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EC number: 424-190-3 | CAS number: 105641-66-5 DIAZO ER 1273
- 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
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Remarks:
- With regard to the very low water solubility of the test item, no analytical verification of test item concentrations was performed. No analytical method with a sufficiently high sensitivity could be developed.
- Details on test solutions:
- A saturated solution with a nominal loading rate of 100 mg test item/L was prepared once 24 ± 1 hour prior to the start of the exposure.
The undiluted saturated solution and a further of four dilution levels were tested in a geometric series with a dilution factor of 2: 6.25 – 12.5 – 25.0 – 50 – 100% of the saturated solution, corresponding to the nominal test item loading rates of 6.25 – 12.5 – 25.0 – 50.0 – 100 mg/L. The dilution levels are based on the results of a preliminary range finding test (non-GLP).
Control: Six replicates (without test item) were exposed under the same conditions as the test loadings. The control solution was prepared without test item following the same method as specified for the saturated solution. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Test organism Pseudokirchneriella subcapitata HINDÁK CCAP 278/4 (axenic)
Synonyms Selenastrum capricornutum; Ankistrodesmus subcapitata; Raphidocelis subcapitata; Ankistrodesmus bibraianus (Experimental Phycology and Culture Collection of Algae at the University of Goettingen 2014)
Reason for the selection: Pseudokirchneriella subcapitata is a suitable green alga species of the test organism according to the guideline.
Origin Culture: Collection of Algae and Protozoa (CCAP) SAMS Research Services Ltd, Dunstaffnage Marine Laboratory, Dunbeg, OBAN; Argyll PA37 1QA; Scotland, UK
Cultivation at test facility: Fresh stocks are prepared every month on Z-Agar. Light intensity amounts 2567 – 5130 lux for 24 hours per day.
Culture medium: Nutrient medium Z according to LÜTTGE et al. (1994) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- 33 mg/L CaCO3
- Test temperature:
- 21 - 24 °C, controlled at ± 2 °C
- pH:
- 7.99-9.56
- Conductivity:
- 139 μS/cm
- Nominal and measured concentrations:
- nominal test item loading rates of 6.25 – 12.5 – 25.0 – 50.0 – 100 mg/L, no measured concentrations
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Sterile Erlenmeyer flasks, volume: 250 mL, sealed with cotton wool plugs, fill volume 100 mL
- Initial cells density: Nominal: approximately 5 x 10^3 – 10^4 cells/mL, Actual: 5375 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: 24 hours/day light
- Light intensity and quality: Approximately 4440 to 8880 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Chlorophyll measurement: The cell density was measured daily via Chlorophyll afluorescence, excitation at 436 nm, emission at 685 nm.
- Other: The algae cells were evaluated microscopically at the start and the end of the incubation period - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.46 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: Effect concentration refers to water solubilty.
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 0.46 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: Effect concentration refers to water solubilty.
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 53.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 12.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Validity criteria fulfilled:
- yes
- Conclusions:
- No adverse effects on algae were observed up to the limit of water solubility.
- Executive summary:
The toxicity of the test item to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and Council Regulation (EC) No. 266/2016/Method C.3. The aim of the study was the determination of the effects on growth rate and yield over a period of 72 hours. The study was conducted under static conditions with an initial cell density of 5375 cells/mL. A saturated solution with a nominal loading rate of 100 mg test item/L was prepared once 24 ± 1 hour prior to the start of the exposure. An appropriate amount of the test item was weighed out. The test item was transferred into a glass flask with an appropriate amount of dilution water The saturated solution was stirred for 24 ± 1 hours (1100 rpm, room temperature) with a magnetic stirrer. After completion of stirring, undissolved particles were removed by membrane filtration (membrane filter 0.45 μm, RC, MACHEREY-NAGEL) to achieve the saturated solution. The filter was saturated in order to avoid adsorption during the filtration. The first 25 mL of the filtrate were discarded. The filtration was interrupted for 15 minutes to allow adsorption and saturation of the filter material with dissolved test item. Thereafter, the filtration was continued. The next 25 mL were discarded. The following filtrate, i.e. the saturated solution, was used in the test. During filtration, the filter was always kept covered. The saturated solution was checked via laser beam (Tyndall effect) for undissolved test item. The Tyndall effect was positive. Five concentrations were tested in a geometrical series with a dilution factor of 2: 6.25 - 12.5 - 25.0 - 50.0 - 100% of the saturated solution, corresponding to the nominal test item loading rates of 6.25 – 12.5 – 25.0 – 50.0 – 100 mg/L. Three replicates were tested for each test item concentration and six replicates for the control. The environmental conditions were within the acceptable limits. The test media were visually clear and the highest test item loading rate was slightly brownish colored throughout the test period. With regard to the very low water solubility of the test item, no analytical verification of test item concentrations was performed. No analytical method with a sufficiently high sensitivity could be developed. The test item was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours with the following effect values (based on the nominal test item loadings): The EL50-values for inhibition of growth rate (ErL50) and yield (EyL50) after 72 hours were 53.7 (49.0 – 70.4) mg/L and 35.1 (30.8 – 39.9) mg/L, respectively. The NOELvalues for inhibition of growth rate and yield after 72 hours were 12.5 mg/L. It can thus be conclude that the EC50 and EC10 values for growth rate are higher than the water solubility of 0.46 mg/L.
