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EC number: 212-214-3 | CAS number: 769-78-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Jul - 05 Aug 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Commission Directive No. 2000/32/EC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- Aug 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Vinyl benzoate
- EC Number:
- 212-214-3
- EC Name:
- Vinyl benzoate
- Cas Number:
- 769-78-8
- Molecular formula:
- C9H8O2
- IUPAC Name:
- vinyl benzoate
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E. coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital/β-naphthoflavone (80/100 mg/kg bw/day)
- Test concentrations with justification for top dose:
- Pre-experiment: 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate with and without mtabolic activation for TA 100 and WP2 uvr A
Main Experiment 1:
50, 150, 500, 1500 and 5000 µg/plate with metabolic activation for WP2 uvr A
5, 15, 50, 150, 500, 1500 and 500 µg/plate with and without metabolic activation for remaining strains and without metabolic activation for WP2 uvr A
Main Experiment 2:
50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation for WP2 uvr A
5, 15, 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation for remaining strains - Vehicle / solvent:
- - Vehicle/solvent used: dimethyl sulphoxide
- Justification for choice of solvent/vehicle: The test material was fully soluble in dimethyl sulphoxide at 50 mg/mL in solubility checks performed in-house. Sterile distilled water was not evaluated as a potential vehicle in this test system as information supplied by the sponsor suggested that the test material is insoluble in water.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: clearing of the bacterial background lawn - Evaluation criteria:
- There are several criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the results will be considered first, statistical methods, as recommended by UKEMS (Kirkland ( 1989) Sub-committee on Guidelines for mutagenicity Testing, Report-Part III, Cambridge University Press) can also be used as an aid to evaluation, however, statistical significance will not be the only determining factor for a positive response. A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Acceptance criteria:
The reverse mutation assay may be considered valid if the following criteria are met:
Spontaneous revertants of tester strain cultures for vehicle and negative control should be in the range of historical control data. The appropriate characteristics for each tester strain have been confirmed (eg rfs cell-wall-mutation, pKM101 plasmid R-factor etc.). All tester strain cultures should be in the approximate range of 1 to 9.9 x 10E09 bacteria per mL. Each mean positive control value should be at least two times the respective vehicle control for each strain, thus demonstrating both the intrinsic sensitivity of the tester strains to mutagenic exposure and integrity of the S9-mix. There should be a minimum of four non-toxic test material dose levels. There should be no evidence of excessive contamination. - Statistics:
- Mean value and standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 1500 µg/plate (+/- S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 5000 µg/plate (+/- S9)
- Vehicle controls validity:
- valid
- Untreated negative 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:
- cytotoxicity
- Remarks:
- at and above 1500 µg/plate (+/- S9)
- Vehicle controls validity:
- valid
- Untreated negative 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:
- cytotoxicity
- Remarks:
- at and above 1500 µg/plate (+/- S9)
- Vehicle controls validity:
- valid
- 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
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate (- S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test material precipitate was observed on the plates at any of the dose levels tested in either the presence or absence of S9-mix.
RANGE-FINDING/SCREENING STUDIES: The test material was toxic at and above 1500 μg/plate to TA100 (with and without S9) and WP2uvrA- (without S9) and non-toxic to WP2uvrA- with S9. The test material formulation and S9-mix used in this experiment were both shown to be sterile.
HISTORICAL CONTROL DATA: Positive and vehicle controls were within the normal range of historical control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The test material caused a visible reduction in the growth of the bacterial background lawns of the majority of tester strains, initially from 1500 μg/plate in both the presence and absence of S9. No toxicity was exhibited to Escherichia coli strain WP2 uvr A, in the presence of S9 only, at any test substance dose level. The sensitivity of the tester strains to the toxicity of the test substance varied slightly between strain type, exposure with or without S9 and experiment number. The test material was, therefore, tested up to the maximum recommended dose level of 5000 μg/plate.
