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EC number: 233-072-9 | CAS number: 10028-22-5
- 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 based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Research publication. Well documented meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity of iron compounds in Salmonella typhimurium and L5178Y mouse lymphoma cells.
- Author:
- Dunkel VC, San RHC, Seifried HE, Whittaker P
- Year:
- 1 999
- Bibliographic source:
- DOI 10.1002/(SICI)1098-2280(1999)33:1<28::AID-EM4>3.0.CO;2-S PMID 10037321 Environ Mol Mutagenesis 33(1):28-41.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Method: other: Clive et al/1975 and 1979
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 7782-63-0
- Cas Number:
- 7782-63-0
- IUPAC Name:
- 7782-63-0
- Reference substance name:
- ferrous sulfate (FeSO4 x 7 H2O)
- IUPAC Name:
- ferrous sulfate (FeSO4 x 7 H2O)
- Test material form:
- not specified
- Details on test material:
- Ferrous Sulfate
The substance tested was the heptahydrate (CAS number 7782-63-0), but this does not affect the chemical species available to the test organisms.
Purity: 99%
Source: Sigma
Constituent 1
Constituent 2
Method
- Target gene:
- thymidine kinase (TK) gene
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Fischer's medium for leukemic cells of mice supplemented with 10% horse serum and 0.02% pluronic F-68
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- without S9: 309-1030 µg Fe/mL (i.e. mg Fe/L)
with S9: 0.206-1.236 µg Fe/mL (i.e. mg Fe/L) - Vehicle / solvent:
- Vehicle used: Distilled water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- destilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- destilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: no data
- 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): 12-14 days
SELECTION AGENT (mutation assays): trifluorothymidine (final concentration 3ug/ml) added to cloning mediumfor mutant selection
NUMBER OF REPLICATIONS: duplicate cultures
NUMBER OF CELLS EVALUATED: 1E+06 for mutant selection, 200/plate for mutant count, colony size range 0.2-1.1 mm, counted with an Artek automated colony counter
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Doses of test compound selected for mutagenicity assay were within the range yielding approximately 0-90% cytotoxicity - Evaluation criteria:
- Doubling of mutant frequency over concurrent solvent treated control value together with dose relationship.
- Statistics:
- Colonies larger than 0.1 mm diameter were counted with an Artek automated colony counter. Colony size was also determined.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: L5178Y TK+/- 3.7.C mouse lymphoma cells
Any other information on results incl. tables
Table 1: Number of revertants per plate (mean of 2 plates)
Concentration µg Fe/ml |
Mutant frequency* |
Growth** |
Concentration µg Fe/ml |
Mutant frequency* |
Growth** |
-S9 |
-S9 |
+S9 |
+S9 |
||
0* |
25 |
100 |
0 |
27 |
100 |
20.1 |
25 |
84.5 |
0.804 |
53 |
61.5 |
50.25 |
29 |
72.5 |
1.005 |
67 |
54.5 |
100.5 |
32 |
51.5 |
1.206 |
70 |
41.5 |
150.75 |
46 |
27.5 |
1.508 |
88 |
5.0 |
201.0 |
80 |
10.5 |
|||
Positive control |
430 |
46 |
Positive control |
171 |
52 |
* per 1E+06 survivors
** as % of control
PRECIPITATION CONCENTRATION: None reported
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In the mouse lymphoma TK+/- assay ferrous sulphate FeSO4 x 7H2O showed a weak positive response in the absence of metabolic activation at cytotoxic concentrations and a dose-related increase in mutant frequency in the presence of metabolic activation, with marked increase of cytotoxicity. - Executive summary:
A L5178Y TK+/- mouse lymphoma cell assay was conducted with FeSO4 x 7H2O. The cytotoxicity of the test substance was determined with and without metabolic activation (rat liver S9 mix) prior to the mutagenicity test in order to determine the appropriate testing concentrations. The mutagenicity assay was performed in duplicates. As indication of a positive effect doubling of the mutant frequency was used. The mouse lymphoma cells showed with and without metablic activation a weak increase in the number of induced mutants at cytotoxic concentrations.
FeSO4 x 7H2O is negative for mutagenicity in absence and presence of metabolic activation under the conditions of this test system.
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