Registration Dossier
Registration Dossier
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EC number: 616-123-3 | CAS number: 746595-79-9
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:
- key study
- Study period:
- 2004-08-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP study, without quality assurance, but conducted in GLP facilities. Very brief summary report, minimal experimental details reported. Only two strains of S. typhimurium (TA98 and TA100) reported, although title also refers to E.coli. Positive results make more detailed testing unnecessary.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Only two strains of S. typhimurium (TA98 and TA100) and no E. coli were tested. The number of test substance concentrations is not reported. Positive and negative controls are not stated. No details on the experimental procedures and results are given.
- GLP compliance:
- no
- Remarks:
- The study was conducted according to the current version of the UK and the OECD Principles of GLP, though not subject to Quality Assurance audit.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,4,5-oxadiazepane
- EC Number:
- 616-123-3
- Cas Number:
- 746595-79-9
- Molecular formula:
- C4H10N2O
- IUPAC Name:
- 1,4,5-oxadiazepane
- Details on test material:
- - Colour: Slightly yellow
- Expiration date of the lot/batch: 2005-06 (reanalysis date)
- Storage condition of test material: <30°C (under argon, protect from light)
Constituent 1
Method
- Target gene:
- his G46 (TA100)
his D3052 (TA98)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver-derived metabolic activation system (S9-mix)
- Test concentrations with justification for top dose:
- 5000 - 100 microgram / plate
Maximum concentration = limit concentration - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (dimethylsulphoxide, dried)
- Justification for choice of solvent/vehicle: not reported
Controls
- Negative solvent / vehicle controls:
- not specified
- Positive controls:
- not specified
- Remarks:
- Work was conducted using the same facilities and study procedures which are subject to routine inspection under the QA programme; therefore an appropriate set of controls is expected.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 3 days
NUMBER OF REPLICATIONS: not reported
NUMBER OF CELLS EVALUATED: not reported
DETERMINATION OF CYTOTOXICITY
- Method: not reported - Evaluation criteria:
- Not reported
- Statistics:
- Not reported
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- 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:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: strain/cell type: TA98
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
positive both in the presence and absence of S9 mix - Executive summary:
The test material gave positive (mutagenic) responses in two strains of S. typhimurium (TA98 and TA100), both in the presence and in the absence of metabolic activation, under the conditions of the reported assay.
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