Registration Dossier
Registration Dossier
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EC number: 619-511-0 | CAS number: 141573-96-8
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid
- EC Number:
- 700-093-4
- Cas Number:
- 176969-34-9
- Molecular formula:
- C6H6F2N2O2
- IUPAC Name:
- 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid
- Reference substance name:
- 700-393-4
- IUPAC Name:
- 700-393-4
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix of Aroclor 1254 induced rats
- Test concentrations with justification for top dose:
- 16, 50, 158, 500, 1581 and 5000 µg/plate
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C, cumene hydroperoxide and 2-aminoanthracene
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At doses > 500mg/plate, the substance had a weak strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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):
negative
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