Registration Dossier
Registration Dossier
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EC number: 419-580-5 | CAS number: 13832-70-7
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: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC-Directive 92/69 B.14 Ames test
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 419-580-5
- EC Name:
- -
- Cas Number:
- 13832-70-7
- Molecular formula:
- C48H82O4
- IUPAC Name:
- Olean-12-en-29-oic acid, 3-hydroxy-11-oxo-, octadecyl ester, (3β,20β)- Octadecyl 3-hydroxy-11-oxoolean-12-en-29-oate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9-homogenate.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 10 ... 1000 μg/plate
Concentration range in the main test (without metabolic activation): 10 ... 1000 μg/plate - Vehicle / solvent:
- Solvent: dimethylsulphoxide
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 1000 μg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Salmonella typhimurium TA98, TA100, TA1535 and TA1537
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 μg/plate
- Species / strain:
- other: Salmonella typhimurium TA98, TA100, TA1535 and TA1537
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate
- Species / strain:
- other: Salmonella typhimurium TA98, TA100, TA1535 and TA1537
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1000 μg/plate
- Species / strain:
- other: Salmonella typhimurium TA98, TA100, TA1535 and TA1537
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1000 μg/plate
Applicant's summary and conclusion
- Conclusions:
- negative with metabolic activation
negative without metabolic activation
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