Any other information on results incl. tables
Table 1. Results of Experiment 1
|
Number of revertant colonies (mean of 3 plates ± SD) |
|||||||
S9-Mix |
Without |
|||||||
Test substance (µg/plate) |
TA 100 |
TA 1535 |
WP2 uvr A |
TA 98 |
TA1537 |
|||
SC |
128 ± 4.6 |
26 ± 2.6 |
30 ± 3.8 |
23 ± 5.5 |
10 ± 4.9 |
|||
5 |
128 ± 7.2 |
27 ± 2.1 |
19 ± 7.4 |
23 ± 8.3 |
10 ± 6.0 |
|||
15 |
130 ± 6.5 |
25 ± 3.0 |
22 ± 3.8 |
20 ± 4.0 |
6 ± 1.2 |
|||
50 |
127 ± 8.6 |
19 ± 2.6 |
25 ± 3.2 |
22 ± 4.4 |
12 ± 1.5 |
|||
150 |
135 ± 12.5 |
23 ± 6.8 |
22 ± 7.5 |
17 ± 5.5 |
13 ± 2.1 |
|||
500 |
126 ± 10.4 |
28 ± 9.0 |
25 ± 8.0 |
13 ± 1.7 |
13 ± 2.0 |
|||
1500 |
75 ± 0.6 s |
28 ± 4.2 s |
23 ± 4.5 |
13 ± 3.6 s |
7 ± 2.5 |
|||
5000 |
0 ± 0.0 v |
0 ± 0.0 v |
16 ± 2.3 s |
0 ± 0.0 v |
0 ± 0.0 v |
|||
Positive Control |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||
Dose (µg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|||
Number of revertant colonies/plate |
443 ± 67.0 |
168 ± 32.1 |
540 ± 27.3 |
101 ± 4.5 |
659 ± 69.6 |
|||
S9-Mix |
With |
|||||||
Test substance (µg/plate) |
TA 100 |
TA 1535 |
WP2 uvr A |
TA 98 |
TA1537 |
|||
SC |
128 ± 4.4 |
13 ± 2.1 |
29 ± 6.1 |
22 ± 1.5 |
15 ± 2.0 |
|||
5 |
107 ± 9.3 |
13 ± 1.5 |
N/T |
28 ± 7.8 |
12 ± 2.5 |
|||
15 |
102 ± 6.8 |
13 ± 0.0 |
N/T |
26 ± 4.9 |
13 ± 3.2 |
|||
50 |
108 ± 8.4 |
11 ± 2.1 |
28 ± 2.0 |
21 ± 1.5 |
10 ± 2.3 |
|||
150 |
111 ± 10.2 |
12 ± 3.1 |
23 ± 3.0 |
22 ± 0.6 |
13 ± 7.8 |
|||
500 |
98 ± 14.4 |
14 ± 1.0 |
31 ± 9.8 |
22 ± 7.0 |
10 ± 3.6 |
|||
1500 |
68 ± 14.5 s |
9 ± 3.5 s |
27 ± 4.0 |
16 ± 0.6 s |
8 ± 1.2 |
|||
5000 |
0 ± 0.0 v |
5 ± 1.2 s |
25 ± 0.6 |
14 ± 5.1 s |
7 ± 0.6 s |
|||
Positive Control |
2AA |
2AA |
2AA |
BP |
2AA |
|||
Dose (µg/plate) |
1 |
2 |
10 |
5 |
2 |
|||
Number of revertant colonies/plate |
458 ± 154.0 |
166 ± 25.1 |
168 ± 7.0 |
262 ± 17.0 |
354 ± 48.8 |
|||
SC: Solvent Control (dimethyl sulphoxide) ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine 4NQO: 4-Nitroquinoline-1-oxide 9AA: 9-Aminoacridine 2AA: 2-Aminoanthracene |
BP: Benzo(a)pyrene N/T: Not tested at this dose level s: sparse bacterial background lawn v: very weak bacterial background lawn |
Table 2: Results of Experiment 2
|
Number of revertant colonies (mean of 3 plates ± SD) |
|||||||
S9-Mix |
