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EC number: 451-520-3 | 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
- Principles of method if other than guideline:
- Organisation for Economic Co-operation and Development
(OECD), OECD Guidelines for Testing of Chemicals; Guideline
no. 471: "Genetic Toxicology: Bacterial Reverse Mutation
Test" (Adopted July 21, 1997).
European Economic Community (EEC). Directive 2000/32/EC,
Part B: Methods for the Determination of Toxicity; B.13/14:
"Mutagenicity: "Reverse Mutation Test using bacteria". EEC
Publication Commission Directive (Published June 8, 2000).
ICH. Topic S2A Genotoxicity: Guidance on Specific Aspects of
Regulatory Genotoxicity Tests for Pharmaceuticals.
(CPMP/ICH/141/95) Step 4 Guideline (Approved September 1995)
ICH. Topic S2B Genotoxicity: A Standard Battery for
Genotoxicity Testing of Pharmaceuticals. (CPMP/ICH/174/95)
Step 4 Guideline (Approved September 1997). - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Method
- Metabolic activation system:
- S9 liver homogenate from rat treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 33 ... 3330 µg/plate
Concentration range in the main test (without metabolic activation): 33 ... 3330 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: 333 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:
- ( 3330 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:
In this study, the negative and strain-specific 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.
In the absence of S9-mix, in tester strain TA1537,
Chlorosugar induced 12.2-fold, dose-related, increase in the
number of revertant colonies compared to the solvent
control. In tester strain TA98, the test substance induced
up to a 14-fold, dose-related, increase in the number of
revertant colonies compared to the solvent control. In
tester strain WP2uvrA, the test substance induced up to a
10.4-fold, dose-related, increase in the number of revertant
colonies compared to the solvent control. In the tester
strains TA1535 and TA100, the test substance did not induce
a dose-related, two-fold, increase in the number of
revertant colonies.
In the presence of S9-mix in tester strain TA1537,
Chlorosugar induced up to a 7-fold increase in the number of
revertant colonies compared to the solvent control. In
tester strain TA98, the test substance induced up to a 4-
fold increase in the number of revertant colonies compared
to the solvent control. In tester strain WP2uvrA, the test
substance induced up to a 2.4-fold, dose-related, increase
in the number of revertant colonies compared to the solvent
control. In the tester strains TA1535 and TA100, the test
substance did not induce a dose-related, two-fold, increase
in the number of revertant colonies.
Based on the results of this study it is concluded that the
test substance, or its metabolites is mutagenic in the
Salmonella typhimurium reverse mutation assay and 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
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