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Toxicological information

Genetic toxicity: in vitro

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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
Controlsopen allclose all
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
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
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
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
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
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
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 resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 667 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 333 µg/plate)
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.