Sediment

SFO

Good

3.29

17.6

58.4

Total system

SFO

Moderate

21.03

28.4

94.2

“La Morte” anaerobic

Water

FOMC

Good

1.94

1.0

5.7

Sediment

SFO

Moderate

38.12

2.7

7.9

Total system

FOMC

Moderate

14.55

2.8

12.4

 

Description of key information

The DT50and DT90values of C.I. Yellow 124 in both water/sediment systems are shown in the table below.

Test system

Compartment

Kinetics

Visual fit

ꭓ2

DT50(days)

DT90(days)

“La Véore” aerobic

Water

DFOP

Good

1.01

2.5

11.2

Sediment

SFO

Moderate

4.61

20.6

68.3

Total system

SFO

Moderate

10.6

11.0

36.5

“La Morte” aerobic

Water

FOMC

Good

1.94

1.0

5.7

Sediment

FOMC

Moderate

8.27

10.0

107.3

Total system

FOMC

Moderate

7.18

4.1

40.9

“La Véore” anaerobic

Water

HS

Moderate

9.15

3.1

10.3

Sediment

SFO

Good

3.29

17.6

58.4

Total system

SFO

Moderate

21.03

28.4

94.2

“La Morte” anaerobic

Water

FOMC

Good

1.94

1.0

5.7

Sediment

SFO

Moderate

38.12

2.7

7.9

Total system

FOMC

Moderate

14.55

2.8

12.4

 

Key value for chemical safety assessment

Half-life in freshwater:
3.1 d
at the temperature of:
12 °C
Half-life in freshwater sediment:
20.6 d
at the temperature of:
12 °C

Additional information

The objective of this study was to assess the aerobic transformation rate of the test item in aquatic sediment and the measurement of the distribution of the test substance and its transformation products between the two phases according to OECD guideline 308.

The test was performed in the dark in a water-sediment system. The test item was applied as an aqueous solution into the water phase of the test system. Concentration of the test item and the transformation products was measured regularly in samples taken from the water phase and the sediment. This allowed the measurement of the transformation rate of the test item in the sediment and in a water-sediment system, as well as its distribution between these two phases. The identification of transformation products was based on comparison with control.

The test was performed on two aerobic and anaerobic aquatic sediment for 100 days at the most.

 

Upon addition to the water layer, C.I. Yellow 124 partitioned between the water and sediment.

At the start of incubation, 6.2 - 8.8 μg (corresponding to 62 – 88 % of the applied dose) of the 10 μg the nominally applied of C.I. Yellow 124 were recovered in the layer of water in both systems.

Between 3 and 14 days of incubation, the amount of C.I. Yellow 124 decreased in the water layer and increased in the sediment layer.

Subsequently, C.I. Yellow 124 further decreased in the water layer to approximately 0 μg (LOQ < 0.021 μg of C.I. Yellow 124 / L) and decreased in the sediment layer to approximately 0.2 μg at the end of the incubation period.

In both total systems, the initial amount of detected C.I. Yellow 124 was 7.8-10.8 μg (corresponding to 78 – 108 % of the applied dose). During the whole incubation period a decrease of 7.6 – 10.6 μg was observed.

 

No metabolite was identified through this test. The decrease of C.I. Yellow 124 measured concentration could be due to mineralization (CO2production) or important adsorption on sediment (Non-extractable (bound) residues).

 

The DT50and DT90values of C.I. Yellow 124 in both water/sediment systems are shown in the table below.

Test system

Compartment

Kinetics

Visual fit

ꭓ2

DT50(days)

DT90(days)

“La Véore” aerobic

Water

DFOP

Good

1.01

2.5

11.2

Sediment

SFO

Moderate

4.61

20.6

68.3

Total system

SFO

Moderate

10.6

11.0

36.5

“La Morte” aerobic

Water

FOMC

Good

1.94

1.0

5.7

Sediment

FOMC

Moderate

8.27

10.0

107.3

Total system

FOMC

Moderate

7.18

4.1

40.9

“La Véore” anaerobic

Water

HS

Moderate

9.15

3.1

10.3

Sediment

SFO

Good

3.29

17.6

58.4

Total system

SFO

Moderate

21.03

28.4

94.2

“La Morte” anaerobic

Water

FOMC

Good

1.94

1.0

5.7

Sediment

SFO

Moderate

38.12

2.7

7.9

Total system

FOMC

Moderate

14.55

2.8

12.4

 

[Type of water: freshwater]