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EC number: 421-860-7 | CAS number: -
- 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
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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:
- 3 May to 26 May, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD 471, OECD 472; EU B.14, EU B.13. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 421-860-7
- EC Name:
- -
- Cas Number:
- 156145-64-1
- Molecular formula:
- C20H39N3O3Si
- IUPAC Name:
- (4E,9E)-7-ethenyl-2,4,10,12-tetramethyl-7-{[(E)-(4-methylpentan-2-ylidene)amino]oxy}-6,8-dioxa-5,9-diaza-7-silatrideca-4,9-diene; (4Z,9E)-7-ethenyl-2,4,10,12-tetramethyl-7-{[(E)-(4-methylpentan-2-ylidene)amino]oxy}-6,8-dioxa-5,9-diaza-7-silatrideca-4,9-diene; (4Z,9Z)-7-ethenyl-2,4,10,12-tetramethyl-7-{[(E)-(4-methylpentan-2-ylidene)amino]oxy}-6,8-dioxa-5,9-diaza-7-silatrideca-4,9-diene; (4Z,9Z)-7-ethenyl-2,4,10,12-tetramethyl-7-{[(Z)-(4-methylpentan-2-ylidene)amino]oxy}-6,8-dioxa-5,9-diaza-7-silatrideca-4,9-diene
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): OS-2200 (489-95A).
- Physical state: Clear to light yellow liquid.
- Analytical purity: >92%.
- Lot/batch No.:38659-14.
- Expiration date of the lot/batch: 1 January 1996.
- Storage condition of test material: room temperature in the dark under nitrogen.
Constituent 1
Method
- Target gene:
- Histidine or tryptophan gene.
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:
- other: E. coli WP2 uvrA trp
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver preparations (S9 mix) from rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 0 (control), 321.5, 625, 1250, 2500 and 5000 µg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone.
- Justification for choice of solvent/vehicle: Test item was fully miscible in acetone.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- without S9 mix
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- TA 1535, TA 100, WP2 uvrA
- Positive controls:
- yes
- Remarks:
- without S9 mix
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537
- Positive controls:
- yes
- Remarks:
- without S9 mix
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98
- Positive controls:
- yes
- Remarks:
- with S9 mix
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation) (Main test and confirmation test)
An aliquot of 0.1 mL of a 10 hour bacterial culture and 0.5 mL S9 mix or 0.5 mL 0.1 M phosphate buffer (at pH 7.4) were placed in glass bottles. An aliquot of 0.1 mL of the test solution was added, followed immediately by 2 mL of histidine/tryptophan deficient agar. The mixture was thoroughly shaken and overlaid onto previously prepared petri dishes containing 25 mL minimal agar. Three petri dishes were used for each dose level. A set of plates were also prepared containing only bacterial culture and S-9 mix or phosphate buffer (0 µg/plate). Plates were also prepared without the addition of bacteria in order to assess the sterility of the test substance, S-9 mix and phosphate buffer. All plates were incubated at 37°C for 3 days. After this period revertant colonies were counted using a Seescan Automatic Colony Counter.
DURATION
-Exposure duration: 3 days at 37ºC.
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY: Reductions in revertant colony counts or by the absence of a complete background bacterial lawn. - Evaluation criteria:
- The mean number of revertant colonies for all treatment groups is compared with those obtained for solvent control groups. The mutagenic activity of a test substance is assessed by applying the following criteria:
a)If treatment with a test substance produces an increase in revertant colony numbers of at least twice the concurrent solvent controls, with some evidence of a positive dose-relationship, in two separate experiments, with any bacterial strain either in the presence or absence of S-9 mix, it is considered to show evidence of mutagenic activity in this test system. No statistical analysis is performed.
b)If treatment with a test substance does not produce reproducible increases of at least 1.5 times the concurrent solvent controls, at any dose level with any bacterial strain, it is considered to show no evidence of mutagenic activity in this test system. No statistical analysis is performed.
-If the results obtained fail to satisfy the criteria for a clear "positive" or "negative" response given in paragraphs a and b, the following approach is taken in order to resolve the issue of the substance's mutagenic activity in this test system.
-Repeat tests may be performed using modifications of the experimental method. These modifications include (but are not restricted to), the use of a narrower dose range than that already tested; the use of different levels of liver homogenate S-9 fraction in the S-9 mix. Should an increase in revertant colony numbers be observed which satisfies paragraph a), the substance is considered to show evidence of mutagenic activity in this test system. No statistical analysis is performed.
-If no clear "positive" response can be obtained the test data may be subjected to analysis to determine the statistical significance of any observed increases in revertant colony numbers. The statistical procedures used will be those described by Mahon et al. (1989) - Statistics:
- No statistical analysis.
