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EC number: 809-852-5 | CAS number: 3395-98-0
- 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:
- 29 April 2014 - 25 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-ethenyl-5-methyl-1,3-oxazolidin-2-one
- EC Number:
- 809-852-5
- Cas Number:
- 3395-98-0
- Molecular formula:
- C6H9NO2
- IUPAC Name:
- 3-ethenyl-5-methyl-1,3-oxazolidin-2-one
- Details on test material:
- - Name of test material (as cited in study report): 5-Methyl-3-vinyloxazolidin-2-on
- Physical state: liquid
- Test article number: 14/0031-1
- Analytical purity: > 98%
- Lot/batch No.: DEIMLIB 00028 Fr.8
- Expiration date of the lot/batch: 12th July 2014
- Storage condition of test material: 2-8°C, under nitrogen
Constituent 1
Method
- Target gene:
- His operon
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:
- S9 (Arochlor 1254)
- Test concentrations with justification for top dose:
- 1st Experiment: 5, 16, 50, 160, 500, 1600, 5000 µg/plate
2nd Experiment: 160, 300, 625, 1250, 2500, 5000µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- purified water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- 5-Methyl-3-vinyloxazolidin-2-on was tested for mutation (and toxicity) in four strainsof Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and one strain of Escherichia coli (WP2 uvrA) in two separate experiments at the concentrations detailed previously, using triplicate plates without and with S-9. Vehicle controls were included in quintuplicate and positive controls were included in triplicate in both assays without and with S-9. These platings were achieved by the following sequence of additions to molten agar at 46±1°C:
• 0.1 mL bacterial culture
• 0.1 mL test article solution or control
• 0.5 mL 10% S-9 mix or buffer solution
followed by rapid mixing and pouring on to Vogel-Bonner E agar plates. When set, the plates were inverted and incubated at 37±1°C protected from
light for 3 days. Following incubation, these plates were examined for evidence of toxicity to the background lawn, and where possible revertant
colonies were counted .
As the results of Experiment 1 were negative, treatments in the presence of S-9 in Experiment 2 included a pre-incubation step. Quantities of test
article or control solution, bacteria and S-9 mix detailed above (except positive control volume reduced
to 0.05 mL) were mixed together and incubated for 20 minutes at 37±1°C, with shaking, before the addition of 2.5 mL molten agar at 46±1°C. Plating of these treatments then proceeded as for the normal plate-incorporation procedure. In this way, it was hoped to increase the range of mutagenic
chemicals that could be detected in the assay.
Volume additions for the positive controls in the Experiment 2 pre-incubation treatments were reduced to 0.05 mL due to the vehicle (DMSO) used in the formulation of these chemicals. This, and some other organic vehicles, are known to be near to toxic levels when added at volumes of 0.1 mL in
this assay system when employing the pre-incubation methodology. By reducing the addition volume to 0.05 mL per plate, it was hoped to minimise
or eliminate any toxic effects of the vehicle that may have otherwise occurred.
Toxicity Assessment
The background lawns of the plates were examined for signs of toxicity. Other evidence of toxicity may have included a marked reduction (to ≤0.5-fold) in revertants compared to the concurrent vehicle controls and/or a reduction in
mutagenic response. A minimum of five treatment concentrations were evaluated for mutation in each strain in the absence and presence of S-9. - Evaluation criteria:
- For valid data, the test article was considered to be mutagenic if:
1. A concentration related increase in revertant numbers was ≥2-fold (in strains TA98 or TA100) or ≥3-fold (in strains TA1535, TA1537 or WP2 uvrA) the concurrent vehicle control values
2. The positive trends/effects described above were reproducible.
The test article was considered positive in this assay if both of the above criteria were met.
