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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
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:
- 02 July - 22 October 2018
- 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:
- yes
- Remarks:
- The applied dose could not be analytically verified successfully.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Test material: Harpin fermentation extract (Harpin-αβ extract)
- Batch No. of test material: R134-1
- Appearance: Liquid/ tan, light brown
- Active ingredient content: 0.401% w/w
- Storage conditions: On dry ice (≤ -70 °C), dark, dry - Analytical monitoring:
- yes
- Details on sampling:
- Analytical samples were taken and analysed in the main test from control and all test item concentrations at 0 hours (initial value) from fresh test solutions and after 24 hours, 48 hours and 72 hours from aged test solutions.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION:
- Method: The necessary amount of test item for preparing the stock solution S1 was weighed on a weighing scoop and transferred to a volumetric flask. Test medium was added up to the bench mark and the solution was homogenised by shaking. Lower test solutions were prepared by dilution of the stock solution with test medium and appeared clear. Algae were added to each solution individually resulting in target cell densities of 0.5 × 104 cells per mL in each solution.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): The solution appeared clear and transparent. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata Hindák (Sphaeropleales: Selenastraceae)
- Strain: SAG 61.81
- Source: MBM Sciencebridge GmbH, Hans-Adolf-Krebs-Weg 1, D-37077 Göttingen, Germany
- Method of cultivation: The algae are grown semi-continuously in sterile cultures in the laboratory. Old medium is periodically replaced by fresh mineral solution in order to keep the algae in an exponential growth state. Stock cultureswere ordered regularly from the commercial supplier.
ACCLIMATION
- Acclimation period: 3 to 4 days prior to start of test
- Culturing media and conditions: Same as test
- Any deformed or abnormal cells observed: None specified - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
- Test temperature:
- 22.7 - 23.3°C
- pH:
- Control during the test: 7.17 - 7.97
Test concentrations during the test: 7.22 - 8.24 - Nominal and measured concentrations:
- Nominal test item concentrations: 0.954, 3.05, 9.77, 31.3 and 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL Erlenmeyer flasks with aluminium caps
- Type: closed
- Material, size, headspace, fill volume: 100 mL Erlenmeyer flasks with aluminium caps each containing ~ 50 mL test solution
- Aeration: By continuous agitation
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Not applicable
- Initial cells density: 0.5 × 10^4 cells/mL
- Control end cells density: 24.67 x 10^4 cells/mL
- No. of vessels per concentration (replicates): 3 replicates for each test concentration
- No. of vessels per control (replicates): 6 replicates and one additional replicate without algae
GROWTH MEDIUM
- Standard medium used: yes (AAP-Medium, according to Annex 3 of OECD 201)
- Detailed composition if non-standard medium was used: Not applicable
OTHER TEST CONDITIONS
- pH of the control: 7.17 - 7.97
- Adjustment of pH: The pH was adjusted with NaOH and HCL to 7.5 ± 0.1.
- Photoperiod: Continuous illumination
- Light intensity and quality: 88.1 µEm-2s-1 at cell culture level (mean)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: At 24, 48 and 72 hours from the test initiation, the number of cells in each replicate was determined by fluorescence detection.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Range finding study
- Test concentrations: Nominal test item concentrations: 0.0100, 0.100, 1.00, 10 and 100 mg/L - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (tested in a separate study twice a year to confirm the sensitivity of the test organisms against compounds with known effects under the test conditions).
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 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.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Details on results:
- Biological results: After 72 h at termination of the test no concentration response relation was observed for the inhibition of growth rate and yield. The inhibition of growth rate peaked in -23.0 % at a nominal test item concentration of 100 mg/L and the inhibition of yield peaked in -148.2 % at a nominal test item concentration of 100 mg/L.
The morphology of the algae cells was observed microscopically at test end. The cells were considered normal for the control and up to and including a nominal test item concentration of 100 mg/L.
Analytical results: The initial measured content of TOC in the test item concentrations was below LOD (LOD = 0.5 mg/L) and 0.6131 mg/L. In the aged samples the measured TOC was between 0.9025 mg/L and 2.750 mg/L. The measured TOC concentrations might result from the test medium, since the TOC content of the solution of 100 mg/L in deionized water was determined to be below LOD. Furthermore, the measured concentrations of TOC were of similar values in the test item concentration as corresponding results from the control media measured values, in both the fresh and aged analysed samples.
Due to the properties and the composition of the test item no analytical dose verification was possible with commonly applied analytical methods. Due to correct routinely handling of the test item and the test item solutions, a correct application of the test item is assumed thus toxicological endpoints were evaluated using the nominal of the test item. - Results with reference substance (positive control):
- - Results with reference substance valid?: Yes
- EC50: The EC50 value for growth rate was determined to be 1.60 mg/L (nominal). The EC50 value for yield was 0.990 mg/L (nominal). The EC50 value for biomass integral was 1.06 mg/L (nominal).
