Registration Dossier
Registration Dossier
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EC number: 500-051-3 | CAS number: 26780-96-1
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- The objective of this study was to evaluate the test compound for genetic activity in microbial assayson Salmonella typhimurium strain TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae strain D4 with and without the addition of mammalian metabolic activation preparations.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,2-Dihydro-2,2,4-trimethylquinoline, oligomers
- EC Number:
- 500-051-3
- EC Name:
- 1,2-Dihydro-2,2,4-trimethylquinoline, oligomers
- Cas Number:
- 26780-96-1
- Molecular formula:
- (C12H15N)x
- IUPAC Name:
- 2,2,4-trimethyl-1,2-dihydroquinoline
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- light brown powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium strain TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae strain D4
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 0.5, 5.0, 50, 250 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: nonactivation: methylnitrosoguanidine, 2-nitrofluorene, quinacrine mustard; activation: 2-anthramine, 2-acetylaminofluorene, 8-aminoquinoline, dimethylnitrosamine
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium strain TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae strain D4
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Salmonella typhimurium strain TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae strain D4
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
RESULTS
The test compound, BI0-76-109 FLECTOL H, Lot 5E866, was examined for mutagenic activity in a series of in vitro microbial assays employing Salmonella and Saccharomyces-indicator organisms. The compound was tested directly and in the presence of liver microsomal enzyme preparations from Aroclor-induced rats. The following results were obtained:
A. Toxicity
The compound was tested over a series of concentrations such that there was evidence of some chemically-induced physiological
effects at the high dose level. The low dose in all cases was below a concentration that demonstrated any toxic effect. The dose range employed for the evaluation of this compound was from 0.5 µg ~ 250 µg per plate.
B. Nonactivation Test Results
The results of the tests conducted on the compound in the absence of a metabolic system were all negative.
C. Activation Test Results
The results of the tests ·conducted on the compound in the presence of the rat liver activation system were all negative.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
The objective of this study was to evaluate the test compound for genetic activity in microbial assayson Salmonella typhimurium strain TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae strain D4 with and without the addition of mammalian metabolic activation preparations.
The test compound, BIO-76-109 FLECTOL H, Lot 5E866, did not demonstrate mutagenic activity in any of the assays conducted
in this evaluation and was considered not mutagenic under these test conditions.
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