Registration Dossier
Registration Dossier
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EC number: 419-500-9 | CAS number: 171599-85-2 RED REN 363
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:
- 1996
- 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:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Directive 92/69/EEC, B.14 Ames-Test
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N'-bis{6-chloro-4-[6-(4-vinylsulfonylphenylazo)-2,7-disulfonicacid 5-hydroxy-napht-4-ylamino]-1,3,5-triazin-2-yl}-N-(2-hydroxyethyl)-ethane-1,2-diamine, sodium salt
- EC Number:
- 419-500-9
- EC Name:
- N,N'-bis{6-chloro-4-[6-(4-vinylsulfonylphenylazo)-2,7-disulfonicacid 5-hydroxy-napht-4-ylamino]-1,3,5-triazin-2-yl}-N-(2-hydroxyethyl)-ethane-1,2-diamine, sodium salt
- Cas Number:
- 171599-85-2
- Molecular formula:
- C46H38Cl2N14O19S6
- IUPAC Name:
- tetrasodium 5-[(4-chloro-6-{[2-({4-chloro-6-[(7-{2-[4-(ethenesulfonyl)phenyl]diazen-1-yl}-8-hydroxy-3,6-disulfonatonaphthalen-1-yl)amino]-1,3,5-triazin-2-yl}(2-hydroxyethyl)amino)ethyl]amino}-1,3,5-triazin-2-yl)amino]-3-{2-[4-(ethenesulfonyl)phenyl]diazen-1-yl}-4-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- Salmonella typhimurium & E. coli TA 1535, TA 1537, TA 98, TA 100 & WP2, WP2 uvrA bacteria
- Metabolic activation system:
- - S9-liver fractions of rats, treated with AROCLOR 1254
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 33.3 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 33.3 ... 5000 μg/plate - Vehicle / solvent:
- Solvent: - bidistilled water
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Salmonella typhimurium & E. coli TA 1535, TA 1537, TA 98, TA 100 & WP2, WP2 uvrA bacteria
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity (> 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 & E. coli TA 1535, TA 1537, TA 98, TA 100 & WP2, WP2 uvrA bacteriaSalmonella typhimurium & E. coli TA 1535, TA 1537, TA 98, TA 100 & WP2, WP2 uvrA bacteria
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity (> 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 & E. coli TA 1535, TA 1537, TA 98, TA 100 & WP2, WP2 uvrA bacteria
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity (> 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
Applicant's summary and conclusion
- Conclusions:
- negative with metabolic activation
negative without metabolic activation
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