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EC number: 609-256-3 | CAS number: 365400-11-9
- 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
Toxicity to aquatic plants other than algae
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic plants other than algae
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 - 23 May 2003 (definitive study)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.4400 (Aquatic Plant Toxicity Test using Lemna spp. Tiers I & II))
- Version / remarks:
- 1996 (draft version)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control, 4.69, 9.38, 18.75, 37.5, 75.0, and 150 μg/L (nominal concentrations)
- Sampling method: Samples of test item solutions, including controls, were taken on Day 0 (new solutions) and Day 7 (old solutions) to measure actual exposure concentrations. On Day 0 the test solutions were prepared as uniform batches. On this day a 260-mL aliquot of the uniform test solution was poured into each of the labeled test vessels. A 500 mL sample of the remaining, fresh prepared, test solution was collected for analysis at each concentration. A 20-mL sample of the stock solution was also submitted for analysis on Day 0. On Day 7, a portion of the old test solutions from all replicates within a test concentration was composited. A 500-mL sample of the composite was collected for measured concentration analysis at each test level.
- Sample storage conditions before analysis: no storage - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A primary stock solution (10 mg a.i./L) was prepared by dissolving 0.0108 g of the test item (95.4% a.i.) into 1 L of 20 x AAP media. This stock solution was used to prepare all treatment levels by spiking the appropriate amount of the stock solution into approximately 1.5 L of 20 x AAP contained in labeled 2 L volumetric flasks. Each flask was then brought to a volume of 2 L with 20 x AAP media.
- Controls: yes, medium control
- Chemical name of vehicle: no solvent was used - Test organisms (species):
- Lemna gibba
- Details on test organisms:
- TEST ORGANISM
- Common name: Duckweed
- Strain: Lemna gibba G3
- Source (laboratory, culture collection): Department of Horticultural Science at the University of Minnesota in St. Paul, Minnesota, USA
- Age of inoculum (at test initiation): 7-day old batch culture
- Method of cultivation: The culture was grown under test conditions in an environmental chamber at 25 ± 2.0 °C, with a 24-hour light photoperiod and a light intensity between 453 and 480 foot-candles (4.9 to 5.2 klux) provided by cool white fluorescent lamps
ACCLIMATION
- Culturing media and conditions (same as test or not): same as test - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 7 d
- Test temperature:
- 24.3 - 24.8 °C (mean 24.6 °C)
- pH:
- test start (day 0): 7.8 - 7.9
test end (day 7): 8.6 - 8.7 - Conductivity:
- 1332 - 1342 μmhos/cm (control)
1330 - 1363 μmhos/cm (test concentration) - Nominal and measured concentrations:
- control, 4.69, 9.38, 18.75, 37.5, 75.0, and 150 μg/L (nominal concentrations)
control, 4.14, 9.57, 18.6, 33.1, 74.2, and 152.5 μg ai./L (mean measured concentrations) - Details on test conditions:
- TEST SYSTEM
- Incubation chamber used: yes (environmental chamber)
Test vessel:
- Type (delete if not applicable): open (capped with sterile, petri dish lids)
- Material, size, headspace, fill volume: sterile, 650-ml borosilicate glass crystallization dishes (diameter of 125 mm and a height of 65 mm and depth approximately 25 mm), filled with 260 mL of test solution.
- Type of cover: petri dish lids
- Aeration: no aeration
- Agitation: no but the test vessels were randomized daily during the exposure period.
- Control end cells density: 110 fronds at test end (mean growth rate 0.01217; Mean calculated cumulative biomass 6456)
- No. of colonies per vessel: 13 fronds per vessel
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: destilled water
- Culture medium different from test medium: no
- Intervals of water quality measurement:The pH and conductivity were measured in all test solutions on Day 0 (new batch solutions) and on Day 7 (old solutions). A calibrated datalogger and thermocouple were used to monitor the test system temperature each hour. In addition, manual temperature readings were recorded daily using a calibrated thermometer.
OTHER TEST CONDITIONS
- Sterile test conditions: The study was conducted under axenic conditions. (medium was sterilized using a 0.20 µm filter)
- Adjustment of pH: The batch of nutrient media used to prepare the test solutions was adjusted to pH 7.5 with dilute hydrochloric acid
- Photoperiod: 24-hour light photoperiod
- Light intensity and quality: between 453 and 480 foot-candles (4.9 to 5.2 klux) provided by cool white fluorescent lamps
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The total number of fronds in each test vessel was manually counted on Days 0, 3, 5, and 7. Statistical analysis was performed for the endpoints of frond count (standing crop), growth rate, and cumulative biomass (area under the growth curve). At the same time, phytotoxicity observations were performed to determine the health of the plants in each test vessel.
