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EC number: 452-330-3 | 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
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:
- 13 February 2009 to 16 March 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All
- Sampling method: On days 0, 10 and 19 samples of the 'on' (freshly prepared) dilution water control and exposure concentrations were analysed for the concentration of the test material. Samples for the corresponding 'off' dilution water control and exposure concentrations (one replicate) were analysed on the following renewal day (days 3, 12 and 21). All 'off' samples were centrifuged prior to analysis. Triplicate analyses were performed on the nominal 1.0 mg/L exposure concentration on each sampling occasion. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock concentration of the test material with a nominal concentration of 100 mg/L was prepared. In each instance the concentrate was mixed by inversion and subjected to ultra-sonics for 10 minutes, which resulted in a clear, colourless solution. This newly prepared stock concentration was then used to prepared the 10 and 32 mg/L test solutions on each renewal occasion. This was achieved by the direct addition of the appropriate amounts of concentration to 1000 mL of dilution water in volumetric flasks. For the highest exposure treatment the concentration was used without any further dilution. The 0.32, 1.0 and 3.2 mg/L test solutions were prepared by serial dilution of the concentration by direct additions to 1000 mL of dilution water, also on each renewal occasion. All test solutions were observed to be clear and colourless.
- Controls: Dilution water (DWC) - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Age of parental stock (mean and range, SD): 32 ± 1 days old.
- Feeding during test: yes
- Food type: A mixed algal diet of C. vulgaris, strain CCAP211/12 and P. subcapitata, strain ATCC 2262.
- Amount: 0.06 mg C/day (equivalent to 0.12 mg C/daphnid/day).
- Frequency: Daily
ACCLIMATION
- Acclimation conditions (same as test or not): The parent animals had been maintained with a twice weekly renewal of reconstituted water medium since birth.
- Type and amount of food: Mixed algal diet.
- Feeding frequency: ad libitum.
- Health during acclimation (any mortality observed): The test organisms and the culture from which they were obtained showed no evidence of disease before the test period.
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Culture conditions were such that the reproduction was by parthenogenesis. Daphnia < 24 hours old obtained from a single culture vessel were used for testing. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 248 to 258 mg/L as CaCO3
- Test temperature:
- 19.4 to 20.2 °C
- pH:
- 'on' solutions: 7.7 to 8.3
'off' solutions: 7.8 to 8.3 - Dissolved oxygen:
- 'on' solutions: 8.6 to 9.2 mg/L
'off' solutions: 8.4 to 9.0 mg/L
Equivalent to a range of 93 to 101 % of the air saturation value - Nominal and measured concentrations:
- Nominal concentrations: 0.32, 1.0, 3.2, 10, 32 and 100 mg/L
Measured concentrations are presented in table 3 under the field "Any other information on results incl. tables". Across all exposure treatments, the mean measured concentrations of the 'on' test solutions ranged from 97 to 106 % of the nominal value, with the corresponding 'off' values ranging from 93 to 103 % of nominal. The analysis of the triplicate samples, taken from the nominal 1.0 mg/L solutions showed very good consistency. - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers
- Type : Closed, covered with loose fitting glass lids
- Material, size, headspace, fill volume: Glass beakers containing 80 mL test solution (depth 50 mm)
- Renewal rate of test solution: The test solutions were prepared on the day of use and were renewed every Monday, Wednesday and Friday throughout the study. On each renewal day, new test solutions were dispensed into a second set of vessels and the surviving P0 (parent) generation were transferred to the new solutions.
- No. of organisms per vessel: 1 parent (P0) daphnid per vessel
- No. of vessels per concentration (replicates): 10 per exposure
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The reconstituted water medium used for testing (and maintenance of stock cultures) was Elendt's m4 D. magna medium. Details of water quality and preparation are presented in tables 1 and 2 respectively under the field 'Any other information on materials and methods incl. tables'.
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light: 8 hours dark with 20 minute dawn and dusk transition periods.
