Trichloro(vinyl)silane

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:

2008-08-07 to 2008-09-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a national standard method, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Version / remarks:

2003

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

duplicate not triplicate

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Trichloro(vinyl)silane

EC Number:

200-917-8

EC Name:

Trichloro(vinyl)silane

Cas Number:

75-94-5

Molecular formula:

C2H3Cl3Si

IUPAC Name:

trichloro(vinyl)silane

Method

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 uvr A

Metabolic activation:

with and without

Metabolic activation system:

phenobarbitol and 5,6 benzoflavone induced rat liver S9

Test concentrations with justification for top dose:

0-5000 μg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: tetrahydrofuran
- Justification for choice of solvent/vehicle: test substance hydrolyses in water and reacts on contact with DMSO and acetone, and is stable in tetrahydrofuran.

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, TA 100, E coli 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 without activation

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

TA 1533, E coli WP2 uvrA with activation

Controls 5

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

TA 98, TA 100, TA 1537 with activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation;

DURATION
- Preincubation period: 20 min (in sealed tubes in presence of nitrogen)
- Exposure duration: 48 hours (sealed culture)
- Expression time (cells in growth medium): 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours

NUMBER OF REPLICATIONS: duplicate

DETERMINATION OF CYTOTOXICITY
- Method: pthrt: microscopic examination

Evaluation criteria:

A substance is judged to be positive when there is a clear, reproducible dose-related increase in the number of revertant colonies and a reproducible two-fold or more increase in the number of revertant colonies relative to the negative control.

Statistics:

Colonies were counted using a colony analyser, and the mean of two plates calculated. No statistical analysis was used for the evaluation of results.

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

Remarks:

at 5000 μg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no information
- Effects of osmolality: no information
- Evaporation from medium: plates sealed to prevent this
- Precipitation: no precipitation was observed

RANGE-FINDING/SCREENING STUDIES: Preliminary test served as a range-finding study

COMPARISON WITH HISTORICAL CONTROL DATA: yes

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Preliminary testNumber of revertants per plate (mean of 2 plates)

-	TA 98			TA 100			TA 1535
Conc. μ/plate	- MA	+ MA	Cytotoxic (yes/no)	- MA	+ MA	Cytotoxic (yes/no)	- MA	+ MA	Cytotoxic (yes/no)
0*	26	32	no	99	126	no	10	9	no
5	28	28	no	104	129	no	9	9	no
20	29	26	no	102	110	no	9	10	no
78	26	28	no	122	124	no	11	9	no
313	27	33	no	116	136	no	11	11	no
1250	30	26	no	101	117	no	8	9	no
5000	0	0	yes	0	0	yes	0	0	yes
Positive control	409	262	-	429	1231	-	499	254	-

*solvent control with tetrahydrofuran

Table 2: Preliminary testNumber of revertants per plate (mean of 2 plates)

-	TA 1537			E coli WP2 uvrA
Conc. μg/plate	- MA	+ MA	Cytotoxic (yes/no)	- MA	+ MA	Cytotoxic (yes/no)
0*	8	11	no	29	32	no
5	8	8	no	25	26	no
20	8	10	no	25	27	no
78	10	9	no	25	34	no
313	8	9	no	29	26	no
1250	8	9	no	26	26	no
5000	0	0	yes	0	0	yes
Positive control	409	110	-	202	1092	-

*solvent control with tetrahydrofuran

Table 3: Main testNumber of revertants per plate (mean of 2 plates)

-	TA 98			TA 100			TA 1535
Conc. μ/plate	- MA	+ MA	Cytotoxic (yes/no)	- MA	+ MA	Cytotoxic (yes/no)	- MA	+ MA	Cytotoxic (yes/no)
0*	24	31	no	118	120	no	8	11	no
156	23	27	no	106	114	no	8	9	no
313	23	28	no	116	121	no	10	11	no
625	25	25	no	103	110	no	8	8	no
1250	23	34	no	105	117	no	9	10	no
2500	23	31	no	104	121	no	9	11	no
5000	0	0	yes	0	0	yes	0	0	yes
Positive control	363	334	-	460	1221	-	469	238	-

*solvent control with tetrahydrofuran

 

Table 4: Main testNumber of revertants per plate (mean of 2 plates)

-	TA 1537			E coli WP2 uvrA
Conc. μg/plate	- MA	+ MA	Cytotoxic (yes/no)	- MA	+ MA	Cytotoxic (yes/no)
0*	8	9	no	26	27	no
156	8	8	no	28	28	no
313	9	10	no	28	26	no
625	8	8	no	26	32	no
1250	9	11	no	24	26	no
2500	9	9	no	26	26	no
5000	0	0	yes	0	0	yes
Positive control	389	120	-	209	875	-

 

Applicant's summary and conclusion

Conclusions:

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

Trichloro(vinyl)silane was tested for mutagenicity according to the appropriate national guideline and under GLP in the presence and in the absence of activation. No increase in the number of revertants was seen. It was concluded that Trichloro(vinyl)silane is negative for bacterial mutagenicity under the conditions of the test.