Without |
|||||||
Test substance (µg/plate) |
TA 100 |
TA 1535 |
WP2 uvr A |
TA 98 |
TA1537 |
|||
SC |
115 ± 18.7 |
18 ± 2.5 |
26 ± 3.2 |
21 ± 1.0 |
8 ± 0.6 |
|||
5 |
123 ± 9.2 |
19 ± 7.0 |
N/T |
19 ± 3.5 |
10 ± 2.9 |
|||
15 |
118 ± 10.1 |
20 ± 1.2 |
N/T |
15 ± 3.5 |
15 ± 6.7 |
|||
50 |
122 ± 11.2 |
19 ± 5.0 |
27 ± 3.0 |
17 ± 8.5 |
10 ± 6.0 |
|||
150 |
117 ± 7.0 |
24 ± 1.7 |
21 ± 1.5 |
15 ± 4.6 |
13 ± 5.7 |
|||
500 |
116 ± 14.8 |
19 ± 3.8 |
28 ± 4.7 |
20 ± 7.8 |
10 ± 1.0 |
|||
1500 |
100 ± 4.9 s |
25 ± 2.5 s |
25 ± 5.7 |
14 ± 4.2 s |
7 ± 4.0 |
|||
5000 |
77 ± 13.3 s |
17 ± 3.6 v |
23 ± 2.5 s |
6 ± 1.5 v |
8 ± 3.6 s |
|||
Positive Control |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||
Dose (µg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|||
Number of revertant colonies/plate |
302 ± 14.2 |
179 ± 6.0 |
400 ± 14.7 |
100 ± 15.0 |
219 ± 31.7 |
|||
S9-Mix |
With |
|||||||
Test substance (µg/plate) |
TA 100 |
TA 1535 |
WP2 uvr A |
TA 98 |
TA1537 |
|||
SC |
101 ± 2.5 |
10 ± 2.1 |
29 ± 5.8 |
19 ± 5.9 |
11 ± 2.0 |
|||
5 |
115 ± 20.6 |
10 ± 2.0 |
N/T |
23 ± 6.1 |
14 ± 0.6 |
|||
15 |
98 ± 12.3 |
8 ± 1.0 |
N/T |
21 ± 3.1 |
10 ± 2.5 |
|||
50 |
88 ± 8.0 |
8 ± 3.5 |
28 ± 8.1 |
22 ± 7.1 |
15 ± 3.1 |
|||
150 |
98 ± 15.0 |
9 ± 2.1 |
31 ± 7.5 |
17 ± 3.8 |
16 ± 5.5 |
|||
500 |
96 ± 6.4 |
11 ± 3.1 |
24 ± 8.0 |
20 ± 6.0 |
11 ± 2.1 |
|||
1500 |
83 ± 4.4 |
8 ± 2.5 |
31 ± 5.9 |
17 ± 5.1 |
10 ± 1.5 |
|||
5000 |
62 ± 8.0 s |
7 ± 3.1 |
23 ± 2.3 |
13 ± 3.2 s |
13 ± 6.2 |
|||
Positive Control |
2AA |
2AA |
2AA |
BP |
2AA |
|||
Dose (µg/plate) |
1 |
2 |
10 |
5 |
2 |
|||
Number of revertant colonies/plate |
525 ± 118.2 |
220 ± 24.5 |
340 ± 37.0 |
223 ± 16.4 |
218 ± 27.4 |
|||
SC: Solvent Control (dimethyl sulphoxide) ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine 4NQO: 4-Nitroquinoline-1-oxide 9AA: 9-Aminoacridine 2AA: 2-Aminoanthracene |
BP: Benzo(a)pyrene N/T: Not tested at this dose level s: sparse bacterial background lawn v: very weak bacterial background lawn |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the Ames test the test substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvr A) tested with and without metabolic activation up to the limit dose of 5000 µg/plate.
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