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EC number: 810-766-5 | CAS number: 1802886-42-5
- 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:
- from 2018-01-25 to 2018-05-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Remarks:
- HPLC-MS
- Details on sampling:
- For determination of the test item concentrations, three parallel samples were taken from the test solutions and six parallel samples from the control. Formulation samples were diluted with mobile phase or directly measured and the control samples were directly injected.
- Vehicle:
- no
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green algae
- Strain: 61.81 SAG
- Source: SAG: Collection of Algal Cultures, Inst. Plant Physiology, University of Göttingen, Untere Karspüle 2, D-37073 Göttingen, Germany
- Age of inoculum (at test initiation): 3 days - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 21.5 - 23.5 °C
- pH:
- 8.07 - 9.15
- Nominal and measured concentrations:
- Nominal concentrations: 0, 0.05, 0.13, 0.3, 0.8 and 2 mg/L
Measured concentration: 0, 0.052, 0.126, 0.32, 0.77 and 2.06 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Material, size, headspace, fill volume: glass, ~250 mL volume, 100 mL test medium
- Aeration: no
- Initial cells density: 1 x 10^4 cells/mL
- Control end cells density: 103.17 x 10^4 cells/mL
- No. of organisms per vessel: 0.1 mL algal biomass (10^7 algal cells per mL)
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: OECD Medium prepared according to OECD 201
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: continuously illuminated
- Light intensity and quality: 8053 lux
TEST CONCENTRATIONS
- Range finding study: yes, 3 range-finding tests were performed
- Test concentrations: Test 1: 0.01, 0.1, 1, 10, 50, 100 mg/L; Test 2: 0.005, 0.01, 0.1, 1, 5 mg/L; Test 3: 0.005, 0.01, 0.1, 1, 3 mg/L
- Results used to determine the conditions for the definitive study: At 3 mg/L in Test 3 a 100 % inhibition was observed. Therefore, the maximum test concentration for the definitive test was determined to be 2 mg/L.
EFFECT PARAMETERS MEASURED :
- Determination of cell concentrations: microscope with counting chambe at 24, 48 and 72 hours - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.237 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95 % CI: 0.120 - 0.350 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.732 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95 % CI: 0.522 - 1.101 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.05 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.077 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks:
- yield
- Remarks on result:
- other: 95 % CI: 0.048 - 0.106 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.298 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks:
- yield
- Remarks on result:
- other: 95 % CI: 0.236 - 0.379 mg/L
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Results with reference substance (positive control):
- The date of the last study with the reference item Potassium dichromate was: 12 – 15 September 2017. The following results were obtained:
The 72h ErC50: 0.82 mg/L, (95 % confidence limits: 0.57 – 1.25 mg/L)
The 72h EyC50: 0.51 mg/L, (95 % confidence limits: 0.45 – 0.57 mg/L) - Validity criteria fulfilled:
- yes
- Conclusions:
- In this 72-h algal growth inhibition test with Raphidocelis subcapitata, the obtained results showed that the test item had significant toxic effects on the growth of Raphidocelis subcapitata. The EC10 and EC50 based on growth rate were determined to be 0.237 mg/L and 0.732 mg/L, respectively. The NOEC was determined to be 0.05 mg/L.
- Executive summary:
The effect of the test item on the growth of a unicellular green algal species Raphidocelis subcapitata was determined according to OECD 201, Regulation (EC) No. 226/2016 Method C.3 and EPA OPPTS 850.5400 under GLP. The study was conducted under static conditions with an initial cell density of 1E+4 cells/mL for a period of 72 hours. A concentration series of 0.05, 0.13, 0.3, 0.8 and 2 mg/L of the test item and control were tested. The measured concentrations of the test item at the start and at the end of the test were in the range of 92 - 106 % of the nominal concentration. The measured concentrations deviated not more than 20 % from the nominal concentration, therefore, the nominal concentration was used to determine exposure concentrations. All validity criteria were fulfilled, therefore, the test is considered to be valid. The EC50-values for inhibition of growth rate (ErC50) and for inhibition of yield (EyC50) were determined to be 0.732 mg/L and 0.298 mg/L, respectively. The ErC10 and EyC10 values were determined to be 0.237 mg/L and 0.077 mg/L, respectively. The NOEC was determined to be 0.05 mg/L. The obtained results showed that the test item had significant toxic effects on the growth of Raphidocelis subcapitata.
Reference
Growth inhibition: The results of the statistical evaluation (Dunnett’s test (α = 0.05; 2-sided)) showed that the 0 - 72 h average specific growth rate and yield were statistically significantly different from the untreated control in the concentration range of 0.13 - 2 mg/L and not significantly different at the test concentration of 0.05 mg/L.
Shape of the algal cells: No morphological abnormalities were observed in the control and in the lowest concentration of 0.05 mg/L during the test. Some swollen cells were observed together with the normal cells in the concentrations of 0.13 and 0.3 mg/L. At the test concentration of 0.8 mg/L cells with pinches were noticed among normal and swollen cells, while at the highest test concentration of 2 mg/L only thin and swollen cells, furthermore, cells with pinches were found during the study.
Cell density in the control: The cell density in the control has increased from nominal N = 1E+4 cells/mL at the start of the test (0 hours) to N = 103.17E+4 cells/mL (mean value) after 72 hours in the in the control.
Table 1: Summary of Biological Endpoints
Endpoints |
Growth rate (µ) |
Yield (y) |
Calculation based on measured concentrations |
||
EC10 |
0.237 |
0.077 |
95 % conf. limits |
0.120 – 0.350 |
0.048 – 0.106 |
EC20 |
0.349 |
0.122 |
95 % conf. limits |
0.210 – 0.492 |
0.086 – 0.159 |
EC50 |
0.732 |
0.298 |
95 % conf. limits |
0.522 – 1.101 |
0.236 – 0.379 |
NOEC |
0.05 |
0.05 |
LOEC |
0.13 |
0.13 |
Description of key information
In a 72-h algal growth inhibition test with Raphidocelis subcapitata, the obtained results showed that the test item had significant toxic effects on the growth of Raphidocelis subcapitata. The EC10 and EC50 based on growth rate were determined to be 0.237 mg/L and 0.732 mg/L, respectively. The NOEC was determined to be 0.05 mg/L.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 0.732 mg/L
- EC10 or NOEC for freshwater algae:
- 0.237 mg/L
Additional information
The effect of the test item on the growth of a unicellular green algal species Raphidocelis subcapitata was determined according to OECD 201, Regulation (EC) No. 226/2016 Method C.3 and EPA OPPTS 850.5400 under GLP. The study was conducted under static conditions with an initial cell density of 1E+4 cells/mL for a period of 72 hours. A concentration series of 0.05, 0.13, 0.3, 0.8 and 2 mg/L of the test item and control were tested. The measured concentrations of the test item at the start and at the end of the test were in the range of 92 - 106 % of the nominal concentration. The measured concentrations deviated not more than 20 % from the nominal concentration, therefore, the nominal concentration was used to determine exposure concentrations. All validity criteria were fulfilled, therefore, the test is considered to be valid. The EC50-values for inhibition of growth rate (ErC50) and for inhibition of yield (EyC50) were determined to be 0.732 mg/L and 0.298 mg/L, respectively. The ErC10 and EyC10 values were determined to be 0.237 mg/L and 0.077 mg/L, respectively. The NOEC was determined to be 0.05 mg/L. The obtained results showed that the test item had significant toxic effects on the growth of Raphidocelis subcapitata.
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