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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:
reference to same study
Reason / purpose:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.