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Toxicological information

Genetic toxicity: in vitro

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
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

Constituent 1
Chemical structure
Reference substance name:
N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide
EC Number:
806-543-7
Cas Number:
215917-77-4
Molecular formula:
C19H17N3O3S
IUPAC Name:
N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide
Specific details on test material used for the study:
Lot No.: 140220

Method

Species / strainopen allclose all
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 / 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 resultsopen allclose all
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
Positive controls validity:
valid
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
Positive controls validity:
valid
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
Positive controls validity:
valid
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
Positive controls validity:
valid
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
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The test substance was negative for mutagenic activity.