Iron ores, agglomerates

Genetic toxicity: in vitro

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

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.