Trimethoxyphenylsilane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not stated.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

The study was conducted according to an EU test method but full details are not available. It was compliant with GLP. The restrictions were that no units for concentration of the test material was provided and only the positive control with activation was not adequate to test S9 efficacy.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC directive L251, 27, 137 1984

Deviations:

yes

Remarks:

no Units for concentration of the test material was provided and the only positive control with activation was not adequate to test S9 efficacy.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxyphenylsilane

EC Number:

221-066-9

EC Name:

Trimethoxyphenylsilane

Cas Number:

2996-92-1

Molecular formula:

C9H14O3Si

IUPAC Name:

trimethoxy(phenyl)silane

Method

Target gene:

his operon for S. typhimurium strains and trp operon for E. coli strains.

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.

Test concentrations with justification for top dose:

312.5, 625, 1250, 2500 and 5000 µg/plate - with and without metabolic activation.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Ethanol.

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Anthramine

Remarks:

with metabolic activation: All strains; 10 µg/plate

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Remarks:

without metabolic activation:TA-1537; 50 µg/plate

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

without metabolic activation: TA-98; 10 µg/plate

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without metabolic activation: TA-1537; 50 µg/plate

Controls 5

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without metabolic activation: TA-1535, TA-100; 10 µg/plate

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium (plate incorporation)

DURATION
- Expression time (cells in growth medium): 72 hours

NUMBER OF REPLICATIONS: triplicates each in two independent experiments.

DETERMINATION OF CYTOTOXICITY
- Method: Not reported.

METABOLIC ACTIVATION SYSTEM: S-9 mix was prepared in accordance with published procedures (Ames, et al, 1975; Matsushima, et al, 1976), using a 9, 000 x g supernatant prepared from Sprague-Dawley adult male rat liver induced by Aroclor 1254 five days prior to kill.

Evaluation criteria:

Not reported

Statistics:

Not reported

Results and discussion

Test results

Test results 1

Species / strain:

E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

Not reported

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative with and without metabolic activation

In a bacterial mutagenicity assay according to EEC directive L251, 27, 137 1984 and to GLP, no mutagenic effect was seen in any of the strains tested. Appropriate solvent and positive controls were included and gave expected results. The test substance is non-mutagenic in test strains used.