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EC number: 235-920-3 | CAS number: 13047-13-7
- 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
- Endpoint:
- toxicity to aquatic plants other than algae
- Remarks:
- lemna
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2017 to 28 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one
- EC Number:
- 235-920-3
- EC Name:
- 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one
- Cas Number:
- 13047-13-7
- Molecular formula:
- C11H14N2O2
- IUPAC Name:
- 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Concentrations: all concentrations on day 0 and 6 (fresh) and on day 1 and 7 (24h-old) --> 2.0 mL from the approximate centre of the test vessels
- Sample storage conditions before analysis: anaylsed freshly
- sample preparation:diluted in a 1:1 (v:v) ratio with 1% L-ascorbic acid in Imodified Steinberg medium and analyzed ( the substance is known to be stabel in 0.5% L-ascorbic acid in water)
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Preparation of test solutions started with the highest concentration of 100 mg/L with magnetic stirring to accelerate dissolution of the test item in medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. At the end of the preparation procedure, all test solutions were clear and colorless besides the highest concentration that was observed to be slightly yellow.
Due to the light sensitive nature of the test item, preparation was performed under dimmed light and the glassware was wrapped in aluminum foil.
Test organisms
- Test organisms (species):
- Lemna minor
- Details on test organisms:
- TEST ORGANISM
- Common name: lemna minor (duckweed)
- Source (laboratory, culture collection): in-house culture (started at the Friedrich-Schiller-Universität Jena)
- Method of cultivation: exposed to light in a climate room at a temperature of 22-26°C.
ACCLIMATION: 7 days before the start of the test, pre-cultures were started with 2 or 3 plants each with a maximum of 3 fronds. The total number of fronds increased by a factor of ≥ 7 in 7 days with a doubling time of ≤ 2.5 days. The culture consisted of young, rapidly growing colonies with bright green fronds that varied in size without visible lesions, chlorosis, gibbosity or necrosis. The pre-culture was maintained under the same conditions as used in the test.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 7 d
Test conditions
- Hardness:
- no data
- Test temperature:
- 23-25°C
- pH:
- fresh 5.2-5.7
old 4.8-6.1 (increase over duration of the study) - Dissolved oxygen:
- no data
- Nominal and measured concentrations:
- nominal: 0, 1.0, 3.2, 10, 32 and 100 mg/L
measured (TWA): 0, 0.80, 2.6, 7.5, 24 and 88 mg/L (see table) - Details on test conditions:
- TEST SYSTEM
- Incubation chamber used: yes (23 - 25°C)
- Test vessel: 250 ml, all-glass, containing 150 ml of test solution
- Aeration: no
- Agitation: yes swirled
- Renewal rate of test solution: density
- No. of fronds per colony: 3 plants, with a total of 9 fronds
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes (modified Steinberg medium according to the guideline)
TEST MEDIUM / WATER PARAMETERS: Modified Steinberg medium; according to ISO 20079, formulated using Milli-RO water
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: continuously
- Light intensity and quality: TLD-lamps Intensity at the start: 92-102 µE.m-2.s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of frond number: manual counting at renewals
- Determination of biomass: fresh weight on day 0 and 7
- Determination of frond area: no data
RANGE-FINDING STUDY
- Test concentrations: 0, 0.1, 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: expected EC50 for the inhibition of yield (no of fronds) > 100 mg/L, expected EC50 for inhibition of yield (biomass) 10-100 mg/L
- Analytics: The actual concentrations measured in the freshly prepared solutions were at the level of 19-96% of nominal at the start of the test and 29-93% of nominal in the last renewal period. The actual concentrations decreased to 30-49% of initially measured at the end of the first and 22-28% of initially measured in the last renewal period. This finding is not in line with the findings of the method development study and therefore in the main study samples were analysed freshly (immediately after taking without storage). - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 88 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- frond number
- Remarks on result:
- other: growth rate
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.6 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- frond number
- Remarks on result:
- other: growth rate and yield
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- 55 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: growth rate
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- < 0.8 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: growth rate and yield
- Details on results:
- see tables
Plants exposed to the two highest concentrations were observed to be smaller than the control plants from day 4 of exposure. From day 6 of exposure plants exposed to the three highest concentrations were observed to be smaller and have shorter roots than the control plants. - Reported statistics and error estimates:
- Determination of the NOEC/LOEC and calculation of the ECx (x=10, 20, 50)
For determination of the NOEC and the EC50 the approaches recommended in the OECD guideline 201 were used. An effect was considered to be significant if statistical analysis of the data obtained for the test concentrations compared with those obtained in the negative control revealed significant inhibition of growth rate or inhibition of yield (Williams Multiple Sequential t-test Procedure, α=0.05, one-sided, smaller).
