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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study, carried out by Research Institute for Animal Science in Biochemistry and Toxicology (Japan)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Principles of method if other than guideline:
OECD Guide-line 471 and 472
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Produced by Sumitomo Chemical, Lot No.71012, Purity:99.23%

Method

Target gene:
no data
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2uvrA
Details on mammalian cell type (if applicable):
no data
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
-S9 mix: 0, 6.25, 12.5, 25, 50, 100, 200 µg/plate
+S9 mix: 0, 6.25, 12.5, 25, 50, 100, 200 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: -S9 mix; 2-(2-Furyl)-3-(5-nitro-2- furyl) acrylamide(TA100, TA98, WP2), Sodium azid (TA1535) and 9-Aminoacridine(TA1537) +S9 mix; 2-Aminoanthracene(all strains)
Remarks:
no

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: Toxicity was observed at 100 and 200 µg/plate in TA strains with and without S9 mix, and 100 µg/plate without S9 mix and 200 µg/plate with S9 mix in E. coli WP2 uvrA
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

*Genotoxic effects:            +   ?    -
With metabolic activation: [ ] [ ] [ X ]
Without metabolic activation: [ ] [ ] [ X ]

Applicant's summary and conclusion

Conclusions:
Bacteria gene mutation is negative with and without metabolic activation.
Executive summary:

method: bacterial reverse mutation assay with Salmonella typhimurium TA100, TA1535, TA98, TA1537, Echerichia coli

according OECD TG 471/472

result: negative, with and without metabolic activation

reference: MHW, Japan (1999)