Registration Dossier

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
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was not conducted in a GLP facility, but was conducted equivalent to OECD Guideline 471 "Bacterial Reverse Mutation Test".

Data source

Reference
Reference Type:
publication
Title:
The Induction of Bacterial Mutation and Hepatocyte Unscheduled DNA Synthesis by Monosubstituted Anilines
Author:
Christina Z. Thompson et al.
Year:
1983
Bibliographic source:
Christina Z. Thompson, Leo E. Hill, Janet K. Epp and Gregory S. Probst (1983) The induction of bacterial mutation and unscheduled DNA synthesis by monosubstituted anilines. Environmental Mutagenesis, 5:803-811.

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test item was obtained either from Aldrich Chemical Company, Inc. (Milwaukeem, WI) or from Eastman Chemical Company (Rochester, NY).

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: histidine auxotroph
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
other: histidine auxotroph
Species / strain / cell type:
E. coli WP2
Additional strain / cell type characteristics:
other: tryptophan auxotroph
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
other: tryptophan auxotroph
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S-9
Test concentrations with justification for top dose:
The study was conducted up to a maximum concentration of 1,000 ug/mL agar.
Vehicle / solvent:
All dilutions were made using reagent-grade dimethyl sulfoxide (DMSO), and a final concentration of 1 % DMSO did not influence toxicity or the genetic endpoints of the test.
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
2-acetylaminofluorene
Remarks:
Migrated to IUCLID6: and Streptozotocin

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

The test item exhibited no evidence of inducing bacterial mutation to the strains of bacteria tested in this study, both with and without metabolic activation.