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EC number: 845-262-4 | CAS number: 1809816-36-1
- 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 algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 May 2020 to 20 July 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 28 July 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 10, 3.125, 0.98, 0.30, 0.095, 0.030, 0.009 mg/L
- Sampling method: One sample from the freshly prepared filtrate and duplicate samples from the freshly prepared test media of all test concentrations and the control (without algae) was taken at test start. Additionally, samples were taken after 24 and 48 hours by taking aliquots of each replicate which were pooled per treatment group.
All samples were diluted by a factor of two with acetonitrile.
Additional samples of the control and the dilution solvent were taken at each sampling without any sample treatment
- Sample storage conditions before analysis: All samples were stored in a freezer (≤ - 20 °C), protected from light until analysis was performed. Afterwards the samples were again stored deep frozen and were kept stored up to the date of the final report. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: a supersaturated stock solution of nominal 100 mg test item/L was prepared by suspending 100.0 mg test item in 1000 mL test water for preparing the test concentrations. The stock suspension was stirred for 47.5 hours at room temperature in the dark to dissolve as much test item as possible. Then, non-dissolved fractions of the test item were separated from the test medium by membrane filtration (0.45 µm cellulose acetate filter). The solution with dissolved test item was used to prepare the desired 1:10, 1:32, 1:102, 1:328, 1:1049, 1:3355 and 1:10737 dilutions.
- Controls: negative control (0 mg/L) - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata (KORSHIKOV)
- Strain: strain No. 61.81 SAG
- Source: Originally supplied by Sammlung von Algenkulturen, Albrecht von Haller Institut für Pflanzenwissenschaften, Universität Göttingen, 37073 Göttingen, Germany
- Age of inoculum: exponentially growing culture set up 4 days prior to test start
- Method of cultivation: according to guideline (same as during test)
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 21.5 - 22.9
- pH:
- 7.8 - 9.3
- Nominal and measured concentrations:
- Measured concentrations (geom. mean): 1.33, 4.13, 21.9, 96,4, 364, 1618, 6114 µg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 50ml Erlenmeyer flasks, loosely covered
- Initial cells density: 5000 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: continuous
- Light intensity and quality: 5045 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: spectrophotometric measurement
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3
- Range finding study: yes
- Test concentrations: 1, 10 and 100 mg/L - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1 651 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 96.4 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 615 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 21.9 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- - Exponential growth in the control: yes
- Observation of abnormalities: no
- Unusual cell shape: no - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: 0.20 mg/L (yield), 0.20 mg/L (growth rate), 0.063 mg/L (biomass) - Validity criteria fulfilled:
- yes
- Conclusions:
- The influence of (R)-3-Amino-2-(2,4-difluorophenyl)-1,1-difluoro-1-(5-(4-(2,2,2-trifluoroethoxy)phenyl)pyridin-2-yl)propan-2-ol L-tartrate on the growth of the freshwater green algae Pseudokirchneriella subcapitata was assessed in a static concentration-response test. The 72-hour EyC50 was calculated to be 615 µg test item/L and the 72-hour ErC50 value was calculated to be 1651 µg test item/L. The 72-hour NOEyC was determined to be 21.9 µg test item/L and the associated 72-hour LOEyC was 96.4 µg test item/L. The 72-hour NOErC was determined to be 96.4 µg test item/L and the associated 72-hour LOErC was 394 µg test item/L.
- Executive summary:
In a 72 hour acute toxicity study, the cultures of Pseudokirchneriella subcapitata strain No. 61.81 SAG were exposed to (R)-3-Amino-2-(2,4-difluorophenyl)-1,1-difluoro-1-(5-(4-(2,2,2-trifluoroethoxy)phenyl)pyridin-2-yl)propan-2-ol L-tartrate at measured concentrations of 1.33, 4.13, 21.9, 96,4, 364, 1618, 6114 µg/L (geom. mean) under static conditions in accordance with the OECD 202 guideline. The NOEC and EC50 values based on growth rate were 96.4 and 1651 µg/L, respectively. The % growth inhibition in the treated algal culture as compared to the control ranged from -1.2 to 100 .
This toxicity study is classified as acceptable and satisfies the guideline requirements for green algae short-term toxicity study.
