2-(3,4-epoxycyclohexyl)ethyltriethoxy 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:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate test protocol and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The used protocol is in compliance with: OECD 471, 1983 EC Directive 92/69, B.13 and B.14

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-050-4

EC Name:

-

Cas Number:

10217-34-2

Molecular formula:

C14H28O4Si

IUPAC Name:

triethoxy(2-{7-oxabicyclo[4.1.0]heptan-3-yl}ethyl)silane

Details on test material:

Test article ID (as cited in the study): Y-4036 is beta-(3,4-epoxycyclohexyl)ethyltriethoxysilane
Molecular formula: C13H26O4Si
Molecular weight: 274,43
Physical state: Clear, pale liquid
Analytical purity: 98.3%
Lot/batch no: 16912-29
Test article receipt: 1995-09-18 (expiration date was not provided)
Stability under test conditions: Stable
Storage condition of test material: At room temperature; protected from exposure to light
Certificate of analysis: see appendix IV (GC, FTIR, GC/MS)

Method

Species / strain

Species / strain / cell type:

bacteria, other: Salmonella typhimurium: TA98, TA100, TA1535, TA1537 E-Coli: WP2 uvrA(pKM101), WP2 (pKM101)

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S9-homogenate

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 3.3 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 3.3 ... 5000 µg/plate

Vehicle / solvent:

Solvent: Acetone

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

all Salmonella strains

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S9 Activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

WP2 uvrA (pKM101) strain

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S9 Activation

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

WP2 (pKM101) strain

Positive control substance:

other: sterigmatocystin

Remarks:

with S9 Activation

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

TA98 strain

Positive control substance:

2-nitrofluorene

Remarks:

without S9 Activation

Controls 5

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

TA100, TA1535

Positive control substance:

sodium azide

Remarks:

without S9 Activation

Controls 6

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

TA1537

Positive control substance:

9-aminoacridine

Remarks:

without S9 Activation

Controls 7

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

both E. coli strains

Positive control substance:

methylmethanesulfonate

Remarks:

without S9 Activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: 60 minutes at 37°C (methodology by Yahagi et al. (1977))
- Exposure duration: 48 to 72 hours at 37°C
- Expression time (cells in growth medium): 48 to 72 hours at 37°C

NUMBER OF REPLICATIONS: 3 plates per test concentration


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; background lawn assessment

Evaluation criteria:

For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article. Data sets for strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value. Data sets for strains TA98, TA100 and WP2 uvrA (pKM101) and WP2 (pKM101) were judged positive if the increase in mean revertants at the peak of the dose response is equal or greater than two times the mean vehicle control value.

Statistics:

For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.

Results and discussion

Test results

Test results 1

Species / strain:

other: as specified above

Metabolic activation:

with

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(>= 667 µg/plate)

Test results 2

Species / strain:

other: as specified above

Metabolic activation:

without

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(>= 333 µg/plate)

Test results 3

Species / strain:

other: as specified above

Metabolic activation:

with

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(>= 333 µg/plate)

Additional information on results:

Comparison with historical control data: Number of spontaneous revertants were within acceptable range.

Remarks on result:

other: other: preliminary test

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Experiment B5 (without S9)	TA98		TA100		TA1535		TA1537
Conc. µg/plate	average revertants per plate	standard deviation	average revertants per plate	standard deviation	average revertants per plate	standard deviation	average revertants per plate	standard deviation
0	26	3	115	5	6	3	6	2
3.3							4	3
10	26	2	124	15	8	1	5	3
33	17	2	126	12	12	2	7	4
100	20	2	118	10	9	0	6	2
333	21	5	18	11	7	3	1	2
1000	17	3	14	3	6	3	0	0
5000	20	5	14	4	5	2
Pos	504	36	515	27	394	25	201	107

(with S9)	TA98		TA100		TA1535		TA1537		WP2 (pKM101)
Conc. µg/plate	average revertants per plate	standard deviation	average revertants per plate	standard deviation	average revertants per plate	standard deviation	average revertants per plate	standard deviation	average revertants per plate	standard deviation
0	25	2	142	18	10	5	7	2	61	11
3.3							7	1
10	20	5	117	4	14	1	8	3	45	4
33	22	3	151	4	12	2	11	1	63	8
100	24	4	136	5	12	2	5	2	67	3
333	22	2	66	13	12	4	3	3	58	13
1000	8	5	21	10	6	1	1	1	49	10
5000	8	2	3	2	7	4			67	5
Pos	1101	38	1132	165	88	7	111	12	312	1

Applicant's summary and conclusion

Conclusions:

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

2-(3,4-epoxycyclohexyl)ethyltriethoxy silane has been tested in a reliable study according to OECD TG 471 and under GLP. The test substance did not show any reproducible mutagenic activity in any of the tester strains with or without metabolic activation (Aroclor-induced rat liver S9). It is concluded that the test subtance is negative for mutagenicity to bacteria under the conditions of the test.