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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:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2000
Reference Type:
other: Authoritative data base
Title:
Study ID : 241786
Year:
2012
Bibliographic source:
NTP (National Toxicological Program)by Mortelmans K, Zeiger E. The Ames Salmonella/microsome mutagenicity assay. Mutat Res. 2000 Nov 20;455(1-2):29-60.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Preincubation : In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium (or E. coli) plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen*. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene. The number of colonies is usually counted after 2 days.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Substance Name : 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid
Molecular Formula : C6H6N2O6S
Substance type: organic

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
10% & 30% HLI =induced male Syrian hamster liver S9 ; 10% & 30% RLI = induced male Sprague Dawley rat liver S9
Test concentrations with justification for top dose:
0-5000 ug/Plate
Vehicle / solvent:
Vehicle Control : Dimethyl Sulfoxide
Controlsopen allclose all
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl Sulfoxide
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Migrated to IUCLID6: without S9
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl Sulfoxide
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (with S9)
Details on test system and experimental conditions:
Test System : Salmonella typhimurium

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
negative
Remarks:
with 10% HLI
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
negative
Remarks:
with 30% HLI
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
negative
Remarks:
with 10% RLI
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
negative
Remarks:
with 30% RLI
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
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

Genetic toxicity in vitro for 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid in S. typhimurium TA 100 at dose concentration of 0-5000 ug/Plate is found to be negative with and without metabolic activation.
Executive summary:

Genetic toxicity in vitro for 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid in S. typhimurium TA 100 at dose concentration of 0-5000 ug/Plate is found to be negative with and without metabolic activation.