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EC number: 287-625-4 | CAS number: 85566-16-1
- 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
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:
- From Feb. 2022 to Jul. 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- yes
- Remarks:
- test was conducted utilizing modified exposure media, closed test system, and reduced inoculation density. Test with reference substance under same conditions indicates that these deviations from test guidelines do not affect the results.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Purity: 99.842 %
- Water solubility: 0.7 mg/L ± 0.06 mg/L - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
exposure start (0h): uninoculated, replicate 7; end of exposure (72 h) combined inoculated replicates of each test group and replicate 0 uninoculated from each test group
- Sampling method: For each concentration, two retained samples were be taken at each time point.
- Sample storage conditions before analysis: freezer (at approx.-20 °C) - Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: according to OECD 23 (poorly water soluble)
- Loading rate: 0 (control), 1, 3.2, 10, 32, and 100 mg/L
- Controls: analytical monitoring technical not feasible
- Chemical name of vehicle (organic solvent, emulsifier or dispersant):
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no, clear appearance and negative Tyndall effect - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- -Test species and strain: Raphidocelis subcapitata KORSHIKOV(SAG 61.81)
- Age (on study day 0): A stock algal culture is maintained continuously at the test facility. Before the exposure an inoculum culture is prepared from the stock culture and incubated for 4 days at 21 – 24 °C (max. temperature difference 2 °C). After this time, the inoculum culture is in exponential growth phase and can be used to initiate the test (study day 0).
- Supplier: Collection of algal cultures in University of Göttingen/Germany
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 23°C
- pH:
- 7.5-10.1
- Nominal and measured concentrations:
- Nominal: 1, 3.2, 10, 32, 100 and control; Measured: analytically concentration verification is technical not feasible therefore nominal concentrations were used according to the guidance OECD 23
- Details on test conditions:
- TEST SYSTEM
- Type: closed
- Material, size, headspace, fill volume: Erlenmeyer flasks (nominal volume 250 mL) plugged with gas permeable silicone sponge caps, 100 ml fill volume
- Test volume: 300 mL
- Initial cells density: 0.3 x 10^4 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- No. of other replicates: 1 per test group for concentration control analysis; 1 per test group uninoculated for fluorescence background determination and test substance stability
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: yes (2.8 to 7.0 by 1M HCl)
- Photoperiod: permanent illumination
- Light intensity and quality: 5378 - 5661 lux (mean: 5489 lux, coefficient of varation: 2.71%) at a wavelength of 400 - 700 nm
- Stirring rate: Continuous (approx. 130 rpm)
- Control of conditions: pH (0 and 72 h); Fluorescence (0, 24, 48 and 72 h), light (0 and 72 h)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: fluorometer, correlation between fluorescence and cell density was determined by direct microscopic count (two counts in a Neubauer haemocytometer. These data were used to derive a linear correlation between fluorescence and cell density.
- Other: Algal morphology (microscopically)
TEST CONCENTRATIONS
- Spacing factor for test concentrations: <= 3.2
- Justification for using less concentrations than requested by guideline:
- Range finding study; yes according to GLP but without status
- Results used to determine the conditions for the definitive study: E(fluorescence)C50 >100 mg/L; ErC50 >100 mg/L
CULTURING APPARATUS
-Details on culturing apparatus used: Vötsch Industrietechnik GmbH Bioline (VB1014) controlled climate cabinet
- Reference substance (positive control):
- yes
- Remarks:
- 3,5 Dichlorphenol
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: test material loading rate
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: test material loading rate
- Basis for effect:
- growth rate
- Details on results:
- OBSERVATIONS
- Algae morphology: no remarkable observations
- Dissolution behavior: clear test solution, green coloration caused by algae after 48 h - Results with reference substance (positive control):
- - Results with reference substance valid? yes (ErC50 = 0.9 – 4.4 mg/L after 72 hours)
- EC50: 2.13 mg/L
- Other: conducted under same modified conditions as the study - Reported statistics and error estimates:
- TOXRAT Professional 2.10 was used for statistical evaluation. The data are illustrated using plots of percent inhibition (response) versus concentration. ECx values and confidence limits were calculated by probit analysis (Finney, 1971). The LOEC was determined by comparing the means of the calculated yield or growth rate of the various concentration levels with the control using Dunnett’s multiple t-test (onesided). The NOEC was the next tested concentration below the LOEC
- Validity criteria fulfilled:
- yes
- Conclusions:
- No inhibition of algal growth was observed up the highest tested concentration.
