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EC number: 688-147-2 | CAS number: 82428-30-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- {7-oxabicyclo[4.1.0]heptan-3-yl}methyl 2-methylprop-2-enoate
- EC Number:
- 688-147-2
- Cas Number:
- 82428-30-6
- Molecular formula:
- C11 H16 O3
- IUPAC Name:
- {7-oxabicyclo[4.1.0]heptan-3-yl}methyl 2-methylprop-2-enoate
- Test material form:
- liquid
- Details on test material:
- - Name: 3,4-Epoxycyclohexylmethyl methacrylate
- Chemical Name: 2-Propenoic acid, 2-methyl-7-oxabicyclo[4.1.0]hept-3-ylmethyl ester
- CAS No.: 82428-30-6
- Physical State / Colour: liquid / light yellow, transparent
- Density: 1.079 g/mL at 20 °C
- Molecular Weight: 196.2 g/mol
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine Corneas
- Strain:
- other: not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL
- Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- - 2 h (opacity measurement)
- 3.5 h total (determination of optical density) - Number of animals or in vitro replicates:
- 3 corneas
- Details on study design:
- - 3 corneas for the test item
- 3 corneas as negative controls treated with physiological saline 0.9% NaCl
- 3 corneas as positive control treated with ethanol 100%
- The BCOP assay is considered to be valid if the in vitro irritation score obtained with the positive control falls within the two standard deviations of the current historical mean.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean test item
- Value:
- 10.16
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- IVIS 2.08
- Positive controls validity:
- valid
- Remarks:
- IVIS 86.02
Any other information on results incl. tables
RESULTS
Cornea No. | Test Item | Corr. Opacity | Corr. OD490 | IVIS |
1 | Neg. Control | 0.00 | 0.027 | |
2 | Neg. Control | 4.00 | 0.021 | |
3 | Neg. Control | 1.00 | 0.035 | |
mean | Neg. Control | 1.67 | 0.028 | 2.08 |
4 | Pos. Control | 50.33 | 1.919 | |
5 | Pos. Control | 64.33 | 2.053 | |
6 | Pos. Control | 53.33 | 2.031 | |
mean | Pos. Control | 56.00 | 2.001 | 86.02 |
7 | Test Item | 13.33 | -0.001 | |
8 | Test Item | 9.33 | -0.022 | |
9 | Test Item | 8.33 | -0.012 | |
mean | Test Item | 10.33 | -0.011 | 10.16 |
The following mean in vitro irritation score was calculated: 10.16
No prediction can be made regarding the classification of the test substance 3,4-Epoxycyclohexylmethyl methacrylate according to the evaluation criteria. Further testing in another suitable method is required.
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
HISTOPATHOLOGY
Negative control samples did not show any histological lesions.
In positive control samples, the main lesions consisted of vacuolated corneal epithelia and single cell apoptosis. In one sample (PK1), there was a marked epithelial flattening/height reduction associated with a focal chronic injury. This corneal sample is deemed to be affected before study start by an inflammatory/degenerative that is supported by the presence of brownish pigment (hemosiderin). In sample PK 3, there was a slight laceration of the cuboidal basal cell layer.
In test item treated samples, there was slight multifocal apoptosis/necrosis in the epithelium of all specimens.
Applicant's summary and conclusion
- Interpretation of results:
- other: Irritation score of 10.16 and histopathological findings indicate slight signs of irritation
- Remarks:
- Criteria used for interpretation of results: BCOP standard evaluation criteria
- Conclusions:
- No prediction can be made regarding the classification of the test substance 3,4-Epoxycyclohexylmethyl methacrylate according to the evaluation criteria. Further testing in another suitable method is required.
Under the conditions of this study, 3,4-Epoxycyclohexylmethyl methacrylate caused indicators for irritation consisting of slight multifocal apoptosis/necrosis associated with multifocal vacuolation in the epithelium of all specimen. - Executive summary:
The eye irritancy potential of 3,4-Epoxycyclohexylmethyl methacrylate was investigated in the bovine corneal opacity and permeability assay.
- Preparation of the test item: tested as provided by the sponsor
- Mean in vitro irritation score: 10.16
- Classification: No prediction can be made
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
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