Registration Dossier
Registration Dossier
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EC number: 267-990-6 | CAS number: 67969-88-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 August 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium 1-amino-9,10-dihydro-4-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]amino]-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 267-990-6
- EC Name:
- Sodium 1-amino-9,10-dihydro-4-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]amino]-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 67969-88-4
- Molecular formula:
- C27H20N2O8S2.Na
- IUPAC Name:
- sodium 1-amino-9,10-dihydro-4-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]amino]-9,10-dioxoanthracene-2-sulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat liver homogenate)
- Test concentrations with justification for top dose:
- main plate incorporation test: 50, 160, 500, 1600, 5000 µg/plate (+/- S9)
dose levels chosen based on findings including cytotoxicity in preincubation test - Vehicle / solvent:
- deionised water (water soluble substance)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Remarks:
- sodium azide: dissolved in deionised water; other positive controls: dissolved in DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
- Cell density at seeding (if applicable):
DURATION
- Preincubation period: 30 min at 30°C
- Exposure duration: 48 h
- OTHER: 37°C, darkness - Rationale for test conditions:
- in accordance with OECD 471
- Evaluation criteria:
- in accordance with OECD 471
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- 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
- Species / strain:
- S. typhimurium TA 1537
- 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
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 100
- 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
- Species / strain:
- E. coli WP2 uvr A
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: heavy precipitation at 1600 µg/plate and above
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxic effects in all strains at 50 µg/plate and above in the absence of S9
Toxic effects were reproduced
Applicant's summary and conclusion
- Conclusions:
- The test item did induce a mutagenic effect in bacterial test systems either in the presence or in the absence of an exogenous metabolising system. Acid Blue 281 caused cytotoxic effects at 50 µg/plate and above in the absence of metabolic activation (S9 mix) in all strains tested. The test item does not meet the classification criteria for mutagenicity according to the CLP Regulation.
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