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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent

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
Controlsopen allclose all
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)
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:
other: Sodium Azide
Remarks:
TA 100 (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)

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 resultsopen allclose all
Key result
Species / strain:
S. typhimurium, other: TA97 and TA100
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
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.