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EC number: 224-632-3 | CAS number: 4432-31-9
- 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:
- 2017-01-31 to 2017-09-21
- 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:
- adopted 23rd March 2006, Annex 5 corrected: 28th July 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- March 01, 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 108 mg/L
- Sampling method: - For determination of the test item concentration, six replicate samples were taken from the test item treatment group and one from the control at the start and at the end of the experiment. The analysis was performed using LC/MS/MS. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution used in the test was prepared by mechanical dispersion. An amount of 0.0869 g test item was dissolved in 800 mL dilution water (OECD medium) in order to obtain the concentration of 108 mg/L. The test solution was freshly prepared in the testing laboratory just before introduction of algae (start of the experiment). - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: 61.81 SAG
- Source: SAG: Collection of Algal Cultures, 37073 Göttingen, Germany
- Method of cultivation: algae were kept as stock culture on solid agar - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Hardness:
- not specified
- Test temperature:
- 22.6 – 23.1 °C (in test flask) and 21.9 – 23.9 °C (in climate chamber)
- pH:
- 7.32– 8.17 (in the control group) and 6.63-7.99 (in the treatment groups)
- Dissolved oxygen:
- not specified
- Salinity:
- not applicable
- Conductivity:
- not specified
- Nominal and measured concentrations:
- Nominal conc.: 108 mg/L
Measured conc.: The measured concentrations showed very good correlation with the nominal concentrations. The recovery rate after 72 hours was 97 %. - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass flasks 250 mL
- Type: air-permeable stoppers
- Material, size, fill volume: - glass, 250 mL, 100 mL
- Initial cells density: 10000 cells/mL
- Control end cells density: approx. 1000000 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted algal growth medium (acc. to OECD TG 201)
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: continuous illumination
- Light intensity and quality: 7673 Lux
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: manual counting at 24, 48 and 72-h using a microscopic method with a counting chamber
TEST CONCENTRATIONS
- Range finding study: Yes
- Test concentrations: 108 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 108 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield (migrated information)
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 108 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 108 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 108 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 108 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: area under the growth curve
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 108 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 108 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 108 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: area under the growth curve
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Effect concentrations exceeding solubility of substance in test medium: no - Results with reference substance (positive control):
- - Results with reference substance valid? YES
- EC50: The 72h ErC50: 0.71 mg/L (95 % confidence limits: 0.66 – 0.77 mg/L)
The 72h EyC50: 0.46 mg/L (95 % confidence limits: 0.42 – 0.49 mg/L) - Validity criteria fulfilled:
- yes
- Conclusions:
- Under the test conditions no effects on algae were observed. The No Observed Effect Concentration (NOEC) was determined to be 108 mg/L and the 72-h EC50 values based on growth rate and yield were > 108 mg/L.
- Executive summary:
The effect of the test item on algal growth was assessed using the unicellular green alga Raphidocelis subcapitata (formerly known as Pseudokirchneriella subcapitata and Selenastrum capricornutum) in a study according to OECD TG 201 under GLP. For this purpose, alga was exposed to the test item for 72 hours. Based on the results of a non-GLP preliminary test, in which the test item had no toxic effect on algae up to 100 mg/L (limit concentration). Therefore the main test was performed at 108 mg/L including a concurrent control and the reference substance potassium dichromate which served as the reference control. This concentration was chosen for regulatory purposes to achieve the limit test concentration of 100 mg/L for the test item even after a possible correction for the water content. As measured test item concentration remained within ± 20 % of the nominal over the test period of 72 hours, therefore the biological results were based on the nominal concentration. Exponentially-growing cultures of Raphidocelis subcapitata were exposed to the test item over several generations under defined conditions (static test). The algal growth was determined over a fixed test period of 72 hours in relation to a concurrent untreated control culture. Per test concentration and control, six replicates were used. The alga cell concentration was approximately 10e4 cells/mL at the start of the test for all test cultures. Glass flasks with a total capacity of 250 mL were used as test vessels. The volume of the test liquid in the vessels was 100 mL. The alga cell concentration was determined by microscope in each testing flask at 24, 48 and 72 hours. All validity criteria were fulfilled. The No Observed Effect Concentration (NOEC) was determined to be 108 mg/L and the Lowest Observed Effect Concentration (LOEC) was determined to be >108 (limit concentration). Consequently, the 72-h EC50 values based on growth rate and yield were also > 108 mg/L. As a limit test was performed and as no effects were observed, no further statistical analysis was performed.
