Registration Dossier
Registration Dossier
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EC number: 807-880-2 | CAS number: 1125812-54-5
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-[(4-acetylnaphthalen-1-yl)formamido]-N-(2,2,2-trifluoroethyl)acetamide
- EC Number:
- 807-880-2
- Cas Number:
- 1125812-54-5
- Molecular formula:
- C17H15F3N2O3
- IUPAC Name:
- 2-[(4-acetylnaphthalen-1-yl)formamido]-N-(2,2,2-trifluoroethyl)acetamide
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium, other: 7001-7006
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 7 concentrations from 0, 16, 50, 160, 500, 1600 and 5000 µg/mL
- Vehicle / solvent:
- DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- other: 2-aminoanthracene (+S9 mix)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: 7001-7006
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
Applicant's summary and conclusion
- Conclusions:
- The intermediate MR-008-4 is not mutagenic
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