Dichlorodicyclopentylsilane

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:

1996-12-10 until 1997-02-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD test under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Silane CP 2
- Physical state: liquid
- Analytical purity: 96.3% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 10466 QB
- Expiration date of the lot/batch: 1997-12-01
- Stability under test conditions: 2 hours in DMSO (water-free)
- Storage condition of test material: in original container, at room temperature, in the dark

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 Mix

Test concentrations with justification for top dose:

Experiment 1 (plate incorporation test): 33.3; 100, 333.3, 1000, 2500 and 5000 µg/plate
Experiment 2 (pre-incubation test): 10, 33.3, 100, 333.3, 1000, and 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the solvent was chosen becuase of irts solubility properties nad its relative nontoxicity to the bacteria. The test substance is stable in the solvnet for 2 hours.

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

positive control for TA 1535, TA 100 without S9 Mix

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylene-diamine

Remarks:

positive control for TA 1537, TA 98 without S9 Mix

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthrancene

Remarks:

positive control for all strains with S9 Mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertants, bachground growth

Evaluation criteria:

in accordance with the Guideline

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:

cytotoxicity

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'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance is not mutagenic in the Salmonella typhimurium Reverse Mutation Assay.

Executive summary:

The Ames Test did not produce any positive results for Tester Strains TA 1535, TA 1537, TA 98 and TA 100 both with and without metabolic activation. The negative, solvent and positive controls worked as expected.