Registration Dossier
Registration Dossier
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: 214-711-0 | CAS number: 1189-08-8
- 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:
- 04/2020-06/2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 471, GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008 B13/14, dated 30-05-2008
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Ninth addendum of OECD 471, adopted 21-07-1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-methyltrimethylene dimethacrylate
- EC Number:
- 214-711-0
- EC Name:
- 1-methyltrimethylene dimethacrylate
- Cas Number:
- 1189-08-8
- Molecular formula:
- C12H18O4
- IUPAC Name:
- 4-[(2-methylprop-2-enoyl)oxy]butan-2-yl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL:
- Name of Test material: 1,3-BDDMA
- physical state: liquid, colorless
Method
- Target gene:
- his locus
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:
- Phenobarbital/ beta-naphthoflavone induced rat liver S9 Mix
- Test concentrations with justification for top dose:
- In the pre-experiment the concentration rage of the test item was 3-5000 µg/plate. The pre-experiment is reported as experiment I. Since only slight toxic effects were observed 5000 µg/plate were chosen as maximal concentration. The concentration range included two logarithmic decades.
Experiment I (plate incorporation test): 3/ 10/ 33/ 100/ 333/ 1000/ 2500/ 5000 µg/plate
Experiment II (pre-incubation test): 33/ 100/ 333/ 1000/ 2500/ 5000 µg/plate - Vehicle / solvent:
- On the day of experiment, the test item was dissolved in DMSO (purity >99%). The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria. All formulations were prepared freshly before treatment and used within two hours of preparation.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene: with metabolic activation: all strains; 4-nitro-o-phenylene-diamine: without metabolic activation: TA 1537 and TA 98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation) and pre-incubation
EXPERIMENTAL PERFORMANCE:
For each strain and dose level, including the controls, three plates were used.
Experiment I (Plate incorporation): Test solution at each dose level (solvent or reference mutagen solution (positive control)), S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation), bacteria suspension and overlay were mixed in a test tube and poured onto the selective agar plates.
Experiment II (Pre-incubation): The test solution at each dose level, the S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation) and the bacteria suspension were mixed in the test tube and incubated at 37 +/- 1.5°C for 60 minutes.
After the pre-incubation, 2.0 ml overlay agar was added to each tube. The mixture was poured on minimal agar plates. After solidification, the plates were incubated upside down for at least 48 hours at 37 +/- 1.5°C in the dark.
In parallel to each test, a sterile control of the test item was performed and documented in the raw data. Therefore, sterile stock solution, S9 mix/ S9 mix substitution buffer were mixed with 2.0 ml overlay agar and poured on minimal agar plates.
The colonies were counted using the validated computer system, which was connected with a PC with printer to print out the individual values, the means from the plates for each concentration together with standard deviations and enhancement factors as compared to the spontaneous reversion rates. Due to the precipitation of the test item the colonies were partly counted manually.
DETERMINATION OF CYTOTOXICITY:
Pre-Experiment for Toxicity: To evaluate the toxicity of the test item a pre-experiment was performed with all strains used. Eight concentrations were tested for toxicity and mutation induction with each 3 plates. The experimental conditions in this pre-experiment were the same as described for the experiment I (plate incorporation test). Toxicity of the test item results in a reduction in the number of spontaneous revertants (below a factor of 0.5) or a clearing of the bacterial background lawn.
The pre-experiment is reported as main experiment I since the acceptance criteria are met. - Evaluation criteria:
- The Salmonella typhimurium and Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control;
- the spontaneous reversion rates in the negative and solvent control are in the range of our historical data;
- the positive control substances should produce an increase above the threshold of twofold (strains TA 98, TA 100, and WP2 uvrA) or threefold (strains TA 1535 and TA 1357) the colony count of the corrresponding solvent control;
- a minimum of five analysable dose levels should be present with at least three dose levels showing no signs of toxic effects, evident as a reduction in the number of revertants below the indication factor of 0.5. - Statistics:
- no appropriate statistical method available
Results and discussion
Test resultsopen allclose all
- 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
- Species / strain:
- S. typhimurium TA 1537
- 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
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity observed in Experiment II without metabolic activation at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity observed in Experiment I with metabolic activation at 5000 µg/plate and in Experiment II without metabolic activation above 2500 µg/plate and with metabolic activation at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- 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
Applicant's summary and conclusion
- Conclusions:
- 1,3-BDDMA is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Executive summary:
This study was performed to investigate the potential of Visiomer (R) 1,3-BDDMA to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. 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: 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes from 2500 to 5000 µg/plate in experiment I and at 5000 µg/plate in experiment II. Precipitation of the test item in the overlay agar on the incubated agar plates was observed at 5000 µg/plate. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed reduced background growth in experiment I in strain TA 1537 and TA 100 and in experiment II in strain TA 1537, TA 98 and TA 100.
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occured in strain TA 100 with S9 mix in experiment I and strain TA 98 and TA 100 in experiment II.
No substantial increase in revertant colony number of any of the five tested strains was observed following treatment with Visiomer(R) 1,3-BDDMA at any dose, 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 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 par changes or frameshifts in the genome of the strains used.
Therefore, Visiomer(R) 1,3-BDDMA is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.