Additionally, the EC10 and EC20 were determined to meet the recommendations as put down in "A Review of Statistical Data Analysis and Experimental Design in OECD Aquatic Toxicology Test Guidelines" by S. Pack, August 1993.
Calculation of ECx values was based on probit analysis using linear maximum likelihood regression with the percentages of growth rate inhibition and the percentages of yield inhibition versus the logarithms of the corresponding average exposure concentrations of the test item.
The calculations were performed with ToxRat Professional v. 3.2.1 (ToxRat Solutions® GmbH, Germany).
Any other information on results incl. tables
Growth rate based on frond numbers
Period (day) |
Replicate |
CH01610, Average exposure concentration (mg/L) |
|||||
Control |
0.80 |
2.6 |
7.5 |
24 |
88 |
||
0-7 |
1 |
0.356 |
0.379 |
0.34 |
0.324 |
0.319 |
0.264 |
|
2 |
0.378 |
0.347 |
0.371 |
0.338 |
0.276 |
0.256 |
|
3 |
0.371 |
0.383 |
0.36 |
0.308 |
0.293 |
0.264 |
|
4 |
0.348 |
|
|
|
|
|
|
5 |
0.338 |
|
|
|
|
|
|
6 |
0.34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Mean: |
|
0.355 |
0.37 |
0.357 |
0.324 |
0.296 |
0.261 |
Std.Dev.: |
|
0.0165 |
0.0198 |
0.016 |
0.0148 |
0.0218 |
0.0045 |
n: |
|
6 |
3 |
3 |
3 |
3 |
3 |
CV: |
|
4.7 |
5.3 |
4.5 |
4.6 |
7.4 |
1.7 |
|
0.362 |
0.358 |
0.317 |
0.335 |
0.339 |
0.277 |
The doubling time of frond number in the control was 2.0 days,
corresponding to a
12-fold increase in seven days and an average specific growth rate of
0.355 d-1.
Individual Biomass (g)
Time |
CH01610, Average exposure concentration (mg/L) |
|||||
Control |
0.80 |
2.6 |
7.5 |
24 |
88 |
|
0 h |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
|
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
0.0170 |
|
0.0170 |
|
|
|
|
|
|
|
0.0170 |
|
|
|
|
|
|
0.0170 |
|
|
|
|
|
n: |
6 |
3 |
3 |
3 |
3 |
3 |
Mean: |
0.0170 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
|
|
|
|
|
|
7 d |
0.1977 |
0.1176 |
0.1254 |
0.0881 |
0.0778 |
0.0558 |
0.2381 |
0.1430 |
0.1238 |
0.0965 |
0.0588 |
0.0487 |
|
0.1972 |
0.1642 |
0.1398 |
0.0794 |
0.0663 |
0.0538 |
|
0.1677 |
|
|
|
|
|
|
|
0.1651 |
|
|
|
|
|
|
0.1784 |
|
|
|
|
|
n: |
6 |
3 |
3 |
3 |
3 |
3 |
Mean: |
0.1907 |
0.1416 |
0.1297 |
0.088 |
0.0676 |
0.0528 |
Std.Dev.: |
0.0271 |
0.0233 |
0.0088 |
0.0086 |
0.0096 |
0.0037 |
CV: |
14 |
16.5 |
6.8 |
9.7 |
14.1 |
6.9 |
Individual Growth Rates (Biomass)
Time |
CH01610, Average exposure concentration (mg/L) |
|||||
Control |
0.80 |
2.6 |
7.5 |
24 |
88 |
|
7 d |
0.351 |
0.276 |
0.285 |
0.235 |
0.217 |
0.17 |
0.377 |
0.304 |
0.284 |
0.248 |
0.177 |
0.15 |
|
0.35 |
0.324 |
0.301 |
0.22 |
0.194 |
0.165 |
|
0.327 |
|
|
|
|
|
|
0.325 |
|
|
|
|
|
|
