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Diss Factsheets
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EC number: - | CAS number: -
- 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.07.2018 - 20.02.2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Based on the results of a preliminary non-GLP range finding test, the following concentrations (loading rates) in a geometrical series were tested in the definitive test:
100, 31.6, 10.0, 3.16, and 1.00% of the filtrate of a stock solution at a loading rate of 100 mg/L (spacing factor: square root of 10).
Test solutions
- Details on test solutions:
- The growth medium was OECD medium as described in the test guideline, modified to optimisegrowth of Raphidocelis subcapitata. The OECD growth medium
was prepared with a 10-fold concentrated iron (Fe)-EDTA complex (see bold font in recipe below) compared to the original recipe according to guideline
OECD 201. The growth rates of the algae in pre-culture were not sufficient in original OECD medium but satisfactory in the modified medium
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Study design
- Test type:
- static
- Water media type:
- freshwater
- Total exposure duration:
- 72 h
- Remarks on exposure duration:
- The test item was applied once at start of the test.
Test conditions
- Test temperature:
- Mean: 22.9 °C
Minimum value: 22.9 °C, Maximum value: 23.8 °C
Number of measurements: 79
The temperature was within the required range of 21–24 °C, controlled at ±2 °C, as required in the guideline and the study plan. - pH:
- pH of test medium: 8.2
pH in test solutions: 7.5 - 9.5
pH values at the beginning (pH0) and pH values at the end (pH72) of the test:
Nominal concentration pH(0) 8.1 pH(72)
% of filtrate at loading rate
of 100 mg test item / L
Control 8.1 9.5
1.00 8.1 9.0
3.16 8.1 9.0
10.0 8.1 8.4
31.6 7.9 8.2
100 7.5 8.0
The pH-drift observed in the control was <1.5 pH units, as required in the guideline and the study plan. - Nominal and measured concentrations:
- Nominal concentration Measured concentration Measured concentration Geometric mean concentration
Test period: 0 h Test period: 72 h
%* or mg test item / L mg test item / L mg test item / L mg test item / L
0.00 n.d. n.d. n.d.
1.00 0.991 0.673 0.817
3.16 3.06 1.31 2.00
10.0 10.1 7.38 8.63
31.6 32.8 29.5 31.1
100 100 101 100
*% of saturated solution at a loading rate of 100 mg test item / L
At time 0 hours the measured concentrations ranged between 97.0–104% of the nominal concentrations (expressed in mg/L assuming full solubility of the test item).
After 72 hours exposure, the two highest test concentrations remain between 93 and 101% of nominal, while the lower concentration levels decreased to 41.0–74.0% of the nominal concentrations (expressed in mg/L assuming full solubility of the test item) Since the test item concentrations did not remain stable within ±20% of the initially measured concentrations throughout the exposure period, the biological results are additionally expressed based on geometric mean of the concentrations measured at start (0 h) and end of exposure (72 h). - Details on test conditions:
- After temperature adaptation of the test solutions, 2.101 mL of the algal pre-culture (Raphidocelissubcapitata) were added to volumetric flasks containing
1000 mL of the test solutions, respectively to achieve an algal cell concentration of approximately 0.5×104 cells/mL. These manipulations were performed
under a laminar flow box. The test solutions were homogenised by manual shaking 15 times overhead, before adding 100±5 mL of the test media to each
test vessel to ensure a homogeneous distribution of the algal cells.
The test vessels were placed onto a shaker under light and temperature controlled conditions. The medium was sterilised by sterile filtration (pore size 0.2 μm)
before use. All glassware and materials used for testing purposes were sterilised for at least 3 hours at ≥150 °C using a heating furnace or autoclaved for
20 minutes at 120°C with a maximum pressure of 1.4 bar, except preparation flask (volumetric flask) used for preparation of test solution. - Reference substance (positive control):
- yes
- Remarks:
- A reference test using potassium dichromate (K2Cr2O7) as reference item were performed in August 2018 (ECT study number: IAO1804). Standard: Growth rate ErC50 (0–72 h): 0.953 (0.919 –0.988 mg/L; 95%-CL)
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 14.8 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- At start, cell numbers were determined microscopically using a counting chamber.After 24, 48 and 72 hours, the cell numbers were determined by measuring the fluorescence intensity in 4 samples of 200 μL of test solution per replicate using a fluorometer
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.817 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 46.87 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Results with reference substance (positive control):
- A reference test using potassium dichromate (K2Cr2O7) as reference item were performed in August
2018 (ECT study number: IAO1804).
Result: Standard: Growth rate ErC50 (0–72 h): 0.953 (0.919 – 0.988 mg/L; 95%-CL)
Based on an international ring test (ISO (2004). Water Quality – Freshwater algal growth inhibition test with unicellular green algae. European Standard
EN ISO 8692, October 2004.) mentioned in OECD guideline 201, the ErC50 (72h)-value for potassium dichromate obtained from different laboratories
was 1.19 mg/L with a standard deviation of 0.27 mg/L.
The ErC50 value for the toxic reference item, potassium dichromate, was determined as 0.953 mg/L.
This value is within the range of the international ring test (ISO (2004)). Therefore, the results of this
reference test are acceptable and the test conditions are reliable.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- All validity criteria were fulfilled as required by the study plan:
- Executive summary:
The EC50 for yield of Raphidocelis subcapitata was stated to be 16.7% of filtrate at a loading rate of
100 mg test item/L, equivalent to 14.8 mg DCHA-Oleat/L based on measured concentrations.
The NOEC based on nominal concentration appeared to be 1.00% of filtrate at a loading rate of 100 mg
test item/L, equivalent to 0.817 mg DCHA-Oleat/L based on measured concentrations.
The EC50 for growth rate of Raphidocelis subcapitata was stated to be 51.4% of filtrate at a loading
rate of 100 mg test item/L, equivalent to 46.87 mg DCHA-Oleat/L based on measured concentrations.
The NOEC based on nominal concentration appeared to be 3.16%of filtrate at a loading rate of 100 mg
test item/L, equivalent to 2.00 mg DCHA-Oleat/L based on measured concentrations.
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