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EC number: 247-074-2 | CAS number: 25524-95-2
- 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:
- 23 April 2019 - 31 May 2019
- 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
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Remarks:
- (incl. certificate)
- Details on sampling:
- - Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group, using a haemocytometer and light microscope.
- All samples were taken for immediate analysis. Duplicate sets of samples were taken at 0 and 72 hours and stored frozen for further analysis if required.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION OF TEST SOLUTION
A nominal amount of test item (200 mg) was dissolved in culture medium and the volume adjusted to 2 liters to give a 100 mg/L stock solution from which a series of dilutions was made to give further stock solutions of 1.0, 3.2, 10 and 32 mg/L. An aliquot (900 mL) of each of the stock solutions was separately inoculated with algal suspension (5.6 mL) to give the required test concentrations of 1.0, 3.2, 10, 32 and 100 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, 24, 48 and 72 hours using high performance liquid chromatography with mass spectrometry. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: CCAP 278/4
- Source: Culture Collection of Algae and Protozoa (CCAP), SAMS Research Services Ltd, Scottish Marine Institute, Oban, Argyll, Scotland.
- Method of cultivation: Prior to the start of the test sufficient master culture was added to approximately 100 mL volumes of culture media contained in conical flasks to give an initial cell density of approximately 10^3 cells/mL. The flasks were plugged with polyurethane foam stoppers and kept under constant agitation by orbital shaker (approximately 150 rpm) and constant illumination at 24 ±1 °C until the algal cell density was approximately 10^4 to 10^5 cells/mL. - Test type:
- static
- Water media type:
- other: The culture medium was prepared using reverse osmosis purified deionized water
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- Not Specified
- Test temperature:
- 24 ±1 ºC
- pH:
- 7.5 ± 0.1
- Nominal and measured concentrations:
- The range-finding test
Nominal (mg/L): 0.10, 1.0, 10 and 100
The Definitive Test
Nominal (mg/L): 1.0, 3.2, 10, 32 and 100
Measured (geometric mean ) (mg/L): 0.35, 1.1, 4.6, 18 and 71 - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass conical flasks
- Type: closed with polyurethane foam stoppers
- Fill volume: 100 mL of test preparation
- Aeration: no
- Type: Static
- Initial cells nominal density: 5.00 x 10^3 cells per mL
- Control end cells density: 5.00 x 10^3 cells per mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
NaNO3: 25.5 mg/L
MgCl2.6H2O: 12.16 mg/L
CaCl2.2H2O: 4.41 mg/L
MgSO4.7H2O: 14.6 mg/L
K2HPO4: 1.044 mg/L
NaHCO3: 15.0 mg/L
H3BO3: 0.186 mg/L
MnCl2.4H2O: 0.415 mg/L
ZnCl2: 0.00327 mg/L
FeCl3.6H2O: 0.160 mg/L
CoCl2.6H2O: 0.00143 mg/L
Na2MoO4.2H2O: 0.00726 mg/L
CuCl2.2H2O: 0.000012 mg/L
Na2EDTA.2H2O: 0.30 mg/L
The culture medium was prepared using reverse osmosis purified deionized water and the pH adjusted to 7.5±0.1 with 0.1M NaOH or HCl.
TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: The pH of the control and each test preparation was determined at initiation of the test and after 72 hours exposure.
The pH was measured using a Hach HQ30d Flexi handheld meter.
The temperature within the incubator was recorded daily.
The appearance of the test media was recorded daily.
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: yes
- Photoperiod: Continuous illumination
- Light intensity and quality: Approximately 7000 lux provided by warm white lighting (380 to 730 nm) and constantly shaken at approximately 150 rpm.
TEST ORGANISM OBSERVATIONS
Samples were taken at 24, 51 and 72 hours and the cell densities determined using a haemocytometer and light microscope. Three determinations were made for each sample.
The nominal inoculated cell concentration (5.00 x 10^3 cells/mL) was taken as the starting cell density.
