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Diss Factsheets
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EC number: 701-308-4 | CAS number: -
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- January 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Teratogenicity was estimated for three major constituents in Small Vinyl Ester including methacrylic acid. Estimations were performed the QSAR programs MultiCASE (MC4PC v2.1.0.18) and the PASS system developed using drug data. The estimations were performed by the Danish QSAR Group at DTU Food.
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
Data source
Reference
- Reference Type:
- other: QSAR report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Principles of method if other than guideline:
- QSAR estimation using the MultiCASE (MC4PC v2.1.0.18) human teratogenicity model and the PASS system (February 2010) developed using drug data.
Test material
- Reference substance name:
- 2-hydroxy-3-{4-[2-(4-{2-hydroxy-3-[(2-methylprop-2-enoyl)oxy]propoxy}phenyl)propan-2-yl]phenoxy}propyl 2-methylprop-2-enoate
- EC Number:
- 701-308-4
- Cas Number:
- 36425-15-7
- Molecular formula:
- n/a
- IUPAC Name:
- 2-hydroxy-3-{4-[2-(4-{2-hydroxy-3-[(2-methylprop-2-enoyl)oxy]propoxy}phenyl)propan-2-yl]phenoxy}propyl 2-methylprop-2-enoate
- Details on test material:
- The teratogenicity potential was estimated for the main constituent of Small Vinyl Ester (bisGMA) and for two other constituents (epoxy-monoGMA, 3% and dihydroxy-monoGMA, 2%). The teratogenicity potential was not estimated for polymeric reaction products (13% of Small Vinyl Ester). These are higher molecular weight analogues to the main constituent, bisGMA and is judged to have the same or lower teratogenic potential than bisGMA, inter alia due to very low systemic bioavailability.
Constituent 1
Results and discussion
Any other information on results incl. tables
The QSAR predictions show the following results, cf. Section 13 QSAR evaluations).
bisGMA contains no substructures that significantly correlates to the human teratology model in MultiCASE. The PASS system indicates a potential for teratogenicity and embryotoxicity.
polymeric reaction products is judged to have the same or lower potential to cause reproduction toxicity as bisGMA, inter alia due to very low systemic bioavailability.
epoxy-monoGMA is out of the domain of the human teratology model in MultiCASE. The PASS system indicates a potential for teratogenicity and embryotoxicity, possibly due to interference with lipid metabolism.
dihydro-monoGMA contains no substructures that significantly correlates to the human teratology model in MultiCASE. The PASS system indicates a potential for teratogenicity and embryotoxicity, possibly due to interference with lipid metabolism.
methacrylic acid is assessed by the EU to be not toxic to reproduction. (Risk Assessment Report, 1st priority list, vol. 25. 2002).Applicant's summary and conclusion
- Conclusions:
- The constituents of Small Vinyl Ester does not contain substructures that is correlated to potential for teratogenic potential in the MultiCASE human teratogenicity model (bisGMA, dihydroxy-monoGMA and polymeric reaction products) or is outside the model's domain (epoxy-monoGMA). However, the PASS system developed for drugs indicate potential of the constituents for teratogenicity and embryotoxicity. The residual monomer methacrylic acid is assessed by the EU to be not toxic to reproduction. The overall conclusion is that Small Vinyl Ester may have a low potential to be toxic to reproduction.
- Executive summary:
The constituents of Small Vinyl Ester do not contain sub-structures that are correlated with potential for teratogenic potential in the MultiCASE human teratogenicity model (bis-GMA, dihydroxy-monoGMA and polymeric reaction products) or are outside the model's domain (epoxy-monoGMA). However, the PASS system developed for drugs indicate potential of the constituents for teratogenicity and embryotoxicity. The residual monomer methacrylic acid is assessed by the EU to be not toxic to reproduction.
The overall conclusion is that Small Vinyl Ester may have a low potential to be toxic to reproduction.
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