- Determination of frond number: manual counting
- Determination of biomass: [dry weight] The plants from each replicate were dried at approximately 60 °C for at least 24 hours, transferred to a desiccator to cool to ambient temperature, and then weighed to determine the dry weight.
RANGE-FINDING STUDY
- Test concentrations: control, 0.001, 0.01, 0.1, 1.0 and 10.0 mg a.i./L (nominal)
- Results used to determine the conditions for the definitive study: Inhibition for frond counts and plant dry weights as compared to the control group were: 0.001 mg/L (-1, -3), 0.01 mg/L (-3, -14), 0.10 mg/L (80, 88), 1.0 mg/L (83, 88) and 10.0 mg/L (83, 88), respectively. The test item concentrations of the definitive test were based on these results. - Reference substance (positive control):
- no
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- 110 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 9.57 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: growth rate and fronds count
- Duration:
- 7 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 18.6 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: growth rate and fronds count
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- 42.4 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: cumulative biomass
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 18.6 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: cumulative biomass
- Duration:
- 7 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 33.1 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: cumulative biomass
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- 44.9 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- frond number
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- 30.2 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: fronds dry weight
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 9.57 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: fronds dry weight
- Duration:
- 7 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 18.6 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: fronds dry weight
- Details on results:
- - Decrease in frond size: A reduction in frond size was also noted in the treatment levels 33.1, 74.2, and 152.5 μg a.i./L on day 3. Observations on Day 5 revealed a reduction in frond size in the highest four treatment levels (18.6, 33.1, 74.2, and 152.5 μg a.i./L). On day 7 observations revealed reduced frond size in the highest four treatment groups
- Other: Observations made on Day 3 revealed a few occurrences of brown fronds in each of the highest three treatment levels (33.1, 74.2, and 152.5 μg a.i./L). Transparent fronds were seen in the 74.2 μg a.i./L treatment level. On day 5 brown fronds in the highest three treatment levels, and transparent fronds in the highest treatment level. On Day 7 brown and transparent fronds in the highest three treatment groups.
- Any stimulation of growth found in any treatment: yes, at 4.14 µg a.i./L (-2% inhibition)
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no observations
- Others: Analytical and biological results in detail are summarized in tables 1-6 in section "any other information on results incl tables" - Results with reference substance (positive control):
- no positive control was used
- Reported statistics and error estimates:
- Raw or transformed data from treatment groups were compared to the control group for normality and homogeneity of variance using the Shapiro-Wilks test and Levene's test of equal variance, respectively.If normality and homogeneity of variance were demonstrated for the raw or transformed values, then parametric analyses were conducted using analysis of variance (ANOVA) followed by Dunnett's test. If normality and/or homogeneity of variance were not demonstrated on raw or transformed values, nonparametric procedures were used. The ranks of the raw values were determined, and then an analysis of variance and a one-tailed Dunnett's test were performed on these ranks. Statistical analyses were conducted using PC-based computer programs (SAS version 8).
Further statistical analysis was conducted to determine if the inhibition on growth was significant. Statistical analysis was performed for the endpoints of frond count (standing crop), growth rate, and cumulative biomass (area under the growth curve). All treatment levels were compared to the control group for the above endpoints. Statistical analysis of the data did not passed the criteria for normality and homogeneity of variance for the standing crop and growth rate endpoints. Therefore, a nonparametric analysis was conducted for these endpoints. For the cumulative biomass endpoint, the data passed the criteria for normality and homogeneity of variance so a parametric analysis was conducted for this endpoint. - Validity criteria fulfilled:
- yes
- Remarks:
- See Table 7 in "Any other information on results incl. tables".
Reference
Mean measured calculations were based on the recoveries of the test solutions on days 0 and 7. This represents a range of 88 to 102% of the nominal test concentrations (Table 2). Recoveries for the control test solution were below the limit of quantitation (0.96 μg/L).
Percent inhibition of frond counts ranged from –2 to 69% as compared to the control. Percent inhibition for cumulative biomass and growth rate ranged from -1 to 75% and 0 to 55%, respectively.
