α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))

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:

January 2 - February 19, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study.

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)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))

EC Number:

406-420-4

EC Name:

α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))

Cas Number:

69430-40-6

Molecular formula:

Unspecified example: C18.3H46.8O5.8Si4.1

IUPAC Name:

2,2,4,4,6,12,15-heptamethyl-6-[(trimethylsilyl)oxy]-3,5,10,13,16-pentaoxa-2,4,6-trisilaheptadecane

Details on test material:

- Name of test material (as cited in study report): DC 5067
- Substance type: Reaction mass (mixture)
- Physical state: Liquid
- Analytical purity: > 99%
- Lot/batch No.: AB 090122
- Expiration date of the lot/batch: December 1, 1991
- Stability under test conditions: Stable
- Storage condition of test material: In the original container at room temperature in the dark
- Other:

Method

Target gene:

n/a

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

9-mix

Controls

Untreated negative controls:

other: The vehicle of the test article.

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Migrated to IUCLID6: TA1535

Results and discussion

Test results

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:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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

TOXICITY OF THE TEST SUBSTANCE

The survival of the TA100 culture is determined by comparing the number of colonies on the plates containing the test substance with those on the solvent control plate. Both in the absence and presence of S9-mix the survival of strain TA100 is not reduced up to test substance concentrations of 5000 µg/plate. Based on these data, the test substance was tested up to a concentration of 5000 µ/plate in the absence and presence of S9-mix.

THE AMES SALMONELLA/MICROSOME PLATE TEST

All bacterial strains showed negative responses over the entire dose range of the test substance, i.e. no dose-related, two-fold, increase in the number of revertants in two independently repeated experiments. The negative and strain-specific positive control values fell within our laboratory background historical ranges indicating that the test conditions were optimal and that the metabolic activation system functioned properly.

CONCLUSION

Based on the results of this study it is concluded that the test substance can be considered as not mutagenic in the Ames Salmonella/microsome assay.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

Based on the results of this study it is concluded that the test substance can be considered as not mutagenic in the Ames Salmonella/microsome
assay.

Executive summary:

DC5067 was tested in the Ames Salmonella/microsome plate test up to 5000 µg/plate in the absence and presence of S9-mix. The test substance did not induce a dose-related increase in the number of revertant (His⁺) colonies in each of the four tester strains (TA1535; TA1537; TA9B and TAl00). These results were confirmed in an independently repeated experiment. The test substance can, therefore, be considered as not mutagenic in this test system.