Registration Dossier
Registration Dossier
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EC number: 201-383-9 | CAS number: 81-88-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- STUDIES ON THE PHARMACOKINETICS AND MUTAGENIC POTENTIAL OF RHODAMINE B
- Author:
- ELLIOTT,GS, MASON,RW AND EDWARDS,IR
- Year:
- 1 990
- Bibliographic source:
- TOXNET CCRIS citing this publication (J. TOXICOL., CLIN. TOXICOL. 28(1):45-59, 1990)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
- EC Number:
- 201-383-9
- EC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
- Cas Number:
- 81-88-9
- Molecular formula:
- C28H31N2O3.Cl
- IUPAC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- RAT, LIVER, S-9, BETA-NAPHTHOFLAVONE AND PHENOBARBITAL
- Test concentrations with justification for top dose:
- 0.01-4 MG/PLATE OF COMMERCIAL RHODAMINE B500
- Vehicle / solvent:
- distilled water
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- preincubation test
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
Applicant's summary and conclusion
- Conclusions:
- In an Ames test using the pre-incubation method, basic violet 10 was found positive in S. typhimurium strain TA98 with metabolic activation, when tested at doses of 0.01 to 4 mg/plate in distilled water.
The results do not support the hypothesis that rhodamine B is a genotoxic hazard in the mammalian organism
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