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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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13.1.2020 - 17.1.2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- 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: 00601016
- Expiration date of the lot/batch: 03/2022
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 determination of the test item concentrations was carried out by HPLC method.
Preliminary test: The analytical determination of the test item concentrations was performed at the beginning of the test and at the end of the test. The samples for analysis were taken from the highest (100 mg·L-1) and the lowest test concentration (1.0 mg·L-1). 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 analysed on the day of delivery. The samples for analysis at the end of the test (48 hours) were delivered to analytical laboratory immediately after the end of testing. The samples were analysed on the day of delivery.All samples were stored at laboratory temperature.
The analytical results showed, that the test item was stable in dilution water at the conditions of the test.
Test solutions
- Details on test solutions:
- The stock solution of the test item was prepared in the dilution water. 50 mg of the test item was weighed into 500 mL of the dilution water for the preliminary test. The stock solution was ultrasonicated for 10 minutes The concentrations of solutions used in the preliminary test were obtained by dilution of the stock solution with dilution water.
Test solution
Stock solution of test item: 50.05 mg / 500 mL
Test concentrations: 100, 50, 10, 5, 1 mg·L-1
Conductivity of deionized water: 1.55 µS·cm-1
pH of dilution water: 8.0
Oxygen content of dilution water: 8.2 mg·L-1
Content of (Ca+Mg) in dilution water: 2.49 mmol·L-1
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia magna Straus were obtained by aperiodic parthenogenesis from own laboratory breeding. Daphnia were fed by a mixture of algae. The sensitivity of the test species is periodically monitored by testing with the reference item, potassium dichromate.
TEST ORGANISM
- Common name: Daphnia Magna
- Strain: Straus
- Source: own laboratory breeding
- Age at study initiation: young daphnia born in 24 hours
- Method of breeding: aperiodic parthenogenesis
- Feeding during test: no
ACCLIMATION
The grow-up gravid females are separated into dilution water. Young daphnia born in 24 hours are segregated to the handling container from which they entered the experiment.
- Type and amount of food: a mixture of algae
- Health during acclimation: no mortality observed
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 2.49 mmol·L-1
- Test temperature:
- 202°C, with a variation of 1°C at each individual test
- pH:
- 8
- Dissolved oxygen:
- 8.2 mg·L-1
- Conductivity:
- 1.55 µS·cm-1
- Nominal and measured concentrations:
- 1, 5, 10, 50, 100 mg/L + C(control)
Determined concentration of test substance
0 hours: 1,03 ; 100,4 mg·L-1
48 hours: 0,94, 99,9 mg·L-1 - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass beakers 50ml
- Type (delete if not applicable): open
- Aeration: no
- Lighting: 16 hours light and 8 hours dark cycle
- Number of test animals: 20 for each concentration and control
- Number of replicates (per concentration): 4
- Number of test animals per replicate: 5
- Biomass loading rate: at least 2 ml per individual
The holding and culturing of the Daphnia is performed at conditions (light, temperature, medium) similar to those which are used in the test. For holding and culturing of the daphnia the M4 medium was used (according to Annex 2
of the EU method C.2 and according to Annex 3 of the OECD TG 202). For test was used dilution water (according to Annex 2 of the EU method C.2 and according to Annex 3 of the OECD TG 202). Dilution water was prepared just before the test by admixing 2.5 mL of stored solutions A, B, C and D into 1 000 mL of deionized water. Because culturing and test medium was different we included pre-test acclimation period: brood daphnids were maintained in dilution water for 48 hours prior to the start of the test
Dilution water
A. 117.6 g CaCl2·2H20 in 1L deionized water (Batch No.: PP/2018/07142, exp.: 04/2021, Lach-Ner, s. r.o.)
B. 49.3 g MgSO4·7H2O in 1L deionized water (Batch No.: PP/2018/08687, exp.: 04/2023, Lach-Ner, s. r.o.)
C. 25.9 g NaHCO3 in 1L deionized water (Batch No.: PP/2016/04662, exp.: 02/2020, Lach-Ner, s. r.o.)
D. 2.3 g KCl in 1L deionized water (Batch No.: PP/2019/10337, exp.: 02/2022, Lach-Ner, s. r.o.) - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC0
- Effect conc.:
- 0 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 0 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- The sensitivity of the test species and correctness of test performance is periodically verified by testing with the reference item, potassium dichromate.
The results of the verification test with K2Cr2O7, carried out in period from 22.05. to 24.05.2019 are the following:
24 hour – EC50 = 1.34 mg·L-1 (95% confidence limit: 1.16 – 1.64 mg·L-1)
48 hour – EC50 = 0.78 mg·L-1 (95% confidence limit: 0.68 – 0.91 mg·L-1)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The experiment with the concentration of 100 mg·L-1 included in the preliminary test has been performed using 20 daphnia, therethrough the conditions of the limit test given in guidelines have been fulfilled. It was demonstrated that the EC50 is higher than this concentration.
Evaluation of results:
No immobilisation was observed in the test. Therefore exact values of EC50 could not be calculated and the values of EC are given in the form of a range. The EC0 and EC100 values are identified by direct observation. The nominal concentrations were used for all evaluations and results.
Test results:
24 hour – EC50 > 100 mg·L-1 (nominal concentration)
48 hour – EC50 > 100 mg·L-1 (nominal concentration)
24 hour – EC0 = 100 mg·L-1 (nominal concentration)
48 hour – EC0 = 100 mg·L-1 (nominal concentration)
24 hour – EC100 > 100 mg·L-1 (nominal concentration)
48 hour – EC100 > 100 mg·L-1 (nominal concentration) - Executive summary:
The test item, ATIBA-A, was tested in acute immobilisation test on Daphnia magna.
The test was performed according to method C.2 – Daphnia sp. Acute Immobilisation Test, Council Regulation (EC) No. 440/2008, published in O.J.L 142, 2008.
The preliminary test was performed in a range of the test item nominal concentrations 1 – 100 mg·L-1. The test was performed as static.
Based on no toxicity of the test item found in the preliminary test, the study was terminated. The experiment with the concentration of 100 mg·L-1 included in the preliminary test has been performed using 20 daphnia, therethrough the conditions of the limit test given in guideline have been fulfilled. It was demonstrated that the EC50 is higher than this concentration.
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. Further the nominal concentrations were used for all evaluation and results.
Test results:
24 hour – EC50 > 100 mg·L-1 (nominal concentration)
48 hour – EC50 > 100 mg·L-1 (nominal concentration)
24 hour – EC0 = 100 mg·L-1 (nominal concentration)
48 hour – EC0 = 100 mg·L-1 (nominal concentration)
24 hour – EC100 > 100 mg·L-1 (nominal concentration)
48 hour – EC100 > 100 mg·L-1 (nominal concentration)
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