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EC number: 252-021-1 | CAS number: 34432-92-3
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14/03/2018 to 04/04/2018
- 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 for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- yes
- Remarks:
- See "Any other information" for details
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- No further details specified in the study report.
- Analytical monitoring:
- yes
- Details on sampling:
- Test item quantification was performed according to a validated analytical method (RRCo-000072-02). Full study details can be found in Section 8 - Analytical Methods.
- Vehicle:
- yes
- Remarks:
- acetone
- Details on test solutions:
- Since the test item is poorly soluble under the test conditions, a saturated solution of test item (limit of solubility LS) was prepared. A stock solution in acetone was prepared and mixed with glass beads. The solvent was eliminated with rotary evaporator and the glass beads were rinsed with water. Then, the saturated solution was prepared by agitation of the glass beads in test medium during at least 24h with a loading rate approximately 2g/L. The test solutions were prepared continuously by dilution of this saturated solution with peristaltic pump.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia, Daphnia magna Strauss clone 5, between 6 and 24 hours old and produced from parthenogenically reproducing brood female population were used. Daphnia are issued from the breeding lab. The juvenile stemming at least from the second litter were used to start the test.
Culture conditions:
Medium: Elendt M4
Temperature: 20 °C ± 2
Light/dark cycle: 16 h/8 h
pH: Between 6 and 9
Hardness (CaCO3): Between 140 and 250 mg.L-1
Daily feeding: Pseudokirchneriella subcapitata and Chlorella vulgaris suspensions (about 10 mL/replicates/day) - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Remarks on exposure duration:
- As per the guideline.
- Post exposure observation period:
- No post exposure observations period specified in the study report.
- Hardness:
- (CaCO3): Between 140 and 250 mg.L-1
- Test temperature:
- 20.4 - 21.1 °C
- pH:
- 7.8 - 8.1
- Dissolved oxygen:
- 8.6 - 9.0 %
- Salinity:
- Not applicable.
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- definitive measured concentrations of 0.52; 2.67; 9.87; 27.14 and 375.25 μg.L-1
- Details on test conditions:
- Based on the results of the range-finder, 5 concentrations were prepared in Elendt-M4 medium. A control was set up with the test medium only. There were 4 replicates for each treatment with 10 daphnia per replicate.
Organisms were maintained at temperature of 20°C ± 2°C and light intensity between 1000 and 1500 lux with a light:dark cycle of 16 hours light and 8 hours dark.
4 to 5 times a week, the number of living offspring produced in each replicate were recorded. pH dissolved oxygen and temperature were recorded once a week.
Every day, the daphnias were fed with Pseudokirchneriella subcapitata and Chlorella vulgaris suspensions (about 10 mL per day). - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 2.65 µg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LC50
- Effect conc.:
- 22.8 µg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.68 µg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality & reproduction
- Details on results:
- The study is valid since:
-the mortality of the parent animals (female Daphnia) was not exceed 20% at the end of the test.
-the mean number of living offspring produced per parent animal surviving at the end of the test was ≥ 60.
-EC50 with reference item over a period of 24 hours must be between 0.6 and 2.1 mg.L-1.
Based on the reproduction rate, the EC50 after a 21 days exposure period was calculated to be 2.65 μg.L-1. Based on the survival rate, the LC50 after a 21 days exposure period was calculated to be 22.8 μg.L-1.
The lowest NOEC was estimated to be at 0.68 μg.L-1. - Results with reference substance (positive control):
- 24-hour EC50 (mg.L-1): 1.428. See "Any other information on results incl. tables" below.
- Reported statistics and error estimates:
- The LOEC, the NOEC and the ECx were determined using the following data:
-The total number of living offspring per parent animal not accidentally or fortuitously dead at the end of the test.
-The total number of living offspring per parent animal alive at the end of the test.
The NOEC (No Observed Effect Concentration) were determined by statistical test from replicate data on survival and reproduction. Statistical calculations were made using R statistical software and the R script MOSAIC repro and surv. - Validity criteria fulfilled:
- yes
- Conclusions:
- The effects of C.I. Solvent Yellow 124 diluted in OECD test medium at the definitive measured concentrations of 0.68; 2.67; 9.87; 27.14 and 375.25 µg.L-1 to Daphnia magna were investigated under laboratory conditions.