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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: No toxicity was observed in the preliminary test study up to 5000 µg/plate test item. Therefore 5000µg/plate was chosen as the top dose level in the mutation tests.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Mean reverntan colonies*:
Test 1:
Material |
Concentrat. (µg/plate) |
Without metabolic activation |
With metabolic activation |
||||||||
Base pair exchange type |
Frameshift type |
Base pair exchange type |
Frameshift type |
||||||||
TA100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
TA100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
||
Solvent control |
|
121 |
17 |
70 |
24 |
13 |
121 |
16 |
69 |
23 |
14 |
OS-2200 |
5000.0 |
100 |
15 |
39 |
21 |
14 |
111 |
19 |
50 |
24 |
8 |
2500.0 |
117 |
14 |
58 |
22 |
13 |
131 |
13 |
64 |
26 |
11 |
|
1250.0 |
118 |
14 |
62 |
19 |
9 |
101 |
14 |
62 |
25 |
11 |
|
625.0 |
132 |
11 |
75 |
23 |
11 |
112 |
15 |
66 |
27 |
11 |
|
312.5 |
120 |
14 |
61 |
20 |
10 |
119 |
13 |
63 |
26 |
12 |
|
Negative control |
0.0 |
120 |
13 |
69 |
23 |
10 |
139 |
14 |
72 |
21 |
10 |
Positive control |
EENG |
355 |
210 |
745 |
- |
- |
- |
- |
- |
- |
- |
NF |
- |
- |
- |
191 |
- |
- |
- |
- |
- |
- |
|
9 AC |
- |
- |
- |
- |
X |
- |
- |
- |
- |
- |
|
AA |
- |
- |
- |
- |
- |
354 |
147 |
246 |
106 |
70 |
Test 2:
Material |
Concentrat. (µg/plate) |
Without metabolic activation |
With metabolic activation |
||||||||
Base pair exchange type |
Frameshift type |
Base pair exchange type |
Frameshift type |
||||||||
TA 100# |
TA1535# |
WP2uvrA# |
TA 98# |
TA1537# |
TA100# |
TA1535# |
WP2uvrA# |
TA98# |
TA1537# |
||
Solvent control |
|
108 |
12 |
66 |
26 |
10 |
120 |
14 |
75 |
24 |
8 |
OS-2200 |
5000.0 |
109 |
12 |
53 |
25 |
7 |
120 |
13 |
47 |
14 |
10 |
2500.0 |
115 |
11 |
67 |
20 |
8 |
107 |
14 |
81 |
23 |
6 |
|
1250.0 |
85 |
12 |
58 |
20 |
6 |
133 |
18 |
77 |
17 |
7 |
|
625.0 |
96 |
13 |
63 |
29 |
6 |
128 |
12 |
76 |
15 |
6 |
|
312.5 |
115 |
9 |
66 |
24 |
10 |
120 |
11 |
81 |
20 |
9 |
|
Negative control |
0.0 |
112 |
9 |
68 |
27 |
8 |
129 |
21 |
90 |
15 |
5 |
Positive control |
EENG |
312 401$ |
200 |
567 |
- |
- |
- |
- |
- |
- |
- |
NF |
- |
- |
- |
181 |
- |
- |
- |
- |
- |
- |
|
9 AC |
- |
- |
- |
- |
X |
- |
- |
- |
- |
- |
|
AA |
- |
- |
- |
- |
- |
205 |
109 |
311 |
77 |
50 |
X Too many colonies to count
accurately
ENNG N-Ethyl-N’-nitro-N-nitrosoguanidine
9 AC 9-Aminoacridine
NF 2-Nitrofluorene
AA 2-Aminoanthracene
* Values are the mean of 3 plates
# S-9 data obtained from a separate experiment due to a contamination
$ Additional control data obtained from the separate S-9 mix experiment
No substantial increases in revertant colony numbers of any of the tester strains were observed following treatment with OS-2200 (489-95A) at any dose level, in the presence or absence of S-9 mix, in either mutation test.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
OS-2200 when tested in acetone shows no evidence of mutagenic activity in the described bacterial system. - Executive summary:
An in-vitro bacterial reverse assay (Ames test) was performed on OS-2200 in accordance with OECD Guideline 471, 472 and EU methods B.13/14 with histidine dependent auxotrophic mutants of Salmonella typhimurium (strains TA 1535, TA 1537, TA 98 and TA 100) and a tryptophan dependent mutant of Escherichia coli (WP2 uvrA). In the preliminary toxicity test with dose levels of up to 5000 µg/plate no toxicity was observed. Therefore, the dose levels tested in the main test were 5000, 2500, 1250, 625, 312.5 µg/plate. Two independent mutation tests were performed, in the presence md absence of liver preparations from Aroclor 1254-induced rats. Negative controls, solvent controls and positive controls were included in each test. No signs of toxicity were observed towards the tester strains in either mutation tests following exposure to OS-2200 . No evidence of mutagenic activity was seen at any concentration of OS-2200 in either mutation test. The concurrent positive control compounds demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. It was concluded that OS-2200 showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.
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