Registration Dossier
Registration Dossier
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EC number: 408-050-9 | CAS number: 76855-69-1 4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
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:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V, B13/14
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
- EC Number:
- 408-050-9
- EC Name:
- (2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
- Cas Number:
- 76855-69-1
- Molecular formula:
- C13H25NO4Si
- IUPAC Name:
- (2R,3R)-3-[(1R)-1-[(tert-butyldimethylsilyl)oxy]ethyl]-4-oxoazetidin-2-yl acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 derived from phenobarbital/B-naphthoflavone-induced Sprague Dawley rats
- Test concentrations with justification for top dose:
- in main test (with metabolic activation): 100... 5000 ug/plate
in main test (without metabolic activation): 100... 5000 ug/plate - Vehicle / solvent:
- solvent: dried dimethylsulphoxide
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 ug/plate
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 ug/plate
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: preliminary test
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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