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EC number: 252-743-7 | CAS number: 35835-94-0
- 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:
- 19 February 2018 - 24 March 2018
- 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
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken from the control and each test group from the bulk test preparation at 0 hours and from the pooled replicates at 72 hours for quantitative analysis. All samples were stored frozen prior to analysis. Duplicate samples were taken at 0 and 72 hours and stored frozen for further analysis.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
An amount of test item (50.5 mg) was dissolved in culture medium with the aid of ultrasonication for approximately 10 minutes and the volume adjusted to 500 mL to give a nominal 100 mg/L stock solution from which a series of dilutions was made to give further stock solutions of 10, 3.2, 1.0, 0.32 and 0.10 mg/L. An aliquot (500 mL) of each of the 0.10, 0.32, 1.0, 3.2 and 10 mg/L stock solutions was separately inoculated with algal suspension (2.5 mL) to give the required test concentrations of 0.10, 0.32, 1.0, 3.2 and 10 mg/L.
The stock solutions and each of the prepared concentrations were inverted several times to ensure adequate mixing and homogeneity.
The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0 and 72 hours - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green alga
- Strain: CCAP 278/4
- Source (laboratory, culture collection): Culture Collection of Algae and Protozoa (CCAP), SAMS Research Services Ltd, Scottish Marine Institute, Oban, Argyll, Scotland
- Method of cultivation: Master cultures were maintained in the laboratory by the periodic replenishment of culture medium
ACCLIMATION
- Culturing media and conditions (same as test or not): same
- Any deformed or abnormal cells observed: no - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 24 ±1 ºC
- pH:
- 7.4 -7.8 at test start, 7.8 - 8.4 at test end
- Nominal and measured concentrations:
- 0, 0.10, 0.32, 1.0, 3.2 and 10 mg/L (nominal)
Analysis of the test preparations at 0 and 72 hours showed measured test concentrations to range from 89% to 98% of nominal and so the results are based on the nominal test concentrations only. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass conical flasks containing 100 mL of test preparation
- Aeration: constantly shaken at approximately 150 rpm for 72 hours.
- Type (delete if not applicable): closed
- Initial cells density: 5.00E03 cells/mL
- Control end cells density: 1.73E+06 cells/mL (mean)
- 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:
- Culture medium different from test medium: The culture medium used for both the range-finding and definitive tests was the same as that used to maintain the stock culture.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: continuous illumination (intensity approximately 7000 lux) provided by warm white lighting (380 to 730 nm)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: electronic particle counter
- Chlorophyll measurement: no
- Other:
Samples were taken at 19, 42 and 72 hours and the cell densities determined using a Coulter® Multisizer Particle Counter. Three determinations were made for each sample. The nominally inoculated cell concentration (5.00E03 cells/mL) was taken as the starting cell density. To determine the potential effect of the test item on the appearance of algal cells, a sample was removed from each test and control culture (replicates pooled) at the end of the test. The shape and size of the algal cells was inspected microscopically and any abnormalities recorded.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: sqrt(10)
- Range finding study
- Test concentrations: range-finding test: 0, 0.10, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study:
The results showed no effect on growth at the test concentration of 0.10 mg/L. However, growth was observed to be reduced at 1.0, 10 and 100 mg/L.
Based on this information test concentrations of 0.10, 0.32, 1.0, 3.2 and 10 mg/L were selected for the definitive test. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 4.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence limits
- Remarks:
- 3.6 to 5.3 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.77 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% confidence limits
- Remarks:
- 0.53 to 1.1 mg/L
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): All test and control cultures were inspected microscopically at 72 hours. After 72 hours there were no abnormalities detected in the control or test cultures at 0.10, 0.32, 1.0 and 3.2 mg/L, however cell debris was observed to be present in the test cultures at 10 mg/L.
