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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-12-01 to 1998-12-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The restrictions were that only four strains of bacteria were used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
1983
Deviations:
yes
Remarks:
4 strains used
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropyltriethoxysilane
EC Number:
213-048-4
EC Name:
3-aminopropyltriethoxysilane
Cas Number:
919-30-2
Molecular formula:
C9H23NO3Si
IUPAC Name:
silane
Test material form:
liquid

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbital and ß-Naphthoflavone induced rat liver S9
Test concentrations with justification for top dose:
0, 50, 160, 500, 1600 and 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO

- Justification for choice of solvent/vehicle: none given in report
Controlsopen allclose all
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)
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA 100, TA 1535 (without activation)
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)
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); preincubation

DURATION

- Preincubation period: 30 minutes

- Exposure duration: 72 hours

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

NUMBER OF REPLICATIONS: 3 plates per test concentration

DETERMINATION OF CYTOTOXICITY

- Method: relative total growth; background lawn assessment
Evaluation criteria:
For a test compound to be considered positive, it must (in two independent experiments) cause at least a doubling in the mean revertants per plate of at least one tester strain. This increase must be accompanied by a dose response towards increasing concentrations of the test article. Single increases in revertant frequencies, which are not dose-related and not reproducible in two independent tests are considered non-relevant. If however these increases do occur in both tests, this will be taken as an indication of mutagenic effect.
Statistics:
Mean number of revertants per plate and the standard deviation around the mean were calculated.

Results and discussion

Test results
Key result
Species / strain:
other: Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: >5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
COMPARISON WITH HISTORICAL CONTROL DATA: Numbers of spontaneous revertants were within acceptable range
Remarks on result:
other: No mutagenic potential

Any other information on results incl. tables

Table 2a: Experiment 1 Plate incorporation assay Number of revertants per plate (mean of 3 plates)

 

TA98

TA100

TA1535

Conc.
(
µg/plate)

— MA

+ MA

Cytotoxic
(yes/no)

— MA

+ MA

Cytotoxic
(yes/no)

— MA

+ MA

Cytotoxic
(yes/no)

0*

14

30

No

139

151

No

8

9

No

50

16

37

No

147

144

No

8

11

No

160

16

28

No

138

143

No

8

10

No

500

14

29

No

136

150

No

11

9

No

1600

22

41

No

136

150

No

9

13

No

5000

21

27

No

10

171

Yes

10

9

No

Positive Control

104.2

1490

No

536

1592

No

316

153

No

*solvent control with DMSO

Table 2b: Experiment 1 Plate incorporation assay Number of revertants per plate (mean of 3 plates)

 

TA1537

Conc.
(
µg/plate)

— MA

+ MA

Cytotoxic
(yes/no)

0*

5

13

No

50

0

11

No

160

2

15

No

500

2

10

No

1600

2

9

No

5000

0

3

Yes

Positive Control

84

109

No

*solvent control with DMSO

Table 3a: Experiment 2 Pre incubation assay Number of revertants per plate (mean of 3 plates)

 

TA98

TA100

TA1535

Conc.
(
µg/plate)

— MA

+ MA

Cytotoxic
(yes/no)

— MA

+ MA

Cytotoxic
(yes/no)

— MA

+ MA

Cytotoxic
(yes/no)

0*

19

25

No

121

116

No

12

9

No

250

21

25

No

97

102

No

7

11

No

500

20

30

No

98

91

No

13

11

No

1000

17

32

No

100

99

No

11

15

No

2000

18

31

No

101

110

No

8

10

No

4000

16

30

No

100

103

No

9

14

No

Positive Control

103

1628

No

608

1384

No

341

216

No

*solvent control with DMSO

Table 3b: Experiment 2 Pre incubation assay Number of revertants per plate (mean of 3 plates)

 

TA1537

Conc.
(
µg/plate)

— MA

+ MA

Cytotoxic
(yes/no)

0*

15

16

No

250

17

10

No

500

17

13

No

1000

17

15

No

2000

13

15

No

4000

12

13

No

Positive Control

263

131

No

*solvent control with DMSO

Applicant's summary and conclusion

Conclusions:
3-aminopropyl(triethoxy)silane has been tested in a reliable study according to OECD TG 471 and in compliance with GLP using Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537. The test substance did not show any reproducible mutagenic activity in any of the strains tested up to limit concentrations with and without metabolic activation in either the plate incorporation or the repeat preincubation assay. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.