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EC number: 607-234-8 | CAS number: 234446-82-3
- 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 gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to methods similar to OECD471, non-GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity of Iron Compounds in Salmonella typhimurium and L5 178Y Mouse Lymphoma Cells
- Author:
- Dunkel, V.C., San, R.H.C., Seifried, H.E., Whittaker, P.
- Year:
- 1 999
- Bibliographic source:
- Environmental and Molecular Mutagenesis 33:28-41
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- other: Clive and Spector 1975
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Sodium feredetate
- EC Number:
- 239-802-2
- EC Name:
- Sodium feredetate
- Cas Number:
- 15708-41-5
- Molecular formula:
- C10H12FeN2O8.Na
- IUPAC Name:
- iron(3+) sodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
- Details on test material:
- Substance: Sodium iron (III) EDTA
CAS No.: 15708-41-5
Molecular formula: NaFeEDTA (Hamp-ene, 13% Fe)
Purity: 98%
Supplier: W.R. Grace & Co.
EDTA-Na2 was used as non-Fe contaning control compound
Substance: Disodium EDTA
CAS No.: 6381-92-6
Molecular formula: Na2EDTA 2H2O (Hamp-ene Na, pure)
Purity: 100%
Supplier: W.R. Grace Bc Co.
Constituent 1
Method
- Target gene:
- thymidine kinase (TK) deficiency
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The cells wcre grown in Fischer's medium for leukemic cells of mice (Irvine Scientific, Irvine, CA) supplemented with 10% horse serum (Hyclone Laboratories, Logan, UT) and 0.02% pluronic F-68 (BASF Wyandotte Corp., Wyandotte, MI).
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
New cultures were initiated at approximately 3-month intervals rrom cells stored in liquid N2. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- EDTA-FeNa
- S9 mix
0, 1.3, 2.6, 162.5, 325.0 µg Fe/ml = 0, 9.80, 19.60, 1225.21, 2450.43 EDTA-FeNa
+ S9 mix
0, 0.026, 0.052, 1.625, 3.250 µg Fe/ml = 0, 0.20, 0.39, 12.25, 24.50
(mol weight Fe 55.847, mol weight EDTA-FeNa 3H2O 421.096)
EDTA-Na2
- S9 mix
0, 250, 500, 1000, 1500, 2000 µg/ml
+ S9 mix
0, 250, 500, 1000, 1500, 2000, 4000 µg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: EDTA-FeNa: -S9 mix 4.7*10-6M EMS, +S9mix 9*10-5M MCA, EDTA-Na2: -S9 mix 0.25 µg/ml EMS, +S9mix 5.0 µg/ml 3-MCA
- Remarks:
- EDTA-Na2 was used as non-Fe contaning control compound
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 10-12 days
- Fixation time (start of exposure up to fixation or harvest of cells): 292-340 hours
SELECTION AGENT (mutation assays): TFT
NUMBER OF REPLICATIONS: duplicate
NUMBER OF CELLS EVALUATED: colonies > 0.1 mm were counted.
DETERMINATION OF CYTOTOXICITY
- Method: growth rate - Evaluation criteria:
- Doubling of the mutant frequency over the concurrent solvent-treated control value as an indication of a positive effect, together with evidence
of a dose-related increase. - Statistics:
- Not applicable.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- EDTA-FeNa
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- -S9 mix >2.6 µg Fe/ml, + S9 mix >0.052 µg Fe/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- EDTA-Na2
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- +S9 mix > 2000 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: study was performed, results not reported.
COMPARISON WITH HISTORICAL CONTROL DATA: no data
ADDITIONAL INFORMATION ON CYTOTOXICITY: no data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
ambiguous
The authors of this study concluded that EDTA-FeNa is positive in the mouse lymphoma mutagenicity study. However doubling of the number of mutants is only observed at test concentrations that cause significant cytotoxicity. Not taking into account the cytotoxic concentrations does not give a dose related increased in mutant frequency. OECD476: "Care should be taken to avoid conditions which would lead to results not reflecting intrinsic mutagenicity. Positive results which do not reflect intrinsic mutagenicity may arise from changes in pH, osmolality or high levels of cytotoxicity." Therefore we concluded that the results from this study are ambiguous. - Executive summary:
The mutagenic activity of EDTA-FeNa and EDTA-Na2 was tested in a mammalian gene mutation assay with L5178Y mouse lymphoma cells. The authors of this study concluded that EDTA-FeNa is positive in the mouse lymphoma mutagenicity study. However doubling of the number of mutants is only observed at test concentration that cause significant cytotoxicity. Not taking into account the cytotoxic concentrations does not give a dose related increased in mutant frequency. EDTA-Na2 is much less cytotoxic and is negative in this assay.
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