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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from test report
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 473 and B.10 EEC Method concil Dir. 67/548 17th Amendment
- Principles of method if other than guideline:
- Data is from test report
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cytogenicity (B10)
Test material
- Reference substance name:
- -
- EC Number:
- 421-450-8
- EC Name:
- -
- Cas Number:
- 154702-15-5
- Molecular formula:
- C44H59N7O5
- IUPAC Name:
- Bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl)anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate
- Reference substance name:
- bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl) anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate
- IUPAC Name:
- bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl) anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate
- Details on test material:
- CAs No: 154702-15-5
Chemical Name: Bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl)anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate
Nature of the chemical: Organic
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): >= 5 ... <= 2500 μg/ml
Concentration range in the main test (without metabolic activation): >= 5 ... <= 2500 μg/ml - Vehicle / solvent:
- DMSO
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 18 hours
Expression time: 14 Hours
Fixation time: 18 and 32 Hours.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 2500 μg/ml)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 2500 μg/ml)
- Species / strain:
- mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 833 μg/ml)
- Species / strain:
- mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 833 μg/ml)
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
In neither chromosome aberration tests, RA3643 induced a biologically relevant and statistically significant increase in the percentage of cells with structural chromosome aberrations at any of the concentrations and time points analysed, when compared with the vehicle control value.
Positive control substance were Cyclophosphamide (in the presence of S-9) and Mitomycin C (in the absence of S-9) respectively. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
other: negative with and witout metabolic activation
The test material shows negative genetic toxicity with and without metabolic activation on mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test - Executive summary:
The test material shows negative genetic toxicity with and without metabolic activation on mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test
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