- Light intensity: 7.2 µ Einsteins m^-2 s^-1
EFFECT PARAMETERS MEASURED:
Mortality of the P0 generation was recorded daily for each test vessel. Mortality was defined as animal being immobile or if there was no observed movement of appendages or post-abdomen within 15 seconds (after gentle agitation of the container if necessary). Observations were made at the same time for possible symptoms of toxicity. Observations were made daily from day 0 for the presence of live and dead offspring (F1 generation) in each vessel. - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Remarks:
- Length
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Remarks:
- length
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: overall
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: overall
- Details on results:
- - Mortality of parent animals: Survival in the treated Daphnia was comparable to the control. Mortalities, presence of males and other visual observations in the P0 generation D. magna were recorded during the test. There was one mortality in the DWC after 16 days. This satisfies the guideline validity criteria of ≤20 % control mortality at the end of the test. Exposure concentration mortalities were observed in 32 mg/L (2 mortalities - days 13 and 14) and 100 mg/L (3 mortalities - days 9, 13 and 14).
- Body length and weight of parent animals: The lengths of the 32 mg/L and the 100 mg/L treatments were found to be significantly lower
than the DWC.
- Type and number of morphological abnormalities: A male was confirmed in both the 3.2 mg/L and 100 mg/L exposure concentrations. White spots were also noted in one daphnid in the 32 mg/L, which subsequently became a mortality. One D. magna in the 100 mg/L concentration was observed to be a male on day 7, however, this was re-evaluated and confirmed to be a female upon release of its first brood. One other D. magna in the 100 mg/L concentration was observed to have white spots on Day 15, but subsequently recovered. The incidence of males and white patches in the abdomen of P0 daphnids was considered to be unrelated to the test substance concentration since there was no pattern of increase in these observations with increasing test concentration.
- Time to first brood release or time to hatch: All P0 D. magna had released their first offspring by day 10
- Brood size The mean number of offspring produced in the control, per surviving parent, at the end of the test was 89, exceeding the minimum of 60 specified in the guideline. The residual standard deviation (coefficient of variation) around the mean number of living offspring per parent in the DWC was 13.8 %, and therefore below the maximum of 25% recommended in the guideline. - Reported statistics and error estimates:
- Mortality: Survival in the exposure treatments was compared to the control using Fisher’s Exact Test. No significant reduction (p = < 0.05, bonferroni adjusted value p = 0.026) in survival in any exposure treatment was determined when compared to the control.
Length: Some of the data for length were found to be non-normally distributed and were therefore assessed for equality of variances between treatments using Levene’s test. Variances were found to be equal between treatments, therefore, a one-way ANOVA followed by a Dunnett’s test (two sided) was used to identify significant differences (p = 0.05) between the DWC and exposure treatments.
Reproduction: Prior to statistical analysis, an adjustment was made for mortality, by only including the P0 female D. magna surviving to the end of the study, and by excluding any males. The reproductive data were found to be non-normal and so were assessed for equality of variance with Levene’s test. Variances were found to be equal between treatments, therefore, a one-way ANOVA was used to identify significant differences (p = 0.05) between the DWC and exposure treatments. - Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the test, there were no statistically significant effects (p = 0.05) on P0 survival for any treatment, when compared to the control. There were statistically significant effects (p = 0.05) on P0 length for the 32 mg/L and the 100 mg/L concentrations, and on reproduction for the 100 mg/L concentration, when compared to the control. Taking all biological parameters into account the overall NOEC of the test material to Daphnia magna was determined to be 10 mg/L and the LOEC of the test material to Daphnia magna was determined to be 32 mg/L. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The effects of the test material to on the survival and reproduction on aquatic invertebrates was investigated in Daphnia magna in accordance with the standardised guidelines OECD 211. The Daphnia were exposed to the test material in a range of concentrations (0.32, 1.0, 3.2, 10, 32 and 100 mg/L under semi-static test conditions. The mean measured concentrations of the test substance were 97 -106 % ('on' values) and 93 -103 % ('off' values) of the nominal exposure concentrations; the results and conclusions were therefore based on nominal concentrations. There were no statistically significant effects (p <0.05) on survival for any treatment. The reproduction data showed that the offspring of the 100 mg/L treatment was found to be significantly lower when compared to the control. The lengths of the 32 mg/L and the 100 mg/L treatments were found to be significantly lower when compared to the control. The overall NOEC of test material was determined to be 10 mg/L. The LOEC of the test material was determined to be 32 mg/L.
