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EC number: 643-078-7 | CAS number: 87855-59-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 010
- 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
- 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.
Constituent 1
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.
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