Sodium 2-methyl-2-[(1-oxoallyl)amino]propanesulphonate

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:

1991

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

Test material information

Constituent 1

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

IUPAC Name:

2-(acryloylamino)-2-methylpropane-1-sulfonic acid

Details on test material:

- Name of test material (as cited in study report): OS 61349H
- Molecular formula (if other than submission substance): C7H13NO4S
- Molecular weight (if other than submission substance): 207.25
- Smiles notation (if other than submission substance): O\C(=N/C(C)(C)CS(=O)(=O)O)C=C
- InChl (if other than submission substance): InChI=1/C7H13NO4S/c1-4-6(9)8-7(2,3)5-13(10,11)12/h4H,1,5H2,2-3H3,(H,8,9)(H,10,11,12)
- 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

Method

Target gene:

Histidine operon

Species / strain

Species / strain 1

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 2

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

other: Rfa mutation or ampicillin resistance

Species / strain 3

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 results

Test results 1

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

Test results 2

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

Test results 3

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.