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EC number: 440-780-3 | 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)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: SAT: TA1535, TA1537,TA100 et TA98 ECW: WP2uvrA
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 3 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 3 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: DMSO
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- other: See Conclusions
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- other: See Conclusions
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1000 µg/plate)
- Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that the substance is mutagenic in the Salmonella typhimurium reverse mutation assay and that is not mutagenic in the Escherichia coli reverse mutation assay.
- Executive summary:
The substance was tested in the 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 typhimurium-requiring strain of Escherichia coli WP2uvrA in two independent experiments, modified according to Prival and Mitchell. In the dose range finding test, BLUE MOP 6314 was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The substance did not precipitate on the plates at this dose level. Toxicity was observed in tester strain TA100. In the first mutation assay was tested up to concentrations of 5000µg/plate in
the absence and presence of S9-mix in the strains TA1535, TA1537 and TA98. Toxity was observed in the absence of S9-mix.
In the second mutation assay, BLUE MOP 6314 was tested up to concentrations of 3330 and 5000µg/plate in the absence and presence of S9-mix respectively in the strains TA1535, TA1537, TA98 and TA100. BLUE MOP 6314 was tested up to concentrations of 5000µg/plate in strain WP2uvrA.
In the absence of S9-mix in tester strain TA1537 induced up to 36 - and 27 -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 TA98 induced up to 106- and 60-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
induced an up to 2.2-fold, dose related, increase in the number of revertant colonies compared to the solvent control in the first experiment only.
In the presence of S9-mix in tester strain TA1537 induced up to 9.6- and 49-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 TA98 induced up to 29- and 26-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 induced an up to 3.4-fold, dose related, increase in the number of revertant colonies compared to the solvent control in the first experiment only.
In the other two tester strains (TA1535 and WP2uvrA) in the absence and presence of S9-mix did not induce a dose-related increase in the number of revertant colonies in two independently repeated experiments.
Based on the results of this study it is concluded that the substance is mutagenic in the Salmonella typhimurium reverse mutation assay and that it is not mutagenic in the Escherichia coli reverse mutation assay.
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