- At the start of the test all control and test cultures were observed to be clear colorless solutions. After the 72-Hour test period all control, 0.10 and 0.32 mg/L test cultures were observed to be green dispersions. The 1.0 mg/L test cultures were light green dispersions; the 3.2 mg/L test cultures were extremely pale green dispersions whilst the 10 mg/L test cultures were clear colorless solutions. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
ErC50 (0 to 72 hour) : 1.6 mg/L; 95% confidence limits 1.4 to 1.8 mg/L
EyC50 (0 to 72 hour) : 0.77 mg/L; 95% confidence limits 0.68 to 0.87 mg/L
No Observed Effect Concentration based on growth rate: 0.25 mg/L
No Observed Effect Concentration based on yield: 0.25 mg/L
Lowest Observed Effect Concentration based on growth rate: 0.50 mg/L
Lowest Observed Effect Concentration based on yield: 0.50 mg/L
The results from the positive control with potassium dichromate were within the normal ranges for this reference item. - Reported statistics and error estimates:
- One way analysis of variance incorporating Bartlett's test for homogeneity of variance (Sokal and Rohlf, 1981) and Dunnett's multiple comparison procedure for comparing several treatments with a control (Dunnett, 1955) was carried out on the growth rate and yield data after 72 hours for the control and all test concentrations to determine any statistically significant differences between the test and control groups. All statistical analyses were performed using the SAS computer software package (SAS, 1999 - 2001).
- Validity criteria fulfilled:
- yes
- Conclusions:
- NOEC (growth rate): 0.32 mg/L
ErC10 (0 to 72 hour): 1.2 mg/L
ErC50 (0 to 72 hour): 4.4 mg/L; 95% confidence limits 3.6 to 5.3 mg/L
NOEC (yield): 0.1 mg/L
EyC10 (0 to 72 hour): 0.13 mg/L
EyC50 (0 to 72 hour): 0.77 mg/L; 95% confidence limits 0.53 to 1.1 mg/L - Executive summary:
A study was performed to assess the effect of the test item ETPPAAc on the growth of the green alga Pseudokirchneriellasubcapitata. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) No 761/2009.
Following a preliminary range-finding test, Pseudokirchneriella subcapitata was exposed to an aqueous solution of the test item at concentrations of 0.10, 0.32, 1.0, 3.2 and 10 mg/L (three replicate flasks per concentration) for 72 hours, under constant illumination and shaking at a temperature of 24 ±1 °C.
Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group, using a Coulter®Multisizer Particle Counter.
Analysis of the test preparations at 0 and 72 hours showed measured test concentrations to range from 89% to 98% of nominal and so the results are based on nominal test concentrations only.
Exposure of Pseudokirchneriella subcapitata to the test item gave the following results based on the nominal test concentrations:
NOEC (growth rate): 0.32 mg/L
ErC10 (0 to 72 hour): 1.2 mg/L
ErC50 (0 to 72 hour): 4.4 mg/L; 95% confidence limits 3.6 to 5.3 mg/L
NOEC (yield): 0.1 mg/L
EyC10 (0 to 72 hour): 0.13 mg/L
EyC50 (0 to 72 hour): 0.77 mg/L; 95% confidence limits 0.53 to 1.1 mg/L
Reference
Validity Criteria
The following data show that the cell concentration of the control cultures increased by a factor of 347 after 72 hours. This increase was in line with the OECD Guideline that states the enhancement must be at least by a factor of 16 after 72 hours.
Nominal cell density of control at 0 hours: 5.00E03 cells per mL
Mean cell density of control at 72 hours: 1.73E06 cells per mL
The mean coefficient of variation for section by section specific growth rate for the control cultures was 7% and hence satisfied the validation criterion given in the OECD Guideline which states the mean must not exceed 35%.
The coefficient of variation for average specific growth rate for the control cultures over the test period (0 to 72 hour) was 1% and hence satisfied the validation criterion given in the OECD Guideline which states that this must not exceed 7%.
