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EC number: 245-366-4 | CAS number: 22984-54-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic toxicity in vitro:
In vitro gene mutation in bacteria: Weight of evidence: Based on read-across approach the experimental data on analogue butanone oxime (test methods similar to OECD 471), butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be negative for genetic toxicity in vitro.
In vitro cytogenicity in mammalian cells: Weight of evidence: Based on read-across approach the experimental data on analogue butanone oxime (test method similar to OECD 473) butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be negative against chromosomal aberrations with and without S9.
In vitro gene mutation study in mammalian cells: Key study: Based on read-across approach the experimental data on analogue butanone oxime where mutagenicity was observed only in presence of cytotoxicity and without metabolic activation, there cannot be concluded that butan-2-one O,O',O''-(methylsilanetriyl)oxime induces gene mutation in mammalian cells.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- (at strain 1535 with induced male Syrian hamster liver S9)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Based on the read-across approach from experimantal results on analogue butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic in strains TA97, TA98, or TA100 with and without S9 and mutagenic in strain TA1535, with S9 syrian hamster liver metabolic activation but non-mutagenic with S9 rat liver metabolic activation nor without metabolic activation.
- Executive summary:
A Salmonella typhimurium mutagenicity test was performed on analogue substance butanone oxime up to 10000 µg/plane according to NTP's preincubation protocol (test method similar to OECD Guideline 471). Based on the results on butanone oxime, the read-across approach was applied and butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic in strains TA97, TA98, or TA100 with and without S9 up to an estimate concentration of 11534.28 µg/plate. The analogue butanone oxime was observed to be mutagenic over a concentration range of 100 to 10000 μg/plate, only in Salmonella typhimurium strain TA1535 and in the presence of induced hamster liver S9 but not in the presence of induced rat liver S9 nor without exogenous metabolic activation. Based on the read-across approach from these results, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be at most weakly genotoxic since it induced mutations under very specific conditions (strain 1535 with S9 syrian hamster liver).
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 1.15 mL/chamber)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to an estimated concentration of 1.15 mL/chamber
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Based on the read-across approach from analogue butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic with or without metabolic activation under test condition.
- Executive summary:
A Salmonella typhimurium mutagenicity test was performed on butanone oxime up to 1 mL/chamber according to NTP's dessicator procedure (test method similar to OECD Guideline 471). No mutagenic activity was observed in Salmonella typhimurium strainsTA98 or TA100 treated within the closed environment of a desiccator, with or without metabolic activation. Based on these result, the read-across was applied and butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic up to 1.15 mL/chamber under test conditions.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 11534.28 µg/plate)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to an estimated concentration of 11534.28 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to an estimated concentration of 11534.28 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to an estimated concentration of 11534.28 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to an estimated concentration of 11534.28 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- Based on the read-across approach from analogue butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic with or without metabolic activation under test condition.
- Executive summary:
A Salmonella typhimurium mutagenicity test was performed on analogue substance butanone oxime up to 10000 µg/plate in accordance with a test method similar to OECD Guideline 471. Butanone oxime did not induce a mutagenic response in Salmonella typhimurium tested strains TA98, TA100, TA1535, TA1537 and TA1538 with and without S9 rat or hamster liver enzyme activation. Based on the read-across approach from these experimental results, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic up to an estimated concentration of 11534.28 µg/plate with and with metabolic activation and under test conditions.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (up to an estimated concentration of 5767.14 µg/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Based on the read-across approach from experimental data on butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic with or without metabolic activation under test conditions.
- Executive summary:
A bacterial reverse mutation assay was performed on the analogue substance butanone oxime up to 5000 µg/plate in accordance with OECD Guideline 471. Butanone oxime was not mutagenic to any of the strains (Salmonella typhimurium TA100, TA1535, TA98, TA1537 andEscherichia coli WP2 uvrA) with or without metabolic activation. Based on these results, the read-across approach was applied and butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic up to an estimated concentration of 5767.14 µg/plate with and with metabolic activation and under test conditions.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 5767.14 µg/mL)
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Based on the read-across approach from experimental data on butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-clastogenic with or without metabolic activation under test conditions.
- Executive summary:
A cytogenetic Chromosome aberration tests with cultured Chinese hamster ovary cells was performed on analogue substance butanone oxime up to 5000 µg/ml according to NTP's standard protocol (test method similar to OECD Guideline 473).No increase in chromosomal aberrations was observed on the analogue substance with or without metabolic activation for a harvest time of 20 and 12 hours respectively. Based on the read-across approach, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-clastogenic up to and estimated concentration of 5767.34 µg/mL with and without metabolic activation and under test conditions.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- other: Chinese hamster lung (CHL/IU) cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 1 mg/mL)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (up to an estimated concentration of 1 mg/mL)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Based on the read-across approach from experimental data on butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-clastogenic with or without metabolic activation under test conditions.