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: 3.2
- Range finding study: yes
- The range-finding test concentrations: Nominal (mg/L): 0.10, 1.0, 10 and 100. (Chemical analysis of the test preparations at 0 hours showed measured test concentrations to range from 0.109 to 96.9 mg/L (95 to 109% of nominal concentrations). There was a significant decline in the measured test concentration at 72 hours in the range of 0.0114 to 51.5 mg/L (9 to 52% of nominal), indicating that the test item was unstable under test conditions.)
- The definitive test concentrations: (mg/L) Nominal : 1.0, 3.2, 10, 32 and 100; Measured: 0.35, 1.1, 4.6, 18 and 71. (Analysis of the test preparations at 0 hours showed measured test concentrations to range from 0.937 to 97.5 mg/L (93 to 98% of nominal concentrations). Analysis of the test preparations at 24, 48 and 72 hours showed a general decline in the measured test concentrations during the test to range from 0.771 to 99.6 mg/L at 24 hours and from 0.0481 to 56.1 mg/L at 48 hours and less than the limit of quantification (determined to be 0.0010 mg/L) to 26.4 mg/L (<1 to 26% nominal) at 72 hours, with the greatest losses occurring at the lower test concentrations. Given this decline in measured test concentrations it was considered justifiable to base the results on the geometric mean measured test concentrations in order to give a "worst case" analysis of the data. In cases where the measured concentration was less than the LOQ of the analytical method following current regulatory advice a value of half the LOQ (i.e. 0.00050 mg/L) was used to enable calculation of the geometric mean measured concentration)
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 30 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- It was not possible to calculate 95% confidence limits for the EC50 value as the data generated did not fit the models available for the calculation of confidence limits
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 18 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 12 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks on result:
- other:
- Remarks:
- 95% Confidence Limits (mg/L): 9.6-16
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 18 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Times: Samples were taken at 24, 51 and 72 hours
- Observation of abnormalities: After 72 hours there were no abnormalities detected in the control or test cultures at 0.35, 1.1 and 4.6 mg/L; however some enlarged and misshapen cell were observed to be present in the test cultures at 18 and 71 mg/L.
- Any observations: 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, 0.35, 1.1, 4.6 mg/L were observed to be bright green dispersions; the test cultures at 18 mg/L were observed to be green, slightly hazy dispersions and at 71 mg/L the cultures were observed to be hazy dispersions. - Results with reference substance (positive control):
- - A positive control: Potassium dichromate (study number YJ31TQ), conducted between 12 November 2018 and 03 December 2018.
- Exposure of Pseudokirchneriella subcapitata (CCAP 278/4) to the reference item gave the following results:
ErC50 (0 to 72 hour): 1.5 mg/L; 95% confidence limits 1.3 to 1.7 mg/L
EyC50 (0 to 72 hour): 0.76 mg/L; 95% confidence limits 0.69 to 0.85 mg/L
NOEC (growth rate): 0.50 mg/L
LOEC (growth rate): 1.0 mg/L
NOEC (yield): 0.50 mg/L
LOEC (yield): 1.0 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;
- Dunnett's multiple comparison procedure;
- All statistical analyses were performed using the SAS computer software package (SAS, 1999 - 2001).
