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EC number: 939-538-4 | CAS number: 1471313-87-7
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
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study acoording to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- sodium 2-[(9E)-N-methyloctadec-9-enamido]ethane-1-sulfonate
- EC Number:
- 939-538-4
- Cas Number:
- 1471313-87-7
- Molecular formula:
- not applicable
- IUPAC Name:
- sodium 2-[(9E)-N-methyloctadec-9-enamido]ethane-1-sulfonate
- Test material form:
- other: solid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA 97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- post-mitochondrial (S9) fraction of induced rat liver
- Test concentrations with justification for top dose:
- TA 97a: 0.0016 - 0.16 mg/plate (-S9), 0.016 - 1.6 mg/plate (+S9)
TA 98: 0.05 - 5 mg/plaze (+/-S9)
TA 100: 0.016 - 1.6 mg/palte (+/-S9)
TA 102: 0.05 - 5 mg/plate (+/-S9)
TA 1535: 0.016 - 1.6 mg/plate (+/-S9) - Vehicle / solvent:
- Bidistilled water
Controls
- Untreated negative controls:
- yes
- Remarks:
- aqua bidest
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- cumene hydroperoxide
- other: 4-nitro-o-phenylenediamine, nitrofurantoine, 2-aminoanthracene, danthron, ICR 191
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS: 3
- Evaluation criteria:
- Induction rate of mean values from revertant colonies of test item and revertant colonies of corresponding control
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA 97a
- 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 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 TA 100
- 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 TA 102
- 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 TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Hostapon TPHC is not point mutagenic in the Ames test
- Executive summary:
The point mutagenic effects of sodium methyl oleyl taurate were investigated in the reverse bacterial mutation assay (Ames tets) according to OECD TG 471 in two independent studies following the principles of GLP. Test systems used were Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 with and without the metabolic activation system S9 from induced rat liver. Positive and negative controls had been included. Duration of each study was 48 hours. The test item was dissolved in bidestilled water and applied once at concentrations between 0.0016 mg/plate up to 5.0 mg/plate (depending on cytotoxicity). Under the conditions of this test, no increase in revertant colonies in any of the tester strains were obderved. Based hereupon, it is concluded that the test item is not mutagenic in this bacterial test system.
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