Table 1: Measured Test Concentrations of test iteml During the Exposure of Lemna gibba G3
Measured Concentration (μg a.i./L) |
||||
Nominal Conc. (μg a.i./L) |
Day 0 (new) |
Day 7 (old) |
Mean Standard Deviation a) |
Percent of Nominal a) |
Control |
ND |
ND |
---- |
---- |
4.69 |
4.77 |
3.51 |
4.14 ± 0.89 |
88 |
9.38 |
10.3 |
8.83 |
9.57 ± 1.04 |
102 |
18.75 |
19.3 |
17.9 |
18.6 ± 0.99 |
99 |
37.5 |
35.4 |
30.8 |
33.1 ± 3.25 |
88 |
75.0 |
76.7 |
71.6 |
74.2 ± 3.61 |
99 |
150 |
157 |
148 |
152.5 ± 6.36 |
102 |
Lab Recovery b) |
|
|
|
|
19.3 |
21.0 |
19.9 |
20.5 ± 0.85 |
106 |
ND = Not detected at or above the validated limit of quantitation (0.96 μg/L)
Conc. = Concentration
a) Calculations for mean, standard deviation, and percent of nominal concentration are based on
recoveries from Day 0 and Day 7
b) Percent recoveries for Day 0 and Day 7 were 109 and 103 %, respectively. Lab spike nominal concentration was 19.3 μg/L each day.
Table 2: Daily Test Temperature Range During the exposure of Lemna gibba G3 to test item
Temperature (°C) |
|||
Exposure Period (Hour) |
Minimum |
Maximum |
Mean |
1 – 24 |
24.3 |
24.6 |
24.5 |
25 - 48 |
24.5 |
24.6 |
24.5 |
49 – 72 |
24.4 |
24.6 |
24.5 |
73 – 96 |
24.5 |
24.8 |
24.6 |
97 – 120 |
24.5 |
24.7 |
24.6 |
121 – 144 |
24.5 |
24.6 |
24.6 |
145 – 168 |
24.6 |
24.7 |
24.6 |
Study |
24.3 |
24.8 |
24.6 |
Daily temperature ranges reported are based upon the hourly temperatures recorded by the datalogger during the exposure period.
Table 3: pH and Conductivity Measurements During the Exposure of Lemna gibba G3 to test item
Mean Measured Concentration (μg a.i./L) |
Day 0 (New) |
Day 7 (Old) |
||
pH |
Cond |
pH |
Cond |
|
Control |
7.9 |
1342 |
8.7 |
1332 |
4.14 |
7.9 |
1346 |
8.7 |
1330 |
9.57 |
7.9 |
1349 |
8.7 |
1341 |
18.6 |
7.9 |
1352 |
8.7 |
1348 |
33.1 |
7.9 |
1362 |
8.6 |
1350 |
74.2 |
7.9 |
1363 |
8.6 |
1357 |
153 |
7.8 |
1362 |
8.6 |
1359 |
Cond = Conductivity in μmhos/cm
Conductivity range = 1330 to 1363 μmhos/cm
Mean conductivity = 1350 μmhos/cm
pH range = 7.8 to 8.7
Table 4: Day 0 and 7 Frond Number During the Exposure of Lemna gibba G3 to test item
Mean Measured Concentration (μg a.i./L) |
Replicate |
Day 0 |
Day 7 |
Day 7 Mean |
Standard Deviation |
Percent* Inhibition |
Control |
A |
13 |
108 |
110 |
3 |
|
B |
13 |
113 |
||||
C |
13 |
109 |
||||
4.14 |
A |
13 |
136 |
113 |
26 |
-2 |
B |
13 |
117 |
||||
C |
13 |
85 |
||||
9.57 |
A |
13 |
105 |
97 |
9 |
12 |
B |
13 |
88 |
||||
C |
13 |
99 |
||||
18.6 |
A |
13 |
75 |
71 |
4 |
35 |
B |
13 |
67 |
||||
C |
13 |
71 |
||||
33.1 |
A |
13 |
51 |
49 |
3 |
55 |
B |
13 |
51 |
||||
C |
13 |
45 |
||||
74.2 |
A |
13 |
44 |
46 |
4 |
58 |
B |
13 |
51 |
||||
C |
13 |
44 |
||||
153 |
A |
13 |
33 |
34 |
1 |
69 |
B |
13 |
33 |
||||
C |
13 |
35 |
* Percent inhibition = 100 - ((mean frond count per test level/mean frond count of control) x 100)
Table 5: Day 7 Frond Count, Cumulative Biomass, and Growth Rate During the Exposure of Lemna gibba G3 to test item
Mean Measured Concentration (μg a.i./L) |
Frond Counts |
Percent Inhibition1 |
Mean Calculated Cumulative Biomass2 |
Percent Inhibition1 |
Mean Growth Rate3 |
Percent Inhibition1 |
Control |
110 |
- |
6456 |
- |
0.01271 |
- |
4.14 |
113 |
-2 |
6520 |
-1 |
0.01274 0 |
|
9.57 |
97 |
12 |
5752 |
11 |
0.01197 |
6 |
18.6 |
71* |
35 |
5040 |
22 |
0.01010* |
21 |
33.1 |
49* |
55 |
3036* |
53 |
0.00789* |
38 |
74.2 |
46* |
58 |
2192* |
66 |
0.00755* |
41 |
153 |
34* |
69 |
1628* |
75 |
0.00566* |
55 |
* Statistically significant from control (Dunnett's one-tailed test; p £ 0.05)