Based on the reproduction rate, the EC50 after a 21 days exposure period was calculated to be 2.65 µg.L-1. Based on the survival rate, the LC50 after a 21 days exposure period was calculated to be 22.8 µg.L-1.
The lowest NOEC was estimated to be at 0.68 µg.L-1. - Executive summary:
The objective of this study was to assess the effects of the test item on the reproductive output of Daphnia magna over a period of 21 days according to OECD 211 guideline (2 october 2012).
Daphnia magna is a freshwater crustacean that is recommended by the OECD Guideline 211.
Since the test item is poorly soluble under the test conditions, a saturated solution of test item (limit of solubility LS) was prepared. A stock solution in acetone was prepared and mixed with glass beads. The solvent was eliminated with rotary evaporator and the glass beads were rinsed with water. Then, the saturated solution was prepared by agitation of the glass beads in test medium during at least 24h. The test solutions were prepared by dilution of this saturated solution. The test was performed under continuous flow-through condition.
Test item quantification was performed according to a validated analytical method using a LC-MS/MS from Thermo (LC Ultimate 3000 and MS Quantiva) as mass spectrometry detection to measure Yellow 124 concentration once a day in all concentrations. As some of the measured concentrations were not within±20% of nominal or initial concentrations, all results were based on mean measured concentrations.
The effects of C.I. Solvent Yellow 124 diluted in OECD test medium at the definitive measured concentrations of 0.68; 2.67; 9.87; 27.14 and 375.25 µg.L-1to Daphnia magna were investigated under laboratory conditions.
Results are the following:
C.I. Solvent Yellow 124
LC10 Survival (95% confidence limits)
0.431 µg.L-1
[0.096 µg.L-1; 1.15 µg.L-1]
LC50 Survival (95% confidence limits)
22.8 µg.L-1
[11.6 µg.L-1; 50.9 µg.L-1]
EC10 Reproduction (95% confidence limits)
1.29 µg.L-1
[1.19 µg.L-1; 1.4 µg.L-1]
EC50 Reproduction (95% confidence limits)
2.65 µg.L-1
[2.54 µg.L-1; 2.76 µg.L-1]
LC = lethal concentration
EC = effect concentration
C.I. Solvent Yellow 124
NOEC Survival
0.68 µg.L-1
NOEC Reproduction
0.68 µg.L-1
The study is valid since:
-the mortality of the parent animals (female Daphnia) was not exceed 20% at the end of the test.
-the mean number of living offspring produced per parent animal surviving at the end of the test was ≥ 60.
-EC50 with reference item over a period of 24 hours must be between 0.6 and 2.1 mg.L-1.
Based on the reproduction rate, the EC50 after a 21 days exposure period was calculated to be 2.65 µg.L-1. Based on the survival rate, the LC50 after a 21 days exposure period was calculated to be 22.8 µg.L-1.
The lowest NOEC was estimated to be at 0.68 µg.L-1.
