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EC number: 922-551-4 | CAS number: 1187440-66-9
- 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:
- 08 October 2019 - 10 December 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Physical State/Appearance: White flakes powder
Storage Conditions: Room temperature in the dark - Analytical monitoring:
- yes
- Details on sampling:
- Samples of the fresh test preparations were taken on Days 0, 6, 13 and 20 and of the expired test preparations on Days 1, 7, 14 and 21 Samples were taken for immediate analysis. Duplicate samples were taken and stored frozen for further analysis if necessary.
- Vehicle:
- no
- Details on test solutions:
- Nominal amounts of test item were each separately added to the surface of test water to give the required loading rates. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 23 hours and the mixtures allowed to stand for 1 hour. A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. Microscopic inspection of the WAFs showed no micro dispersions or undissolved test item to be present. The aqueous phase or WAF was removed by mid depth siphoning (the first approximate 75 to 100 mL discarded) to give the required loading rate WAFs.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- The test was carried out using 1st instar Daphnia magna derived from in-house laboratory cultures.
Adult Daphnia were maintained in 150 mL glass vessels containing Elendt M4 medium in a temperature controlled room at approximately 20 ºC. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Raphidocelis subcapitata (formally known as Pseudokirchneriella subcapitata)) and GEMMA Micro 300 fish food suspension. Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Remarks on exposure duration:
- Daphnia magna were exposed to a WAF of the test item over a range of test concentrations of for a period of 21 days.
- Post exposure observation period:
- n/a
- Hardness:
- 242 to 268 mg/L as CaCO3 in the control and the highest surviving test group throughout the test.
- Test temperature:
- Temperature was maintained at approximately 19 ºC to 22 ºC throughout the test.
- pH:
- 7.9 - 8.6
- Dissolved oxygen:
- 8.0 - 9.5 mg O2/L
- Salinity:
- CaCl2.2H2O - 293.8mg/L
KCl - 5.8mg/L - Conductivity:
- n/a
- Nominal and measured concentrations:
- In the range-finding test Daphnia magna were exposed to a series of nominal loading rates of 10 and 100 mg/L.
Based on the results of a preliminary range finding test, Daphnia magna were exposed to a WAF of the test item over a range of test concentrations of 10, 18, 32, 56 and 100 mg/L for a period of 21 days. - Details on test conditions:
- For each concentration a single daphnid was placed in 100 mL of the test preparation in 120 mL glass vessels which were then covered to reduce evaporation. For each test and control group 10 replicate test vessels were prepared. The test vessels were maintained in a temperature controlled room at 18 to 22 ºC with a maximum deviation of ±1 ºC with a photoperiod of 16 hours light (not exceeding 1500 Lux) and 8 hours darkness with 20 minute dawn and dusk transition periods for 21 days. The test vessels were not aerated. The diluent water only was aerated prior to use.
The control group was maintained under identical conditions but not exposed to the test item.
The test preparations were renewed daily throughout the test. The adult Daphnia were transferred to fresh media by wide bore pipette before the contents of each vessel were passed through a fine mesh. Young daphnids (live and dead) and any unhatched eggs were collected on the mesh and counted before being discarded.
Each daphnid received approximately 5 to 20 µL of an algal suspension (Raphidocelis subcapitata) daily and approximately 20 µL of GEMMA Micro 300 fish food suspension on Days 0 to 3. Feeding was at a level of approximately 0.1 to 0.2 mg carbon/daphnid/day, dependent on the age and size of the animals. Equal amounts of food were given to each daphnid. - Reference substance (positive control):
- no
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EL10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- morphology
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- morphology
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOELR
- Effect conc.:
- 56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- morphology
- Details on results:
- Range-finding Test:
No immobilization was observed at the test concentrations of control, 10 and 100 mg/L loading rate WAFs. No sub-lethal effects of exposure was observed in all test concentrations
Chemical analysis of the fresh test preparations on Day 0 showed measured test concentrations of 0.00036 to 0.0012 mg/L. The chemical analysis of the old test preparations on Day 2 showed measured test concentrations to range from less than the limit of quantification (LOQ) to 0.00010 mg/L, showing that the test item appears to be unstable under the test conditions.
Definitive Test:
Chemical analysis of the fresh test preparations on Days 0, 6, 13 and 20 showed measured test concentrations to range from less than the limit of quantification (LOQ), which was determined to be 0.00074 to 0.058 mg/L. Chemical analysis of the aged test preparations on Days 1, 7, 14 and 21 showed measured test concentrations to range from less than the LOQ to 0.054 mg/L.
Lethal Effects on the Parental Generation (P1):
One mortality was observed at the test loading rate of 10 mg/L on Day 7. However, statistical analysis of the mortality data using the Fisher’s Exact Binomial Test with Bonferroni Correction test showed that the observed mortality in the 10 mg/L loading rate WAF group were not significantly different (P0.05) when compared to the control group.
No mortalities occurred at the control, 18, 32, 56 and 100 mg/L loading rate WAF groups throughout the test.
