Registration Dossier
Registration Dossier
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EC number: 424-870-1 | CAS number: 27624-67-5
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:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 92/69/EEC (Ames)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 424-870-1
- EC Name:
- -
- Cas Number:
- 27624-67-5
- Molecular formula:
- C14H16N4O9S3
- IUPAC Name:
- 2,4-diamino-5-(2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100. bacteria
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 μg/plate - Vehicle / solvent:
- dimethyl sulphoxide
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100. bacteria
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- other: Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100. bacteria
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- other: Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100. bacteria
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- The vehicle control plates produced counts of revertant
colonies within the normal range.
All of the positive control chemicals used in the test
produced marked increases in the frequency of revertant
colonies, both with and without the metabolising system.
The test material caused no visible reduction in the growth
of the bacterial lawn at any of the dose levels to any of
the strains of Salmonella tested. The test material was,
therefore, tested up to the maximum recommended dose of 5000
μg/plate. An intense test material-induced colouration was
observed at 5000 μg/plate, this did not, however, interfere
with the scoring of revertant colonies.
No precipitate was observed at any dose level.
No significant increase in the frequency of revertant
colonies was recorded for any of the bacterial strains with
any dose of the test material, either with or without
metabolic activation. The test material was considered to be
non-mutagenic under the conditions of the test. - Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Conclusions:
- negative with metabolic activation
negative without metabolic activation
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