Benzenesulfonamide, N-[2-[[(phenylamino)carbonyl]amino]phenyl]-

Genetic toxicity: in vitro

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:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Test guideline under Japan chemical Control Law

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-benzenesulfonamidophenyl)-3-phenylurea

EC Number:

806-543-7

Cas Number:

215917-77-4

Molecular formula:

C19H17N3O3S

IUPAC Name:

1-(2-benzenesulfonamidophenyl)-3-phenylurea

Test material form:

solid: particulate/powder

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

- Type and identity of media: Oxoid Nutrient Broth No. 2 dissolved in purified water and autoclaved. This was stored in cold storage until use.

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Details on mammalian cell type (if applicable):

- Type and identity of media: Oxoid Nutrient Broth No. 2 dissolved in purified water and autoclaved. This was stored in cold storage until use.

Metabolic activation:

with and without

Metabolic activation system:

Preincubation with S9 mix

Test concentrations with justification for top dose:

Range-finding test: 1.22, 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate (with and without S9 mix)
Main test I and II: 39.1, 78.1, 156, 313, 625 and 1250 (with and without S9 mix) for the S.typhimurium strains and 39.1, 78.1, 156, 313, 625, 1250,
2500 and 5000 µg/plate (with and without S9 mix) for the E.coli strain.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test substance was insoluble in water, and soluble in DMSO with no increases in temperature, foaming or discolouration observed.

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

other: 9-Aminoacridine hydrochloride monohydrate (9-AA), 2-Aminoanthracene (2-AA), and 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 3 plates per dose (main tests)

Evaluation criteria:

The test substance was judged to have mutagenicity (positive) when the test substance induced a dose-dependant increase in the number of the
revertant colonies (mean) to a level equal to or greater than 2-fold of the negative (solvent) control value (mean value) in any one of the tester strains with or without S9-mix, and when the dose-dependant increase was reproducible. Other results were judged to be negative.

Statistics:

No statistical analysis was performed with the test in the study.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

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:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

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

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Key result

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

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Key result

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

True negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test substance was negative for mutagenic activity.