Results Synopsis
Test Organism: Pseudokirchneriella subcapitata
Test Type: static
72 hr EC50 1651 µg/L 95% C.I.: 1544 to 1767 mg/L
72 hr NOEC: 96.4.µg/L
Endpoint(s) Effected: growth rate
Reference
Validity criteria
Cell density increase in control cultures: 22.9-fold increase within 72 hours
Coefficient of Variation of sectional growth rates in control cultures: 6.4%
Coefficient of Variation of average growth between control replicates: 0.8%
Table 1: Influence of (R)-3 -Amino-2 -(2,4 -difluorophenyl)-1,1 -difluoro-1 -(5 -(4 -(2,2,2 -trifluoroethoxy)phenyl)pyridin-2 -yl)propan-2 -ol L tartrate on the growth of Pseudokirchneriella subcapitata
Parameter |
Yield [µg test item/L] |
Growth rate [µg test item/L] |
72-hour EC50 |
615 |
1651 |
95% CI |
543-711 |
1544-1767 |
72-hour EC20 |
343 |
932 |
95% CI |
288-393 |
756-1061 |
72-hour EC10 |
253 |
691 |
95% CI |
198-300 |
508-832 |
72-hour NOEC |
21.9 |
96.4 |
72-hour LOEC |
96.4 |
394 |
Table 2: Yield and percentage inhibition of yield during the test period
Geometric Mean Measured Concentrations [µg test item/L] |
Yields y [10000 cells/ml] and % inhibition of y |
|||||
0-24 hours |
0-48 hours |
0-72 hours |
||||
y |
% |
y |
% |
y |
% |
|
Control |
2.261 |
- |
18.377 |
- |
110.930 |
|
1.33 |
2.537 |
-12.2 |
18.860 |
-2.6 |
118.284 |
-6.6 |
4.13 |
2.123 |
6.1 |
17.687 |
3.8 |
106.380 |
4.1 |
12.9 |
1.985 |
12.2* |
18.446 |
-0.4 |
114.721 |
-3.4 |
96.4 |
1.985 |
12.2* |
17.273 |
6.0* |
100.997 |
9.0* |
394 |
1.777 |
21.4* |
14.237 |
22.5* |
82.725 |
25.4* |
1618 |
0.950 |
58.0* |
2.369 |
87.1* |
8.270 |
92.5* |
6114 |
0.040 |
98.2* |
0.031 |
99.8* |
0.000 |
100.0* |
negative values in % inhibition indicate an increase in growth relative to that of the control
* mean value significantly different from the control (tested with Williams t-test, a = 0.05, one sided smaller)
Table 3: Growth rates and percentage inhibition of growth rate during the test period
Geometric Mean Measured Concentrations [µg test item/L] |
Growth rates µ [10000 cells/ml] and % inhibition of y |
|||||
0-24 hours |
0-48 hours |
0-72 hours |
||||
µ |
% |
µ |
% |
µ |
% |
|
Control |
1.707 |
- |
1.815 |
- |
1.802 |
- |
1.33 |
1.802 |
-5.6 |
1.828 |
-0.7 |
1.823 |
-1.2 |
4.13 |
1.657 |
3.0 |
1.797 |
1.0 |
1.788 |
0.8 |
12.9 |
1.603 |
6.1 |
1.817 |
-0.1 |
1.813 |
-0.6 |
96.4 |
1.603 |
6.1 |
1.785 |
1.6 |
1.770 |
1.7 |
394 |
1.516 |
11.2 |
1.690 |
6.9 |
1.704 |
5.4 |
1618 |
1.058 |
38.1 |
0.866 |
52.3 |
0.937 |
48.0 |
6114 |
0.072 |
95.8 |
0.028 |
98.4 |
0.000 |
100.0 |
negative values in % inhibition indicate an increase in growth relative to that of the control
* mean value significantly different from the control (tested with Bonferroni-Welch t-test (24h), Williams t-test (48h) and Step down Jonckheere-Terprtra (72h), a = 0.05, one sided smaller)
Description of key information
In a 72 hour acute toxicity study, the cultures of Pseudokirchneriella subcapitata strain No. 61.81 SAG were exposed to (R)-3-Amino-2-(2,4-difluorophenyl)-1,1-difluoro-1-(5-(4-(2,2,2-trifluoroethoxy)phenyl)pyridin-2-yl)propan-2-ol L-tartrate at measured concentrations of 1.33, 4.13, 21.9, 96,4, 364, 1618, 6114 µg/L (geom. mean) under static conditions in accordance with the OECD 202 guideline. The NOEC and EC50values based on growth rate were 96.4 and 1651 µg/L, respectively. The % growth inhibition in the treated algal culture as compared to the control ranged from -1.2 to 100 .
This toxicity study is classified as acceptable and satisfies the guideline requirements for green algae short-term toxicity study.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 1 651 µg/L
- EC10 or NOEC for freshwater algae:
- 96.4 µg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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