Inhibition of Growth Rate and Yield in the Definitive Test
Nominal Concentration |
Growth Rate (cells/mL/hour) |
Yield (cells/mL) |
|||
0 to 72 Hour |
% Inhibition |
0 to 72 Hour |
% Inhibition* |
||
Control |
R1 |
0.082 |
- |
1.85E+06 |
- |
R2 |
0.081 |
1.71E+06 |
|||
R3 |
0.082 |
1.79E+06 |
|||
R4 |
0.081 |
1.75E+06 |
|||
R5 |
0.081 |
1.74E+06 |
|||
R6 |
0.080 |
1.54E+06 |
|||
Mean |
0.081 |
1.73E+06 |
|||
SD |
0.001 |
1.04E+05 |
|||
0.10 |
R1 |
0.080 |
1 |
1.62E+06 |
|
R2 |
0.080 |
1 |
1.64E+06 |
|
|
R3 |
0.079 |
2 |
1.50E+06 |
|
|
Mean |
0.080 |
1 |
1.59E+06 |
8 |
|
SD |
0.001 |
|
7.56E+04 |
|
|
0.32 |
R1 |
0.077 |
5 |
1.26E+06 |
|
R2 |
0.076 |
6 |
1.22E+06 |
|
|
R3 |
0.077 |
5 |
1.30E+06 |
|
|
Mean |
0.077 |
5 |
1.26E+06 |
27 |
|
SD |
0.001 |
|
3.94E+04 |
|
|
1.0 |
R1 |
0.071 |
12 |
8.14E+05 |
|
R2 |
0.070 |
14 |
7.56E+05 |
|
|
R3 |
0.069 |
15 |
6.93E+05 |
|
|
Mean |
0.070 |
14 |
7.54E+05 |
56 |
|
SD |
0.001 |
|
6.03E+04 |
|
|
3.2 |
R1 |
0.056 |
31 |
2.75E+05 |
|
R2 |
0.056 |
31 |
2.71E+05 |
|
|
R3 |
0.053 |
35 |
2.24E+05 |
|
|
Mean |
0.055 |
32 |
2.57E+05 |
85 |
|
SD |
0.002 |
|
2.84E+04 |
|
|
10 |
R1 |
0.023 |
72 |
2.19E+04 |
|
R2 |
0.010 |
88 |
5.24E+03 |
|
|
R3 |
0.008 |
90 |
3.62E+03 |
|
|
Mean |
0.014 |
83 |
1.03E+04 |
99 |
|
SD |
0.008 |
|
1.01E+04 |
|
*In accordance with the OECD test guideline only the mean value for yield for each test concentration is calculated
R = Replicate
SD =Standard Deviation
Description of key information
NOEC (growth rate) : 0.32 mg/L
ErC10 (0 to 72 hour) : 1.2 mg/L
ErC20 (0 to 72 hour) : 1.9 mg/L
ErC50 (0 to 72 hour) : 4.4 mg/L; 95% confidence limits 3.6 to 5.3 mg/L
OECD TG 201, Pseudokirchneriella subcapitata, static
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 4.4 mg/L
- EC10 or NOEC for freshwater algae:
- 1.2 mg/L
Additional information
A study was performed to assess the effect of ETPPAAc on the growth of the green alga Pseudokirchneriella subcapitata. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) No 761/2009.
Following a preliminary range-finding test, Pseudokirchneriella subcapitata was exposed to an aqueous solution of the test item at concentrations of0.10,0.32,1.0,3.2and10 mg/L (three replicate flasks per concentration) for 72 hours, under constant illumination and shaking at a temperature of 24 ±1 °C.
Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group, using a Coulter® Multisizer Particle Counter.
Analysis of the test preparations at 0 and 72 hours showed measured test concentrations to range from 89% to 98% of nominal and so the results are based on nominal test concentrations only.
Exposure of Pseudokirchneriella subcapitata to the test item gave the following results based on the nominal test concentrations:
NOEC (growth rate) : 0.32 mg/L
ErC10 (0 to 72 hour) : 1.2 mg/L
ErC20 (0 to 72 hour) : 1.9 mg/L
ErC50 (0 to 72 hour) : 4.4 mg/L; 95% confidence limits 3.6 to 5.3 mg/L
NOEC (yield) : 0.1 mg/L
EyC10 (0 to 72 hour) : 0.13 mg/L
EyC20 (0 to 72 hour) : 0.25 mg/L
EyC50 (0 to 72 hour) : 0.77 mg/L; 95% confidence limits 0.53 to 1.1 mg/L
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