Acetamide, N,N'-(ethenylmethylsilylene)bis[N-ethyl-

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:

June 15 - July 06, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-[ethenyl(N-ethylacetamido)methylsilyl]-N-ethylacetamide

EC Number:

643-078-7

Cas Number:

87855-59-2

Molecular formula:

C11 H22 N2 O2 Si Si(CH3)(CH=CH2)[N(CH2CH3)(C(=O)CH3)]2

IUPAC Name:

N-[ethenyl(N-ethylacetamido)methylsilyl]-N-ethylacetamide

Test material form:

solid: compact

Details on test material:

Identilication: ZMA T Number 4094103
Lot Number: 091217
Expiration Date: 26 Dec 2010
Source: Korea Biogen Co., Ltd., 690 Sinduk·Ri, Suugname·Myuan, Chuna·City, Chungnam, 330·893, Korea
CAS Number: Not provided
Physical Description: Amber liquid as dctcnnined by HES Study Number 11429·101
Stability: Stable in absence of water, moisture, or humid air
Purity: According to information provided by the submitter, the test article to be treated as a mono·constituent, but the area percent
for one of the components, methyl vinyl bis(nethylacetamido )silane was detennined as part of the characterization (HES Study Number 11429-101). The result was 77.9 ± 003 area % purity.
Solubility: As test article will be applied neat, information not applicable
Characterization: HES Study Number 11429,· 101
Storage Conditions: Room temperature according to infonnation provided by samplc submitter
Archive: A reserve sample was not retained for this study.

Method

Target gene:

Salmonella typhimurium
Strains / Genotype
TA 1537 / his C 3076; rfa; uvrB
TA98 / his D 3052; rfa; uvrB; R-factor
TA 1535 / his G 46; rfa; uvrB
TA 100 / his G 46; rfa; uvrB; R-factor

Escherichia coli
Strains / Genotype
WP2 uvrA / trp; uvrA

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

2-aminoanthracene, 2-AA in DMSO

Test concentrations with justification for top dose:

33, 100, 333, 1000, 2500 and 5000 µg/plate

Controls

Untreated negative controls:

yes

Remarks:

No test item or solvent added

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

methylmethanesulfonate

other: 4-Nitro-o-phenylenediamine (4-NOPD); 2-aminoanthracene, 2-M

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In conclusion, it can be stated that during the described mutagenicity test and under the
experimental conditions reported, the test item did not induce gene mutations by base pair
changes or frameshifts in the genome of the strains used.
Therefore, ZMAT Number 4094103 is considered to be non-mutagenic in this Salmonella
Iyphimurium and Escherichia coli reverse mutation assay.

Executive summary:

This study was performed to investigate the potential of ZMAT Number 4094103 to induce gene mutations in the plate incorporation test (Experiment I) and the pre-incubation test (Experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coil strain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations: Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1,000; 2,500; and 5,000 pg/plate Experiment II: 33; 100; 333; 1,000; 2,500; and 5,000 pg/plate No reduced background growth was observed in all strains in both experiments up to the highest concentrations. No toxic effects, evident as a reduction in the number of revertants (below the indication' factor of 0.5) were observed in both experiments with and without S9 mix. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with ZMAT Number 4094103 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct in-crease of induced revertant colonies. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, ZMAT Number 4094103 is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.