- Executive summary:
An in vitro mammalian cell chromosome aberration assay was performed on the analogue substance butanone oxime up to 0.87 mg/mL in accordance with Guidelines for Screening Mutagenicity Testing of Chemicals (Japan). The analogue butanone oxime induced neither structural chromosomal aberrations nor polyploidy in Chinese hamster lung (CHL/IU) cells up to the limit concentration of 10 mM (0.87 mg/ml), in the absence or presence of an exogenous metabolic activation system under test conditions. Base on the read-across approach from these results, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-clastogenic up to an estimated concentration of 1 mg/mL with or without metabolic activation and under test conditions.
- Endpoint:
- in vitro DNA damage and/or repair study
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 576.71 μg/mL without S9 and 5767.34 μg/mL with S9)
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Based on the read-across approach from experimental data on butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined not to induce sister chromatid exchanges with or without metabolic activation under test conditions.
- Executive summary:
A Sister Chromatid Exchange tests with cultured Chinese hamster ovary cells was performed on the analogue substance butanone oxime up to 500 µg/mL with metabolic activation and up to 5000 µg/mL without metabolic activation according to NTP's standard protocol (test method similar to OECD Guideline 479). No induction of sister chromatid exchanges was observed at concentrations up to toxicity (500 μg/mL) in the absence of S9 or up to the assay limit (5000 μg/mL) in the presence of S9. Based on these results, the read-across approach was applied and butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined not to induce sister chromatid exchanges up to an estimated concentration of 576.71 µg/mL with metabolic activation and 5767.34 µg/mL without metabolic activation, under test conditions.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- (only with cytotoxicity in the absence of S9)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Based on experimental data on analogue butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be mutagenic in the absence of S9 activation, but only in the presence of cytotoxicity. Test item is determined to be non-mutagenic in the presence of S9 activation.
- Conclusions:
- Based on the read-across approach from experimental data on butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be negative for mutagenic activity in mouse lymphoma L5178Y cells in the presence of S9 metabolic activation, and positive in the absence of S9 metabolic activation but in the presence of cytotoxicity.
- Executive summary:
A Mouse Lymphoma L5178Y mammalian cell mutagenicity test was performed on the analogue test substance butanone oxime up to 6.5 µg/plate in accordance with a test method similar to OECD Guideline 476. The analogue butanone oxime was negative for mutagenic activity in the presence of S9 metabolic activation, but positive in the absence of S9 metabolic activation and in the presence of cytotoxicity. Based on the read-across approach from these results, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic with metabolic activation and mutagenic without metabolic activation but in presence of cytotoxicity up to an estimated concentration of 7.50 µg/plate under test conditions.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Genetic toxicity in vivo:
Key study: Based on read-across approach from experimental data on analogue butanone oxime (test method similar to OECD 474), butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be negative for in vivo cytogenicity in mammalian cells.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- (up to an estimated concentration of 11534.28 ppm)
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Conclusions:
- Based on read-across approach from experimental data on the analogue butanone oxime, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined not to cause cytogenetic damage based on the in-vivo micronucleous test up to an estimated concentration of 11534.28 ppm (1534 mg/kg bw/day in males and 3656.34 mg/kg bw/day in females) and under test conditions.
- Executive summary:
A Mammalian Erythrocyte Micronucleus Test was performed on the analogue substance butanone oxime up to 10000 ppm (1330 mg/kg bw/day in males and 3170 mg/kg bw in females) according to NTP's standard protocol (test method similar to OECD Guideline 474). No increase in the frequency of micronucleated normochromatic erythrocytes was observed in the peripheral blood of male or female mice administered butanone oxime via drinking water for 13 weeks under test conditions. The percentage of normochromatic erythrocytes among the population of circulating erythrocytes was markedly decreased at the highest dose tested in male and female mice. Based on these results, the read-across approach was applied and butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined not to cause cytogenetic damage based on the in-vivo micronucleous test up to an estimated concentration of 11534.28 ppm (1534 mg/kg bw/day in males and 3656.34 mg/kg bw/day in females) and under test conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In vitro gene mutation in bacteria: Read-across from experimental data on the analogue substance butanone oxime: Weight of evidence:
A Salmonella typhimurium mutagenicity test was performed on analogue substance butanone oxime up to 10000 µg/plane according to NTP's preincubation protocol (test method similar to OECD Guideline 471). Based on the obteined experimental results, the read-across approach was applied and butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic in strains TA97, TA98, or TA100 with and without S9 up to an estimate concentration of 11534.28 µg/plate and mutagenic only in the strain TA1535 and in the presence of induced hamster liver S9 but not in the presence of induced rat liver S9 nor without exogenous metabolic activation.
Moreover, as part of study this study, a NTP's dessicator procedure was performed on the analgoue butanone oxime up to 1 mL/chamber on Salmonella typhimurim strains TA98 and TA100. Based on the read-across approach, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic up to and estimated concentration of 1.15 mL/chamber under test conditions.
