Registration Dossier
Registration Dossier
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EC number: 208-494-1 | CAS number: 530-78-9
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:
- other information
- Study period:
- Feb 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Flufenamic acid
- EC Number:
- 208-494-1
- EC Name:
- Flufenamic acid
- Cas Number:
- 530-78-9
- Molecular formula:
- C14H10F3NO2
- IUPAC Name:
- 2-{[3-(trifluoromethyl)phenyl]amino}benzoic acid
- Details on test material:
- Flufenamic acid, batch number BXR2GXS, 99% content
Constituent 1
Method
- Target gene:
- histidin gene locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Flufenamic acid: 16-5000 µg/plate without S9; 5-1581 µg/plate with S9
Sodium-azide: 10 µg/plate (TA 1535)
Nitrofurantoin: 0.2 µg/plate (TA 100)
4-Nitro-1,2-phenylene diamine: 10 µg/plate (TA 1537), 0.5 µg/plate (TA 98)
Mitomycin C: 0.2 µg/plate (TA 102 in plate incorporation trials)
Cumene hyperoxide: 50 µg/plate (TA 102 in preincubation trials)
2-Aminoanthracene: 3 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Remarks:
- No solvent control was used since sufficient evidence was available in the literature and from testing laboratory experience, indicating that the solvents used had no influence on the spontaneous mutant counts of the used strains.
- Positive controls:
- yes
- Positive control substance:
- other: Sodium-azide, Nitrofurantoin, 4-Nitro-1,2-phenylene diamine, Mitomycin C, Cumene hyperoxide, 2-Aminoanthracene
Results and discussion
Test results
- Species / strain:
- 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:
- There was no indication of a bacteriotoxic effect at doses of up to and including 16 µg/plate. Higher doses had a strain-specific bacteriotoxic effect; therefore, they could only be used for assessment purposes up to and including 500 µg/plate.
- 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
- Executive summary:
Flufenamic acid was initially investigated using the Salmonella/microsome plate incorporation test for point-mutagenic effects in doses up to and including 5000 µg/plate without S9 mix and up to and including 1581 µg/plate with S9 mix on the five histidine-auxotrophic Salmonella typhimurium LT2 strains TA 1535, TA 100, TA 1537, TA 98 and TA 102. The independent repeat was performed as preincubation for 20 minutes at 37°C at doses of up to and including 1300 µg/plate.
There was no indication of a bacteriotoxic effect of Flufenamic acid at doses of up to and including 16 µg/plate. No inhibition of growth was noted as well. Higher doses had a strain-specific bacteriotoxic effect. Therefore, they could only be used for assessment purposes up to and including 500 µg/plate. At 1581 µg/plate the substance precipitated.
No evidence of mutagenic activity of Flufenamic acid was found without and with S9 mix.
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