Sub-lethal Effects on the Parental Generation (P1):
The daphnids in all test concentrations were observed to be the same size and color as the control daphnids apart from one daphnid in the 10 mg/L loading rate WAF test group which was observed to be pale on Day 6 before being observed to be dead on Day 7.
The results showed that there were no statistically significant differences (P0.05) between the control and the 10, 18 and 32 mg/L loading rate WAF test groups in terms of length of the daphnids after 21 days exposure to the test item. The 56 and 100 mg/L loading rate WAF test groups showed a statistically significant difference from the control after 21 days in terms of length of the daphnids.
Effects on Reproduction:
After 21 days there were no statistically significant differences between the control and all the test groups in terms of the number of live young produced per adult.
Effects on the Filial Generation (F1):
Information on the effects of the test item on the F1 generation is limited, since, by study design, the young are removed soon after liberation from the brood pouch. However, an assessment made at each media renewal showed the "filial" daphnids produced by all the test groups were in the same general condition as the young produced by the controls over the duration of the test.
Young were first produced in the control test group on Day 9 of the test.
Water Quality Criteria:
Temperature was maintained at approximately 19 ºC to 22 ºC throughout the test, while there were no treatment related differences for oxygen concentration or pH.
The water hardness was observed to be in the range 242 to 268 mg/L as CaCO3 in the control and the highest surviving test group throughout the test.
Throughout the test the light intensity was observed to be in the range 892 to 1426 lux.
See tables 1 - 6. - Results with reference substance (positive control):
- n/a
- Reported statistics and error estimates:
- The 21 Day ELx values for parental generation immobilization were calculated by Probit analysis using Linear Maximum-Likelihood Regression.
The ELx values for reproduction after 21 days were calculated by Probit analysis using Linear Maximum-Likelihood Regression.
The ELx values for body length were calculated using the 3-Parameter Normal Cumulative Distribution Function.
All ELx determinations were performed using the ToxRatPro software package (TOXRAT).
For the determination of the Lowest Observed Effect Loading Rate (LOEL) and the No Observed Effect Loading Rate (NOEL), the number of parental generation Daphnia mortalities for the control and each test group were compared using Fisher’s Exact Binomial Test with Bonferroni Correction Procedure. For the determination of the LOEL and NOEL the numbers of live young produced per adult over the duration of the test (excluding any parents which died accidentally or inadvertently) for the control and each test group were compared using Step-down Jonckheere-Terpstra Test incorporating Shapiro-Wilks test on normal distribution and Levene’s test on variance homogeneity. Results from the control and each test group’s Daphnia length data were compared using Williams Multiple Sequential t-test Procedure incorporating Shapiro-Wilks test on normal distribution and Levene’s test on variance homogeneity. All statistical analyses were performed using the ToxRatPro software package (TOXRAT). - Validity criteria fulfilled:
- yes
- Conclusions:
- Table one summarises the results after exposure of Daphnia magna to the test item based on the nominal test concentrations.
Reference
Table 1 - Summary of results
Endpoint |
Concentration (mg/L LR WAF) |
95% Confidence Limits (mg/L LR WAF) |
|
Immobilization |
EL10 |
Not determined |
Not applicable |
EL20 |
Not determined |
Not applicable |
|
EL50 |
Not determined |
Not applicable |
|
No Observed Effect Loading Rate |
100 |
- |
|
Lowest Observed Effect Loading Rate |
Not determined |
- |
|
Reproduction |
EL10 |
Not determined |
Not applicable |
EL20 |
Not determined |
Not applicable |
|
EL50 |
Not determined |
Not applicable |
|
No Observed Effect Loading Rate |
100 |
- |
|
Lowest Observed Effect Loading Rate |
Not determined |
- |
|
Body Length |
EL10 |
>100 |
Not determined |
EL20 |
Not determined |
Not applicable |
|
EL50 |
Not determined |
Not applicable |
|
No Observed Effect Loading Rate |
32 |
- |
|
Lowest Observed Effect Loading Rate |
56 |
- |
Table 2 - Range-finding Test Data
Nominal Loading Rate |
Percentage Immobilization After 10 Days Exposure |
Sub-lethal Effects |
Total Number of Live Young in First Brood |
Control |
0 |
None |
80 |
10 |
0 |
None |
87 |
100 |
0 |
None |
74 |
Table 3 - Summary of Findings Following the Exposure of Daphnia magna for 21 Days
Nominal Loading Rate |
