Disodium C-isodecyl sulphonatosuccinate

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:

April 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test was conducted according to OECD/EC guidelines and GLP principles. Test substance applied as received.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Version / remarks:

including METI, MHLW and MAFF

Deviations:

no

Principles of method if other than guideline:

No info on version of guidelines used (year).

GLP compliance:

yes (incl. QA statement)

Remarks:

issued 2 December 2002

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium C-isodecyl sulphonatosuccinate

EC Number:

253-452-8

EC Name:

Disodium C-isodecyl sulphonatosuccinate

Cas Number:

37294-49-8

Molecular formula:

C14H26O7S.2Na

IUPAC Name:

disodium 4-[(2-methylnonyl)oxy]-4-oxo-3-sulfonatobutanoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): PRODUCT XSM 2697 (CT-825-05)
- Physical state: clear, colourless slightly viscous liquid
- Purity: Mixture - tested "as sold"
- Storage condition of test material: Room temperature in the dark

Method

Target gene:

Histidine or tryptophan gene

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S9-mix (prepared at SPL from livers of rats exposed to phenobarbitone/ beta-naphtoflavone)

Test concentrations with justification for top dose:

Experiment 1:
Salmonella strains: 15, 50, 150, 500, 1500, 5000 µg/ plate;
E.coli strain: 50, 150, 500, 1500, 5000 µg/ plate.
Experiment 2:
TA100, TA1535: 15, 50, 150, 500, 1500, 5000 µg/ plate;
WP2uvrA, TA98, TA1537: 50, 150, 500, 1500, 5000 µg/ plate.

Vehicle / solvent:

- Vehicle used: Water
- Justification for choice of vehicle: The test material was fully miscible in distilled water at 50 mg/ml in solubility checks performed at SPL.
- The test material was accurately weighed and approximate half-log dilutions were prepared in sterile water by mixing on a vortex mixer on the day of each experiment.
- Formulations adjusted for the stated water content (water content = 51% of the test material).

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

N-ethyl-N'-nitro-N-nitrosoguanidine: 3 µg/ plate (TA100), 5 µg/ plate (TA1535), 2 µg/ plate (WP2uvrA); 9-Aminoacridine: 80 µg/ plate (TA1537); 4-Nitroquinoline-1-oxide: 0.2 µg/ plate (TA98)

Remarks:

without S9-mix

Controls 2

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

2-Aminoanthracene: 1 µg/ plate (TA100), 2 µg/ plate (TA1535 and TA1537), 10 µg/ plate (WP2uvrA); Benzo(a)pyrene 5 µg/ plate (TA98)

Remarks:

with S9-mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: 3

Evaluation criteria:

The test material may be considered positive in this test system if the following criteria are met:
The test material should have induced a reproducible, dose-related and statistically significant increase in the revertant count in at least one strain of bacteria.

Statistics:

Dunnett's method of linear regression

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

At 5000 µg/ plate, for TA100 and TA1535 (+/- S9-mix).

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

PRELIMINARY TOXICITY TEST:
The test material was toxic to TA100 at 5000 µg/ plate (sparse bacterial background lawn) with and without S9-mix. The test substance was not toxic to WP2uvrA when tested up to and including 5000 µg/ plate.

Any other information on results incl. tables

No test material precipitate was observed on the plates at any of the doses tested with or without S9 -mix.

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

In an Ames test performed according to OECD/ EC guidelines and GLP principles, product XSM 2697 (CT-825-05; a 50% solution of disodium 4-isodecyl sulfosuccinate) was found to be not mutagenic with or without metabolic activation when tested up to and including 5000 µg/ plate.

Executive summary:

An Ames test was performed with product XSM 2697 (CT-825-05; a 50% solution of disodium 4-isodecyl sulfosuccinate) according to OECD/ EC guidelines and GLP principles. The concentration of the test material was adjusted for the water (51%) content and tested up to and including 5000 µg/ plate. The test material was toxic to TA100 at 5000 µg/ plate (sparse bacterial background lawn) with and without S9-mix, but did not show cytotoxicity in the other strains. Appropriate positive controls and vehicle controls were included and gave a response within historical range, demonstrating that test system was valid. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation. Based on these results, it can be concluded that the test substance was not mutagenic with or without metabolic activation when tested in a reverse mutation assay when tested up to and including cytotoxic concentrations.