3-aminobenzenesulphonic acid

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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 / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

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

Controls

Controls 1

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

Controls 2

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

Controls 3

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

Controls 4

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 results

Test results 1

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

Test results 2

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

Test results 3

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

Test results 4

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

Test results 5

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.