- For each individual test vessel (mean values for yield), percentage inhibition (arithmetic axis) was plotted against test concentration (logarithmic axis) and a line fitted by computerized interpolation using the Xlfit software package (IDBS). ECx values were then determined from the equation for the fitted line. Where appropriate 95% confidence limits for the EC50 values were calculated, using the simplified method of evaluating dose-effect experiments of Litchfield and Wilcoxon (1949). - Validity criteria fulfilled:
- yes
- Conclusions:
- The effect of the test item on the growth of Pseudokirchneriella subcapitata has been investigated over a 72 Hour period and based on the geometric mean measured test concentrations gave the following results:
Inhibition of Growth Rate
ErC10: 15 mg/L
ErC50: 30 mg/L;
NOEC: 4.6 mg/L
LOEC: 18 mg/L
Inhibition of Yield
EyC10: 2.4 mg/L
EyC50: 12 mg/L
NOEC: 4.6 mg/L
LOEC: 18 mg/L - Executive summary:
A study was performed to assess the effect of the test item on the growth of the green alga Pseudokirchneriella subcapitata. The study was conducted according to OECD test guideline 201 and EC Method C.3, and in compliance with GLP. Following a preliminary range-finding test, Pseudokirchneriella subcapitata was exposed to aqueous solutions of the test item at nominal concentrations of 1.0, 3.2, 10, 32 and 100 mg/L for 72 hours. Exposure of Pseudokirchneriella subcapitata to the test item gave the following results based on the geometric mean measured test concentrations:
Response Variable
EC50 (mg/L)
95% Confidence Limits (mg/L)
NOEC (mg/L)
LOEC (mg/L)
Growth Rate
30
Not determined*
4.6
18
Yield
12
9.6
-
16
4.6
18
*It was not possible to calculate 95% confidence limits for the EC50value as the data generated did not fit the models available for the calculation of confidence limits
Reference
Inhibition of Growth Rate
ErC10(0 to 72 hour): 15 mg/L
ErC20(0 to 72 hour): 20 mg/L
ErC50(0 to 72 hour): 30 mg/L;*
There were no statistically significant differences (P ≥0.05), between the control and 0.35, 1.1 and 4.6 mg/L test groups, however, all other test concentrations were significantly different (P<0.05) and therefore the NOEC based on growth rate was 4.6 mg/L. Correspondingly the LOEC based on growth rate was 18 mg/L.
*It was not possible to calculate 95% confidence limits for the EC50value as the data generated did not fit the models available for the calculation of confidence limits
Inhibition of Yield
EyC10(0 to 72 hour): 2.4 mg/L
EyC20(0 to 72 hour): 4.3 mg/L
EyC50(0 to 72 hour): 12 mg/L; 95% confidence limits 9.6 to 16 mg/L
There were no statistically significant differences (P ≥0.05), between the control and 0.35, 1.1 and 4.6 mg/L test groups, however, all other test concentrations were significantly different (P<0.05) and therefore the NOEC based on yield was 4.6 mg/L. Correspondingly the LOEC based on yield was 18 mg/L.
Validation Criteria
· The cell concentration of the control cultures must increase by a factor of at least 16 over the test period; actual achieved 356
· The mean of the coefficients of variation of the section by section daily growth rates in the control cultures during the course of the test (Days 0 to 1, 1 to 2 and 2 to 3, for the 72‑Hour tests) must not exceed 35%; actual achieved 19%
· The coefficient of variation of the average specific growth rate in replicate control cultures must not exceed 7%; actual achieved 2%
Description of key information
Inhibition of Growth Rate:
ErC10: 15 mg/L
ErC50: 30 mg/L; *
NOEC: 4.6 mg/L
LOEC: 18 mg/L
* It was not possible to calculate 95% confidence limits for the EC50 value as the data generated did not fit the models available for the calculation of confidence limits
Inhibition of Yield:
EyC10: 2.4 mg/L
EyC50: 12 mg/L; 95% confidence limits 9.6 to 16 mg/L
NOEC: 4.6 mg/L
LOEC: 18 mg/L
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 30 mg/L
- EC10 or NOEC for freshwater algae:
- 4.6 mg/L
Additional information
An algal growth inhibition study was conducted to determine the effect of Jasminlactone on the growth of Pseudokirchneriella subcapitata. The study was conducted according to OECD test guideline 201 and EC Method C.3, and in compliance with GLP.
Following a preliminary range-finding test, triplicate algal cultureswas exposed to aqueous solutions of the test item at nominal concentrations of 1.0, 3.2, 10, 32 and 100 mg/L 72 hours at a temperature of 24 ± 1 °C under static test conditions. Six replicate control cultures were also incubated concurrently with the test samples. Due to decline in measured test concentrations it was considered justifiable to base the results on the geometric mean measured test concentrations, which were determined to be 0.35, 1.1, 4.6, 18 and 71 mg/L.
The growth rate and yield of Pseudokirchneriella subcapitatawere affected by the presence of Jasminlactone at measured test concentrations of 18 and 71 mg/L, the highest two concentrations tested. The NOEC and LOEC for both growth rate and yield were 4.6 and 18 mg/L, respectively.
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