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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions; Ames test performed only with 4 strains, instead of 5
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The experimental procedure were according to Ames BN (1973), Proc. Nat.Acad.Sci. (USA) 70: 2281-2285 and Ames BN (1975), Mutation Res. 31, 347-364.
GLP compliance:
not specified
Remarks:
The study was performed before the adoption of the GLP principles.
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Triiron tetraoxide
EC Number:
215-277-5
EC Name:
Triiron tetraoxide
Cas Number:
1317-61-9
Constituent 2
Reference substance name:
iron(II,III) oxide
IUPAC Name:
iron(II,III) oxide
Details on test material:
- Name of test material (as cited in study report): magnetite (Bayferrox AC 5110M)
- Molecular formula (if other than submission substance): Fe3O4
No further information on the test material is provided

Method

Target gene:
not applicable
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Spague Dawley rats liver S9 mixture, after injection with Aroclor 1254 (500 mg/kg bw)
Test concentrations with justification for top dose:
8, 40, 200, 1000, 5000 µg Fe3O4/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: endoxan (equivalent to 100 µg cyclophosphamid for strain TA1535 and 200 µg cyclophosphamid for strain TA100), 2-Aminoanthracene, trypaflavine (strains TA1537 and TA98)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Incubation period: 48 h, at 37°C

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:
Positive: a reproducible dose-dependent increase in the number of mutants im at least one strain. Both negative controls should yield the expected number of revertant colonies.
Statistics:
no data

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
but tested to precipitating concentration
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
no data
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Iron(II,III) oxide (Fe3O4) was not mutagenic in the Salmonella/microsome (Ames) test performed, with and without metabolic activation.
Executive summary:

Iron(II,III) oxide (Fe3O4) was tested in an Ames test with four strains of S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) at the following concentrations: 8, 40, 200, 1000, 5000 µg Fe3O4/plate. Precipitation of the substance occured at the highest concentration. The test was negative both with and without metabolic activation.