Registration Dossier
Registration Dossier
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EC number: 468-670-0 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 2000/32/EC, B.13/14 OECD 471 (1997)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Method
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone.
- 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: Dimethyl sulfoxide
- Details on test system and experimental conditions:
- Type of bacteria/strain: Salmonella typhimurium reverse mutation assay with four
histidine-requiring strains of Salmonella typhimurium
(TA1535, TA1537, TA100 and TA98) and in the Escherichia coli
reverse mutation assay with a tryptophan-requiring strain
of Escherichia coli WP2uvrA.
Concentration of the test substance resulting in precipitation: 1000 µg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1000 µg/plate)
- Additional information on results:
- Observations:
The test substance did not induce a dose-related, two-fold
increase in the number of revertant (His+) colonies in each
of the four tester strains (TA1535, TA1537, TA98 and TA100)
and in the number of revertant (Trp+) colonies in tester
strain WP2uvrA both in the absence and presence of S9-
metabolic activation. These results were confirmed in an
independently repeated experiment.
In this study, the negative and strain-specific positive
control values were within our laboratory historical control
data ranges indicating that the test conditions were
adequate and that the metabolic activation system functioned
properly. - 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
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