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EC number: 233-899-5 | CAS number: 10421-48-4
- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- iron(2+) sulfate heptahydrate
- IUPAC Name:
- iron(2+) sulfate heptahydrate
- Reference substance name:
- 7782-63-0
- EC Number:
- 616-510-7
- Cas Number:
- 7782-63-0
- IUPAC Name:
- 7782-63-0
- Reference substance name:
- iron(II)sulphate heptahydrate
- IUPAC Name:
- iron(II)sulphate heptahydrate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Sulfuric acid, iron(2+) salt (1:1), heptahydrate
- Molecular formula (if other than submission substance): FeSO4. 7H2O
- Molecular weight (if other than submission substance): 278.01
- Physical state: powder, blue-green crystals
- Analytical purity: 91.6 wt%
- Impurities (identity and concentrations): Mg 0.22%, Mn 0.2%, Zn 87 ppm
- Stability under test conditions:
- Storage condition of test material: room temperature under Argon
- Other: MP 64°C, Water solubility: 32.8g/l at 0°C
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- His Operon (S. typhimurium strains) and Trp Operon (E. coli strain)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix obtained from SD rat liver, induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- 0, 156, 313, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: aminofluorene for TA100 and TA98; sodium azide for TA1535; TA1535: NaN3, N-ethyl-N'-nitrosogunanidine for WP2uvrA/pKM101 and 9-aminoacridine hydrochloride for TA1537 +S9: 2-amonoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
PLATES/TEST: 3
NUMBER OF REPLICATIONS: 2 tests
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- Evaluation criteria:
- No information but standard test guideline criteria apply
- Statistics:
- Colonies were counted for 3 plates. Mean values which are at least twice as high as the negative vehicle control are considered as positive. Otherwise it is considered as negative.
Results and discussion
Test results
- Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100; E. coli WP2 uvrA pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was observed at a concentration of > 2500 µg/plate with or without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- There was no precipitation at any test concentration.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Mutagenicity of ferrous sulfate heptahydrate in reverse mutation test in bacteria
|
|
number of revertants: mean value of negative control
|
number of revertants: mean value of positive control
|
max. number of revertants: mean value of test material [µg/plate] |
without S9-mix |
||||
Base-pair change type |
TA100 |
101 ± 6 |
630 ± 29 |
113 ± 7 [5000] |
TA 1535 |
9.5 ± 3 |
436 ± 21 |
13 ± 3 [ 313] |
|
WP2uvrA/pKM101 |
74.5 ± 4 |
3227 ± 107 |
92 ± 7 [2500] |
|
Frame-shift type |
TA 98 |
15.5 ± 3 |
604 ± 30 |
20 ± 4 [156] |
TA1537 |
7.5 ± 2 |
211 ± 28 |
11 ± 1 [313] |
|
without S9-mix |
||||
Base-pair change type |
TA100 |
103 ± 6 |
1897 ± 202 |
136 ± 18 [5000] |
TA 1535 |
12 ± 3 |
241 ± 17 |
14 ± 5 [ 2500] |
|
WP2uvrA/pKM101 |
96 ± 7 |
831 ± 72 |
106 ± 1 [5000] |
|
Frame-shift type |
TA 98 |
26.5 ± 7 |
479 ± 30 |
29 ± 3 [313] |
TA1537 |
13 ± 3 |
227 ± 17 |
21 ± 2 [1250] |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Ferrous sulfate heptahydrate was tested for bacterial mutagenicity according OECD 471 under GLP using the preincubation method. It did not induce an increase in reversions in any of the strains tested in either the initial or the repeat test. Solvent and positive controls gave the expected results. It is concluded that ferrous sulfate heptahydrate is not mutagenic to bacteria under the conditions of the test. - Executive summary:
Ferrous sulfate heptahydrate was tested for bacterial mutagenicity according OECD 471 under GLP using the preincubation method. It did not induce an increase in reversions in any of the strains tested in either the initial or the repeat test. Solvent and positive controls gave the expected results. It is concluded that ferrous sulfate heptahydrate is not mutagenic to bacteria under the conditions of the test.
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