Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 442-110-5 | 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: Annex V (Ames)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and Escherichia coli WP2uvrA
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 100 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 100 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Dimethylsulfoxide
- 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:
- 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)
- Additional information on results:
- Observations:
Without S9-mix:
In tester strain TA1537, STI571 D6 induced up to 5.8-fold,
dose related, increase in the number of revertant colonies
compared to the solvent control in the first experiment and
up to 2.7-fold, not dose related, increase in the second
experiment.
In the other four tester strains (TA1535, TA98, TA100 and
WP2uvrA), STI571 D6 did not induce a dose-related, two-fold,
increase in the number of revertant colonies in two
independently repeated experiments.
With S9-mix:
In tester strain TA1537, STI571 D6 induced up to 6.5-fold,
dose related, increase in the number of revertant colonies
compared to the solvent control in the first experiment and
up to 3.7-fold, not dose related, increase in the second
experiment. In tester strain TA98, STI571 D6 induced up to
1.4- and 3.9-fold, dose related, increases in the number of
revertant colonies compared to the solvent control in the
first and second experiment, respectively. In tester strain
TA100, STI571 D6 induced up to 5.1- and 6.7-fold, dose
related, increases in the number of revertant colonies
compared to the solvent control in the first and second
experiment, respectively.
In the other two tester strains (TA1535 and WP2uvrA), STI571
D6 did not induce a dose-related, two-fold, increase in the
number of revertant colonies in two independently repeated
experiments.
Based on the results of this study it is concluded that
STI571 D6 is mutagenic in the Salmonella typhimurium reverse
mutation assay and STI571 D6 is not mutagenic in the
Escherichia coli reverse mutation assay. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
positive 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.