Reference
Validity of the Test
- The cell density in the control cultures increased by a factor of 103.67 within 72 hours. This corresponds to a specific growth rate of 1.55 /day.
- The mean coefficient of variation (CV) for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72 h-tests) in the control cultures did not exceed 35 %
- CV for section-by-section growth rate day 0-1: 26.44 %
- CV for section-by-section growth rate day 1-2: 19.17%
- CV for section-by-section growth rate day 2-3: 6.36 %
The mean coefficient of variation for section-by-section specific growth rates: 17.32 %.
The coefficient of variation of average specific growth rates during the whole test period (day 0-3) in the control cultures was 1.02 %.
All validity criteria were met. Therefore, the study was considered as valid.
Analytical Results
The mean measured concentration of the test item was 105 % of the nominal at the start and 97 % at the end of the test. The measured test item concentration remained within ± 20 % of the nominal during the test period of 72 hours. Therefore the biological results were based on the nominal concentration.
Biological Results
No inhibition was observed in the treated group after 72 hours of exposure compared to the control which was considered to be within the normal biological range.
Table 1: Summary of the Biological Endpoints
Parameter (0-72 h) | Growth rate (ji) [mg/L] | Yield (y) [mg/L] | |
EC50 95 % conf. limits | > 108 not calculated | > 108 not calculated | |
NOEC | 108 | 108 |
|
LOEC | > 108 | > 108 |
|
Description of key information
Under the test conditions no effects on algae were observed. The No Observed Effect Concentration (NOEC) was determined to be 108 mg/L and the 72-h EC50 values based on growth rate and yield were > 108 mg/L (reference 6.1.5-1).
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 108 mg/L
- EC10 or NOEC for freshwater algae:
- 108 mg/L
Additional information
The effect of the test item on algal growth was assessed using the unicellular green alga Raphidocelis subcapitata (formerly known as Pseudokirchneriella subcapitata and Selenastrum capricornutum) in a study according to OECD TG 201 under GLP. For this purpose, alga was exposed to the test item for 72 hours. Based on the results of a non-GLP preliminary test, in which the test item had no toxic effect on algae up to 100 mg/L (limit concentration). Therefore the main test was performed at 108 mg/L including a concurrent control and the reference substance potassium dichromate which served as the reference control. This concentration was chosen for regulatory purposes to achieve the limit test concentration of 100 mg/L for the test item even after a possible correction for the water content. As measured test item concentration remained within ± 20 % of the nominal over the test period of 72 hours, therefore the biological results were based on the nominal concentration. Exponentially-growing cultures of Raphidocelis subcapitata were exposed to the test item over several generations under defined conditions (static test). The algal growth was determined over a fixed test period of 72 hours in relation to a concurrent untreated control culture. Per test concentration and control, six replicates were used. The alga cell concentration was approximately 10e4 cells/mL at the start of the test for all test cultures. Glass flasks with a total capacity of 250 mL were used as test vessels. The volume of the test liquid in the vessels was 100 mL. The alga cell concentration was determined by microscope in each testing flask at 24, 48 and 72 hours. All validity criteria were fulfilled. The No Observed Effect Concentration (NOEC) was determined to be 108 mg/L and the Lowest Observed Effect Concentration (LOEC) was determined to be >108 (limit concentration). Consequently, the 72-h EC50 values based on growth rate and yield were also > 108 mg/L. As a limit test was performed and as no effects were observed, no further statistical analysis was performed.
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