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Registration Dossier
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EC number: 842-055-0 | CAS number: 2356133-42-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 June to 29 June 2001
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: TOX-GEN-MUT-005
- Version / remarks:
- Internal Eli lilly procedure
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6-(1-methylpiperidine-4-carbonyl)pyridin-2-amine dihydrate dihydrochloride
- EC Number:
- 842-055-0
- Cas Number:
- 2356133-42-9
- Molecular formula:
- C12H17N3O.2HCl.2H2O
- IUPAC Name:
- 6-(1-methylpiperidine-4-carbonyl)pyridin-2-amine dihydrate dihydrochloride
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- S9 fraction prepared from the livers of Aroclor 1254-induced rats.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Concentrations for 312.5, 625, 1250, 2500 and 5000ug/plate were selected based on the result of a preliminary range-finding assay
- Vehicle / solvent:
- DMSO
Controls
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- Agar plates are prepared prior to study initiation and maintained at room temperature for approximately 1 week or refrigerated for up to 1 month until sued. Test concentrations used in the mutagenicity assay were selected based on a preliminary range-finding assay of the test article with S. typhimurium strains TA98, TA100, TA1535, TA1537 and Esxherichia coli WP2uvrA. Test concentrations selected for this study are listed in the Doser Level Seciton. On the day prior to study initiation, a cultre of each baterial strain is inoculated and incubated overnight. Top agar is prepared prior to study iniiation. Just prior to plate incorporation, an S9 mix is prepared for metabolic activiation and is maintained on ice throughout the plating procedure.
- Evaluation criteria:
- The vehicle control (DMSO, water or other appropriate vehicle control) must show a normal range of bacterial colonies for each baterial strain and should be consistent with historical data. The positive controls (MNNG, 2NF, 9AmAc and 2AA) must show a mutagenic response and should be consistent with historical data. In the absence of toxicity or precipitation, a maximum treatment concentration of 5000ug/plate is considered sufficient high to support study validity.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
Applicant's summary and conclusion
- Conclusions:
- The substance was not mutagenic without or with metabolic activation in the Ames S.typhimurium/E. coli bacterial mutation assay.
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