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EC number: 202-057-9 | CAS number: 91-29-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Toxicological evaluations- 4-Nitro-4’-aminodi-phenylamine-2-sulfonic acid CAS no 91-29-2
- Author:
- B. G. Chemie
- Year:
- 2 000
- Bibliographic source:
- BG RCI, No. 120, BG Chemie, Pg no 1-11, 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Salmonella / microsome assay was performed to determine the mutagenic nature of 4-Nitro-4'-aminodiphenylamine-2-sulfonic acid
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(4-aminoanilino)-5-nitrobenzenesulphonic acid
- EC Number:
- 202-057-9
- EC Name:
- 2-(4-aminoanilino)-5-nitrobenzenesulphonic acid
- Cas Number:
- 91-29-2
- Molecular formula:
- C12H11N3O5S
- IUPAC Name:
- 2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate
- Details on test material:
- - Name of test material: 2-(4-aminoanilino)-5-nitrobenzenesulphonic acid
- IUPAC name: 2-[(4-aminophenyl)amino]-5-nitrobenzenesulfonic acid
- Molecular formula: C12H11N3O5S
- Molecular weight: 309.301 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities: No data
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 4-Nitro-4'-aminodiphenylamine-2-sulfonic acid
- IUPAC name: 2-[(4-aminophenyl)amino]-5-nitrobenzenesulfonic acid
- Molecular formula: C12H11N3O5S
- Molecular weight: 309.301 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 58.5%
- Impurities: 41.5% water
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA 100, TA 1535, TA 1537 and TA 1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix prepared from Aroclor 1254-induced rat liver
- Test concentrations with justification for top dose:
- 4 up to 5000 µg/plate
- Vehicle / solvent:
- No data
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation
DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: No data available
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:
OTHER: - Rationale for test conditions:
- No data
- Evaluation criteria:
- The plates were observed for a dose dependent increase in the number of revertants/plate
- Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium, other: TA100 and TA1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- Weakly
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium, other: TA1537, TA1538 and TA98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data
Applicant's summary and conclusion
- Conclusions:
- 4-Nitro-4'-aminodi-phenylamine-2-sulfonic acid did not induce gene mutation in Salmonella typhimurium strains TA100 and TA1535 in the presence of S9 metabolic activation system and TA98, TA100, TA1535 and TA1537 in the absence of metabolic activation system. It howver induced gene mutation in strains TA98, TA1537 and TA1538 in the presence of S9 metabolic activation system and induced weak positive mutation in strain TA1538 in the absence of S9 metabolic activation system.
- Executive summary:
Salmonella / microsome assay was performed to determine the mutagenic nature of 4-Nitro-4'-aminodiphenylamine-2-sulfonic acid. The study was performed as per the standard plate incorporation assay using Salmonella typhimurium strains TA98, TA100, TA1537, TA1535 and TA1538 in the presence and absence of S9 metabolic activation system. The test chemical was tested at dose levels of 4 upto 5000 µg/plate. The plates were observed for a dose dependent increase in the number of revertants/plate. 4-Nitro-4'-aminodi-phenylamine-2-sulfonic acid did not induce gene mutation in Salmonella typhimurium strains TA100 and TA1535 in the presence of S9 metabolic activation system and TA98, TA100, TA1535 and TA1537 in the absence of metabolic activation system. It howver induced gene mutation in strains TA98, TA1537 and TA1538 in the presence of S9 metabolic activation system and induced weak positive mutation in strain TA1538 in the absence of S9 metabolic activation system.
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