Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
