Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 815-031-2 | CAS number: 1411949-02-4
- 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:
- from 2017-05-16 to 2017-11-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008-05-30
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-isobutyl-4-vinyl-1,3-dioxolane
- EC Number:
- 815-031-2
- Cas Number:
- 1411949-02-4
- Molecular formula:
- C9H19O2
- IUPAC Name:
- 2-isobutyl-4-vinyl-1,3-dioxolane
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- his/trp
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/beta-naphthoflavone induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II and IIa:
Strain TA 100 (Exp. II): 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The remaining strains (Exp. II): 33; 100; 333; 1000; 2500; and 5000 µg/plate
Strain TA 98 (Exp. IIa): 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
In the pre-experiment the concentration range of the test item was 3 – 5000 µg/plate. The pre-experiment is reported as experiment I.
Based on the toxic effects observed in experiment I, six, respectively seven concentrations were tested in experiment II or experiment IIa. The concentration range included two logarithmic decades. 5000 µg/plate were chosen as maximal concentration in experiment II. The additional experiment IIa was performed after discussion with the sponsor to confirm the data on bacteriotoxicity observed in experiment II. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix: 10 µg/plate in TA 1535 and TA 100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- Without S9 mix: 10 µg/plate in strain TA 98, 50 µg/plate in strain TA 1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without S9 mix: 2.0 µL/plate in E.coli WP2 uvrA
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With S9 mix: 2.5 µg/plate in TA 1535, TA 1537, TA 98, TA 100; 10.0 µg/plate in E.coli WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
SELECTION AGENT (mutation assays): Plates with selective agar (without histidine/tryptophan) were used.
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: Reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without S9 mix: 1000 - 5000 µg/plate with S9 mix: 2500 - 5000 µg/plate
- 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:
- 1000 - 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- with and without S9 mix: 2500 - 5000 µg/plate
- 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:
- with s9 mix: 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test item precipitated in the overlay agar in the test tubes in experiment II at 5000 µg/plate with and without metabolic activation.
Any other information on results incl. tables
Table 1: Summary of Experiment I
Metabolic Activation |
Test Group |
Dose Level [µg/plate] |
Revertant Colony Counts (Mean ± SD) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
E. coli |
|||
Without |
DMSO |
|
12±4 |
11±4 |
25±5 |
159±24 |
41±7 |
Untreated |
|
14±33 |
12±4 |
33±6 |
191±29 |
37±6 |
|
Test Item |
3 |
9±2 |
11±5 |
24±5 |
186±17 |
37±1 |
|
10 |
12±5 |
10±2 |
19±2 |
169±12 |
39±12 |
||
33 |
9±1 |
9±2 |
24±6 |
192±6 |
41±6 |
||
100 |
10±3 |
10±1 |
18±3 |
190±10 |
39±4 |
||
333 |
13±6 |
9±3 |
31±6 |
188±10 |
37±4 |
||
1000 |
11±4 |
9±2 |
19±4 |
132±20 |
31±5 |
||
2500 |
11±2 |
8±2 |
18±5 |
77±7 |
25±3 |
||
5000 |
9±2 |
9±3 |
22±3 |
72±14 |
28±6 |
||
NaN3 |
10 |
1367±25 |
|
|
2411±77 |
|
|
4-NOPD |
10 |
|
|
423±40 |
|
|
|
4-NOPD |
50 |
|
86±13 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
1085±44 |
|
With |
DMSO |
|
19±3 |
18±3 |
36±2 |
195±23 |
58±10 |
Untreated |
|
19±2 |
19±7 |
45±11 |
178±16 |
73±1 |
|
