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Registration Dossier
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EC number: 287-842-4 | CAS number: 85586-40-9
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:
- January 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to Guideline Study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Principles of method if other than guideline:
- 1) B.N. Ames, W.W. Durston, E. Yamasaki and R.D. Lee, Carcinogens are mutagens. A simple test system combining liver homogenate for activation
and bacteria for detection, Proc. Nat. Acad. Sci, USA 70 (1973) 2281-2285
2) M.H.L. Green, and W.J. Muriel: Mutagen testing using trp+ reversion in Escherichia coli, Mutation Res. 38 (1976) 3 - 32. - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt
- EC Number:
- 287-842-4
- EC Name:
- 5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt
- Cas Number:
- 85586-40-9
- Molecular formula:
- C29H19N3Na4O17S5 C29H23N3O17S5.xNa
- IUPAC Name:
- 5-(Benzoylamino)-4-hydroxy-3-((1-sulpho-6-((2-(sulphooxy)ethyl)sulphonyl)-2-naphthyl)azo)naphthalene-2,7-disulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- see below
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9-mix
- Test concentrations with justification for top dose:
- 4 to 10000 µg/plate
- Vehicle / solvent:
- aqua bidest
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene; mehylhydrazone derivative; streptocotocine
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Reactive Red 180 is not mutagenic in this bacterial test system either with or without exogenous metabolic activation at the dose levels investigated. - Executive summary:
Compound 410 / 81 A was examined in the mutagenicity screening test in bacteria first described by Ames and co-workers. Under the conditions we employed 410 / 81 A in concentrations of 4 µg to 10000 µg showed no mutagenic activity.
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