[3-(2,3-epoxypropoxy)propyl]trimethoxysilane

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:

1987-09-09 to 1987-10-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The restrictions were that only three strains of bacteria were used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only three strains used

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

[3-(2,3-epoxypropoxy)propyl]trimethoxysilane

EC Number:

219-784-2

EC Name:

[3-(2,3-epoxypropoxy)propyl]trimethoxysilane

Cas Number:

2530-83-8

Molecular formula:

C9H20O5Si

IUPAC Name:

trimethoxy[3-(oxiran-2-ylmethoxy)propyl]silane

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA97, TA98, TA100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S9

Test concentrations with justification for top dose:

8, 40, 200, 1000, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Ethylene glycol dimethylether

- Justification for choice of solvent/vehicle: none given in report

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 97 (without activation)

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

TA 98 (without activation)

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Sodium Azide

Remarks:

TA 100 (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:

All strains (with activation)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION

- Expression time (cells in growth medium): 48 hours

NUMBER OF REPLICATIONS: 3 plates per test concentration

DETERMINATION OF CYTOTOXICITY

- Method: relative total growth; background lawn assessment

Evaluation criteria:

Colony counts for test substance compared with solvent controls. A positive response is indicated by a two-fold increase in mean revertant numbers compared with the solvent control.

Statistics:

Mean values calculated from individual plate counts. Statistical significance calculated using F-test.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium, other: TA97

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>5000 µg/plate

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

A statistically significant increase in revertants noted in Salmonella typhimurium strains TA 97 and TA 100 both in the absence and presence of S-9.

Any other information on results incl. tables

Table 2 :  Mutagenicity assay, Number of revertants per plate (mean of 3 plates)

	TA 97			TA 98			TA 100
Conc. (µg/plate)	— MA	+ MA	Cytotoxic (yes/no)	— MA	+ MA	Cytotoxic (yes/no)	— MA	+ MA	Cytotoxic (yes/no)
0*	77.8	142.2	No	18.2	43.4	No	87.4	133.6	No
8	62	123.7	No	14	46.3	No	96	141	No
40	63.3	132	No	18	34.5	No	98.7	144.7	No
200	57.3	135.7	No	22	35.3	No	120	169.7	No
1000	70.7	168.3	No	19.3	34.3	No	243	301.3	No
5000	154.7	276.7	No	18.7	44.3	No	598.7	690.7	No
Positive Control	340.8	357.8	No	905	969.6	No	502.8	432.2	No

*solvent control with Ethylene glycol dimethylether

Applicant's summary and conclusion

Conclusions:

3-Glycidoxypropyltrimethoxysilane (CAS 2530-83-8) (GLYMO) has been tested in a valid study according to a protocol that is similar to OECD TG 471 and under GLP. GLYMO produced a fivefold increase in revertants in Salmonella typhimurium TA 100, and a two fold increase in TA 97 with and without metabolic activation. The test substance is considered mutagenic in Salmonella typhimurium strains TA97 and TA100 both in the absence and presence of S-9 under the conditions of the test.