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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: GLP compliant guideline study, published in peer reviewed literature, minor restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Principles of method if other than guideline:
The main study was conducted in accordance with “Methods of Testing New Chemical Substances” (Kanpogyo No. 237, Yakuhatsu No. 306, and 62 Kikyoku No. 303 Notifications dated March 31, 1987) and OECD Guidelines for the Testing of Chemicals 471 and 472, and based on chemical substance GLP (Kanpogyo No. 39, Yakuhatsu No. 229, and 59 Kikyoku No. 85 Notifications dated March 31, 1984, and Kankiken No. 233, Eisei No. 38, and 63 Kikyoku No. 823 Notifications revised on November 18, 1988).
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminobenzenesulphonic acid
EC Number:
204-473-6
EC Name:
3-aminobenzenesulphonic acid
Cas Number:
121-47-1
Molecular formula:
C6H7NO3S
IUPAC Name:
3-aminobenzene-1-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): 3-Aminobenzenesulfonic acid
- Purity : 98.6%

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S-9: Rat liver, induced with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
0, 312.5, 625, 1250,2500, 5000 µg/plate
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
Strain TA100, TA1535, TA98, TA1537, E. coli WP2 uvrA, with metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Strain TA 1537 without metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Strain TA1535 without metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: AF-2
Remarks:
Strain TA100, WP2, TA98, without metabolic activation
Details on test system and experimental conditions:
Procedures: Plate incorporation method
Plates/test: 3
Number of replicates: 2

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
No toxicity was observed up to a concentration of 5000 µg/plate with or without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Gentoxicity: negative
Executive summary:

A bacterial reverse mutation study was conducted to investigate whether or not 3‑aminobenzenesulfonic acid is mutagenic. Using Salmonella typhimurium TA100, TA1535, TA98 and TA1537, and Escherichia coli WP2 uvrA strains as test bacteria, the dose-setting study and the main study were both conducted by the direct method and by the metabolic activation method, using 50-5000 mg/plate in the dose-setting study and 312.5-5000 mg/plate in the main study. The results revealed no increase in the number of revertant colonies in any of the five strains of test bacteria used, at any dose, in either of the two runs of the main study, and so 3‑aminobenzenesulfonic acid was judged not to be mutagenic in the study system used.