1 Percent inhibition = 100 - ((mean value per test level/mean of controls) x 100).
2 Cumulative biomass is equal to the area under the growth curve
3 Growth rate is calculated from the frond count data
Table 6: Day 7 Frond Dry Weights During the Exposure of Lemna gibba G3 to test item
Mean Measured Concentration (μg a.i./L) |
Replicate |
Day 7 Dry Weight (grams) |
Day 7 Mean (grams) |
Standard Deviation (grams) |
Percent* Inhibition |
Control |
A |
0.0088 |
0.0107 |
0.0017 |
|
B |
0.0119 |
|
|
||
C |
0.0114 |
|
|
||
4.14 |
A |
0.0120 |
0.0105 |
0.0019 |
0 |
B |
0.0111 |
|
|
||
C |
0.0084 |
|
|
||
9.57 |
A |
0.0098 |
0.0091 |
0.0008 |
13 |
B |
0.0082 |
|
|
||
C |
0.0093 |
|
|
||
18.6 |
A |
0.0070 |
0.0066** |
0.0004 |
37 |
B |
0.0062 |
|
|
||
C |
0.0066 |
|
|
||
33.1 |
A |
0.0046 |
0.0041** |
0.0006 |
61 |
B |
0.0034 |
|
|
||
C |
0.0042 |
|
|
||
74.2 |
A |
0.0034 |
0.0032** |
0.0003 |
70 |
B |
0.0033 |
|
|
||
C 0.0029 |
|
|
|
||
153 |
A |
0.0025 |
0.0024** |
0.0005 |
77 |
B |
0.0019 |
|
|
||
C |
0.0028 |
|
|
* Percent inhibition = 100 - ((mean dry weight per test level/mean dry weight control) x 100).
** Statistically significant from control (Dunnett's one-tailed test; p 0.05)
Table 7: Validity criteria for OECD 221 (2006)
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The doubling time of frond number in the control must be less than 2.5 days (60 h), corresponding to approximately a seven-fold increase in seven days and an average specific growth rate of 0.275 d-1. |
The frond number in the controls increased by an average factor of 8.5 in seven days. |
yes |
Description of key information
EC50 (7 d) = 110 µg a.i./L (mean measured, Lemna gibba, growth rate, OPPTS 850.4400)
NOEC (7 d) = 9.57 µg a.i./L (mean measured, Lemna gibba, growth rate, OPPTS 850.4400)
Key value for chemical safety assessment
- EC50 for freshwater plants:
- 110 µg/L
- EC10 or NOEC for freshwater plants:
- 9.57 µg/L
Additional information
One experimental study is available investigating the effects of the substance to aquatic plants (M-107686-01-1). The study was performed according to OPPTS 850.4400 (GLP) under static conditions using Lemna gibba as test organism.
The duckweed Lemna gibba G3 was exposed for 7 days to the nominal (mean measured) concentrations: control (<1.00), 4.69 (4.14), 9.38 (9.57), 18.75 (18.6), 37.5 (33.1), 75.0 (74.2) and 150 (152.5) µg a.i./L. Growth was determined by frond counts on days 0, 3, 5, and 7. Samples of the test item solutions, including controls, were taken on Day 0 (new solutions) and Day 7 (old solutions) to measure actual exposure concentrations.
The mean measured concentrations were 4.14, 9.57, 18.6, 33.1, 74.2, and 152.5 μg a.i./L for the 4.69, 9.38, 18.75, 37.5, 75.0, and 150 μg/L nominal concentrations, respectively. The measured concentrations were in the range of 88 to 102% of the nominal test concentrations. Observations revealed reduced frond size in the highest four treatment groups (18.6, 33.1, 74.2, and 152.5 µg a.i./L) as well as brown and transparent fronds in the highest three treatment groups (33.1, 74.2, and 152.5 µg a.i./L). The NOEC and LOEC in the 7-day exposure of Lemna gibba G3 to the test item were 9.57 and 18.6 µg a.i./L, respectively for the standing crop, growth rate and frond dry weight endpoints. Frond dry weight was the most sensitive endpoint. The NOEC and EC50 for this endpoint were 9.57 and 30.2 µg a.i./L, respectively. However, since growth rate is the preferred endpoint according to ECHA Guidance R.7b (ECHA, 2016) it was used as the key value (EC50 (7 d): 110 µg/L; NOEC (7 d): 9.57 µg/L). All endpoints were based on the mean measured concentrations.
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