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EC number: 284-943-5 | CAS number: 84989-53-7
- 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
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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:
- 2017-12-11 to 2018-03-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 28 July 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(N,N-dimethylpropane-1,3-diamine-N)[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]cobalt(1+) chloride
- EC Number:
- 284-943-5
- EC Name:
- Bis(N,N-dimethylpropane-1,3-diamine-N)[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]cobalt(1+) chloride
- Cas Number:
- 84989-53-7
- Molecular formula:
- C42H44CoN12.Cl
- IUPAC Name:
- hydroxylamine
- Test material form:
- solid: particulate/powder
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 4.00, 1.25, 0.391, 0.122, 0.0381, 0.0119 mg/L and control
- Sampling method: taken in the main test at 0 hours (initial value) from fresh test solutions and after 24 hours, 48 hours and 72 hours from aged solutions from all test item concentrations and control. For each sampling also a retain sample was taken.
- Sample storage conditions before analysis: all samples were analysed immediately after sampling
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solution: weight necessary amount of test item in volumetric flask and added test medium up to the benchmark, then homogenised by shaking and 20 minutes of ultrasonication. A clear, transparent and turquoise solution was obtained. For lower test solutions: dilution appropriate solution with test medium.
- Test concentration: 4.00, 1.25, 0.391, 0.122, 0.0381, 0.0119 mg/L and control
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: SAG 61.81
- Source (laboratory, culture collection): MBM Sciencebridge GmbH, Hans-Adolf-Krebs-Weg 1, D-37077 Göttingen, Germany.
- Method of cultivation: grown semi-continuously in sterile cultures in the laboratory. Old medium is periodically replaced by fresh mineral solution.
- Culture conditions: Illumination: continuously (approx. 4440 - 8880 lux at cell culture level or 60 - 120 µEm-2s-1); Temperature: 21 - 24 °C; Culture flasks: 100 mL Erlenmeyer flasks; CO2 supply by shaking on a rotating shaker, approximately 105 rpm
ACCLIMATION
- Acclimation period: 3 to 4 day
- 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:
- 22.6 – 23.3 °C
- pH:
- 7.55 to 7.76 at 0 h and 7.67 to 7.88 at 72 h
- Nominal and measured concentrations:
- Nominal concentrations: 4.00, 1.25, 0.391, 0.122, 0.0381, 0.0119 mg/L and 0 mg/L
Measured concentrations (geometric mean): 0.492, 0.111, 0.0708, 0.0555, 0.0339, < LOQ and 0 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks (100 mL) with aluminium caps
- Type : closed
- Material, size, headspace, fill volume: volume: 100 mL, fill volume: ~ 50 mL
- Initial cells density: 0.5E+04 cells/mL
- CO2 supplied: by continuous agitation
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes, modified AAP-Medium. As the test item contains metal components, the content of Na2EDTA·2H2O in the employed AAP-medium was reduced to 0.100 mg/L (instead of 0.300 mg/L) as recommended by OCSPP 850.4500.
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: Continuously from the side
- Light intensity and quality: 88.3 µEm-2s-1 (mean)
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: fluorescence measurement at 24, 48 and 72 hours. Since the test item fluoresced by itself, a correction was done using a blank measurement, i.e. solution without algae.
- Other: morphological appearance: at the end of the test; pH-value: at t = 0 h and t = 72 h; temperature: measured continuously and recorded at hours 0, 24, 48 and 72 h; light intensity: measured once a year, and confirmed for one representative position at test start; test solution appearance: conducted daily
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
Range finding study
- Test concentrations: 10.0, 5.00, 1.00, 0.100, 0.0100 mg/L and control
- Results used to determine the conditions for the definitive study: After 72 h at termination of the test a concentration response relation was observed for the inhibition of growth rate and yield from nominal test item concentrations of 0.0100 to 10.0 mg/L. The inhibition of growth rate peaked at 160.1 % and the inhibition of yield peaked at 101.2 % at a nominal test item concentration of 10.0 mg/L - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate, also tested in modified medium
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.066 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.044 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.049 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.034 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.034 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Details on results:
- - Morphology evaluation: The cells were considered normal for the control and up to and including a nominal test item concentration of 0.122 mg/L. No cells were observed at nominal test item concentrations of 0.391 - 4.00 mg/L.
- Physicochemical Data: pH and temperature during the test, light intensity were within the range specified by OECD 201.
