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EC number: 433-360-6 | CAS number: 34036-80-1
- 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:
- 1997-05-13 to 1997-10-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method equivalent to OECD Guideline 471 and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 433-360-6
- EC Name:
- -
- Cas Number:
- 34036-80-1
- Molecular formula:
- C18H29N3O3Si
- IUPAC Name:
- 6-{[(butan-2-ylidene)amino]oxy}-3,9-dimethyl-6-phenyl-5,7-dioxa-4,8-diaza-6-silaundeca-3,8-diene
- Reference substance name:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime
- IUPAC Name:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): OS-9000
- Physical state: colorless to yellow liquid
- Expiration date: 13 May 1998
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- 75, 200, 600, 1800, 5000 µg/plate
- Vehicle / solvent:
- Solvent: Dimethyl sulfoxide (DMSO)
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- With S9, Salmonellal strains and WP2 uvrA
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 1.0 µg/plate (Salmonella), 10 µg/plate (WP2 uvrA)
- Positive controls:
- yes
- Remarks:
- Without S9; TA98
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- 1.0 µg/plate
- Positive controls:
- yes
- Remarks:
- Without S9; TA100 andTA1535
- Positive control substance:
- sodium azide
- Remarks:
- 1.0 µg/plate
- Positive controls:
- yes
- Remarks:
- Without S9; TA1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 75 µg/plate
- Positive controls:
- yes
- Remarks:
- Without S9; WP2 uvrA
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- 1000 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
Overnight cultures were prepared by inoculating into a vessel containing ~50 mL of culture medium. Following inoculation, each flask was placed in a resting shaker/incubator at room temperature (125 rpm at 37±2 ºC) 12 hours before the anticipated time of harvest. Each culture was monitored spectrophotometrically for turbidity and was harvested at a percent transmittance yielding a titer of approximately 10E+09 cells/mL. The actual titers were determined by viable count assays on nutrient agar plates.
Test article dilutions were prepared immediately before use. One-half (0.5) mL of S9 or Sham mix, 100 µL of tester strain and 50 pL of vehicle or test article were added to 2.0 mL of molten selective top agar at 45±2 ºC. After vortexing, the mixture was overlaid onto the surface of 25 mL of minimal bottom agar. When plating the positive controls, the test article aliquot was replaced by a 50 µL aliquot of appropriate positive control. After the overlay had solidified, the plates were inverted and incubated for approximately 48 to 72 hours at 37±2 ºC. Plates that were not counted immediately following the incubation period were stored at 4±2 ºC until colony counting could be conducted.
DURATION
- Exposure duration:
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS:
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
The condition of the bacterial background lawn was evaluated for evidence of test article toxicity by using a dissecting microscope.
Revertant colonies for a given tester strain and activation condition were counted either entirely by automated colony counter or entirely by hand unless the assay was the preliminary toxicity assay or the plate exhibited toxicity. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually.
OTHER EXAMINATIONS:
Precipitate was evaluated by visual examination without magnification.
OTHER: - 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 TA1533 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 were judged positive if the increase in mean revertants at the peak of the dose response is equal to 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 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The preliminary toxicity assay was used to establish the dose-range over which the test article would be assayed. Ten dose levels of the test article (up to 5000 µg/plate) were plated, one plate per dose, with overnight cultures of TA98, TA100, TA1535, TA1537 and WP2 uvr4 on selective minimal agar in both the presence and absence of rat liver S9 activation. Precipitate was observed at 13333 µg/plate but no appreciable toxicity was observed. Based on the findings of the toxicity assay, the maximum dose plated in the mutagenicity assay was 5000 µg/plate.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Salmonella/E. coli Mutagenicity Assay
With metabolic activation (liver microsomes)
Dose |
TA90 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
0 |
12±1 |
206±16 |
11±5 |
9±2 |
25±1 |
75 |
19±2 |
200±47 |
9±3 |
11±2 |
18±2 |
200 |
19± 3 |
228±7 |
11±1 |
12±2 |
16±2 |
600 |
14±4 |
230±1 |
11±0 |
13±1 |
18±1 |
1800 |
17±4 |
198±34 |
13±2 |
10±5 |
13±3 |
5000 |
13±3 |
171±25 |
20±1 |
6±1 |
10±0 |
Positive |
164±8 |
724±28 |
534±27 |
1273±46 |
132±4 |
Without metabolic activation
Dose |
TA90 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
0 |
23±2 |
192±25 |
13±2 |
12±2 |
19±5 |
75 |
20±5 |
198±11 |
17±6 |
12±5 |
15±5 |
200 |
17±3 |
197±22 |
14±2 |
7±3 |
17±5 |
600 |
18±5 |
225±14 |
13±1 |
11±2 |
14±1 |
1800 |
18±3 |
201±29 |
17±1 |
10±2 |
25±2 |
5000 |
19±3 |
212±34 |
18±5 |
9±1 |
17±1 |
Positive |
462±35 |
795±34 |
102±12 |
96±17 |
253±9 |
Precipitate was generally observed at >= 1800 µg/plate but no appreciable toxicity was observed.
No positive responses were observed with any of the tester strains in the presence and absence of S9 activation.
All the validity criteria were fulfiled.
The results of the Bacterial Reverse Mutation Assay with an Independent Repeat Assay indicate that, under the conditions of this study, test substance did not cause a positive response with any of the tester strains in the presence and absence of metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this study, test substance did not cause a positive response with any of the tester strains in the presence and absence of metabolic activation. - Executive summary:
A bacterial reverse mutation assay was performed in an equivalent method to OECD 471 with S. typhimurium tester strains TA98, TA100, TA1535 and TA1537 and E. coli tester strain WP2 uvrA in the presence and absence of Aroclor-induced rat liver S9. The assay was performed in two phases, using the plate incorporation method. Based on the findings of the toxicity assay, the maximum dose plated in the mutagenicity assay was 5000 µg per plate. In the mutagenicity assay, no positive response was observed. Precipitate was generally observed at >=1800 µg per plate but no appreciable toxicity was observed. All the validity criteria were fulfiled. Under the conditions of this study, test article was concluded to be negative in the Bacterial Reverse Mutation Assay with an Independent Repeat Assay.
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