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Toxicological information

Genetic toxicity: in vitro

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Qualifier:
according to
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. certificate)
Remarks:
issued 2 December 2002
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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).
Controlsopen allclose all
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
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.