Registration Dossier
Registration Dossier
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EC number: 230-939-3 | CAS number: 7378-99-6
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:
- supporting study
- Study period:
- April
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: only two strains
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Dimethyl(octyl)amine
- EC Number:
- 230-939-3
- EC Name:
- Dimethyl(octyl)amine
- Cas Number:
- 7378-99-6
- Molecular formula:
- C10H23N
- IUPAC Name:
- dimethyl(octyl)amine
- Details on test material:
- - Stability under test conditions: no determinations of stability
- Storage condition of test material: at ambient temperature until required
Constituent 1
Method
- Target gene:
- Histidine-requiring gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Metabolic activation system:
- 2-Aminofluorene (10µg/plate)
- Test concentrations with justification for top dose:
- A solution of the substance was prepared in ethanol at 50mg/mL, and four half-long dilutions were prepared from this solution. Aliquots (0.1mL) of each concnetration of the substance were placed in sterile tubes.
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material did not exhibit any mutagenic activity under the conditions of test. - Executive summary:
The material was examined for mutagenic activity in two histidinedependent auxotrophs of Salmonella typhimurium, strains TA 98 and TA100, using pour-plate assays. The studies, which were conducted in the presence and absence of an activating system derived from rat liver (S-9mix), employed a range of levels of the substance from 50 to 5000µg per plate, selected following a preliminary toxicity test in strain TA98. The tests included solvent (ethanol) controls with and without S-9 mix. Marked increases in the number of revertant colonies were inducted by the known mutagens benzo(a)pyrene, 2 -nitrofluorence and sodium azide when examined under similar conditions. It was concluded that the substance did not exhibit any mutagenic activity under the conditions of the test.
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