Based on the read-across approach from the experimental results obtained in the study conducted by Rogers-Back et al. on the analogue butanone oxime, where the analogue butanone oxime did not induce a mutagenic response in Salmonella typhimurium tested strains TA98, TA100, TA1535, TA1537 and TA1538 with and without S9 rat or hamster liver enzyme activation, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic up to an estimated concentration of 11534.28 µg/plate with and with metabolic activation and under test conditions.
In the study performed by the Ministry of Health, Labour and Welfare of Japan, a bacterial reverse mutation assay was performed on the analogue substance butanone oxime in accordance with OECD Guideline 471. The analogue butanone oxime was not mutagenic to any of the strains (Salmonella typhimurium TA100, TA1535, TA98, TA1537 andEscherichia coli WP2 uvrA) with or without metabolic activation. Based on these resulta, the read-across approach was applied and butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic up to an estimated concentration of 5767.14 µg/plate with and with metabolic activation and under test conditions.
According to the available data, the weight of evidence approach was applied and the test item butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be negative for in vitro gene mutation in bacteria.
In vitro cytogenicity in mammalian cells (chromosome aberration): Read-across from experimental data on analogue butanone oxime: Weight of evidence:
A cytogenetic Chromosome aberration tests with cultured Chinese hamster ovary cells was performed on analogue substance butanone oxime up to 5000 µg/ml according to NTP's standard protocol (test method similar to OECD Guideline 473). No increase in chromosomal aberrations was observed on the analogue substance with or without metabolic activation for a harvest time of 20 and 12 hours respectively. Based on the read-across approach, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-clastogenic up to and estimated concentration of 5767.34 µg/mL with and without metabolic activation and under test conditions.
In a study performed by the Ministry of Health, Labour and Welfare from Japan, an in vitro mammalian cell chromosome aberration assay was performed on the analogue substance butanone oxime up to 0.87 mg/mL in accordance with Guidelines for Screening Mutagenicity Testing of Chemicals (Japan). The analogue butanone oxime induced neither structural chromosomal aberrations nor polyploidy in Chinese hamster lung (CHL/IU) cells up to the limit concentration of 10 mM (0.87 mg/ml), in the absence or presence of an exogenous metabolic activation system under test conditions. Base on the read-across approach from these results, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-clastogenic up to an estimated concentration of 1 mg/mL with or without metabolic activation and under test conditions.
The test item butan-2 -one O,O',O''-(methylsilanetriyl)oxime was determined to be negative for in vitro cytogenicity in mammalian cells.
In vitro gene mutation in mammalian cells: Read-across from experimental data on analogue butanone oxime:
Key study: In the study by Rogers-Back et al., a Mouse Lymphoma L5178Y mammalian cell mutagenicity test was performed on the analogue test substance butanone oxime up to 6.5 µg/plate in accordance with a test method similar to OECD Guideline 476. The analogue butanone oxime was negative for mutagenic activity in the presence of S9 metabolic activation, but positive in the absence of S9 metabolic activation and in the presence of cytotoxicity. Based on the read-across approach from these results, butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined to be non-mutagenic with metabolic activation and mutagenic without metabolic activation but in presence of cytotoxicity up to an estimated concentration of 7.50 µg/plate under test conditions.
Since mutagenicity was observed only in presence of cytotoxicity and in absence of metabolic activation, it cannot be concluded that butan-2 -one O,O',O''-(methylsilanetriyl)oxime induced gene mutation in mammalian cells.
In vivo cytogenicity in mammalian cells: Read-across approach from experimental results on the analogue substance butanone oxime:
Key study: A Mammalian Erythrocyte Micronucleus Test was performed on the analogue substance butanone oxime up to 10000 ppm (1330 mg/kg bw/day in males and 3170 mg/kg bw in females) according to NTP's standard protocol (test method similar to OECD Guideline 474). No increase in the frequency of micronucleated normochromatic erythrocytes was observed in the peripheral blood of male or female mice administered butanone oxime via drinking water for 13 weeks under test conditions. The percentage of normochromatic erythrocytes among the population of circulating erythrocytes was markedly decreased at the highest dose tested in male and female mice. Based on these results, the read-across approach was applied and butan-2-one O,O',O''-(methylsilanetriyl)oxime was determined not to cause cytogenetic damage based on the in-vivo micronucleous test up to an estimated concentration of 11534.28 ppm (1534 mg/kg bw/day in males and 3656.34 mg/kg bw/day in females) and under test conditions.
Butan-2 -one O,O',O''-(methylsilanetriyl)oxime was determined to be negative for in vivo cytogenicity in mammalian cells.
Justification for classification or non-classification
Based on the available information on genetic toxicity in vitro and in vivo, butan-2 -one O,O',O''-(methylsilanetriyl)oxime was considered to be negative for genetic toxicity, and therefore the substance is not classified according to CLP Regulation (EC) No 1272/2008.
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