Registration Dossier
Registration Dossier
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Reaction mass of trisodium bis[5-amino-2-(hydroxy-κO)-3-{[1-(hydroxy-κO)-2-naphthyl]diazenyl-κN1}benzenesulfonato(3-)]chromate(3-), trisodium bis[2-(hydroxy-κO)-3-{[1-(hydroxy-κO)-2-naphthyl]diazenyl-κN1}-5-nitrobenzenesulfonato(3-)]chromate(3-) and heptasodium bis[4-(hydroxy-κO)-3-{[2-(hydroxy-κO)-5-nitro-3-sulfophenyl]diazenyl-κN2}-6-(4-sulfoanilino)naphthalene-2-sulfonato(5-)]chromate(7-)
EC number: 944-619-2 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other: data obtained after Article 25(3) request
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Acid Black 173 - Similar Substance 01
- IUPAC Name:
- Acid Black 173 - Similar Substance 01
- Test material form:
- not specified
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 0 ... 4800 μg/plate
Concentration range in the main test (without metabolic activation): 0 ... 5000 μg/plate - Vehicle / solvent:
- Water
Results and discussion
Test results
- Species / strain:
- other: TA 98, 100, 1535, 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 2400 μg/plate
- Additional information on results:
- In higher doses of 2400, mg/plate the test substance shows a weak, root-specific, bacteria toxic effect.
Applicant's summary and conclusion
- Conclusions:
- Non mutagenic
- Executive summary:
Method
The test substance has been assessed for its genetic toxicity potential according to the EU method B.14 (Ames test).
Result
Non mutagenic
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