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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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 September - 24 September 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation 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 (100 mL in 250 mL Schott bottles) were taken from the test item concentration and control at test start and after 24 hours from fresh and aged solutions and after 48 hours from aged solutions. For each sampling also a retain sample was taken. Additionally a sample of the test item in pure form was taken.
All samples were stored refrigerated until they were transferred to the analytical laboratory. - Vehicle:
- no
- Details on test solutions:
- 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. Afterwards the solution was clear and transparent. The preparation procedure was repeated after 24 hours. At least 50 mL of the prepared solutions were transferred to each test vessel
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna Straus
- Strain/clone: Clone V
- Source: The animals are continuously bred in the laboratory and were originally purchased in a healthy condition from the Federal Environment Agency in Berlin/Germany.
- Age: Freshly hatched daphnids less than 24 hours old were used for the test.
- Feeding during test: No - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- Total hardness: 13 dH (232 mg/L as CaCO3)
- Test temperature:
- 19.4 - 21.0°C
- pH:
- Initial pH of control: 7.87
Test: 7.77 - 7.96 - Dissolved oxygen:
- Initial: 8.9 mg/L
Test: ≥ 8.7 mg/L - Nominal and measured concentrations:
- Nominal concentration: 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass vessel
- Type: closed (covered with a glass plate)
- Material, size, headspace, fill volume: 100 mL glass vessels were filled up with > 50 mL test solution and covered with a glass plate (thus reducing evaporation)
- Aeration: None
- No. of organisms per vessel: 5 daphnia/ vessel
- No. of vessels per concentration (replicates): 4 replicates per treatment
- No. of vessels per control (replicates): 4 replicates for control
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: >10 mL of test solution for each animal
TEST MEDIUM / WATER PARAMETERS
- Medium: Elendt M4 medium
OTHER TEST CONDITIONS
- Adjustment of pH: Not specified
- Photoperiod: 16 hours photoperiod /8 hours darkness daily
- Light intensity: Not specified
EFFECT PARAMETERS MEASURED: After 24 h and 48 h the immobilised daphnids were counted. All daphnids not able to swim within 15 seconds after gentle agitation of the test vessel were considered to be immobilised. If present, behavioural changes of daphnids were recorded at 24 and 48 hours after starting the test
VEHICLE CONTROL PERFORMED: No - Reference substance (positive control):
- yes
- Remarks:
- Two concentrations of the reference item potassium dichromate (1.00 mg/L, 2.00 mg/L) were tested around the same time period as the study
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Biological results:
After 24 and 48 hours of exposure no immobilisation was observed in the control and the test item concentration 100 mg/L.
No behavioural changes could be observed.
Analytical results:
The initial measured content of TOC was below LOD (LOD = 0.5 mg/L; measured value 307 µg/L (0 hours fresh) and 390 µg/L (24 hours fresh)) at 100 mg/L. In the aged sample the measured TOC was below LOD (measured value 363 µg/L) at 100 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. Therefore the toxicological endpoints were evaluated using nominal concentrations. Due to correct routinely handling of the test item and the test item solutions, a correct application of the test item is assumed. - Results with reference substance (positive control):
- The results indicate an EC50 (24 h) of the reference item potassium dichromate between 1.00 and 2.00 mg/L. Since the results are in accordance with the requirements of the OECD guideline 202 and fall within the historical data generated with the reference item at the testing facility, the daphnids were suitable for the determination of the toxicological effects of the test item.
- Validity criteria fulfilled:
- yes
- Remarks:
- In the study the control immobilisation was 0% (should be ≤ 10 %). The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in all test units. In this test, the dissolved oxygen concentration at the end of the test was ≥ 8.7 mg/L.
- Conclusions:
- According to the results of the test, the EC50 (48 h) for immobilisation was estimated to be > 100 mg/L (nominal). The corresponding NOEC (48 h) was 100 mg/L (nominal).
Reference
Table1: Results of the test, 24 h values
|
Nominal test item concentration [mg/L] |
|
|
Control |
100 |
|
Immobilised daphnids after 24 h |
|
Replicate 1 |
0 |
0 |
Replicate 2 |
0 |
0 |
Replicate 3 |
0 |
0 |
Replicate 4 |
0 |
0 |
Σ |
0 |
0 |
% |
0 |
0 |
Table 2: Results of the test, 48 h values
|
Nominal test item concentration [mg/L] |
|
|
Control |
100 |
|
Immobilised daphnids after 48 h |
|
Replicate 1 |
0 |
0 |
Replicate 2 |
0 |
0 |
Replicate 3 |
0 |
0 |
Replicate 4 |
0 |
0 |
Σ |
0 |
0 |
% |
0 |
0 |
Table 3: Determined concentration ofTOC in the test samples
Test item nominal [mg/L] |
Harpin-αβ nominal [mg/L] |
Sampling |
TOC [µg/L] |
% Standard Deviation |
|
Control |
0 |
0 fresh |
< LOD (265)* |
6.94 |
|
24 fresh |
< LOD (263)* |
3.02 |
|||
48 aged |
< LOD (496)* |
1.38 |
|||
100 |
0.4 |
0 fresh |
< LOD (307)* |
0.13 |
|
24 fresh |
< LOD (390)* |
0.50 |
|||
48 aged |
< LOD (363)* |
6.00 |
|||
Limit of detection (LOD) = 0.5 mg/L TOC
*value results from the test medium (containing vitamins and other organic carbons)
Table 4: Determined of the TOC content of the test item as a bulk material
Test item nominal [mg/L] |
Harpin-αβ nominal [mg/L] |
TOC [µg/L1)] |
|
100 |
0.4 |
0* |
|
* below Limit of detection (LOD = 0.5 mg/L TOC)
1)Determined in deionized water
Description of key information
A GLP study was performed in accordance with OECD Guideline 202 to assess the toxicity of the test material, Harpin fermentation extract, to Daphnia magna. According to the results of the test, the EC50 (48 h) was supposed to be > 100 mg/L (nominal). The corresponding NOEC (48 h) was 100 mg/L (nominal).
Key value for chemical safety assessment
Additional information
The study performed on EBC 351 (1% Harpin ab), supports the lack of toxicity of 'Cell Free Harpin Extract of Harpinαβ produced by fermentation' and that classification is not required.
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