Registration Dossier
Registration Dossier
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EC number: 807-112-6 | CAS number: 1393708-17-2
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:
- July 2014 - Sep. 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- LAUS GmbH Auf der Schafweide 20 D-67489 Kirrweiler
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(diethylcarbamoyl)-1-(3-sulfonatopropyl)pyridin-1-ium
- EC Number:
- 807-112-6
- Cas Number:
- 1393708-17-2
- Molecular formula:
- C13H20N2O4S
- IUPAC Name:
- 3-(diethylcarbamoyl)-1-(3-sulfonatopropyl)pyridin-1-ium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PYRIDINIUMSULFONATE
- Substance type: white powder with lumps
- Analytical purity: 99.8 % (HPLC)
- Composition of test material, percentage of components: Pure substance
- Lot/batch No.: CHZT000001
- Expiration date of the lot/batch: Feb. 2016
- Storage condition of test material: min. - 5 °C - max. +40 °C
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix, rat liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- 5000 / 1500 / 500 / 150 / 50 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine, 2-Amino-anthracene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive - Executive summary:
The test item showed mutagenic effects in the experiment. The number of revertant colonies was increased in comparison with the spontaneous revertants in the treatments with and without metabolic activation using the strains TA100 and TA1535. The last mutagenic concentration was 500 μg/plate. A dose-response-relationship was detected.
The test item showed no precipitates on the plates in all tested concentrations.
Cytotoxicity of the test item was not detected. The bacterial background lawn was visible and the number of revertants was not significantly decreased.
Therefore, it can be stated, that under the test conditions, the test item is mutagenic in the strains TA100 and TA1535 in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535.
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