Reference
POTASSIUM DICHROMATE RESULTS
24 hours after exposure
ID |
Rate [mg reference item.L-1] |
Immobilized daphnids 24 hours after exposure |
Total of immobilized daphnids |
Mean of immobilized daphnids (%) |
|||
Replicates |
|||||||
A |
B |
C |
D |
||||
T |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C1 |
0.5 |
0 |
0 |
0 |
0 |
0 |
0 |
C2 |
0.9 |
0 |
1 |
0 |
0 |
1 |
5 |
C3 |
1.35 |
3 |
1 |
2 |
2 |
8 |
40 |
C4 |
2.025 |
5 |
4 |
4 |
5 |
18 |
90 |
C5 |
3.0375 |
5 |
5 |
5 |
5 |
20 |
100 |
24-hour EC50
24-hour EC50 (mg.L-1) |
95% confidence limits (mg.L-1) |
Starting date |
1.428 |
13.48 – 1.509 |
21 February 2018 |
Physical-chemical parameters (pH, Oxygen, Temperature) (mean of 4 replicates)
pH |
C11 |
C12 |
C13 |
C14 |
C15 |
C16 |
14/03/18 |
7.9 |
7.9 |
7.9 |
7.9 |
7.9 |
8.0 |
23/03/18 |
7.9 |
7.9 |
7.8 |
8.0 |
7.9 |
8.1 |
29/03/18 |
8.0 |
8.1 |
8.1 |
8.1 |
8.0 |
8.0 |
04/04/18 |
7.9 |
8.0 |
8.0 |
7.9 |
8.0 |
8.1 |
Dissolved Oxygen (mg.L-1) |
C11 |
C12 |
C13 |
C14 |
C15 |
C16 |
14/03/18 |
8.8 |
8.8 |
8.7 |
8.6 |
8.9 |
8.7 |
23/03/18 |
8.7 |
8.7 |
8.7 |
8.7 |
8.7 |
8.7 |
29/03/18 |
8.9 |
9.0 |
8.8 |
8.9 |
8.9 |
8.8 |
04/04/18 |
8.7 |
8.7 |
8.6 |
8.7 |
8.8 |
8.7 |
|
Temperature (°C) |
14/03/18 |
21.1 |
23/03/18 |
20.4 |
29/03/18 |
21.1 |
04/04/18 |
20.9 |
Reproduction and survival
|
Replicates |
Number of juveniles |
Total juveniles per replicate |
Number juveniles per adult |
Number of adults of the end of the test |
Total juveniles per surviving adult |
Mean juveniles per surviving parent |
Coefficient of variation for control fecundity |
||||||
Day 12 |
Day 13 |
Day 14 |
Day 15 |
Day 16 |
Day 20 |
Day 21 |
||||||||
Control C11 |
R1 |
62 |
20 |
116 |
56 |
129 |
265 |
111 |
759 |
75.9 |
10 |
75.9 |
86.3 |
- |
R2 |
69 (1 dead) |
35 |
81 |
49 |
140 |
248 |
178 |
800 |
80 |
9 |
88.9 |
|||
R3 |
72 |
28 (1 dead) |
104 |
52 |
165 |
279 |
124 |
824 |
82.4 |
9 |
91.6 |
|||
R4 |
119 (1 dead) |
32 |
136 |
57 |
125 |
251 |
78 |
798 |
79.8 |
9 |
88.7 |
|||
0.68 μg. L-1 C12 |
R1 |
76 (1 dead day 9) |
41 |
81 (1 dead) |
46 |
89 |
307 |
73 |
713 |
71.3 |
8 |
89.1 |
84.7 |
2% |
R2 |
95 |
29 |
102 |
55 |
112 |
294 |
138 |
825 |
82.5 |
10 |
82.5 |
|||
R3 |
73 |
37 (1 dead) |
131 |
58 |
106 (1 dead) |
245 |
33 |
683 |
68.3 |
8 |
85.4 |
|||
R4 |
74 (1 dead) |
28 |
138 |
50 |
99 |
282 |
64 |
735 |
73.5 |
9 |
81.7 |
|||
2.67 μg.L-1 C13 |
R1 |
0 (2 dead (days 7 and 8)) |
10 |
61 |
28 |
52 |
156 |
10 |
317 |
31.7 |
8 |
39.6 |
45.3 |
47% |
R2 |
16 (2 dead (days 5 and 8)) |
17 |
35 |
24 |
33 |
142 |
51 |
318 |
31.8 |
8 |
39.8 |
|||
R3 |
0 (2 dead day 8) |
12 |
69 |
29 |
84 |
161 |
18 |
373 |
37.3 |
8 |
46.6 |
|||
R4 |
37 (2 dead day 7) |
15 |
57 (1 dead) |
31 |
38 |
139 (1 dead) |
14 |
331 |
33.1 |
6 |
55.2 |
|||
9.87 μg.L-1 C14 |
R1 |
0 (2 dead day 7 and 1 dead day 8) |
0 |
1 |
2 |
0 |
4 |
5 |
12 |
1.2 |
7 |
1.7 |
1.5 |
97% |
R2 |
0 |
0 |
1 |
1 |
0 |
6 |
0 |
8 |
0.8 |
10 |
0.8 |
|||
R3 |
0 (1 dead day 6) |
0 |
0 |
0 |
0 |
10 |
0 |
10 |
1 |
9 |
1.1 |
|||
R4 |
2 (1 dead day 8) |
0 |
0 |
2 |
0 |
8 |
9 |
21 |
2.1 |
9 |
2.3 |
|||
27.14 μg.L-1 C15 |
R1 |
0 (3 dead day 5, 2 dead days 6 and 7, 3 dead day 9) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
100% |
R2 |
0 (5 dead day 5, 4 dead day 6, 1 dead day 8) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
R3 |
