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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: No deviation from OECD-471 guideline, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
GLP Certificate as an annexe in the study report.
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Method

Target gene:
Salmonella typhimurium LT2 Histindine mutation
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
other: rfa, uvrB, pKM101
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
other: rfa, uvrB, pKM101
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
other: rfa, uvrB, pKM101, pAQ1
Species / strain / cell type:
S. typhimurium TA 1535
Additional strain / cell type characteristics:
other: rfa, uvrB
Species / strain / cell type:
S. typhimurium TA 1537
Additional strain / cell type characteristics:
other: rfa, uvrB
Metabolic activation:
with and without
Metabolic activation system:
liver microsomal fraction of rat treated with Aroclor 1254
Test concentrations with justification for top dose:
Concentrations were 156.25, 312.5, 625, 1250 and 2500 µg/plate in the fist experiment; 78.12, 156.25, 312.5, 625 and 1250 µg/plate in the second experiment (pre-incubation method).
Vehicle / solvent:
DMSO, dimethylsulfoxide (CAS 67-68-5, EC 200-664-3)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
mitomycin C
other: 2-anthramine (CAS n°613-13-8 )

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
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

APP-6669 concentrations did not induce any increase in the number of revertants, in both experiments, with and without S9 metabolic activation, in any of the five strains (TA98, TA100, TA102, TA1535, TA1537). It can thus be clearly concluded that APP-6669 is not mutagenic under the conditions of a bacterial reverse mutation assay (OECD-471 guideline).