Reference
Microscopic evaluation of the cells at the start and the end of exposure revealed no morphological abnormalities. The environmental conditions (pH-value, room temperature, light intensity) were determined to be within the acceptable limits. The test media were clear throughout exposure period with exception of the highest test concentration which was slightly brown colored (possible turbidity related to algae growth not taken into account). The reference item toxicity is in the valid range which was established by calculation of the average of the historic reference data since 2006, and the limits were set using the threefold standard deviation of these values.
Description of key information
No adverse effects on algae were observed up to the limit of water solubility.
Key value for chemical safety assessment
Additional information
The toxicity of the test item to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and Council Regulation (EC) No. 266/2016/Method C.3 from 2020-08-24 to 2020-08-28, with the definitive exposure phase from 2020-08-25 to 2020-08-28 at the test facility. The aim of the study was the determination of the effects on growth rate and yield over a period of 72 hours. The study was conducted under static conditions with an initial cell density of 5375 cells/mL. A saturated solution with a nominal loading rate of 100 mg test item/L wasprepared once 24 ± 1 hour prior to the start of the exposure. An appropriate amount of the test item was weighed out. The test item was transferred into a glass flask with an appropriate amount of dilution water The saturated solution was stirred for 24 ± 1 hours (1100 rpm, room temperature) with a magnetic stirrer. After completion of stirring, undissolved particles were removed by membrane filtration (membrane filter 0.45 μm, RC, MACHEREY-NAGEL) to achieve the saturated solution. The filter was saturated in order to avoid adsorption during the filtration. The first 25 mL of the filtrate were discarded. The filtration was interrupted for 15 minutes to allow adsorption and saturation of the filter material with dissolved test item. Thereafter, the filtration was continued. The next 25 mL were discarded. The following filtrate, i.e. the saturated solution, was used in the test. During filtration, the filter was always kept covered. The saturated solution was checked via laser beam (Tyndall effect) for undissolved test item. The Tyndall effect was positive. Five concentrations were tested in a geometrical series with a dilution factor of 2: 6.25 - 12.5 - 25.0 - 50.0 - 100% of the saturated solution, corresponding to the nominal test item loading rates of 6.25 – 12.5 – 25.0 – 50.0 – 100 mg/L. Three replicates were tested for each test item concentration and six replicates for the control. The environmental conditions were within the acceptable limits. The test media were visually clear and the highest test item loading rate was slightly brownish colored throughout the test period. With regard to the very low water solubility of the test item, no analytical verification of test item concentrations was performed. No analytical method with a sufficiently high sensitivity could be developed. The test item was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours with the following effect values (based on the nominal test item loadings): The EL50-values for inhibition of growth rate (ErL50) and yield (EyL50) after 72 hours were 53.7 (49.0 – 70.4) mg/L and 35.1 (30.8 – 39.9) mg/L, respectively. The NOELvalues for inhibition of growth rate and yield after 72 hours were 12.5 mg/L. It can thus be conclude that the EC50 and EC10 values for growth rate are higher than the water solubility of 0.46 mg/L.
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