Registration Dossier
Registration Dossier
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EC number: 412-440-4 | CAS number: 2725-22-6
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:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 412-440-4
- EC Name:
- -
- Cas Number:
- 2725-22-6
- Molecular formula:
- C33-H39-N3-O2
- IUPAC Name:
- 2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol
Constituent 1
Method
- Target gene:
- Not specified
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium, TA98, TA100, TA1535, and TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver microsomal enzymes from male Spraque-Dawley rats
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 667...10000 μg/plate
Concentration range in the main test (without metabolic activation): 667...10000 μg/plate - Vehicle / solvent:
- Solvent: Acetone
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 667 μg/plate
- Rationale for test conditions:
- not specified
- Evaluation criteria:
- not specified
- Statistics:
- not specified
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 μg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 μg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >10000 μg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >10000 μg/plate
- Additional information on results:
- Observations:
The vihicle control value for tester strain TA98 in the presence of microsomal enzymes was outside the acceptable range. Therefore, tester strain TA98 was retested in the presence of microsomal enzymes. - Remarks on result:
- other: other: preliminary test
Applicant's summary and conclusion
- Conclusions:
- Gene mutation test was performed according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) to determine the mutagenic nature of the test chemical. No cytotoxicity was observed till 10000 μg/plate dose range. Thus the test chemical was considered to be not mutagenic in nature.
- Executive summary:
Gene mutation test was performed according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) to determine the mutagenic nature of the test chemical. Salmonella typhimurium, TA98, TA100, TA1535, and TA1538 starins were used with and without metabolic activation system obtained from Liver microsomal enzymes from male Spraque-Dawley rats. Concentration range in the main test (with metabolic activation): 667 to 10000 μg/plate and Concentration range in the main test (without metabolic activation): 667 to 10000 μg/plate were used. No cytotoxicity was observed till 10000 μg/plate dose range. Thus the test chemical was considered to be not mutagenic in nature.
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