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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:
- 2019-03-12 to 2019-09-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline Study; EU method; GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD No 23, Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Remarks:
- gas chromatography with MS/MS detection
- Details on sampling:
- Quadruplicate samples from the freshly prepared test media (containing algae) of all test concentrations and from the control were taken at the start of the test.
For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the test period, quadruplicate samples from the test media of all test concentrations and the control (containing algae) were taken at the end of the test (after the 72 hours test period) by pooling the contents of the test beakers of each treatment.
In addition, quadruplicate samples from the test media of all test concentrations and the control were taken after 24 and 48 hours test duration from the additional vessel prepared for analytical sampling.
All samples were adjusted to pH10 with 1 M sodium hydroxide solution before storage.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Test Concentrations: An aqueous solution of the test item in test media with a concentration (nominal: 110 mg/L) as close to saturation as possible (referred to as a ´stock solution´) was obtained first (see ´Dosage of test item´ below). This stock solution and dilutions of this “stock solution” by 1:3, 1:9, 1:27 and 1:81 were prepared for testing. Additionally, a control was tested in parallel. These concentrations refer to nominal concentrations of 110, 36.7, 12.2, 4.07 and 1.36 mg test item/L.
Control: In the control, test water was used without addition of the test item.
Dosage of Test Item: Before test start, a ´stock solution´ (110 mg/L) of the test item in test medium was prepared by mixing 111.9 mg test item into 1017.27 mL test water. The test medium was stirred with an excess of the test item in a vessel for 24 hours. Afterwards the test medium was allowed to settle until phase separation for 1 hour. This ´stock solution´ was withdrawn from a tap at the center of the vessel, after first flushing the tap and tubing with a small aliquot, and then mixed with test water to produce the desired dilutions of 1:3, 1:9, 1:27 and 1:81.
Appearance of the Test Item in Test Medium: There were no remarkable observations.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Species: Pseudokirchneriella subcapitata, Strain No. 61.81 SAG
Origin: The algae were supplied by the "Sammlung von Algenkulturen, Pflanzenphysiologisches Institut der Universität Göttingen", 37073 Göttingen, Germany.
Breeding Conditions: The algae were cultivated in the laboratories of IBACON under standardised conditions according to the test guidelines.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- Calculated water hardness of the test water: 0.24 mmol/L (= 24 mg/L) as CaCO3
- Test temperature:
- 22 to 23°C
- pH:
- 7.9 - 8.1 at test start and 9.0 to 9.2 at test end
- Nominal and measured concentrations:
- An aqueous solution of the test substance in test media with a concentration (nominal: 110 mg/L) as close to saturation as possible (referred to as a ´stock solution´) was obtained first (see ´Dosage of test item´ below). This stock solution and dilutions of this “stock solution” by 1:3, 1:9, 1:27 and 1:81 were prepared for testing. These concentrations refer to nominal concentrations of 110, 36.7, 12.2, 4.07 and 1.36 mg test item/L.
The mean measured values of the freshly prepared samples (0h) are:
135 µg test item/L in the WAF stock solution of nominal 110 mg test item/L
48.4 µg test item/L in the 1:3 dilution of the stock solution
16.3 µg test item/L in the 1:9 dilution of the stock solution
The mean measured values of the aged samples (24h) are:
95.9 µg test item/L in the WAF stock solution of nominal 110 mg test item/L
34.3 µg test item/L in the 1:3 dilution of the stock solution
10.97 µg test item/L in the 1:9 dilution of the stock solution
The mean measured values of the aged samples (48h) are:
78.5 µg test item/L in the WAF stock solution of nominal 110 mg test item/L
25.1 µg test item/L in the 1:3 dilution of the stock solution
The mean measured values of the aged samples (72h) are:
64.1 µg test item/L in the WAF stock solution of nominal 110 mg test item/L- Details on test conditions:
- Water Temperature: The temperature was measured daily in an Erlenmeyer flask filled with water and incubated under the same conditions as the test flasks.
