Registration Dossier
Registration Dossier
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EC number: 218-746-2 | CAS number: 2224-15-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Remarks:
- Japan Existing Chemical Data Base: All the tests reported were performed in accordance with the chemicals GLP under the Law concerning Examination and Regulation of Manufacture, etc. of Chemical Substances and also meet the requirements of the OECD GLP.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-[ethylenebis(oxymethylene)]bisoxirane
- EC Number:
- 218-746-2
- EC Name:
- 2,2'-[ethylenebis(oxymethylene)]bisoxirane
- Cas Number:
- 2224-15-9
- Molecular formula:
- C8H14O4
- IUPAC Name:
- 2,2'-[ethylenebis(oxymethylene)]bisoxirane
- Details on test material:
- weight per epoxy: 115
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- dose-finding study - with and without S9 mix - all strains: 0, 5, 15, 50, 150, 500, 1500, 5000
main study - without S9 mix - TA100, TA1535: 0, 9.77, 19.5, 39.1, 78.1, 156.3, 312.5, 625, 1250, 2500, 5000
main study - without S9 mix - WP2uvrA: 0, 78.1, 156.3, 312.5, 625, 1250, 2500, 5000
main study - without S9 mix - TA98, TA1537: 0, 312.5, 625, 1250, 2500, 5000
main study - with S9 mix - TA100, TA1535: 0, 39.1, 78.1, 156.3, 312.5, 625, 1250, 2500, 5000
main study - with S9 mix - WP2uvrA: 0, 78.1, 156.3, 312.5, 625, 1250, 2500, 5000
main study - with S9 mix - TA98, TA1537: 0, 312.5, 625, 1250, 2500, 5000 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water for injection
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- furylfuramide
- other: 2-aminoanthracene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitates were noted at any concentration on the surface of the agar plate at the start and on completion of incubation
Applicant's summary and conclusion
- Conclusions:
- The test substance tests positive under the conditions of this assay.
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