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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: well-documented report, comparable to guideline/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.9 %

Method

Target gene:
bacterial strains
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9 mix
Test concentrations with justification for top dose:
20 ug - 5000 ug/plate (all tester strains)
20 ug - 7500 ug/plate (TA 100)
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene with S-9 mix, N-methyl-N'-nitro-Nnitroso- guanidine, 4-nitro-o-phenylenediamine and 9-aminoacridine chloride monohydrate without S-9 mix
Details on test system and experimental conditions:
Bacterial test strains were used in the presence and absence of S-9 mix. Three test plates per dose or per control were run in each of the two experiments.
Evaluation criteria:
In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.
Statistics:
none

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Toxicity: No bacteriotoxic effect was observed.
Mutagenicity: TA 1535 and TA 100: A weakly positive reaction was observed with and without S-9 mix depending in the strain and test conditions at doses 2 2500 ug/plate (factor 1.7 - 3.4). TA 1535 and TA 98: No increase in the number of his+ revertants.
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):
positive

According to the results of the present study, the test substance n-Butylenoxid-1,2 is weakly mutagenic in the Ames test under the experimental conditions chosen here.