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EC number: 283-042-4 | CAS number: 84539-54-8
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000-09-04 to 2000-11-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): EDDHAS Fe 3K; EDDHAS Fe, sel de K
- Molecular formula (if other than submission substance): C18H14FeN2O12S2(3K)
- Molecular weight (if other than submission substance): 687.3
- Smiles notation (if other than submission substance): O=C(O)C(NCCNC(C(=O)O)c1cc(ccc1(O))S(=O)(=O)O)c2cc(ccc2(O))S(=O)(=O)O
- InChl (if other than submission substance): InChI=1S/C18H20N2O12S2/c21-13-3-1-9(33(27,28)29)7-11(13)15(17(23)24)19-5-6-20-16(18(25)26)12-8-10(34(30,31)32)2-4-14(12)22/h1-4,7-8,15-16,19-22H,5-6H2,(H,23,24)(H,25,26)(H,27,28,29)(H,30,31,32)
- Substance type: chelate
- Physical state: brownish/red powder
- Analytical purity: 55±2
- Purity test date: 2000-10-24
- Expiration date of the lot/batch: 2001-01-24
- Stability under test conditions: at least 6 months from receipt (date of receipt: 24 July 2000)
- Storage condition of test material: at room temperature and protected from humidity
Constituent 1
Method
- Target gene:
- Not applicable
The in vitro chromosome aberration test is able to identify substances that cause structural chromosome aberrations in cultured mammalian cells.
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 (containing 20% fetal calf serum)
- Additional strain / cell type characteristics:
- not applicable
- Remarks:
- stable karyotype with 46 chromosomes and an average cell cycle time of 12-14 hours
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix consisiting of enzymatic systems induced by Aroclor 1254 in rat liver microsomal fraction (S9 fraction) and the cofactors necessary for their function
- Test concentrations with justification for top dose:
- With a treatment volume of 100 µL/5.5 mL culture medium, the dose-levels were as follows:
First experiment: 78.125, 156.25, 312.5, 625, 1250, 2500, 3750 and 5000 µg/mL (with and without S9 mix)
Second experiment: 156.25, 312.5, 625, 1250, 2500 and 5000 mg/mL (with and without S9 mix) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: culture medium
- Justification for choice of solvent/vehicle: The test substance was freely soluble in the culture medium.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- culture medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 mix
Migrated to IUCLID6: 3 µg/mL (3h of treatment) or 0.2 µg/mL (continuous treatment)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- culture medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9 mix
Migrated to IUCLID6: 50 µg/mL or 25 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 hours in the first experiment (with and without S9 mix) and in the second experiment (with S9 mix); 20 hours and 44 hours in the second experiment (without S9 mix)
- Expression time (cells in growth medium): 17 hours in the first experiment (with and without S9 mix) and in the second experiment (with S9 mix); 41 hours in the second experiment (with S9 mix)
- Fixation time (start of exposure up to fixation or harvest of cells): 20 hours in the first experiment (with and without S9 mix); 20 and 44 hours in the second experiment (with and without S9 mix).
SPINDLE INHIBITOR (cytogenetic assays): Colcemid (10 µg/mL)
STAIN (for cytogenetic assays): Giemsa
NUMBER OF CELLS EVALUATED:
200 metaphases/dose level (with 100 metaphases/culture whenever possible. Only 50 metaphases/culture were analysed when at least 10% cells with structural chromosome aberrations were observed)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes (were recorded when present)
- Determination of endoreplication: yes (were recorded when present) - Evaluation criteria:
- A reproducible and statistically significant increase in the frequency of cells with structural chromosome aberrations for at least one of the dose-levels and one of the two harvest times was considered as a positive result. Reference to historical data or other considerations of biological relevance, was also taken into account in the evaluation of the findings.
- Statistics:
- For each test and for each harvest time, the frequency of cells with structural chromosome aberrations (excluding gaps) in treated cultures was compared to that of the vehicle control cultures. If necessary, the comparison was performed using the X2 test, in which p = 0.05 was used as the lowest level of significance.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes:
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- in the first experiment
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes:
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the second experiment, after 20-hour exposure to the test substance, up to 44% decrease in the mitotic index was noted, mainly at dose-levels > 1250 µg/mL. After 44-hour exposure, up to 51% decrease in the mitotic index was observed.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Remarks:
- No significant increase in the frequency of cells with structural chromosomal aberrations was noted in both experiments.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- No noteworthy toxicity was induced in both experiments
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: At the dose level of 5000 µg/mL, pH was about 7.6 (as for the vehicle control)
- Effects of osmolality: At the dose level of 5000 µg/mL, the osmolality was equal to 320 mOsm/kg H20 (292 for the vehicle control)
- Water solubility: The test substance was freely soluble in the culture medium.
