Registration Dossier
Registration Dossier
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EC number: 251-833-3 | CAS number: 34122-40-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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:
- 1,4,4-trimethyl-2,3-diazabicyclo[3.2.2]non-2-ene 2,3-dioxide
- EC Number:
- 251-833-3
- EC Name:
- 1,4,4-trimethyl-2,3-diazabicyclo[3.2.2]non-2-ene 2,3-dioxide
- Cas Number:
- 34122-40-2
- Molecular formula:
- C10H18N2O2
- IUPAC Name:
- 1,4,4-trimethyl-2,3-diazabicyclo[3.2.2]non-2-ene-2,3-diium-2,3-bis(olate)
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Haskel No. 9864-02
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat-liver homogenate activation system (S9)
- Test concentrations with justification for top dose:
- With activation: 10, 12, 24, 36, 48, 60 µg/plate
Without activation: 2, 4, 6, 8, 10 µg/plate - Vehicle / solvent:
- Distilled water
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Positive control for assay in the presence of activation
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Positive control for assay in the absence of activation
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Positive control for assay in the absence of activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Negative control for assay in the absence of activation
- Untreated negative controls:
- yes
- Remarks:
- S9 negative control included in the activated assay to reassure any activity of the compound in the absence of the S9 activator mixture
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- All plates were incubated at 37 °C for 48 hours.
NUMBER OF REPLICATIONS: 2 plates - Statistics:
- Average number of revertants from two plates
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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test item was tested in Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100. The test item was not mutagenic in the microbial assays either in the presence or absence of a liver microsomal system.
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