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EC number: 208-634-1 | CAS number: 536-45-8
- 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:
- 28 Aug - 29 Nov 2017
- 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)
- Version / remarks:
- 2006, corrected 2011
- Deviations:
- yes
- Remarks:
- See section "Any other information on material and methods incl. tables"
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All test item concentrations and the control were analysed
- Sampling method: At test start and test end, all samples were analysed in duplicates
- Sample storage conditions before analysis: All samples were stored in a freezer (≤ -20 °C), protected from light until analysis was performed. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of 320 mg test item/L was prepared by dissolving 319.9 mg test item into 999.69 mL test water by intense stirring for 15 min. Adequate volumes of this stock solution were diluted with test water to prepare the test media of the desired test concentrations.
- Controls: yes - Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Strain: 61.81 SAG
- Source: supplied by the „Sammlung von Algenkulturen, Albrecht-von-Haller-Institut für Pflanzenwissenschaften, Universität Göttingen", Göttingen, Germany
- Age of inoculum (at test initiation): 4 d
- Method of cultivation: Algae were cultivated in the laboratories of test facility under standardised conditions according to the test guidelines.
ACCLIMATION
- Culturing media and conditions: Same - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- 0.24 mmol/L (= 24 mg/L) as CaCO3
- Test temperature:
- 21.6 - 25 °C
- pH:
- 8.0 - 9.5 (Control)
8.0 - 9.6 (Test item concentration) - Nominal and measured concentrations:
- control, 3.2, 10, 32, 100 and 320 mg test item/L (nominal)
- Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: open (covered with sterile stoppers)
- Material, size, headspace, fill volume: 50 mL Erlenmeyer flasks; 50 mL of test volume; Continuously stirred with magnetic stirrers and incubated in a water bath.
- Initial cells density: 5000 algal cells per mL test medium
- Control end cells density: 107.88 x 10E+04
- No. of vessels per concentration: 3
- No. of vessels per control: 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised water was used to perform the OECD meadia according to OECD 201
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Sterile test conditions: yes (all working steps were performed under the clean bench)
- Photoperiod: Continuous illumination
- Light intensity and quality: 5202 lux (range: 4840 to 5620 lux)
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: Cell density was determined by spectrophotometric measurement, based on a calibration curve
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
Range finding study: non-GLP range-finder was performed without any additional information - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 320 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- > 320 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 320 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Statistically significant but biological not relevant since the inhibition effect is below 10%.
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 320 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 177 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 115 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): The microscopic examination of the shape of the algal cells after 72 h of test duration did not show any difference between the highest test item concentration 320 mg test item/L and the algal cells in the control.
- Other: One replicate of the control was excluded from the calculation based on outlier-test after Dixon & Hartley - Results with reference substance (positive control):
- Pseudokirchneriella subcapitata performed with the Reference Item Potassium Dichromate:
EC50: 1.12 mg test item/L (growth rate)
EC10: 0.541 mg test item/L (growth rate)
NOEC: 0.21 mg test item/L (growth rate) - Reported statistics and error estimates:
- EC values were calculated by a 3-parametric concentration distribution function. The NOEC and LOEC were determined by Williams t-test (yield) and Step-down Jonckheere Terpstra test (growth rate). Moreover an outlier-test after Dixon & Hartley was performed leading to exclusion of one replicate in the control. The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH.
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please see section “Any other information on results incl. tables”.
- Conclusions:
- EC50 (72h) >320 mg/L (P. subcapitata, OECD 201, nominal)
Reference
Table 1: Growth rates µ and percentage Inhibition ofµ during the test period
Nominal concentration [mg test item/L] |
Growth rates µ [1/day] and % inhibition of µ |
|||||
|
0 – 24 h |
0 – 48 h |
0 – 72 h |
|||
|
µ |
% |
µ |
% |
µ |
% |
Control 1) |
1.135 |
- |
1.762 |
- |
1.791 |
- |
3.2 |
1.044 |
8.1 |
1.771 |
-0.5 |
1.789 |
0.1 |
10 |
1.091 |
3.8 |
1.758 |
0.2 |
1.779 |
0.7 |
32 |
1.175 |
-3.5 |
1.748 |
0.8 |
1.778 |
0.8 |
100 |
1.091 |
3.8 |
1.706 |
3.2* |
1.761 |
1.7*2) |
320 |
0.219 |
80.7 |
1.539 |
12.6* |
1.613 |
9.9*2) |
1) One replicate was excluded as an outlier (confirmed by Dixon & Hartley outlier test).
2) Statistically significant but biologically not relevant since the inhibition effect is below 10%.
Table 2: Summary of Analytical Results
Sample Description |
% of nominal 1) |
RSD |
|
[mg test item/L] |
[%] |
n |
|
Control |
n.a. |
n.a. |
4 |
3.2 |
104 |
2 |
4 |
10 |
103 |
2 |
4 |
32 |
91 |
2 |
4 |
100 |
103 |
0 |
4 |
320 |
108 |
1 |
4 |
1 mean value of all measured samples per treatment group
RSD: relative standard deviation per treatment group
n: number of analysed samples
n.a.: not applicable
Table 3: Validity criteria for OECD 201.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The biomass in the control cultures should have increased exponentially by a factor of at least 16 within the 72-hour test period. |
216 |
Yes |
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72-hour tests) in the control cultures must not exceed 35% |
35% |
Yes |
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures must not exceed 7% in tests with Pseudokirchneriella subcapitata and Desmodesmus subspicatus. For other less frequently tested species, the value should not exceed 10%. |
0.9% |
Yes |
Description of key information
EC50 (72h) >320 mg/L (P. subcapitata, OECD 201, nominal)
EC10 (72h) >320 mg/L (P. subcapitata, OECD 201, nominal)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 320 mg/L
- EC10 or NOEC for freshwater algae:
- 320 mg/L
Additional information
One experimental study is available investigating the toxicity of the test item sodium Anisate (CAS 536-45-8) to aquatic freshwater algae.
The study was conducted according to OECD 201 (GLP) using the freshwater algae Pseudokirchneriella subcapitata. The definitive test was carried out with the following concentration range: control, 3.2, 10, 32, 100 and 320 mg test item/L (nominal). The measured concentrations of the test item at test start (0h) and test end ranged between 90% and 109% of the nominal values. Thus, it is justified that the effect concentrations are based on the nominal concentrations. Inhibition of growth was recorded resulting in an ErC10 and ErC50 (72h) of >320 mg/L. Inhibition of yield was recorded resulting in an EyC10 (72 h) of 115 mg/L and EyC50 (72 h) of >320 mg/L.
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