- Executive summary:
An experimental study according to OECD guideline 201 and GLP regulations was conducted to assess the toxicity of the test item to aquatic algae. The test design was slightly modified due to poor water solubility of the test item (UVCB) according to the OECD guidance 23. The study was performed in a closed system and the inoculum density was reduced. An additional reference toxicant test was conducted with the same method modifications described in this study (modified exposure media, closed test system, and reduced inoculation density) to determine any effect on algal response to toxic stress. The ErC50 (72 h) of the control substance 3,5 Dichlorphenol was 3.05 mg/L. These results indicate that the algae are responding normally to toxicant stress under the modified test conditions and that these deviations from test guidelines do not affect the results of this study. The results in this study are consistent with all validity criteria and the test is valid according to the guidelines of this study.
Cultures of Raphidocelis subcapitata were exposed to the test item at loading rates of 0 (control), 1, 3.2, 10 32 and 100 mg/L under static conditions for 72 h in a closed system. The water pH, temperature and lighting intensity were all maintained within acceptable guideline specifications. After 72 h of exposure no growth inhibition was determined up to the highest tested concentration. Therefore, the effect values were >100 mg/L.
The concentration of test substance in test media could not be verified analytically, therefore the effect concentrations are based on the loading rate used to prepare the test substance WAF (Water accommodated fraction) solutions. According to guidance in OECD 23, for tests with chemicals that cannot be quantified by analytical methods at the concentrations causing effects, the effect concentration can be expressed based on the nominal concentrations or in the case of water accommodated fractions on the loading rate.
Reference
Table 1: Effect concentrations in mg/ L based on loading rate obtained after 72 h
Algal Yield [mg/L] | Algal Growth Rate [mg/L] | ||
EyL10 confidence limits 95%: | >100 – | ErL10 confidence limits 95%: | >100 – |
EyL20 confidence limits 95%: | >100 – | ErL20 confidence limits 95%: | >100 – |
EyL50 confidence limits 95%: | >100 – | ErL50 confidence limits 95%: | >100 – |
NOEyL | ≥100 | NOErL | ≥100 |
LOEyL | >100 | LOErL | >100 |
Description of key information
There is a high probability that the test item is not acutely harmful to aquatic algae (EL50 (72 h) > 100 mg/L.
Key value for chemical safety assessment
Additional information
An experimental study according to OECD guideline 201 and GLP regulations with Raphidocelis subcapitata is available to assess the toxicity of the test item to aquatic algae. Since the test item is a complex mixture (UVCB) with poor water solubility
the test design was slightly modified according to the OECD guidance 23. The study was performed in a closed system and the inoculum density was reduced.
The functionality and validity of the test system was confirmed by an additional test with a reference substance conducted with the same method (modified exposure media, closed test system, and reduced inoculation density). The ErC50 (72 h) of the control substance 3,5 Dichlorphenol was 3.05 mg/L. These results indicate that the algae are responding normally to toxicant stress under the modified test conditions and that these deviations from test guidelines do not affect the results of this study. The results in this study are consistent with all validity criteria and the test is valid according to the guidelines of this study.
Cultures of Raphidocelis subcapitata were exposed to the test item at loading rates of 0 (control), 1, 3.2, 10 32 and 100 mg/L under static conditions for 72 h in a closed system. The water pH, temperature and lighting intensity were all maintained within acceptable guideline specifications. After 72 h of exposure no growth inhibition was determined up to the highest tested concentration. Therefore, the effect values were >100 mg/L.
The concentration of test substance in test media could not be verified analytically, therefore the effect concentrations are based on the loading rate used to prepare the test substance WAF (Water accommodated fraction) solutions. According to guidance in OECD 23, for tests with chemicals that cannot be quantified by analytical methods at the concentrations causing effects, the effect concentration can be expressed based on the nominal concentrations or in the case of water accommodated fractions on the loading rate.
In conclusion no adverse effect on algae growth or morphology was observed up to the highest tested concentration which indicates that the test item is not acutely harmful to aquatic algae with a high probability.
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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