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EC number: 226-733-8 | CAS number: 5459-93-8
- 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.6.-19.7.2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out in accordance with internationally valid GLP principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cyclohexyl(ethyl)amine
- EC Number:
- 226-733-8
- EC Name:
- Cyclohexyl(ethyl)amine
- Cas Number:
- 5459-93-8
- Molecular formula:
- C8H17N
- IUPAC Name:
- N-ethylcyclohexanamine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): N-ethylcyclohexylamine
- Physical state: clear colourless liquid
- Analytical purity: 99.5% (w/w)
- Impurities (identity and concentrations): cyclohexanol 0.22% (w/w), alifatic amines 0.23% (w/w), water 0.07% (w/w)
- Lot/batch No.: 89002001
- Expiration date of the lot/batch: 12/2012
- Storage condition of test material: in original packaging at the fridge during the study
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: the highest (86 mg.L-1) and the lowest (5 mg.L-1) test concentration and from the highest (86 mg.L-1) concentration without algae.
- Sampling method: The samples for analysis (0 hours) were prepared at the beginning of the test and immediately delivered in transport box to analytical laboratory. The samples for analysis at the end of the test (72 hours) were delivered to analytical laboratory immediately after the end of testing. The samples were analyzed on the day of delivery.
- Sample storage conditions before analysis: All samples were stored at laboratory temperature.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Since the test substance is poorly soluble in test medium at concentrations needed for the test, the saturated solutions of the test substance in test medium were prepared for preliminary and full test. The saturated solutions were prepared by adding measured amounts of the test substance to the test medium. The saturated solutions were stirred for suitable period (3 hours) on a shaft stirrer and consequently filtered through 0.45 μm filter. These solutions were used for testing.
The suitable period for achieving equilibrated concentration of the test substance was determined in preliminary experiment. For preliminary experiment the saturated solutions were prepared as follows: 100 mg of the test substance in 1000 mL of the test medium was stirred for period 3, 24, 48 and 72 hours on a shaft stirrer, consequently filtered through 0.45 μm filter and the concentrations of the test substance in resulted solutions were determined.
Test organisms
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Strain: Brinkmann 1953/SAG 86.81
- Source (laboratory, culture collection): The collection of autotrophic organisms of The Botanic Institute of the Czech Academy of Science, Třeboň
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: The strain culture was preinoculated from the stock solution and cultivated in flasks with the test medium on indirect daylight at laboratory temperature.
ACCLIMATION
- Acclimation period: 3 days
- Culturing media and conditions (same as test or not): same as test
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 23°C
- pH:
- 7.6
- Nominal and measured concentrations:
- 86, 54, 34, 21, 13, 8, 5 mg.L-1 (nominal concentration)
The analytical determination of the test substance concentrations was performed at the beginning and at the end of the test. The samples for analysis were taken from the highest (86 mg.L-1) and the lowest (5 mg.L-1) test concentration and from the highest (86 mg.L-1) concentration without algae (w.a.):
Measured concentration: 5.34 mg.L-1, 80.9 mg.L-1 and 81.6 mg.L-1 w.a. (0 hours), 5.27 mg.L-1, 79.5 mg.L-1 and 81.4 mg.L-1 w.a. (72 hours) - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks with stoppers venting air
- Aeration: no
- Initial cells density: 5000 cells in a 1 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
- Test medium: The water with conductivity smaller than 5 μS.cm-1 was used for the preparation of solutions.
- According to Method C.3 Algal Inhibition Test were prepared four basic stock solutions. The test medium was prepared by admixing of basic stock solutions.
OTHER TEST CONDITIONS
- Lighting: continuous white light, 4 440 lux to 8 880 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- The density of algae culture was evaluated microscopically at 24, 48 and 72 hours.
- At the beginning and the end of the test the pH of the test mixtures was measured. The light intensity and temperature were measured every 24 hours.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.6
- Range finding study
- Test concentrations: 100, 60, 40, 20 and 10 mg.L-1 (nominal concentration)
- On the basis of preliminary test results the full test was performed. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- other: ErC50
- Effect conc.:
- 53.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence limit: 48.4 – 58.6 mg.L-1
- Duration:
- 72 h
- Dose descriptor:
- other: EyC50
- Effect conc.:
- 8.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% confidence limit: 7.5 – 9.3 mg.L-1
- Duration:
- 72 h
- Dose descriptor:
- other: NOECr
- Effect conc.:
- 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- other: NOECy
- Effect conc.:
- < 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Results with reference substance (positive control):
- - Results with reference substance valid? Yes.
The inhibition of test organisms by the reference substance (72h – ErC50) obtained from last reference test meets the calculated range from the interlaboratory test.
-Reference test: 72 hour – ErC50 = 0.99 mg.L-1 (95% confidence limit: 0.88 – 1.09 mg.L-1)
- Interlaboratory test: 72 hour – ErC50 = 0.38 – 1.30 mg.L-1
Any other information on results incl. tables
TEST EVALUATION
The values of ErC50 and EyC50 were calculated using the software “Toxicita”(product of Water Research Institute, Ostrava, Czech Republic).
The determination of NOEC values was done by ANOVA (Analysis of Variance) analysis. Used ANOVA method is the part of statistical software QC.Expert 2.5 © 1998-2000 (TriloByte, Czech Republic).
For the evaluation EC and NOEC values the nominal concentrations were used.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Executive summary:
The test substance, N-ethylcyclohexylamine, was tested for growth inhibition on algae Desmodesmus subspicatus. The test was performed according to method C.3. - Freshwater Algae and Cyanobacteria, Growth Inhibition Test, Commission Regulation (EC) No. 761/2009, Annex IV.
Since the test substance is poorly soluble in test medium at concentrations needed for the test, the saturated solutions of the test substance in test medium were prepared for preliminary and full test. The saturated solutions were prepared by adding measured amounts of the test substance to the test medium. The saturated solutions were stirred for period 3 hours on a shaft stirrer and consequently filtered through 0.45 μm filter.
The preliminary test was performed in range of test substance nominal concentrations
10 – 100 mg.L-1. The analytical results showed, that the test substance
N-ethylcyclohexylamine was sufficiently stable in the test medium at conditions of the test. Based on the toxicity of the test substance found in preliminary test, the full test was performed in appropriate concentration range.
The full test was performed in range of test substance nominal concentrations 5 – 86 mg.L-1. Samples for analytical determination were taken at the beginning and at the end of the test. The nominal concentrations were used for all evaluations and results, because, if evidence is available to demonstrate that the concentration of the test substance has been satisfactorily maintained within ± 20 percent of the nominal or measured initial concentration throughout the test, then the results can be based on nominal or measured initial values.
Test results:
72 hour – ErC50 = 53.5 mg.L-1 (nominal concentration)
(95% confidence limit: 48.4 – 58.6 mg.L-1)
72 hour – EyC50 = 8.4 mg.L-1 (nominal concentration)
(95% confidence limit: 7.5 – 9.3 mg.L-1)
72 hour – NOECr = 5 mg.L-1 (nominal concentration)
72 hour – NOECy < 5 mg.L-1 (nominal concentration)
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