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EC number: 485-320-2 | CAS number: 221667-31-8
- 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:
- effects on growth of green algae
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 - 28 Jan 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- (1984, 2004 draft)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Version / remarks:
- (1996 draft)
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA Guideline 123-2 (1982)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: The nominal concentrations were 0 (Control), 3.13, 6.25, 12.5, 25, 50, and 100 mg/L (ppm).
- Sampling method: Test solutions from two sampling intervals were received and analyzed on January 24 (Day 0), and January 28, 2005 (Day 4). - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: All of the test solutions were prepared as 1 L uniform batches. The high concentration test solution (100 mg/L) was prepared by adding 0.1026 g of the AE 0001789 (corrected for 97.4% a.i. purity) technical to approximately 300 ml of media in a 1 L volumetric flask. The flask was then brought to a volume of 1 L. It was found from past work that extended mixing would be needed to solubilize the 100 mg a.i./L test solution. Therefore, this solution was allowed to stir for at least 16 hours to facilitate adequate mixing. The remaining test solutions (50.0, 25.0, 12.5, 6.25 and 3.13 mg a.i./L) were prepared using a 50% serial dilution procedure from the high concentration. Each concentration was prepared by adding 500 ml of the next higher concentration to a 1 L volumetric flask containing approximately 300 ml of media. The solutions were then brought to volume (1 L) with media and inverted several times. The control solution consisted of media only. No solvent was used to prepare any of the test solutions. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green algae
- Source: the strain was obtained from an in-house culture (PS 276). The culture was obtained from The University of Texas at Austin (Austin, TX, USA).
- Age of inoculum: 96-hour old batch culture of Pseudokirchneriella subcapitata (in log phase growth)
- Method of cultivation: Algae culture techniques were based on those described by Stein (1973).
ACCLIMATION
- Culturing media and conditions: The batch culture was grown under test conditions in an environmental chamber at 24 ± 2.0°C, with 24 hour light photoperiod, and a light intensity of approximately 400 foot-candles (4.3 klux). - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- soft water: 40 to 60 mg/L as CaCO3
- Test temperature:
- 23.5 to 24.3°C
- pH:
- 7.3 to 9.7
- Nominal and measured concentrations:
- Nominal concentrations: 0 (Control), 3.13, 6.25, 12.5, 25.0, 50.0 and 100 mg a.i./L.
Mean measured concentrations:- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: 250 mL sterile borosilicate glass culture flasks filled with approximately 100 milliliters of test solution and capped with sterile inverted glass beakers.
- Initial cells density: 10^4 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: soft water, according to guideline
OTHER TEST CONDITIONS
- Photoperiod: 24 hours
- Light intensity and quality: An array of cool white fluorescent lights with a light intensity of approximately 4000 lux as measured by a Sper Scientific Light Meter.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: For each study day, density was determined in the three replicates at each test concentration using a model Zl Beckman Coulter® particle counter.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: yes
- Test concentrations: 0.1, 1.0, 10.0 and 100 mg a.i./L plus a control group
- Results used to determine the conditions for the definitive study: Growth was only affected at the 100 mg a.i./L level with an inhibition of 78% based on cell counts.- Reference substance (positive control):
- no
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 99.7 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 99.7 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks:
- and biomass
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 99.7 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 99.7 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Details on results:
- - Exponential growth in the control: yes
Observations:No physical abnormalities were observed in the controls or treatment groups during the study.
Table 1: Mean Measured Test Concentrations of AE 0001789 During the 96-hour Exposure of Pseudokirchneriella subcapitatato AE 0001789
Nominal
Conc.
(mg a.i./L)
Day 0
Measured
Conc.
(mg a.i./L)
Day 0
Percent
(%)
Nominal
Day 4
Measured
Conc.
(mg a.i./L)
Day 4
Percent
(%)
Nominal
Mean
Measured
Conc.
(mg a. i./L)
Percent (%)
Mean
Measured
Conc.
Control
<LOQ
-
<LOQ
-
-
-
3.13
3.17
101
3.04
97
3.10
99
6.25
6.32
101
6.09
97
6.20
99
12.5
12.5
100
12.2
98
12.4
99
25.0
25.0
100
24.6
98
24.8
99
50.0
53.9
108
51.5
103
52.7
105
100
100
100
99.3
99
99.7
100
LOQ = 0.31 mg a.i./L
Table 2: Validity criteria for OECD 201 (2006)
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.
The biomass in the control cultures increased exponentially by a factor of approx. 67 within the 72-hour test period and 159 within the 96-hour period.
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%
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3) in the control cultures was 27%.
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 withPseudokirchneriella subcapitataandDesmodesmus subspicatus. For other less frequently tested species, the value should not exceed 10%.
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures was 2%.
yes
- Validity criteria fulfilled:
- yes
- Remarks:
- See Table 2 in "Any other information on results incl. tables".
Reference
Description of key information
EC50 (72 h): >99.7 mg a.i./L (arith. mean measured, Pseudokirchneriella subcapitata, OECD 201)
NOEC (72 h): >99.7 mg a.i./L (arith. mean measured, Pseudokirchneriella subcapitata, OECD 201)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 99.7 mg/L
- EC10 or NOEC for freshwater algae:
- 99.7 mg/L
Additional information
One study on the effects of the test substance to algae is available (M-252015-01-1). The study was conducted in accordance with the prevailing OECD testing guideline (OECD 201) under GLP conditions. In a test system, the highest tested concentration was 100 mg/L; the measured concentrations were within the range of 99 to 105% of the nominal concentrations. Based on measured concentrations, the 96h EC50 (growth rate) in the green algae Pseudokirchneriella subcapitata was calculated to be >99.7 mg/L test item (>100 mg/L nominal). The NOEC and LOEC values were ≥99.7 mg a.i./L and >99.7 mg a.i./L, respectively. No abnormalities were observed in the controls or treatment groups during the study and the substance shows no effects to freshwater algae up to the highest test concentration of 100 mg a.i./L (nominal).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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