Registration Dossier
Registration Dossier
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EC number: 431-410-1 | CAS number: -
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:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 92/69, Annex V - Method B13 and B14 and OECD No. 471.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix prepared from a liver microsomal fraction (S9 fraction) of rats induced with Arochlor 1254.
- Test concentrations with justification for top dose:
- For the WP2 uvrA Strain:
Concentration range in the main test (without metabolic activation): 312.5 ... 5000 µg/plate
For the WP2 uvrA Strain and TA 98:
Concentration range in the main test (with metabolic activation): 312.5 ... 5000 µg/plate
For the remain strains:
Concentration range in the main test (with metabolic activation): 156.25 ... 2500 µg/plate
Concentration range in the main test (without metabolic activation): 156.25 ... 2500 µg/plate - Vehicle / solvent:
- Solvent: Dimethylsulfoxide (DMSO).
- 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:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1250 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1250 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1250 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1250 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the experimental conditions, the test substance Pseudo Kharismal does not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli. - Executive summary:
Under the experimental conditions, the test substance Pseudo Kharismal does not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli.
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