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EC number: 240-722-5 | CAS number: 16673-34-0
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
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[2-[4-(aminosulphonyl)phenyl]ethyl]-5-chloro-2-methoxybenzamide
- EC Number:
- 240-722-5
- EC Name:
- N-[2-[4-(aminosulphonyl)phenyl]ethyl]-5-chloro-2-methoxybenzamide
- Cas Number:
- 16673-34-0
- Molecular formula:
- C16H17ClN2O4S
- IUPAC Name:
- 5-chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)ethyl]benzamide
- Details on test material:
- Batch No.: 2010/8102 F
Chemical Name: 4-[2-(5-chloro-2-methoxybenzamido)-ethyl] benzenesulfonamide
Colour: Almost white or pale yellow
Physical State: Powder
Purity: 99.5%
Expiry Date: October 2014
Storage Conditions: at room temperature
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: NaN3, 4-NOPD, MMS, 2-AA
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- < 2500 mg/plate in exp II in strain TA1535
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Precipitation of the test item was observed in all tester strains used in experiment I and II (with and without metabolic activation) on the agar plates with the unaided eye. In experiment I precipitation of the test item was found at a concentration of 1000 μg/plate and higher (with and without metabolic activation). In experiment II precipitation of the test item was found at a concentration of 316 μg/plate and higher (with and without metabolic activation).
No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated (with and without metabolic activation) in experiment I and II, with two exceptions: toxic effects of the test item were noted in experiment II in tester strain TA 1535 at concentrations of 2500 μg/plate and higher (with and without metabolic activation). The reduction in the number of revertants down to a mutation factor of 0.5 at a concentration of 316 μg/plate (with metabolic activation) was regarded as not biologically relevant due to lack of a dose-response relationship.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Benzenesulfonamide at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II. The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It can be stated that during the described mutagenicity test and under the experimental conditions reported, Benzenesulfonamide did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, Benzenesulfonamide is considered to be non-mutagenic in this bacterial reverse mutation assay.
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