0.336 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Mean: |
0.344 |
0.302 |
0.29 |
0.234 |
0.196 |
0.162 |
Std.Dev.: |
0.0195 |
0.024 |
0.0095 |
0.0139 |
0.0201 |
0.0101 |
n: |
6 |
3 |
3 |
3 |
3 |
3 |
CV: |
5.7 |
7.9 |
3.3 |
5.9 |
10.2 |
6.2 |
Individual Yield (Biomass)
Time |
CH01610, Average exposure concentration (mg/L) |
|||||
Control |
0.80 |
2.6 |
7.5 |
24 |
88 |
|
7 d |
0.2 |
0.1 |
0.1 |
0.1 |
0.1 |
0 |
0.2 |
0.1 |
0.1 |
0.1 |
0 |
0 |
|
0.2 |
0.1 |
0.1 |
0.1 |
0 |
0 |
|
0.2 |
|
|
|
|
|
|
0.1 |
|
|
|
|
|
|
0.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Mean: |
0.2 |
0.1 |
0.1 |
0.1 |
0.1 |
0 |
Std.Dev.: |
0.03 |
0.02 |
0.01 |
0.01 |
0.01 |
0 |
n: |
6 |
3 |
3 |
3 |
3 |
3 |
CV: |
15.6 |
18.7 |
7.8 |
12 |
18.9 |
10.2 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50 and NOEC for growth rate based on biomass are 55 and < 0.8 mg/L
The EC50 and NOEC for growth rate based on frond number are > 88 and 0.8 mg/L - Executive summary:
Six replicates of Lemna minor colonies were exposed to a control, whereas three replicates per group were exposed to substance concentrations of 1.0, 3.2, 10, 32 and 100 mg/L. The total exposure period was 7 days and test solutions were renewed daily. The initial plant density per replicate was 3 with a total frond number of 9 per replicate. Samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the first and the last renewal period.
The actual concentrations measured in the freshly prepared solutions and ages soutions showed a time weighed average exposure concentrations were 0.80, 2.6, 7.5, 24 and 88 mg/L at nominally1.0, 3.2, 10, 32 and 100 mg/L, respectively.
A dose-related response were observed for all relevant endpoints.
The effect parameters (mg/L) obtained in this study are summarise in tables below.
Parameter (mg/L)
NOEC
LOEC
EC10
EC20
EC50
Frond numbers
Growth rate
Value
2.6
7.5
11
43
>88
lower 95%-cl
5.1
29
n.d.
upper 95%-cl
18
63
n.d.
Yield
Value
2.6
7.5
2.9
8.4
64
lower 95%-cl
0.69
3.5
40
upper 95%-cl
6.0
14
140
Biomass
Growth rate
Value
<0.80
0.80
0.551
2.7
55
lower 95%-cl
0.30
1.8
43
upper 95%-cl
0.87
3.6
76
Yield
Value
<0.80
0.80
0.111
0.411
5.3
lower 95%-cl
0.057
0.26
4.3
upper 95%-cl
0.18
0.59
6.4
n.d. – not determined,1– indicative value obtained by extrapolation of the dose-response curve
In conclusion, under the conditions of the present study with Lemna minor, CH01610 reduced growth rate and inhibited the yield of this fresh water plant species significantly at 7.5 mg/L (LOEC) when calculated based on frond number and at 0.80 mg/L when calculated based on biomass. The NOEC for growth rate reduction and yield inhibition was 2.6 mg/L (fronds) and <0.80 mg/L (biomass).
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