Registration Dossier
Registration Dossier
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EC number: 205-793-9 | CAS number: 151-56-4
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific standards, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
- Principles of method if other than guideline:
- Standard NTP protocol
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Aziridine
- EC Number:
- 205-793-9
- EC Name:
- Aziridine
- Cas Number:
- 151-56-4
- Molecular formula:
- C2H5N
- IUPAC Name:
- aziridine
- Details on test material:
- no data
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA100, TA98
- Metabolic activation:
- with and without
- Metabolic activation system:
- induced male Sprague Dawley rat liver S9 (RLI) or induced male Syrian hamster liver S9 (HLI)
- Test concentrations with justification for top dose:
- 0, 0.3, 1, 3, 10, 33, 100, 333, 1000, 3333, 10000 mg/plate
- Vehicle / solvent:
- no data
- Details on test system and experimental conditions:
- Ames test
- Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA100, TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- other: 1000 µg/plate
- Additional information on results:
- In this study it was clearly shown that the number of reverse mutations increased in the strain TA100 with increasing amounts of the test substance. Using 10 µg/plate of the test substance the number of reverse mutations was about 3-fold (without activation) and 4.4-fold (30%RLI) or 5-fold (30%HLI) higher than in the control.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Some representative results are shown in the following tables:
Strain: TA100
Dose(µg/plate) |
No activation |
30% RLI |
30%HLI |
0 |
97 |
103 |
105 |
0.3 |
91 |
108 |
not tested |
1 |
113 |
169 |
not tested |
3 |
158 |
254 |
not tested |
10 |
314 |
451 |
529 |
33 |
553 |
708 |
701 |
Strain: TA98
Dose(µg/plate) |
No activation |
30% RLI |
30%HLI |
0 |
22 |
22 |
26 |
10 |
20 |
21 |
25 |
33 |
21 |
20 |
27 |
100 |
22 |
20 |
31 |
333 |
26 |
31 |
27 |
1000 |
22 (slight tox) |
25 (slight tox) |
31 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
