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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published data by the US Environmental Protection Agency.

Data source

Reference
Reference Type:
publication
Title:
Validation of Chemical and Biological Techniques for Evaluation of Vapors in Ambient Air Testing of Twelve Vapor-Phase Compounds
Author:
Huges TJ, Sparacino C & Frazier S
Year:
1984
Bibliographic source:
Research Triangle Park NC, Environmental Protection Agency, Health Effects Research Laboratory, Apr 1984

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Bacterial mutagenicity (Ames test in S. typhimurium)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material was one of twelve substances tested for mutagenicity.

Method

Target gene:
Various
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 97
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 98
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium 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:
Aroclor-induced hamster and rat liver S9
Test concentrations with justification for top dose:
The highest dose was 1750 µg/plate as the limiting factor was that hydrogen sulphide gas was limited by its solubility in ethanol, which was the test solvent.
Vehicle / solvent:
Ethanol
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
Salmonella typhimurium TA97, TA98 and TA100 strains, either with or without S9 liver fraction of male rats or hamsters that had been induced with 500 mg/kg Arcoclor.
Evaluation criteria:
Not stated
Statistics:
Not stated

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No further information.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

No evidence of mutagenicity was observed in the Ames test with Salmonella typhimurium TA97, TA98 and TA100.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

No mutagenicity was observed in the Ames test with Salmonella typhimurium TA97, TA98 and TA100.
Executive summary:

No evidence of mutagenicity was observed in the Ames test with Salmonella typhimurium TA97, TA98 and TA100.