Water temperature was:
22.3 to 22.5 °C
pH-Values: The pH was measured in all test item concentrations and the control at the start and the end of the test.
The pH in the control was 8.1 (adjusted from 7.8 using 1 M NaOH) at test start and 9.1 at test end.
The pH at the different test concentrations was 7.9 to 8.0 at test start and 9.0 to 9.2 at test end.
Light Regime: Continuous illumination
Light Intensity: The light intensity was measured once during the test at 6 positions distributed over the experimental area at the surface of the test media.
Mean light intensity: 4933 lux (range: 4560 to 5310 lux)- Reference substance (positive control):
- yes
- Remarks:
- reference item potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 110 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 110 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 110 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 110 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 110 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 110 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- The 72-hour EyC50 was calculated to be > 110 mg test item/L and the ErC50 > 110 mg test item/L. The 72-hour EyC10 was calculated to be 56.2 mg test item/L and the ErC10 > 110 mg test item/L. The 72-hour NOEyC was determined to be ≥ 110 mg test item/L and the associated 72-hour LOEyC of > 110 mg test item/L. The 72-hour NOErC was determined to be ≥ 110 mg test item/L and the associated 72-hour LOErC is > 110 mg test item/L.
The microscopic examination of the shape of the algal cells after 72 hours of test duration did not show any difference between the algae that had been growing up to a nominal test concentration of 110 mg test item/L and the algal cells in the control. Thus, the shape of the algal cells was not obviously affected up to this test concentration, the highest concentration tested. - Results with reference substance (positive control):
- - Results with reference substance were valid.
- EC50: Yield 0.445 [mg test item/L], Growth rate 0.941[mg test item/L],Biomass 0.494 [mg test item/L] - Reported statistics and error estimates:
- Based on the calculated cell densities, the 72 hour EC50, the corresponding EC20 and EC10 values and where possible their 95 %-confidence limits were calculated by three parametric normal concentration distribution function (CDF).
For the determination of the 72 hour LOEC and the 72 hour NOEC, the calculated growth rates and yields at each test concentration were tested for significant differences compared to the control values by Dunnett´s t-test.
The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Cell Density Increase: 189-fold increase within 72 hours; Coefficient of Variation of Sectional (Daily) Growth Rates: 9%; Coefficient of Variation of Average Growth: 2.6%
- Conclusions:
- The influence of dialkyl-methyldihydro-heteropolycycle on the growth of the freshwater green algae Pseudokirchneriella subcapitata was assessed in a static concentration-response test. The 72-hour EyC50 was calculated to be > 110 mg test item/L and the 72-hour ErC50 value was calculated to be > 110 mg test item/L. The 72-hour NOEyC was determined to be ≥ 110 mg test item/L and the associated 72-hour LOEyC was > 110 mg test item/L. The 72-hour NOErC was determined to be ≥ 110 mg test item/L and the associated 72-hour LOErC was > 110 mg test item/L.
The initial concentrations and the maintenance of the exposure concentrations during the test were verified in the analytical part. All reported results refer to nominal concentrations (loading rate) since a supersaturated stock solution via a water accommodated fraction was prepared. - Executive summary:
The influence of dialkyl-methyldihydro-heteropolycycle on the growth of the freshwater green algae Pseudokirchneriella subcapitata was assessed in a static concentration-response test. The 72-hour EyC50 was calculated to be > 110 mg test item/L and the 72-hour ErC50 value was calculated to be > 110 mg test item/L. The 72-hour NOEyC was determined to be ≥ 110 mg test item/L and the associated 72-hour LOEyC was > 110 mg test item/L. The 72-hour NOErC was determined to be ≥ 110 mg test item/L and the associated 72-hour LOErC was > 110 mg test item/L.
The initial concentrations and the maintenance of the exposure concentrations during the test were verified in the analytical part. All reported results refer to nominal concentrations (loading rate) since a supersaturated stock solution via a water accommodated fraction was prepared.
This study is classified acceptable and satisfies the guideline requirements for growth inhibition algae studies.
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