Trimethoxyvinylsilane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Principles of method if other than guideline:

Details of metabolic activation not available from translated report.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxyvinylsilane

EC Number:

220-449-8

EC Name:

Trimethoxyvinylsilane

Cas Number:

2768-02-7

Molecular formula:

C5H12O3Si

IUPAC Name:

ethenyltrimethoxysilane

Method

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:

Phenobarbital and 5,6-benzoflafove induced rat liver S9

Test concentrations with justification for top dose:

0, 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate

Vehicle / solvent:

- Solvent used: Dimethyl sulfoxide

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide

Remarks:

TA 98, 100, WP2 uvrA without activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 1535 without activation

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537 with activation

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-amimoanthracene

Remarks:

all strains with activation.

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; preincubation

NUMBER OF REPLICATIONS: 3 plates per dose, experiment repeated

DETERMINATION OF CYTOTOXICITY
- Method: other: reduction in number of revertants

Rationale for test conditions:

Dosage: Without S9 mix: 0, 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate (TA98, TA100, TA1535, TA1537); 0, 312.5, 625, 1250, 2500, and 5000 µg/plate (WP2uvrA) With S9 mix: 0, 312.5, 625, 1250, 2500 and 5000  µg/plate (TA98, TA100, TA1535, WP2uvrA); 
0, 156.3, 312.5, 625, 1250, 2500 and 5000  µg/plate (TA1537)

Metabolic activation: Phenobarbital and 5,6-benzoflavone induced rat liver S9; full detail of S9 mix are included in the Japanese report though they are not given in the English translation

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate without metabolic activation

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate with and without metabolic activation

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate without metabolic activation

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate without metabolic activation

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Any other information on results incl. tables

Table 1 Experiment 1: without activation (mean of 3 plates)

Concentration µg/plate	TA 100	TA1535	E. coli WP2	TA98	TA1537
0	105	9	34	17	10
156.3	113	8	NR	19	8
312.5	125	8	40	17	10
625	112	7	32	12	6
1250	123	14	34	14	7
2500	115	13	38	18	8
5000	86	7	31	23	9
Positive control	521	558	143	425	263
Cytotoxic*	yes	yes	no	yes	yes

* yes indicates bacterial growth inhibition observed

NT indicates not tested

Table 2 Experiment 1: with activation (mean of 3 plates)

Concentration  µg/plate	TA 100	TA 1535	E coli WP2	TA 98	TA 1537
0	124	44	42	24	11
156.3	NT	NT	NT	NT	17
312.5	1225	12	41	22	15
625	142	9	46	25	15
1250	149	8	42	27	9
2500	148	8	49	35	17
5000	153	12	41	38	14
Positive control	9007	331	868	405	135
Cytotoxic*	no	no	no	no	yes

* yes indicates bacterial growth inhibition observed

NT indicates not tested

Applicant's summary and conclusion

Conclusions:

Trimethoxy(vinyl)silane has been tested in a valid study, conducted according to OECD TG 471 and in compliance with GLP, using the preincubation method. No increase in the number of revertants was observed in any of S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 at any concentration up to 5000 µg/plate with or without metabolic activation. The results of the repeat experiment agreed with those of the first experiment. It is concluded that the test substance is negative for the induction of mutations under the conditions of the test.