Registration Dossier
Registration Dossier
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EC number: 812-243-7 | CAS number: 1189352-83-7
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:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-chloro-3-iodo-5-(trifluoromethyl)benzene
- EC Number:
- 812-243-7
- Cas Number:
- 1189352-83-7
- Molecular formula:
- C7 H3 Cl F3 I
- IUPAC Name:
- 1-chloro-3-iodo-5-(trifluoromethyl)benzene
Constituent 1
Method
- Target gene:
- HisD3052 for strain TA98
Species / strainopen allclose all
- Species / strain / cell type:
- other: Salmonella typhimurium mixed strains (TA7001-7006)
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- rfa uvrB +R
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- In the first experiment: 0, 16, 50, 160, 500, 1600, 5000 µg/mL
In the second experiment (only for TA98): 0, 0.016, 0.05, 0.16, 0.5, 1.6, 5 µg/mL - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- other: 2-aminoanthracene
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: Mixed strains of S.typhimurium (TA7001-7006)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: yes without S9-mix at 1000 µg/mL
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: yes without S9-mix at 50 µg/mL and above
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the study, MR-008-2 is not mutagenic in the Bacterial Reverse Mutation Assay.
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