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EC number: 431-060-1 | CAS number: 153719-38-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
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:
- 1995-11-03 until 1996-03-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 431-060-1
- EC Name:
- -
- Cas Number:
- 153719-38-1
- Molecular formula:
- Hill formula: C4H8N4O3 CAS formula: C4H8N4O3
- IUPAC Name:
- 3-methyl-N-nitro-3,6-dihydro-2H-1,3,5-oxadiazin-4-amine
- Details on test material:
- - Name of test material (as cited in study report): CA 2343 A (Intermediate of CGA 293343)
- Substance type: mono-constituent organic substance
- Physical state: solid, fine, white powder
- Analytical purity: 96.7 %
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: P.503005
- Expiration date of the lot/batch: Date of reanalysis: December 1996
- Stability under test conditions: not reported
- Storage condition of test material: 0 - 5 °C
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
not applicable
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Nominal: 0.2, 0.4,0.8, 1.6,3.2,6.4 and 12.8 mg test substance/l
- Sampling method:
Composite samples (about 150 ml per concentration and control) of each test concentration were drawn by mixing identical volumes of the test solutions taken from the test vessels. Samples of test solutions were taken immediately before exposure and after 72 hours exposure. A sample of the
stock solution was taken 24 hours before exposure.
- Sample storage conditions before analysis: All samples were kept at - 18°C to - 22°C until analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: preparation of stock solutions: 50.2 mg test substance were mixed and made up to 1000 ml with reconstituted water by ultrasonic for 1 minute.
- Eluate: not applicable
- Differential loading: no data
- Controls: blank: reconstituted water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no observations reported
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green algae
- Strain: Selenastrum capricornutum ATCC 22662 = Pseudokirch. subcapitata SAG 61.81)
- Source (laboratory, culture collection): Collection of algae cultures, Pflanzenphysiologisches Institut, University Gottingen, Germany
- Age of inoculum (at test initiation): Preculture: 3 days under test conditions
- Method of cultivation: Initial cell density: 10 100 cells/ml. Culture according to the guideline cited. The parent stock is cultured under conditions similar to the test (e.g. light, temperature, medium). All operations for culturing were carried out under sterile conditions in order to avoid contamination with bacteria and other algae.
ACCLIMATION
- Acclimation period: Preculture: 3 days under test conditions
- Culturing media and conditions (same as test or not): same
- Any deformed or abnormal cells observed: none reported
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- no data
Test conditions
- Hardness:
- 25 mg CaC03/l
- Test temperature:
- 24 ± 1°C
- pH:
- The pH of the test solutions was 8.0 - 8.1 and 8.0 - 8.2 at the start and end of exposure, respectively.
- Dissolved oxygen:
- no data
- Salinity:
- Conductivety: 150 µS/cm
- Nominal and measured concentrations:
- - Nominal test concentrations: 0.2, 0.4, 0.8, 1.6, 3.2, 6.4 and 12.8 mg test substance/l
- Measured: 0.19, 0.38, 0.76, 1.6, 2.9, 6.3, 12.7 mg/l and 0.18, 0.36, 0.71, 1.5, 2.9, 5.9, 12.0 mg/l at the start and the end of exposure, respectively.
The measured concentrations were within 100 ± 20% the nominal concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 100 ml Erlenmeyer flasks (total volume 125 ml), cotton stoppers, 50 ml test solution per flask
- Aeration: Labshaker, 150 rpm
- 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: 10100 cells / ml
- Control end cells density: 990000 cells / ml
- No. of organisms per vessel: 505000
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- No. of vessels per vehicle control (replicates): not applicable
GROWTH MEDIUM
- Standard medium used: yes
- Detailed composition if non-standard medium was used:
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted Water, composition according to the guideline.
