Registration Dossier
Registration Dossier
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EC number: 251-607-4 | CAS number: 33629-47-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- EC Number:
- 251-607-4
- EC Name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- Cas Number:
- 33629-47-9
- Molecular formula:
- C14H21N3O4
- IUPAC Name:
- N-sec-butyl-4-tert-butyl-2,6-dinitroaniline
- Reference substance name:
- Xylene
- EC Number:
- 215-535-7
- EC Name:
- Xylene
- Cas Number:
- 1330-20-7
- Molecular formula:
- C8H10
- IUPAC Name:
- m-xylene
Constituent 1
impurity 1
Method
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:
- Microsomal liver fraction
- Test concentrations with justification for top dose:
- 0, 50, 150, 500, 1500, 5000 µg/plate
For non-toxic and very soluble compounds, the top concentration used is generally 5000 µg/L (OECD).
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: Potassium dichromate ; 2-anthramine
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
Applicant's summary and conclusion
- Conclusions:
- The test compound induced no mutagenic activity in te four Salmonella typhimurium and the two Escherichia coli strains tested.
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