Test Item |
3 |
19±8 |
22±1 |
43±10 |
184±11 |
58±12 |
|
10 |
18±5 |
13±3 |
39±9 |
173±21 |
50±15 |
||
33 |
14±5 |
13±3 |
40±3 |
146±3 |
43±7 |
||
100 |
15±6 |
14±6 |
32±7 |
164±4 |
60±15 |
||
333 |
17±6 |
18±1 |
47±7 |
165±8 |
57±6 |
||
1000 |
21±7 |
13±4 |
44±12 |
193±21 |
52±6 |
||
2500 |
14±3 p |
14±3 p |
37±0 p |
94±9 p |
43±4 |
||
5000 |
6±1 pm |
7±1 pm |
20±5 pm |
44±7 pm |
28±3 |
||
2-AA |
2.5 |
375±21 |
115±29 |
3439±12 |
3859±101 |
|
|
2-AA |
10.0 |
|
|
|
|
331±23 |
|
p precipitate m manual count |
Table 2: Summary of Experiment II
Metabolic Activation |
Test Group |
Dose Level [µg/plate] |
Revertant Colony Counts (Mean ± SD) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
E. coli |
|||
Without |
DMSO |
|
9±3 |
11±5 |
28±11 |
131±27 |
39±3 |
Untreated |
|
9±2 |
7±2 |
36±5 |
192±31 |
42±10 |
|
Test Item |
10 |
|
|
|
130±3 |
|
|
33 |
9±5 |
10±4 |
25±2 |
130±11 |
40±3 |
||
100 |
10±1 |
11±5 |
28±6 |
134±17 |
47±10 |
||
333 |
9±3 |
7±3 |
30±3 |
98±7 |
42±13 |
||
100 |
7±3 |
7±4 |
11±1 |
44±9 |
28±6 |
||
2500 |
8±1 |
3±1 |
1±1 |
5±1 |
23±2 |
||
5000 |
5±2 pm |
0±1 p |
0±0 p |
0±1 p |
19±1 pm |
||
NaN3 |
10 |
1187±26 |
|
|
1881±106 |
|
|
4-NOPD |
10 |
|
|
323±7 |
|
|
|
4-NOPD |
50 |
|
95±7 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
668±63 |
|
With |
DMSO |
|
13±5 |
12±3 |
38±6 |
123±10 |
53±9 |
Untreated |
|
18±6 |
13±2 |
39±10 |
176±15 |
67±8 |
|
Test Item |
10 |
|
|
|
116±9 |
|
|
33 |
15±1 |
15±0 |
42±7 |
127±5 |
51±2 |
||
100 |
14±5 |
16±6 |
40±12 |
104±6 |
53±8 |
||
333 |
13±6 |
12±4 |
44±8 |
92±26 |
51±10 |
||
1000 |
15±7 |
10±2 |
31±5 |
26±1 |
39±3 |
||
2500 |
11±2 |
1±1 |
2±0 |
8±2 |
30±6 |
||
5000 |
6±2 pm |
0±0 p |
0±1 p |
1±1 p |
13±3 pm |
||
2-AA |
2.5 |
389±25 |
109±8 |
4249±284 |
2158±344 |
|
|
2-AA |
10.0 |
|
|
|
|
498±31 |
|
p precipitate m manual count |
Applicant's summary and conclusion
- Conclusions:
- In a bacterial reverse mutation assay (Ames) according to OECD Guideline 471, the test item did not show mutagenic properties.
- Executive summary:
In a bacterial reverse mutation assay (Ames) according to OECD Guideline 471, the potential of the test item to induce gene mutations was investigated in the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed in three independent experiments with and without liver microsomal activation (S9 mix). Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3, 10, 33, 100, 333, 1000, 2500, and 5000 µg/plate
Experiment II and IIa:
Strain TA 100 (Exp. II): 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The remaining strains (Exp. II): 33, 100, 333, 1000, 2500, and 5000 µg/plate
Strain TA 98 (Exp. IIa): 3;10; 33; 100; 333; 1000; and 2500 µg/plate
The test item precipitated in the overlay agar in the test tubes in experiment I at 5000 µg/plate with metabolic activation and in experiment II at 5000 µg/plate with and without metabolic activation. Precipitation of the test item in the overlay agar on the incubated agar plates was observed in experiment I from 2500 to 5000 µg/plate with metabolic activation and in experiment II at 5000 µg/plate with and without metabolic activation. In experiment IIa no precipitation was observed when tested up a top dose of 2500 µg/plate. The undissolved particles had no influence on the data recording of this study. The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), were observed in experiment I in strains TA 1535, TA 1537 and TA 100, in experiment II in all strains except strain TA 1535, and in experiment IIa in strain TA 98. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test item is considered to be non-mutagenic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.