Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

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
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

Method

Species / strain
Species / strain / cell type:
other: TA 1535, TA 97, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
other: histidine deficient
Metabolic activation:
with and without
Metabolic activation system:
S-9
Test concentrations with justification for top dose:
0, 2.5, 7.4, 22.2, 66.7 and 200.0 μg/mL
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: not specified
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
methylmethanesulfonate
other: 2-aminoanthracene and 2-aminofluorene
Details on test system and experimental conditions:
METHOD OF APPLICATION:in agar (plate incorporation)
- Cell density at seeding (if applicable): 5x10^7 to 4x10^8

DURATION
- Preincubation period: 16 hours
- Exposure duration: three days

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: one

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not applicable
Positive controls validity:
not specified
Key result
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at the two highest doses, in absence of S-9 mix
Vehicle controls validity:
not specified
Untreated negative controls validity:
not applicable
Positive controls validity:
not specified
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at the highest dose, in absence of S-9 mix
Vehicle controls validity:
not specified
Untreated negative controls validity:
not applicable
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not applicable
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at two highest doses, in absence of S-9 mix. In presence of S-9 mix at highest dose.
Vehicle controls validity:
not specified
Untreated negative controls validity:
not applicable
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
It was concluded that the test substance did not show mutagenic activity in any of the Salmonella typhimurium strains, either in absence or in the presence of the S-9 mix.
Executive summary:

The test substance was examined for mutagenic activity in the Ames test using the histidine requiring Salmonella typhimurium mutants TA 1535, TA 97, TA 98, TA 100 and TA 102 as indicator strains and a liver mircosome fraction of Aroclor-induced rats for metabolic activation (S-9 mix).

It was concluded that the test substance did not show mutagenic activity in any of the S. typhimurium strains, either in absence or in the presence of the S-9 mix.