Sodium 2-methylprop-2-ene-1-sulphonate

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: EC B.14 study under GLCP, but study protocol dates back to 1992 (no E. coli strains included)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-methylprop-2-ene-1-sulphonate

EC Number:

216-341-5

EC Name:

Sodium 2-methylprop-2-ene-1-sulphonate

Cas Number:

1561-92-8

Molecular formula:

C4H8O3S.Na

IUPAC Name:

sodium 2-methylprop-2-ene-1-sulfonate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Natriummethallysulfonat
- Substance type: organic
- Physical state: solid
- Analytical purity: 99.8
- Impurities (identity and concentrations): not identified
- Composition of test material, percentage of components: pure
- Isomers composition: not appliacble
- Purity test date: 23-0601992
- Lot/batch No.: Ch 92/0650
- Expiration date of the lot/batch: indefinite
- Stability under test conditions: stable
- Storage condition of test material: no specific conditions

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

phenobarbital-induced liver microsomes

Test concentrations with justification for top dose:

0, 40, 200, 1000. 5000 microgr/plate

Vehicle / solvent:

water

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

fotr TA 98 and TA 1583

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

for TA 100 and 1535

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

for TA 1537

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

for TA100

Details on test system and experimental conditions:

pre-icubation test with and without S9 mix, 30 minuts at 30 degr C
Main test with and without S9-mix, incubation time 96 minutes at 37 degr. C ; three plates per concentration; independent repeat

Evaluation criteria:

any statistically significant increase in mutation frequency

Statistics:

not specified

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:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

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:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

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

main test:

	Mutation frequency quotient (relative to vehicle control)
	TA98		TA100		TA1538		TA1537		TA1538
Dose µgr/plate	S9 -	S9 +	S9 -	S9 +	S9 -	S9 +	S9 -	S9 +	S9 -	S9 +
Water	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0
8	0.9	1.3	0.9	0.9	1.1	0.9	1.5	1.1	0.8	1.0
40	1.1	1.2	0.9	1.1	1.0	1.1	1.5	1.1	1.0	1.0
300	1.0	1.3	1.0	1.1	0.8	1.1	1.1	1.1	1.0	1.2
1000	1.0	1.3	1.0	0.8	0.8	0.8	1.3	1.2	1.2	1.2
5000	1.0	1.3	1.0	1.0	0.9	1.0	0.8	1.1	1.1	1.2
Nitrofluorene	2.9								3.4
Sodium azide			4.0		36.8
cyclophosfamide			1.0	2.2
Aminoacridine							9.3

Independent repeat:

	Mutation frequency quotient (relative to vehicle control)
	TA98		TA100		TA1538		TA1537		TA1538
Dose µgr/plate	S9 -	S9 +	S9 -	S9 +	S9 -	S9 +	S9 -	S9 +	S9 -	S9 +
Water	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0	1.0
8	1.0	0.9	1.0	0.9	0.9	1.0	0.9	1.0	1.1	1.0
40	0.9	1.0	1.0	1.0	0.9	0.9	1.0	0.8	1.0	0.9
300	1.0	0.9	0.9	1.0	1.2	1.1	1.0	0.6	1.1	0.9
1000	1.1	1.1	1.0	1.0	0.9	0.7	0.8	0.8	1.0	1.1
5000	0.8	0.8	1.0	1.0	1.1	0.9	1.3	1.3	1.0	1.1
Nitrofluorene	2.3								2.6
Sodium azide			3.6			38.3
cyclophosfamide			1.1	2.7
Aminoacridine							4.1

Applicant's summary and conclusion

Conclusions:

Substance is not mutagenic in a bacterial reverse mutation assay in concentrations up to 5000 microgram per plate

Executive summary:

Substane was tested in a bacterial reverse mutatuin assy with strains TA 98, 100, 1535, 1537 and 1538, with and without phenobarbital-induced S9 mix, with the apprpriate positive controls per strain.

Substance is not mutagenic in this bacterial reverse mutation assay in concentrations up to 5000 microgram per plate