- Other: Significant inhibitory effects were determined for growth rate and yield at test item concentrations of 0.800 mg/L (nominal) and above. Significant inhibitory effects were determined for biomass integral at 0.320 mg/L (nominal) and above. The overall NOEC was therefore determined to be 0.320 mg/L (nominal), the corresponding LOEC was set at 0.800 mg/L (nominal). - Validity criteria fulfilled:
- yes
- Remarks:
- Control cell numbers, were found to increase by a factor of 48.37. Coefficient of Variation (section by section) in the control cultures was 29 %. Coefficient of Variation (average growth rate) in replicate control cultures was 2.2 %.
- Conclusions:
- No statistically significant inhibitory effects on any parameter (growth rate & yield) were observed at any of the test item concentrations, including the highest test item concentration of 100 mg/L (nominal) at test end. Thus the overall LOEC was not determinable and the overall NOEC was set at 100 mg/L (nominal).
The EC10-, EC20- and EC50-value for growth rate and yield were considered to be > 100 mg/L (nominal).
Reference
Table1: Average cell numbers for each sampling time and concentration
Conc. |
Average cell numbers [104/mL] |
|||
[mg/L] |
0 h |
24 h |
48 h |
72 h |
Control |
0.51 |
1.30 |
6.28 |
24.67 |
0.954 |
0.51 |
1.79 |
9.44 |
38.30 |
3.05 |
0.51 |
1.26 |
8.06 |
35.60 |
9.77 |
0.51 |
1.80 |
10.06 |
45.28 |
31.3 |
0.51 |
1.94 |
12.89 |
58.23 |
100 |
0.51 |
2.28 |
14.42 |
60.47 |
Table2: Percentage inhibition of growth rate
Conc. |
% Inhibition of growth rate |
||
[mg/L] |
0 h – 24 h |
0 h – 48 h |
0 h – 72 h |
Control |
0.0 |
0.0 |
0.0 |
0.954 |
-28.0 |
-16.1 |
-10.9 |
3.05 |
6.1 |
-8.9 |
-8.7 |
9.77 |
-34.0 |
-18.0 |
-14.7 |
31.3 |
-42.7 |
-28.7 |
-22.0 |
100 |
-60.2 |
-33.3 |
-23.0 |
Table3: Percentage inhibition of yield
Conc. |
% Inhibitionof yield |
||
[mg/L] |
0 h – 24 h |
0 h – 48 h |
0 h – 72 h |
Control |
0.0 |
0.0 |
0.0 |
0.954 |
-62.0 |
-54.8 |
-56.4 |
3.05 |
5.1 |
-30.8 |
-45.2 |
9.77 |
-63.3 |
-65.5 |
-85.3 |
31.3 |
-81.0 |
-114.6 |
-138.9 |
100 |
-124.1 |
-141.1 |
-148.2 |
Table 4: Determined concentration ofTOC
Test item nominal [mg/L] |
Harpin-αβnominal [mg/L] |
Sampling |
TOC [µg/L] |
% Standard Deviation |
Control |
0 |
0 h fresh |
<LOD (384.4) |
2.60 |
24 h aged |
902.5 |
2.39 |
||
48 h aged |
2120 |
1.88 |
||
72 h aged |
933.7 |
0.49 |
||
0.954 |
0.004 |
0 h fresh |
<LOD (301.6) |
9.28 |
24 h aged |
1380 |
0.49 |
||
48 h aged |
2830 |
0.43 |
||
72 h aged |
2460 |
0.98 |
||
3.05 |
0.0122 |
0 h fresh |
613.1 |
3.02 |
24 h aged |
1020 |
1.83 |
||
48 h aged |
1460 |
0.31 |
||
72 h aged |
2020 |
0.91 |
||
9.77 |
0.0391 |
0 h fresh |
<LOD (418.1) |
1.66 |
24 h aged |
2150 |
1.24 |
||
48 h aged |
2400 |
0.46 |
||
72 h aged |
2610 |
1.27 |
||
31.3 |
0.125 |
0 h fresh |
506.7 |
1.90 |
24 h aged |
2540 |
0.49 |
||
48 h aged |
2100 |
0.13 |
||
72 h aged |
2350 |
1.09 |
||
100 |
0.400 |
0 h fresh |
<LOD (460.6) |
1.48 |
24 h aged |
1560 |
0.09 |
||
48 h aged |
2310 |
1.74 |
||
72 h aged |
2750 |
0.92 |
Limit of Detection (LOD) = 0.5 mg/L TOC
Description of key information
A GLP study was performed in accordance with OECD Guideline 201 to assess the toxicity of the test material, Harpin fermentation extract, to the single cell green alga Pseudokirchneriella subcapitata Hindák.
No statistically significant inhibitory effects on any parameter (growth rate & yield) were observed at any of the test item concentrations, including the highest test item concentration of 100 mg/L (nominal) at test end. Thus the overall LOEC was not determinable and the overall NOEC was set at 100 mg/L (nominal).
The EC50-value for growth rate and yield was considered to be > 100 mg/L (nominal).
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
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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