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: no data
- Alkalinity: no data
- Ca/mg ratio: no data
- Conductivity: 150 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH was measured at Oh and 72h exposure
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: not reported
- Photoperiod: Continuous illumination
- Light intensity and quality: cold white fluorescent light, 120 µE/cm² sec ± 20 % (approx. 8000 lux)
- Salinity (for marine algae): not applicable
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Cell densities were measured at 24, 48 and 72 hours exposure on a "TOA" cell counter. Test results are reported as daily cell concentration (cells/ml), area under the growth curve, which is an estimate of biomass, and average specific growth rate in each test culture.
- Chlorophyll measurement: no
- Other:
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study
- Test concentrations: 0.01, 0.1, 1.0, 10 and 100 mg/l.
- Results used to determine the conditions for the definitive study: A range-finding test was conducted to determine a concentration range of CA 2343 A to use in the definitive test. An initial cell density of 10500 cells/ml was exposed for 72 hours to each of the concentrations. The measured cell concentration at the end of exposure showed an inhibition at test concentration 10 mg/l. Based on the results of the preliminary test the concentrations were selected for the definitive test. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 16.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 15.2 - 18.1 mg/l; slope 2.38
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 8.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 7.3 - 10.2 mg/l; slope 2.69
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: significant on 5% level
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: significant on 5% level
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no abnormalities reported
- Unusual cell shape:
- Colour differences:
- Flocculation:
- Adherence to test vessels:
- Aggregation of algal cells:
- Other:
- Any stimulation of growth found in any treatment: none reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none reported
- Effect concentrations exceeding solubility of substance in test medium: not applicable - Results with reference substance (positive control):
- no reference substance applied
- Reported statistics and error estimates:
- The EC-50 values were calculated according to the maximun likelihood method, logit model (Mc Cullagh, P., Nelder, J.A., 1983: Generalized linear models, Chapman & Hall, London). The modified Dunnett's Multible Comparison Test was used for calculation of NOErC and NOEbC.
Any other information on results incl. tables
Table 1: Inhibition, areas under growth curves (indicator for biomass)
Conc. nominal, mg/l | Mean areas under Growth Curves (A) * 10000 | Inhibition IA (0 -72h) in % |
blank | 1737 | 0 |
0.2 | 2189 | 0 |
0.4 | 2000 | 0 |
0.8 | 2061 | 0 |
1.6 | 1959 | 0 |
3.2 | 2016 | 0 |
6.4 | 1249 | 28.1 |
12.8 | 562 | 67.7 |
Table 2: Inhibion, growth rates
Conc. nominal, mg/l | Mean growth rates (µ) * 0.001 | Inhibition Iµ (0 -72h) |
blank | 64 | 0 |
0.2 | 67 | 0 |
0.4 | 66 | 0 |
0.8 | 66 | 0 |
1.6 | 66 | 0 |
3.2 | 67 | 0 |
6.4 | 58 | 8.6 |
12.8 | 42 | 33.4 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- ErC 50 (0-72h) of CA 2343 A was determined to be 16.4 mg/l based on nominal concentrations. EbC 50 (0-72h) of CA 2343 A was determined to be 8.6 mg/l based on nominal concentrations. The NOErC (0-7%) and NOEbC (0-72h) were both 3.2 mg/l based on the nominal concentrations of CA 2343 A.
- Executive summary:
The purpose of this study was to evaluate the acute toxic effects of test substance CA2343 (oxadiazinamine) to the growth of aquatic green algae Selenastrum capricornutum. The study followed the OECD-Guideline No. 201 and Guideline 92/69/EEC C.3. The test was conducted in a static system, the test duration was 72 hours.
ErC 50 (0-72h) of CA 2343 A was determined to be 16.4 mg/l based on nominal concentrations. EbC 50 (0-72h) of CA 2343 A was determined to be 8.6 mg/l based on nominal concentrations. The NOErC (0-72 h) and NOEbC (0-72h) were both 3.2 mg/l based on the nominal concentrations of CA 2343 A.
These results have some consequences on the classification and labelling of substance CA 2343, see discussion in endpoint summary 6.1 "Aquatic Toxicity".
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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