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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Documentation contains an insufficient level of information to enable a complete assessment on the reliability of the reported results. The study was conducted with silicomanganese slag, rather than with the registered substance itself. Use of data generated with silicomanganese slag, to address information requirements of ferromanganese slag, is considered to be justified on the basis of the similar compositions of the two substances. Both substances are UVCB substances, containing metallic oxides; each substance is obtained as a by-product in the manufacture of SiMn and FeMn alloy, respectively.
Cross-reference
Reason / purpose:
other: Target
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Reason / purpose:
read-across source
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The method was a standard Ames.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
histidine locus
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

Under the conditions of the study the test material was concluded to be non-mutagenic to S. typhimurium TA 98 and S. typhimurium TA 100 with and without metabolic activation.
Executive summary:

An Ames test was conducted with the test material SiMn slag using the Salmonella typhimurium tester strains TA98 and TA100. The bacterial tester strains were exposed to the test material both in the presence and absence of metabolic activation.

Under the conditions of the study the test material was concluded to be non-mutagenic.

Use of data generated with silicomanganese slag, to address information requirements of ferromanganese slag, is considered to be justified on the basis of the similar compositions of the two substances. Both substances are UVCB substances, containing metallic oxides; each substance is obtained as a by-product in the manufacture of SiMn and FeMn alloy, respectively.