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EC number: 474-080-4 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 474-080-4
- EC Name:
- -
- Cas Number:
- 76801-93-9
- Molecular formula:
- C14H18I3N3O6
- IUPAC Name:
- 5-amino-N1,N3-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Not available
- IUPAC Name:
- Unknown impurities
- Test material form:
- solid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 00104016
- Expiration date of the lot/batch: 12/2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
- Stability under test conditions: Stable
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- 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 were analyzed on the day of delivery. 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. 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)
The stock solutions of the test item were prepared in the test medium. 50 mg of the test item was weighed into 500 mL of the test medium for the preliminary and limit test. The stock solutions were ultrasonicated for 10 minutes. The concentrations of test solutions used in the preliminary test were obtained by dilution of the stock solution with test medium.
Differential loading: The preliminary test was performed in a range of the test item nominal concentrations 1 – 100 mg·L-1. The concentration of 100 mg·L-1 was tested in the limit test.
Controls - Preliminary test: The test contained three parallel series of the test item concentrations and three controls without the test item.
Controls - Limit test: The test contained six parallel series of the test item concentration and six controls without the test item.
The water with conductivity smaller than 5 μS·cm-1 was used for the preparation of solutions.
The volume of the test solution was 50 mL in each testing flask. The initial density of 5 000 cells per mL was used in the test.
Test organisms
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: green freshwater algae Desmodesmus subspicatus
- Strain: Desmodesmus subspicatus Brinkmann 1953/SAG 86.81
- Source: the collection of autotrophic organisms of The Botanic Institute of the Czech Academy of Science, Třeboň on date 8.11.2019
- 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. Algae inoculum for the test was sampled from exponentially growing inoculum culture.
- Age of inoculum (at test initiation): The strain culture was always set to pre-culturing of cells for 3-4 days before the start of the test. Inoculum culture was kept 3-4 days under conditions at which the test was performed. After this period the culture was in the state of the exponential growth and had the cell density suitable for the performance of the test. The cell density of the pre-culture was measured just before the start of the test and the needed inoculum volume was calculated.
ACCLIMATION
- Acclimation period: 3-4 days
- Culturing media and conditions (same as test or not): same as test
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 22.0 – 23.0 °C
- pH:
- 8.1 (test medium)
- Conductivity:
- 1.84 µS·cm-1 (deionized water)
- Nominal and measured concentrations:
- Limit test:
nominal concentration: 100 mg·L-1
measured concentration: 99 mg.L-1 (0 h), 96.5 mg.L-1 (72 h)
measured concentration: 101 mg.L-1 (0 h), 99.2 mg.L-1 (72 h) without algae - Details on test conditions:
- Study design: The preliminary test was performed in a range of the test item nominal concentrations 1 – 100 mg·L-1. Based on low toxicity of the test item found in the preliminary test, the limit test with the test item nominal concentration 100 mg·L-1 was performed subsequently.
Limit test
Stock solution of the test item: 100.04 mg·L-1
Test nominal concentration: 100 mg·L-1
Conductivity of deionized water: 1.54 µS·cm-1
pH of the test medium: 8.0
Volume of inoculum algae culture: 1.17 mL in 500 mL mixture
Lighting during the test: 7 490 – 7 495 lux
Temperature during the test: 22.0 – 22.5 °C
Inicial density: 5000 cells per mL
The volume of the test solution was 50 mL in each testing flask. The flasks were placed on a shaker under the lighting ramp and were incubated under continuous illumination and shaking for 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. The density of algae culture was evaluated microscopically at 24, 48 and 72 hours. The cell density was measured by direct counting of living cells in Burker´s counting chamber. The growth rates () and the yield (Y) and subsequently percentage reduction of growth rate and percentage inhibition of yield were calculated. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Results with reference substance (positive control):
- - Results with reference substance valid? Yes
The value EC50 for inhibition of growth rate (72h – ErC50) obtained from our last reference test meets the calculated range from the interlaboratory test. The sensitivity of test species and proficiency of our laboratory in test performance was proved.
Reference test: 72 hour – ErC50 = 0.88 mg·L-1 (95% confidence limit: 0.69 – 1.11 mg·L-1)
Interlaboratory test: 72 hour – ErC50 = 0.57 – 1.33 mg·L-1
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The inhibition of growth rate was 0.4 % and inhibition of yield was 1.4 % in the limit test. Therefore exact values of ErC50 and EyC50 could not be calculated and the value of EC is given in the form of a range.
Final values
72 hour – ErC50 > 100 mg·L-1 (nominal concentration)
72 hour – EyC50 ˃ 100 mg·L-1 (nominal concentration) - Executive summary:
The test item, ATIBA-A, 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 (EU) No.2016/266.
The preliminary test was performed in a range of the test item nominal concentrations
1 – 100 mg·L-1.
The inhibition of growth rate was 1.1 % in the highest concentration and inhibition of yield was 3.9 % in the preliminary test. Based on no toxicity of the test item found in the preliminary test, the limit test was performed subsequently.
Samples for analytical determination were taken at the beginning and at the end of the test. The analytical results showed, that the test item was sufficiently stable in test medium in the conditions of the test, therefore the limit test was performed as static one.
The concentration of 100 mg·L-1 was tested in the limit test. The inhibition of growth rate was 0.4 % and inhibition of yield was 1.4 %.
Samples for analytical determination were taken at the beginning and at the end of the test.
There is stated in the guideline that, if evidence is available to demonstrate that the concentration of the test item has been satisfactorily maintained within ± 20 percent
of the nominal or measured initial concentration throughout the test, the results can be based
on nominal or measured initial values.
In this study concentration of the test item has been satisfactorily maintained within ± 20 percent of the nominal concentration throughout the test.
The nominal concentrations were used for all evaluations and results.
Test results:
72 hour – ErC50>100 mg·L-1(nominal concentration)
72 hour–EyC50˃ 100mg·L-1(nominal concentration)
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