Reference
Table 3: Analytical data
Nominal concentration of the test material (mg/L) |
Exposure day |
Measured concentration of test material (mg/L) |
Percentage of nominal |
||
On solution |
Off solution |
On solution |
Off solution |
||
Dilution water control |
0 |
<LOQ |
- |
N/A |
- |
3 |
- |
<LOQ |
- |
N/A |
|
10 |
<LOQ |
- |
N/A |
- |
|
12 |
- |
<LOQ |
- |
N/A |
|
19 |
<LOQ |
- |
N/A |
- |
|
21 |
- |
<LOQ |
- |
N/A |
|
0.32 |
0 |
0.32 |
- |
100 |
- |
3 |
- |
0.32 |
- |
100 |
|
10 |
0.30 |
- |
94 |
- |
|
12 |
- |
0.32 |
- |
110 |
|
19 |
0.31 |
- |
97 |
- |
|
21 |
- |
0.31 |
- |
98 |
|
1 |
0 |
1.0 |
- |
100 |
- |
3 |
- |
1.0 |
- |
100 |
|
10 |
0.94 |
- |
94 |
- |
|
12 |
- |
1.1 |
- |
100 |
|
19 |
0.96 |
- |
96 |
- |
|
21 |
- |
0.98 |
- |
100 |
|
3.2 |
0 |
3.3 |
- |
103 |
- |
3 |
- |
3.2 |
- |
100 |
|
10 |
3.2 |
- |
100 |
- |
|
12 |
- |
3.2 |
- |
100 |
|
19 |
3.2 |
- |
100 |
- |
|
21 |
- |
3.2 |
- |
100 |
|
10 |
0 |
10 |
- |
100 |
- |
3 |
- |
10 |
- |
100 |
|
10 |
12 |
- |
120 |
- |
|
12 |
- |
10 |
- |
100 |
|
19 |
9.9 |
- |
99 |
- |
|
21 |
- |
10 |
- |
100 |
|
32 |
0 |
33 |
- |
103 |
- |
3 |
- |
33 |
- |
103 |
|
10 |
33 |
- |
103 |
- |
|
12 |
- |
32 |
- |
100 |
|
19 |
33 |
- |
103 |
- |
|
21 |
- |
33 |
- |
103 |
|
100 |
0 |
100 |
- |
100 |
- |
3 |
- |
100 |
- |
100 |
|
10 |
110 |
- |
11 0 |
- |
|
12 |
- |
100 |
- |
100 |
|
19 |
97 |
- |
97 |
- |
|
21 |
- |
99 |
- |
99 |
Analytical data continued
Nominal concentration of test material (mg/L) |
Exposure day |
Triplicate' values |
||
1 |
0 on |
1.0 |
1.0 |
1.0 |
3 off |
1.0 |
1.0 |
1.0 |
|
10 on |
0.93 |
0.95 |
0.95 |
|
12 off |
0.97 |
1.2 |
1.0 |
|
19 on |
0.95 |
0.95 |
0.97 |
|
21 off |
0.97 |
0.99 |
0.99 |
Table 4: Adult length measurements
Nominal concentration of test material (mg/L) |
Length in graticule scale divisions (day 21) per P0D. magna |
Mean length |
Standard deviation |
Meana(mm) |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
||||
Dilution water control |
52 |
M |
53 |
50 |
52 |
54 |
55 |
54 |
55 |
53 |
53 |
1.6 |
4.4 |
0.32 |
50 |
53 |
52 |
54 |
53 |
54 |
52 |
52 |
53 |
54 |
53 |
1.3 |
4.4 |
1.0 |
52 |
52 |
51 |
52 |
52 |
53 |
55 |
53 |
52 |
52 |
52 |
1.1 |
4.4 |
3.2 |
54 |
53 |
53 |
53 |
53 |
54 |
53 |
53 |
50 |
♂ |
53 |
1.2 |
4.4 |
10 |
51 |
50 |
53 |
54 |
54 |
52 |
50 |
53 |
53 |
54 |
52 |
1.6 |
4.4 |
32 |
47 |
48 |
M |
M |
50 |
52 |
48 |
50 |
52 |
53 |
50b |
2.2 |
4.2 |
100 |
49 |
49 |
♂ |
46 |
45 |
M |
M |
47 |
46 |
M |
47b |
1.7 |
3.9 |
aLength in mm (1 mm = 12 scale divisions)
M = mortality
♂ observed male on day 7
bStatistically significant difference between treatment and dilution water control (p=0.005)
Table 5: Reproduction and mortality
Nominal concentration of test material (mg/L) |
Total Number of Offspring per P0 D. magna |
Mean per P0 |
Standard deviation |
Total offspring |
Mean offspring as % of dilution water control |
(%) Mortality of P0 D. magna |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
||||||
Dilution water control |
118 |
Ma |
81 |
80 |
80 |
87 |
81 |
88 |
98 |
90 |
89.2 |
803 |
- |
10 |
10 |
0.32 |
59 |
79 |
85 |
109 |
82 |
118 |
87 |
83 |
85 |
88 |
87.5 |
875 |
98 |
0 |
0 |
1 |
82 |
74 |
114 |
93 |
70 |
83 |
76 |
78 |
73 |
81 |
82.4 |
824 |
92 |
0 |
0 |
3.2 |
74 |
107 |
77 |
76 |
71 |
76 |
85 |
84 |
81 |
♂ |
81.2 |
731 |
91 |
0 |
0 |
10 |
75 |
79 |
84 |
113 |
87 |
77 |
80 |
82 |
125 |
81 |
88.3 |
