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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Small Vinyl Ester is a multi-constituent substance. Its generic composition is seen in Section 1.2. Exposure to Small Vinyl Ester will result in exposure to all the constituents. No toxicokinetic data are available on Small Vinyl Ester. Thus QSAR estimations were performed on several of the constituents.
Oral absorption
Oral absorptions were estimated using MultiCase (MC4PC v2.1.0.18), cf. Section 13 (QSAR evaluations). Relative oral absorption rates were estimated for bisGMA, epoxy-monoGMA and dihydroxy-monoGMA. The following relative oral absorption rates were found:
bisGMA 82%
epoxy-monoGMA 91%
dihydroxy-monoGMA 64%
It is judged that methacrylic acid is orally absorbed to 100%.
These constituents contribute to the total relative oral absorption proportionally to their relative amount in Small Vinyl Ester. Thus it is calculated that Small Vinyl Ester is absorbed orally by 80%. This is confirmed in guinea pigs for bisGMA using radiotracer technique (Reichl et al, 2008 & 2008a).
Dermal absorption
Dermal absorptions were calculated using US-EPA EPIsuite v4.1, cf. Section 7.1.2 (dermal absorption.001). Relative dermal absorption rates for bisGMA, epoxy-monoGMA, dihydroxy-monoGMA and methacrylic acid were calculated for three exposure times (1 h, 8 h and 24 h) based on the QSAR estimations of the dermal absorptions. The relative dermal absorption rates were calculated to approximately 0.035% at 8 h contact time for dihydroxy-monoGMA and even lower for bisGMA, epoxy-monoGMA and polymeric reaction products (judgement), and for shorter contact times. These low dermal absorption rates are negligible in the risk assessment context.
Only for the residual monomer, methacrylic acid the relative absorption rate is not negligible; it was calculated to 9.1, 47.9 and 100%, respectively for 1-hour, 8-hours and 24-hours skin contact. However, it should kept in mind during risk assessment that the calculated systemic dose at 24-hours skin contact (1980 cm2) is 45 mg/kg bw, which is approximately 24 times lower than the lowest LD50 found in rats.
Inhalation absorption
Vapour pressures were calculated using US-EPA EPIsuite v4.0, cf. Section 13 (QSAR evaluations). Vapour pressures were estimated for bisGMA, epoxy-monoGMA, dihydroxy-monoGMA and methacrylic acid. The following vapour pressures were found:
bisGMA 2.0e-13 Pa
epoxy-monoGMA 1.7e-10 Pa
dihydroxy-monoGMA 7.7e-14 Pa
methacrylic acid 132 Pa
The vapour pressures of bisGMA, epoxy-monoGMA, dihydroxy-monoGMA, and also polymeric reaction products (judged) are negligible and will not give to inhalation exposure of vapours.
The vapour pressure of the residual monomer methacrylic acid has a significant vapour pressure that may give rise to inhalation exposure. However, it should be kept in mind during risk assessment that methacrylic acid amounts less than 1% of Small Vinyl Ester and most likely methacrylic acid has affinity to stay in the product.
Distribution and metabolism
The study of Reichl et al (2008, 2008a) showed that bisGMA is rapidly excreted from the body (guinea pigs), only 6% remaining 24 hours after oral exposure. One hour after i.v. injection bisGMA was found in the lungs (22%), the brain (2%) and kidneys (2%); less than 0.1% in tissues of each of heart, testes, spleen, skin, blood. muscle and fat. The high concentration in the lungs led Reichl et al to propose that metabolism of bisGMA primarily takes place in the lungs.
Excretion
More than 65% of an oral dose of bisGMA to guinea pigs was exhaled as CO2 during the first 24 hours. 7% was excreted via the bile.
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.