Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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

Constituent 1
Chemical structure
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:
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
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.