883 |
99 |
0 |
0 |
32 |
107 |
75 |
Mbef |
Mc |
80 |
78 |
113 |
78 |
76 |
81 |
86 |
688 |
96 |
20 |
20 |
100 |
49 |
55 |
♂ |
39 |
41 |
Mc |
Mb |
50 |
31 |
Md |
44.2 |
265* |
50 |
30 |
30 |
M Mortality
aObserved to be dead on day 16
bObserved to be dead on day 13
cObserved to be dead on day 14
dObserved to be dead on day 9
♂ Observed to be male on day 7
* Statistically significant difference between treatment and dilution water control (p = 0.05)
eWhite patches observed in the abdomen (day 7)
fObserved to be transparent in appearance (day 9)
Table 6: Physical chemistry measurements
Nominal concentration of test material (mg/L) |
Dissolved oxygen |
pH |
Temperature |
Hardness as CaCO3 |
||||||||||
Minimum (mg/L) |
Maximum (mg/L) |
Minimum |
Maximum |
Minimum (°C) |
Maximum (°C) |
Minimum (mg/L) |
Maximum (mg/L) |
|||||||
On |
Off |
On |
Off |
On |
Off |
On |
Off |
On |
Off |
On |
Off |
|||
Dilution water control |
8.8 |
8.4 |
9.0 |
9.0 |
7.8 |
8.0 |
8.3 |
8.3 |
19.4 |
20.2 |
248 |
248 |
254 |
254 |
100 |
8.6 |
8.6 |
9.2 |
9.0 |
7.7 |
7.8 |
8.3 |
8.3 |
248 |
254 |
253 |
258 |
Description of key information
21 day NOEC = 10 mg/L, 21 day LOEC = 32 mg/L, Daphnia magna, OECD 211, Hayfield 2009
21 day NOE = 8.88 mg/L, 21 day LOEC >8.88 mg/L, Daphnia magna, OECD 211, Zhen 2016
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 10 mg/L
Additional information
The effects of the test material to on the survival and reproduction on aquatic invertebrates was investigated in water flea (Daphnia magna) in accordance with the standardised guidelines OECD 211. The Daphnia were exposed to the test material in a range of concentrations (0.32, 1.0, 3.2, 10, 32 and 100 mg/L under semi-static test conditions. The mean measured concentrations of the test material were 97-106 % ('on' values) and 93 -103 % ('off' values) of the nominal exposure concentrations; the results and conclusions were therefore based on nominal concentrations. There were no statistically significant effects (p <0.05) on survival for any treatment. The reproduction data showed that the offspring of the 100 mg/L treatment were found to be significantly lower than the control. The lengths of the 32 mg/L and the 100 mg/L treatments were found to be significantly lower than the control. The overall NOEC of test material was determined to be 10 mg/L. The LOEC of the test material was determined to be 32 mg/L. The available data was considered to be complete and the result determined, 21 d NOEC value of 10 mg/L, was taken forward for risk assessment.
The results were confirmed in a second reproductive toxicity study with water flea, conducted to OECD TG 211 and under GLP, which was conducted as part of a notification in China. The study was conducted with semi-static renewal of medium every 72 hours. A range-finding study was performed at nominal test concentrations of 1.00 and 10.0 mg/L and the NOEC was determined to be 10.0 mg/L. Therefore, a limit test was performed at a nominal concentration of 10.0 mg/L (mean measured concentration: 8.88 mg/L) alongside a blank control. Based on mean measured concentrations, the 21-day NOEC for reproduction and survival was 8.88 mg/L (nominal concentration of 10.0 mg/L) and the 21-day LOEC for reproduction and survival was >8.88 mg/L (nominal concentration of > 10.0 mg/L).
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