Registration Dossier
Registration Dossier
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EC number: 239-268-0 | CAS number: 15214-89-8
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:
- 21/05/1991-01/06/1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well document report of a guideline study conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- /OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-acrylamido-2-methylpropanesulphonic acid
- EC Number:
- 239-268-0
- EC Name:
- 2-acrylamido-2-methylpropanesulphonic acid
- Cas Number:
- 15214-89-8
- Molecular formula:
- C7H13NO4S
- IUPAC Name:
- (1Z)-N-(2-methyl-1-sulfopropan-2-yl)prop-2-enimidic acid
- Details on test material:
- - Name of test material (as cited in study report): OS 61349H
- Substance type: organic
- Physical state: solid
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- Histidine operon
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: Rfa mutation or ampicillin resistance
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: Rfa mutation or ampicillin resistance
- Species / strain / cell type:
- E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 microsomal fraction obtained from the liver harvested from rats 5 days following a single intraperitoneal injection of Aroclor 1254
- Test concentrations with justification for top dose:
- 0; 15; 50; 150; 500; 1500 and 5000 microgram/plate
- Vehicle / solvent:
- - Vehicle used: water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile water or DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 9-aminoacridine, sodium azide, N-ethyl-N' -nitro-N-nitrosoguanidine, 2-nitrofluorene depending on the bacterial strain and activation parameters
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS: 3
- Statistics:
- The mean number of revertants per plate and the standard deviation was calculated for each concentration and strain.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slightly toxic to all strains at 5000 microgram/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slightly toxic at 5000 microgram/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slightly toxic at 5000 microgram/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test substance was slightly toxic to all Salmonella strains at the highest dose used (5000 microgram/plate) both with and without metabolic activation. For all bacterial strains tested there was no significant increase in the number of revertants at any dose of test material when compared to thecorresponding negative solvent control. The entire assay was repeated and the results seen in the first experimentwere confirmed. The positive and control solvent control forall experiments were within established historical ranges foreach bacterial strain utilized.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance did not produce a signifIcant increase in the number of revertants, with and without metabolic activation in any test strain.
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