Sodium prop-2-enesulphonate

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium prop-2-enesulphonate

EC Number:

219-676-5

EC Name:

Sodium prop-2-enesulphonate

Cas Number:

2495-39-8

Molecular formula:

C3H6O3S.Na

IUPAC Name:

sodium prop-2-ene-1-sulfonate

Details on test material:

Name of test item: Golpanol ALS wasserfrei
Test item No.: 09/0505-1
Batch identification: 04749356P0
Purity/composition: Mixture, contents of main components: Golpanol ALS 71.3 %, NaCl 26.0 % (for details see analytical data, study code 09L00332)
Physical state, appearance: Solid, white
Storage conditions: Room temperature

Method

Target gene:

His: Salmonella
Trp: E. coli

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

0; 20; 100; 500; 2 500 and 5 000 μg/plate (SPT)
0; 312.5; 625; 1 250; 2 500 and 5 000 μg/plate (PIT)

Vehicle / solvent:

Water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: see "Details on test system"

Details on test system and experimental conditions:

Positive controls:
With S9 mix:
• 2-aminoanthracene (2-AA)
- 2.5 μg/plate, dissolved in DMSO
- strains: TA 1535, TA 100, TA 1537, TA 98
- 60 μg/plate, dissolved in DMSO
- strain: Escherichia coli WP2 uvrA
Without S9 mix:
• N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- 5 μg/plate, dissolved in DMSO
- strains: TA 1535, TA 100
• 4-nitro-o-phenylenediamine (NOPD)
- 10 μg/plate, dissolved in DMSO
- strain: TA 98
• 9-aminoacridine (AAC)
- 100 μg/plate, dissolved in DMSO
- strain: TA 1537
• 4-nitroquinoline-N-oxide (4-NQO)
- 5 μg/plate, dissolved in DMSO
- strain: E. coli WP2 uvrA

Number of Replications: 3 test plates per dose or per control

Evaluation criteria:

Generally, the experiment is considered valid if the following criteria are met:
• The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain
• The sterility controls revealed no indication of bacterial contamination.
• The positive control items both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
• The titer of viable bacteria was ≥ 10e8/mL.
The test item is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test item is generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: see "Additional information on results"

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

- Solubility: No test item precipitation was found with and without S9 mix.
- Toxicity: A weak bacteriotoxic effect (slight decrease in the number of his+ revertants) was observed in the standard plate test only with the strain TA 1535 at 5 000 μg/plate. In the preincubation assay no bacteriotoxicity (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed up to the highest required concentration.
-Conclusion: The test substance Golpanol ALS wasserfrei is not a mutagenic test item in the bacterial reverse mutation test in the absence and the presence of metabolic activation. See table 1 for further information

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Number of revertants in the control or after treatment with test substance indicated as maximum revertant factor in the a.) Standard Plate Test and b.) Preincubation Test

a.) Standard plate test (20 - 5000 µg/plate)
Strain	Metabolic activation system	mean revertants in Controls	maximum revertant factor	dose dependency	Assessment
TA 1535	no	18	1.0	no	negative
	yes	18	1.1	no	negative
TA 100	no	113	1.0	no	negative
	yes	115	1.2	no	negative
TA 1537	no	7	1.1	no	negative
	yes	9	1.0	no	negative
TA 98	no	29	1.0	no	negative
	yes	34	0.9	no	negative
E. coli WP2 uvrA	no	43	1.0	no	negative
	yes	48	1.1	no	negative
b.) Preincubation test (312.5 - 5000 µg/plate)
Strain	Metabolic activation system	mean revertants in Controls	maximum revertant factor	dose dependency	Assessment
TA 1535	no	17	1.1	no	negative
	yes	18	1.1	no	negative
TA 100	no	98	1.0	no	negative
	yes	110	1.0	no	negative
TA 1537	no	9	0.9	no	negative
	yes	10	1.1	no	negative
TA 98	no	28	1.2	no	negative
	yes	37	1.0	no	negative
E. coli WP2 uvrA	no	35	1.1	no	negative
	yes	40	1.1	no	negative