Registration Dossier
Registration Dossier
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EC number: 221-221-0 | CAS number: 3033-77-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- 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: Study well documented, meets generally accepted scientific rinciples, acceptable for risk assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxic effects of glycidyltrimethylammonium chloride.
- Author:
- Vleminckx C, Arany J, Hendrickx B, Moens W
- Year:
- 1 987
- Bibliographic source:
- Mutation Research, Vol. 189, 387-394
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Principles of method if other than guideline:
- Method: other: OECD-Guidelines, modified
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2,3-epoxypropyltrimethylammonium chloride
- EC Number:
- 221-221-0
- EC Name:
- 2,3-epoxypropyltrimethylammonium chloride
- Cas Number:
- 3033-77-0
- Molecular formula:
- C6H14NO.Cl
- IUPAC Name:
- N,N,N-trimethyl(oxiran-2-yl)methanaminium chloride
- Details on test material:
- > 97 % Quab 151
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- 0, 5, 10, 20, 50, 100 µg/ml
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- not specified
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- other: 50 µg/ml
- Remarks on result:
- other: other: Chinese hamster, ovary cells (CHO)
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
| Concentration µg/ml | percentage aberrations excluding gaps | MI |
| 0 | 8 | 10.4 |
| 5 | 9 | 7.7 |
| 10 | 15 | 8.3 |
| 20 | 20 | 6.5 |
| 50 | 35 | 6.0 |
| 100 | 42 | 3.1 |
| positive control 0.02 | 30 | 5.5 |
| positive control 0.10 | 74 | 2.8 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive without metabolic activation
In a study similar to OECD 473, EPTAC was tested without activation and produced an increase in the percentage of cells with aberrations. It is concluded the the test substance is positive under the conditions of the test.
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