Registration Dossier
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EC number: 202-597-5 | CAS number: 97-63-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The study was conducted in accordance with a recognized international scientific procedure and followed the test protocol and procedures of Ames (1975). Complete study results were presented supporting the conclusions that ethyl methacrylate was not mutagenic in this test system. Full description of the test material was provided.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
- Reference Type:
- review article or handbook
- Title:
- The lower alkyl methacrylates: Genotoxic profile of non-carcinogenic compounds
- Author:
- Albertini, RJ
- Year:
- 2 017
- Bibliographic source:
- Regulatory Toxicology and Pharmacology 84, 77-93
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to
- Guideline:
- other: Ames et al. (1975)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Ethyl Methacrylate; CAS: 97-63-2; purity: > 99 %; supplied by Fluka Chemical Co.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rats and male Syrian Hamster livers were prepared immediately prior to use. The S-9 mixes contained 10% S-9.
- Test concentrations with justification for top dose:
- 100-10000 µg/plate
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol (95%)
- Positive controls:
- yes
- Remarks:
- Metabolic activation (S9): 2-Aminoanthracene: with all strains No Metabolic activation: Sodium azide: TA100 and TA1535 4-Nitro-o-phenylenediamine: TA98 9-Aminoacridine: TA1537
- Details on test system and experimental conditions:
- TEST PERFORMANCE: The test followed a pre-incubation protocol. The test material, Salmonella culture, and S-9 mix or buffer were incubated at 37 degrees C, without shaking, for 20 minutes. The top agar was added, and the contents of the tubes mixed and poured onto the surface of Vogel-Bonner medium in a petri dish. The histidine-revertant colonies on these plates were counted after 2 days of incubation at 37 degrees C.
A preliminary cytotoxicity assays was conducted using TA100 to determine the appropriate dose range. Once determined, the test doses were performed in triplicate, repeated one week following the initial trial.
A maximum of 0.5 ml of solvent was added to each plate. Concurrent solvent and positive controls in the presence or absence of S-9 were performed. - Evaluation criteria:
- A positive response was demonstrated when a reproducible dose-related increase over the corresponding solvent control was seen, and it was judged weakly positive if a low-level dose response was seen.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In a reliable published study, the test substance was negative in a bacterial reverse mutation assay.
- Executive summary:
In a reliable published study, the test substance was negative in a bacterial reverse mutation assay.
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