Registration Dossier
Registration Dossier
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EC number: 202-588-6 | CAS number: 97-52-9
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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: pre-GLP
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Executive summary on the ETAD project T 2015 toxicological testing of major colorants, with attachments and cover letter dated June 3, 1988
- Author:
- ETAD
- Year:
- 1 988
- Bibliographic source:
- NTIS/OTS 0000621
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- no details provided; ETAD toxicological method # 005 (July 1980)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-nitro-o-anisidine
- EC Number:
- 202-588-6
- EC Name:
- 4-nitro-o-anisidine
- Cas Number:
- 97-52-9
- Molecular formula:
- C7H8N2O3
- IUPAC Name:
- 2-methoxy-4-nitroaniline
- Reference substance name:
- PNOA
- IUPAC Name:
- PNOA
Constituent 1
Constituent 2
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:
- rat liver S-9 mix
- Test concentrations with justification for top dose:
- 0 - 0.8-4-20-100-500 - 2500 µg/Platte, 6 concentrations
- Vehicle / solvent:
- acetone
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
The test material caused gen mutations in S.typhimurium.
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