- Chemical analysis of test item concentrations: see details in the section 'Any other information on results'. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50: growth rate 0.971 mg/L, yield 0.692 mg/L
Results were considered valid. - Reported statistics and error estimates:
- EC50: Probit analysis following Gompertz distribution for growth rate and following normal distribution for yield
NOEC: Following Jonckheere Terpstra test for growth and Dunnetts t-test for yield (left-sided, p<0.05)
Any other information on results incl. tables
Non-GLP range-finding test:
After 72 h, at termination of the test, a concentration response relation was observed for the inhibition of growth rate and yield from nominal test item concentrations of 0.0100 to 10.0 mg/L. The inhibition of growth rate peaked at 160.1 % and the inhibition of yield peaked at 101.2 % at a nominal test item concentration of 10.0 mg/L
Main study - Biological results:
Individual cell numbers:
Nominal concentration (mg/L) |
Cell numbers (10^4/mL) | |||
0h | 24h | 48h | 72h | |
Control | 0.51 | 1.75 | 5.77 | 19.48 |
0.019 | 0.51 | 1.56 | 5.66 | 18.91 |
0.0381 | 0.51 | 1.44 | 4.79 | 17.61 |
1.222 | 0.51 | 0.85 | 2.14 | 7.00 |
0.391 | 0.51 | 0.35 | 0.67 | 2.35 |
1.25 | 0.51 | 0.17 | 0.29 | 0.4 |
4.00 | 0.51 | 0.07 | 0.08 | 0.06 |
Percentage inhibition of growth rate and yield:
Nominal concentration (mg/L) | % inhibition growth rate | % inhibition yield | ||||
0h-24h | 0h-48h | 0h-72h | 0h-24h | 0h-48h | 0h-72h | |
Control | 0 | 0 | 0 | 0 | 0 | 0 |
0.019 | 9.4 | 0.6 | 0.8 | 15.3 | 2.1 | 3 |
0.0381 | 16 | 7.8 | 2.8 | 25 | 18.6 | 9.9 |
1.222 | 59.8 | 41.4 | 28.4 | 72.6 | 69 | 65.8 |
0.391 | 134 | 89.7 | 60.7 | 112.9 | 97 | 90.3 |
1.25 | 199.6 | 136.3 | 106.8 | 127.4 | 104.2 | 100.6 |
4.00 | 266.2 | 175.3 | 161.3 | 135.5 | 108.2 | 102.4 |
Analytical results:
Determined concentration of test item:
Nominal test concentration (mg/L) | Sampling | Measured test item concentration (mg/L) | Geometric mean concentration (mg/L) |
Control | 0h, fresh | < LOD | - |
24h, aged | < LOD | ||
48h, aged | < LOD | ||
72h, aged | < LOD | ||
0.0119 | 0h, fresh | < LOQ | - |
24h, aged | < LOD | ||
48h, aged | < LOD | ||
72h, aged | < LOD | ||
0.0381 | 0h, fresh | < LOQ | 0.339 |
24h, aged | < LOQ | ||
48h, aged | < LOD | ||
72h, aged | < LOD | ||
0.122 | 0h, fresh | 0.124 | 0.0555 |
24h, aged | < LOQ | ||
48h, aged | < LOQ | ||
72h, aged | < LOD | ||
0.391 | 0h, fresh | 0.313 | 0.0708 |
24h, aged | < LOQ | ||
48h, aged | < LOQ | ||
72h, aged | < LOD | ||
1.25 | 0h, fresh | 1.21 | 0.111 |
24h, aged | < LOQ | ||
48h, aged | < LOQ | ||
72h, aged | < LOQ | ||
4.00 | 0h, fresh | 3.64 | 0.492 |
24h, aged | 0.255 | ||
48h, aged | 0.223 | ||
72h, aged | 0.297 |
Geometric means were calculated from measured concentration of samples at start, 24h, 48h and 72h.
Nominal concentration 0.0119 mg/L: since all tested concentrations were < LOQ or LOD, the concentration is not crucial for the probit analysis and geometric mean was not calculated.
For other concentrations following approach was taken: As prescribed in OECD 23 for difficult to test substances, half of the LOQ value should be employed for calculation of geometric mean (i.e. 0.05 mg/L in this study).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Significant inhibitory effects were observed, with a dose response relation observed in the range 0.0119 to 4.00 mg/L. The EC10 for growth rate was set at 0.0438 mg/L (measured, geometric mean) and for yield at 0.0491 mg/L (measured, geometric mean). The EC50-value for growth rate (ErC50) was determined to be 0.0659 mg/L (measured, geometric mean). The EC50-value for yield (EyC50) was 0.0491 mg/L (measured, geometric mean).
- Executive summary:
The effects of test item on the growth of the single cell green alga Pseudokirchneriella subcapitata were determined according to OECD 201.
Following a static non-GLP range-finding test with nominal test item concentrations of 10, 5, 1.00, 0.100, 0.0100 mg/L and control, a static main test with nominal test item concentrations of 4.00, 1.25, 0.391, 0.122, 0.0381, 0.0119 mg/L and control was performed.
Six replicates were employed for the control and three for each test item concentration. The test was performed in 100 mL Erlenmeyer flasks each containing ~ 50 mL test solution. The pH was recorded at test start and test end. Temperature was measured continuously over the whole test period and recorded daily. Light intensity of the continuous illumination was measured at test start.
All validity criteria met for the study.
Test concentrations were analytically verified UV analysis. The measured initial concentrations of test item in the samples taken at test start were within 80 – 120 %. Afterwards, the concentrations dropped rapidly, often to below LOQ or LOD. As result, the toxicological endpoints were evaluated using the geometric mean of the measured concentrations.
Significant inhibitory effects were determined for growth rate and for yield at test item concentrations of 0.122 mg/L (nominal) and 0.0555 mg/L (measured) and above. The EC10 for growth rate was set at 0.0438 mg/L (measured, geometric mean) and for yield at 0.0491 mg/L (measured, geometric mean). The EC50-value for growth rate (ErC50) was determined to be 0.0659 mg/L (measured, geometric mean). The EC50-value for yield (EyC50) was 0.0491 mg/L (measured, geometric mean).
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