- Precipitation: The final dose-level of 5000 µg/mL showed no precipitate in the culture medium.
RANGE-FINDING/SCREENING STUDIES: No preliminary cytotoxicity test was performed. Dose-levels were selected on the basis of pH, osmolality and solubility.
COMPARISON WITH HISTORICAL CONTROL DATA: in the range - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Chromosomal aberration analysis (experiments without S9 mix):
In the first experiment, after 3-hour exposure to the test substance, no significant increase in the frequency of cells with structural chromosomal aberrations was noted. After 20-hour exposure, a slight but a non significant increase (frequency of 3%) in the frequency of aberrant cells was noted at 5000 µg/mL. However, this increase was not considered as biologically relevant since it was neither dose-related nor reproducible between the two cultures. After 44-hour exposure, even though a slight increase in the frequency of aberrant cells was noted at 5000 µg/mL (3.5%), no statistically significant difference was obtained.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions, the test substance EDDHAS Fe 3K did not induce any clear evidence of chromosome aberrations in cultured human lymphocytes. - Executive summary:
The objective of this study was to evaluate the potential of the test substance EDDHAS Fe 3K to induce chromosome aberrations in cultured human lymphocytes.
Methods
The test substance was tested in two independent experiments, both with and without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9 fraction) of rats induced with Aroclor 1254. No preliminary cytotoxicity test was performed. Dose-levels were selected on the basis of pH, osmolality and solubility. A wide-range of treatment-levels was used for the first experiment and dose-levels for scoring of chromosomal aberrations were selected on the basis of cytotoxicity indicated by reduction of mitotic index (MI). For each culture, heparinised whole blood was added to culture medium containing a mitogen (phytohaemagglutinin) and incubated at 37°C in a humidified atmosphere of 5% CO2 /95% air, for 48 hours.
First experiment
Lymphocyte cultures were exposed to the test or control substances, with or without S9 mix, for 3 hours then rinsed. Cells were harvested 20 hours after the beginning of treatment, corresponding to approximately 1.5 normal cell cycles. One and a half hour before harvest, each culture was treated with a colcemid solution (10 µg/mL) to block cells at the metaphase-stage of mitosis.
Second experiment
- without S9 mix, cells were exposed continuously to the test or control substances,
- with S9 mix, cells were exposed to the test or control substances for 3 hours and then rinsed.
Cells were harvested 20 hours and 44 hours after the beginning of treatment, corresponding to approximately 1.5 normal cell cycles and 24 hours later, respectively. One and a half hour before harvest, each culture was treated with a colcemid solution (10 pg/ml) to block cells at the metaphase-stage of mitosis.
For both experiments, after hypotonic treatment (KCl 0.075 M), the cells were fixed in a methanol/acetic acid mixture (3/1; v/v), spread on glass slides and stained with Giemsa. All the slides were coded for scoring. The test substance EDDHAS Fe 3K was dissolved in culture medium.
The dose-levels of the positive controls were as follows:
- without S9 mix, mitomycin C: 3 µg/mL (3 hours of treatment) or 0.2 µg/mL (continuous treatment),
- with S9 mix, cyclophosphamide: 50 µg/mL or 25 µg/mL.
Results
The test substance was freely soluble in the culture medium. The final dose-level of 5000 mg/mL showed no precipitate in the culture medium and pH and osmolality values were equivalent to those of the vehicle control culture. With a treatment volume of 100 µL/5.5 mL culture medium, the dose-levels both with and without S9 mix were as follows:
- 78.125, 156.25, 312.5, 625, 1250, 2500, 3750 and 5000 µg/mL: for the first experiment,
- 156.25, 312.5, 625, 1250, 2500 and 5000 µg/mL: for the second experiment.
Cytotoxicity:
Except for a moderate toxicity induced at the highest dose-levels without S9 mix in the second experiment, no noteworthy toxicity was induced.
Chromosomal aberration analysis:
The metaphase analysis was performed at the following dose-levels, both with and without S9 mix:
- 2500, 3750 and 5000 µg/mL: for the first experiment,
-1250, 2500 and 5000 µg/mL: for the 20-hour harvest time in the second experiment,
- 5000 µg/mL: for the 44-hour harvest time in the second experiment.
No significant increase in the frequency of cells with structural chromosomal aberrations was noted in both experiments. The frequencies of cells with structural chromosome aberrations of the vehicle and positive controls were as specified in acceptance criteria. The study was therefore considered valid.
Conclusion
Under the experimental conditions, the test substance EDDHAS Fe 3K did not induce any clear evidence of chromosome aberrations in cultured human lymphocytes.
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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