Registration Dossier
Registration Dossier
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EC number: 700-413-2 | CAS number: 6331-96-0
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:
- 2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- 2-amino-4,5-dichlorobenzene-1-sulfonic acid
- EC Number:
- 700-413-2
- Cas Number:
- 6331-96-0
- Molecular formula:
- C6 H5 Cl2 N O3 S
- IUPAC Name:
- 2-amino-4,5-dichlorobenzene-1-sulfonic acid
- Test material form:
- other: solid
- Details on test material:
- approximately 99 % (as indicated by the sponsor)
Constituent 1
Method
- Target gene:
- Histidine-deficient mutants of Salmonella typhimurium LT2
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from the livers of Aroclor 1254-induced male Sprague Dawley rats
- Test concentrations with justification for top dose:
µg per plate
Negative control 0
Test item 50
Test item 160
Test item 500
Test item 1600
Test item 5000
Positive control, NaN3 5 (only TA 100, TA 1535)
Positive control, 2NF 10 (only TA 98)
Positive control, 4NPDA 10 (only TA 1537)
Positive control, MMC 0.2 (only TA 102)
Positive control, Cum 50 (only TA 102 )
Positive control, 2AA 3 all strains
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- monomeric acrylamide
- cumene hydroperoxide
- mitomycin C
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None of the five strains concerned showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls. This applied both to the tests with and without S9 mix
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
None of the five strains concerned showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls. This applied both to the tests with and without S9 mix
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