9 (2 dead day 5, 4 dead day 6, 3 dead day 7, 1 dead day 8) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
R4 |
0 (2 dead days 6 and 7, 6 dead day 8) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
375.25 μg.L-1 C16 |
R1 |
0 (10 dead day 2) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
100% |
R2 |
0 (10 dead day 2) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
R3 |
0 (9 dead day 2, 1 dead day 3) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
R4 |
0 (8 dead day 2, 2 dead day 3) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Description of key information
The lowest NOEC was estimated to be at 0.68 μg.L-1.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.68 µg/L
Additional information
The objective of this study was to assess the effects of the test item on the reproductive output of Daphnia magna over a period of 21 days according to OECD 211 guideline (2 october 2012).
Daphnia magna is a freshwater crustacean that is recommended by the OECD Guideline 211.
Since the test item is poorly soluble under the test conditions, a saturated solution of test item (limit of solubility LS) was prepared. A stock solution in acetone was prepared and mixed with glass beads. The solvent was eliminated with rotary evaporator and the glass beads were rinsed with water. Then, the saturated solution was prepared by agitation of the glass beads in test medium during at least 24h. The test solutions were prepared by dilution of this saturated solution. The test was performed under continuous flow-through condition.
Test item quantification was performed according to a validated analytical method using a LC-MS/MS from Thermo (LC Ultimate 3000 and MS Quantiva) as mass spectrometry detection to measure Yellow 124 concentration once a day in all concentrations. As some of the measured concentrations were not within±20% of nominal or initial concentrations, all results were based on mean measured concentrations.
The effects of C.I. Solvent Yellow 124 diluted in OECD test medium at the definitive measured concentrations of 0.68; 2.67; 9.87; 27.14 and 375.25 µg.L-1to Daphnia magna were investigated under laboratory conditions.
Results are the following:
|
C.I. Solvent Yellow 124 |
LC10 Survival (95% confidence limits) |
0.431 µg.L-1 [0.096 µg.L-1; 1.15 µg.L-1] |
LC50 Survival (95% confidence limits) |
22.8 µg.L-1 [11.6 µg.L-1; 50.9 µg.L-1] |
EC10 Reproduction (95% confidence limits) |
1.29 µg.L-1 [1.19 µg.L-1; 1.4 µg.L-1] |
EC50 Reproduction (95% confidence limits) |
2.65 µg.L-1 [2.54 µg.L-1; 2.76 µg.L-1] |
LC = lethal concentration
EC = effect concentration
|
C.I. Solvent Yellow 124 |
NOEC Survival |
0.68 µg.L-1 |
NOEC Reproduction |
0.68 µg.L-1 |
The study is valid since:
-the mortality of the parent animals (female Daphnia) was not exceed 20% at the end of the test.
-the mean number of living offspring produced per parent animal surviving at the end of the test was ≥ 60.
-EC50 with reference item over a period of 24 hours must be between 0.6 and 2.1 mg.L-1.
Based on the reproduction rate, the EC50 after a 21 days exposure period was calculated to be 2.65 µg.L-1. Based on the survival rate, the LC50 after a 21 days exposure period was calculated to be 22.8 µg.L-1.
The lowest NOEC was estimated to be at 0.68 µg.L-1.
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