Registration Dossier
Registration Dossier
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EC number: 452-830-1 | CAS number: -
Toxicological information
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 452-830-1
- EC Name:
- -
- Molecular formula:
- C27 H44 N2 Na2 O6 S3
- IUPAC Name:
- Equimolecular mixture of - Disodium 2-Hexadecylsulfanyl-1-(4-sulfo-butyl)-1H- benzoimidazole-5-sulfonate - Disodium 2-Hexadecylsulfanyl-3-(4-sulfo-butyl)-1H- benzoimidazole-5-sulfonate
Constituent 1
Method
- Target gene:
- histidine-requiring Salmonella typhimurium TA98, TA100, TA1535 and TA1537
tryptophan-requiring Escherichia coli WP2uvrA
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: histidine-requiring
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: tryptophan-requiring
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix induced by a combination of phenobarbital and bèta-naphthoflavone
- Test concentrations with justification for top dose:
- Concentration range in the dose range finding test (without and with 5% S9-metabolic activation): 3 ... 5000 µg/plate
Concentration range in the first main test (without metabolic activation): 3 ... 333 µg/plate
Concentration range in the first main test (with 5% S9-metabolic activation): 3 ... 1000 µg/plate
Concentration range in the second main test (without metabolic activation): up to 333 µg/plate (TA100), up to 666µg/plate (TA1535, TA1537, TA98), up to 5000µg/plate (WP2uvrA)
Concentration range in the second main test (with 10% S9-metabolic activation): up to 1000 µg/plate (TA100), up to 2000µg/plate (TA1535, TA1537, TA98), up to 5000µg/plate (WP2uvrA)
Concentration range in the third main test (without metabolic activation): up to 3330 µg/plate (TA1535)
Concentration range in the third main test (with 5% S9-metabolic activation): up to 5000 µg/plate (TA1535, TA1537, TA100) - Vehicle / solvent:
- dimethyl sulfoxide (test substance was suspended in this vehicle at concentrations of 20mg/ml and higher, but was dissolved in dimethyl sulfoxide at concentrations of 10mg/ml and lower)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- dimethyl sulfoxide
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- positive control for TA1535 without metabolic activation Migrated to IUCLID6: dissolved in saline
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- positive control for TA1537 without metabolic activation Migrated to IUCLID6: dissolved in milli-q water
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- positive control for TA98 without metabolic activation Migrated to IUCLID6: dissolved in dimethyl sulfoxide
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- positive control for TA100 without metabolic activation Migrated to IUCLID6: dissolved in dimethyl sulfoxide
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- positive control for WP2uvrA without metabolic activation Migrated to IUCLID6: dissolved in dimethyl sulfoxide
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene dissolved in dimethyl sulfoxide
- Remarks:
- for all strains with metabolic activation
- Details on test system and experimental conditions:
- The test substance did not precipitate on the plates at the top dose of 5000µg/plate.
- Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
1. the total number of revertants in tester strain TA100 is not greater than two times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 and WP2uvrA is not greater than three times the concurrent control.
2. the negative response should be reproducible in at least one independently repeated experiment
A test substance is considered positive (mutagenic) in the test if:
1. The total number of revertants in tester strain TA100 is greater than two times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three times the concurrent control.
2. the positive response should be reproducible in at least one independently repeated experiment.
These criteria are not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=100µg/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=1000µg/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at highest tested concentration
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1535 and TA1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at highest tested concentration
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1535 and TA1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- bacteria, other: TA1535 and WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1537 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1535, TA1537 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: preliminary test: dose range finding test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- The test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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