Parental (P1) Generation Mortalities |
Total Number of Live Young |
Number of Live Young from Parents Surviving to the End of the Test |
Number of Live Young at the End of the Test Excluding Parents that were Accidental or Inadvertent Mortalities |
||||
Total |
Accidental |
Inadvertent |
Total |
Average per Parent |
Total |
Average per Parent |
||
Control |
0 |
0 |
0 |
1386 |
1386 |
139 |
1386 |
139 |
10 |
1 |
0 |
1 |
1319 |
1319 |
147 |
1319 |
147 |
18 |
0 |
0 |
0 |
1444 |
1444 |
144 |
1444 |
144 |
32 |
0 |
0 |
0 |
1569 |
1569 |
157 |
1569 |
157 |
56 |
0 |
0 |
0 |
1541 |
1541 |
154 |
1541 |
154 |
100 |
0 |
0 |
0 |
1598 |
1598 |
160 |
1598 |
160 |
Table 4 - Summary of Daily Observations
Day |
Nominal Loading Rate (mg/L) |
|||||||||||
Control |
10 |
18 |
32 |
56 |
100 |
|||||||
Adults Surviving |
Live Young |
Adults Surviving |
Live Young |
Adults Surviving |
Live Young |
Adults Surviving |
Live Young |
Adults Surviving |
Live Young |
Adults Surviving |
Live Young |
|
1 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
2 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
3 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
4 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
5 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
6 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
7 |
10 |
0 |
9 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
8 |
10 |
0 |
9 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
9 |
10 |
138 |
9 |
117 |
10 |
139 |
10 |
140 |
10 |
138 |
10 |
126 |
10 |
10 |
0 |
9 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
1 |
11 |
10 |
32 |
9 |
0 |
10 |
25 |
10 |
52 |
10 |
73 |
10 |
159 |
12 |
10 |
208 |
9 |
222 |
10 |
176 |
10 |
222 |
10 |
168 |
10 |
108 |
13 |
10 |
0 |
9 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
14 |
10 |
34 |
9 |
0 |
10 |
28 |
10 |
54 |
10 |
49 |
10 |
76 |
15 |
10 |
284 |
9 |
344 |
10 |
346 |
10 |
367 |
10 |
316 |
10 |
322 |
16 |
10 |
0 |
9 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
10 |
0 |
17 |
10 |
43 |
9 |
0 |
10 |
3 |
10 |
68 |
10 |
47 |
10 |
78 |
18 |
10 |
278 |
9 |
304 |
10 |
345 |
10 |
311 |
10 |
340 |
10 |
335 |
19 |
10 |
0 |
9 |
0 |
10 |
2 |
10 |
0 |
10 |
0 |
10 |
0 |
20 |
10 |
0 |
9 |
0 |
10 |
0 |
10 |
28 |
10 |
54 |
10 |
0 |
21 |
10 |
369 |
9 |
332 |
10 |
380 |
10 |
327 |
10 |
356 |
10 |
393 |
TOTALS |
10 |
1386 |
9 |
1319 |
10 |
1444 |
10 |
1569 |
10 |
1541 |
10 |
1598 |
Table 5 - Body Length of Surviving Adults at Day 21
Nominal Loading Rate |
IndividualDaphniaLengths (mm) |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|
Control |
4.0 |
4.5 |
4.0 |
3.9 |
3.9 |
4.0 |
3.9 |
3.8 |
4.1 |
4.1 |
10 |
4.2 |
4.0 |
3.8 |
4.2 |
- |
4.0 |
4.0 |
3.9 |
3.8 |
3.8 |
18 |
4.0 |
4.0 |
3.9 |
4.1 |
4.0 |
3.8 |
3.8 |
3.5 |
4.0 |
4.0 |
32 |
3.9 |
3.9 |
4.0 |
3.9 |
3.9 |
4.0 |
4.1 |
3.7 |
3.8 |
3.9 |
56 |
3.8 |
3.8 |
4.1 |
4.0 |
4.0 |
3.3 |
3.8 |
3.4 |
3.5 |
4.0 |
100 |
3.6 |
3.7 |
3.3 |
3.6 |
4.0 |
3.5 |
3.7 |
3.8 |
3.8 |
4.0 |
- No measurement, Daphnia died during the test
Table 6 - Validation Criteria
The following validation criteria were achieved during the test:
|
Required |
Actual |
Control mortality |
≤20% |
0% |
Mean number of live young per surviving adult (control group) |
≥60 after 21 days |
138.6 |
Coefficient of variation for control group* |
≤25% |
8.3% |
No ephippia produced |
0 |
0 |
Dissolved oxygen |
>3 mg O2/L |
≥7.8 mg O2/L |
pH (control group) |
6 to 9 |
7.6 to 8.6 |
*Based on total number of living offspring per parent animal alive at the end of the test
Description of key information
A study was performed to assess the chronic toxicity of the registered substance to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2012) No 211, “Daphnia magna Reproduction Test” referenced as Method C.20 of Commission Regulation (EC) No. 440/2008.
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as Water Accommodated Fractions (WAFs).
Chemical analysis of the fresh test preparations on Days 0, 6, 13 and 20 showed measured test concentrations to range from less than the limit of quantification (LOQ), which was determined to be 0.00074 to 0.058 mg/L. Chemical analysis of the aged test preparations on Days 1, 7, 14 and 21 showed measured test concentrations to range from less than the LOQ to 0.054 mg/L. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.
Effects on Reproduction:
After 21 days there were no statistically significant differences between the control and all the test groups in terms of the number of live young produced per adult.
Lethal Effects on the Parental Generation (P1): No mortalities occurred at the control, 18, 32, 56 and 100 mg/L loading rate WAF groups throughout the test.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
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