Registration Dossier
Registration Dossier
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EC number: 421-450-8 | CAS number: 154702-15-5
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:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: information provided by ECHA
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Section 4 subpart 471 (1981) and subsequent revisions. EEC B14, Section 4.3.1
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 421-450-8
- EC Name:
- -
- Cas Number:
- 154702-15-5
- Molecular formula:
- C44H59N7O5
- IUPAC Name:
- 2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: S.TYPHIMURIUM REVERSE MUTATION ASSAY, duplicate test (Ames test). STR AINS N. TA1535, 1537, 1538, 98 and 100- bacteria
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction (9000 g supernatant) was prepared form adult male SPRAGUE DAWLEY rats pretreated by intraperitoneal route at 500 mg/kg with Aroclor 1254 (Alltech). S9 mix consisted of S9 plus cofactors.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): >= 15 ... <= 1500 µg/plate
Concentration range in the main test (without metabolic activation): >= 15 ... <= 1500 µg/plate - Vehicle / solvent:
- Solvent: Ethanol to obtain a 50 mg
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 µg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1500 µg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1500 µg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (CA 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (CA 5000 µg/plate)
- Additional information on results:
- Observations:
Duplicate observations performed, setting up triplicate plates for each experimental points.
Hydrazine sulphate, 9-Aminoacridine HCl monohydrate,2-Nitrofluorene, Doxorubicine HCl,
2-Aminofluorene and 2-Aminoanthracene served as positive controls to test the mutagenicity of the bacterial strains as well as the activity of the metabolizing system. - Remarks on result:
- other: no mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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