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
1st Experiment:
Compound |
Concentration (µg/plate) |
Revertant numbers/plate |
|||||||||
|
|
TA 98 (-S9) |
TA 98 (+S9) |
TA 100 (-S9) |
TA 100 (+S9) |
TA 1535 (-S9) |
TA 1535 (+S9) |
TA 1537 (-S9) |
TA 1537 (+S9) |
WP2 uvrA (-S9) |
WP2 uvrA (+S9) |
Purified Water |
|
28.6 |
37.4 |
114.6 |
128.2 |
27.6 |
19.2 |
10.4 |
14.0 |
12.0 |
17.4 |
Test item |
5 |
24.0 |
43.0 |
129.7 |
120.7 |
31.3 |
18.7 |
6.0 |
19.0 |
11.3 |
18.3 |
|
16 |
23.3 |
46.7 |
113.0 |
119.3 |
29.3 |
23.0 |
8.3 |
18.7 |
14.3 |
14.3 |
|
50 |
26.3 |
42.3 |
112.7 |
125.3 |
30.3 |
25.0 |
7.3 |
14.7 |
16.7 |
16.7 |
|
160 |
25.3 |
34.3 |
102.0 |
129.3 |
30.3 |
18.3 |
9.3 |
19.0 |
9.0 |
19.3 |
|
500 |
24.3 |
45.3 |
106.3 |
128.0 |
31.7 |
20.3 |
9.0 |
20.3 |
17.3 |
14.0 |
|
1600 |
27.7 |
43.0 |
122.3 |
138.7 |
23.0 |
12.7 |
7.7 |
19.0 |
8.7 |
14.0 |
|
5000 |
24.3 |
44.0 |
109.7 |
137.0 |
31.7 |
26.0 |
9.0 |
18.7 |
8.3 |
14.3 |
Positive Control |
- |
725.3 |
470.7 |
660.3 |
1612.7 |
692.3 |
310.7 |
296.0 |
166.3 |
902.0 |
402.3 |
2 nd Experiment:
Compound |
Concentration (µg/plate) |
Revertant numbers/plate |
|||||||||
|
|
TA 98 (-S9) |
TA 98 (+S9) |
TA 100 (-S9) |
TA 100 (+S9) |
TA 1535 (-S9) |
TA 1535 (+S9) |
TA 1537 (-S9) |
TA 1537 (+S9) |
WP2 uvrA (-S9) |
WP2 uvrA (+S9) |
Purified Water |
|
17.8 |
35.8 |
101.4 |
124.2 |
16.4 |
19.6 |
11.8 |
20.6 |
13.4 |
19.8 |
Test item |
160 |
13.3 |
35.3 |
89.0 |
127.3 |
17.7 |
24.3 |
14.3 |
17.3 |
15.7 |
21.3 |
|
300 |
12.7 |
30.7 |
80.0 |
144.0 |
18.0 |
22.7 |
13.3 |
13.3 |
15.0 |
15.3 |
|
625 |
12.7 |
33.0 |
93.3 |
112.7 |
17.7 |
20.3 |
6.3 |
15.7 |
14.3 |
19.0 |
|
1250 |
8.0 |
44.7 |
103.3 |
128.0 |
18.0 |
19.0 |
9.3 |
11.7 |
14.3 |
20.0 |
|
2500 |
13.3 |
27.0 |
98.7 |
117.3 |
22.0 |
21.0 |
11.3 |
15.7 |
19.0 |
16.7 |
|
5000 |
10.7 |
34.3 |
99.3 |
125.0 |
17.7 |
26.0 |
8.7 |
9.7 |
18.7 |
20.3 |
Positive Control |
- |
748.0 |
490.7 |
778.7 |
1290.0 |
614.3 |
188.7 |
127.0 |
80.7 |
1151.3 |
211.0 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that 5-Methyl-3-vinyloxazolidin-2-on did not induce mutation in four histidine-requiring strains (TA98, TA100, TA1535 and
TA1537) of Salmonella typhimurium and one tryptophan-requiring strain (WP2 uvrA) of Escherichia coli when tested under the conditions of this
study. These conditions included treatments at concentrations up to 5000 μg/plate (the maximum recommended concentration
according to current regulatory guidelines) in the absence and presence of a rat liver metabolic activation system (S-9). - Executive summary:
5-Methyl-3-vinyloxazolidin-2-on was assayed for mutation in four histidine-requiring strains (TA98, TA100, TA1535 and TA1537) of Salmonella typhimurium and one tryptophan-requiring strain (WP2 uvrA) of Escherichia coli, both in the absence and
presence of metabolic activation by an Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9), in two separate experiments.
All 5-Methyl-3-vinyloxazolidin-2-on treatments in this study were performed using formulations prepared in water for irrigation (purified water).
Experiment 1 (plate incorporation test) treatments of all the tester strains were performed in the absence and presence of S-9, using final concentrations of 5-Methyl-3-vinyloxazolidin-2-on at 5, 16, 50, 160, 500, 1600 and 5000 μg/plate, plus vehicle and positive controls. Following these treatments evidence of toxicity was observed at 5000 μg/plate in strain WP2 uvrA in the absence of S-9 only.
Experiment 2 (plate incorporation test without S-9; pre-incubation test with S-9) treatments of all the tester strains were performed. The maximum test concentration of 5000 μg/plate was retained for all strains. Narrowed concentration intervals were employed covering the range 160-5000 μg/plate, in order to examine more closely those concentrations of 5-Methyl-3-vinyloxazolidin-2-on approaching the maximum test concentration and considered therefore most likely to provide evidence of any mutagenic activity. In addition, all treatments in the presence of S-9 were further modified by the inclusion of a pre-incubation step. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected using this assay system. Following these treatments evidence of toxicity was observed at 5000 μg/plate in strain TA1537 in the presence of S-9. A marked reduction in revertant colony numbers was also observed at 1250 μg/plate in strain TA98 in the absence of S-9 but as this was observed only at one intermediate concentration, it was not considered clear evidence of toxicity.
The test article was completely soluble in the aqueous assay system at all concentrations tested, in each of the experiments performed.
Vehicle and positive control treatments were included for all strains in both experiments. The mean numbers of revertant colonies all fell within acceptable ranges for vehicle control treatments, and were elevated by positive control treatments.
Following 5-Methyl-3-vinyloxazolidin-2-on treatments of all the test strains in the absence and presence of S-9, no increases in revertant numbers were observed that were ≥2-fold (in strains TA98 and TA100) or ≥3-fold (in strains TA1535, TA1537
and WP2 uvrA) the concurrent vehicle control. This study was considered therefore to have provided no evidence of any 5-Methyl-3-vinyloxazolidin-2-on mutagenic activity in this assay system.
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