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EC number: 231-927-0 | CAS number: 7779-31-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- April / June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,3,5-trimethylcyclohexyl methacrylate
- EC Number:
- 231-927-0
- EC Name:
- 3,3,5-trimethylcyclohexyl methacrylate
- Cas Number:
- 7779-31-9
- Molecular formula:
- C13H22O2
- IUPAC Name:
- 3,3,5-trimethylcyclohexyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: epiCS, cell systems
- Details on animal used as source of test system:
- Human skin model: The 0.6 cm2 reconstitued epidermis (epiCS, cell systems, batch No.100-AG0648-1) were received on 19 April 2017. The insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. The same day, the insert was placed in a 6 wells culture plate which had been previously filled with 1ml of culture medium. The culture dishes were incubated at 37+/-2°C, 5% CO2, 19 hours and 55 minutes before treatment. Just before the treatment, the culture medium was replaced by a new culture medium.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Grading of reactions:
3 minutes and 1 hour after the test item application, the human epidermis was mashed 20 times with 1ml of DPBS. The rinsed tissue were checked for any coloration and noted to be whitish, comparable coloration to that of the negetive control tissues.
The cell viability was quantified by measurement of the cell succinate deshydrogenase activity. This enzyme was responsible for the MTT reduction into blue formazan crystal. The skin sample was placed in MTT solution of 1 mg/ml concentration for 3 hours between 37°C and 37.7°C, 5% CO2. The precipitated blue formazan product was then extracted using isopropanol during 2 hours under agitation in the dark, and the concentration of formazan was measured by determing the optical density (OD) at 570 nm, just after dilution of the extraction in isopropanol (1:3).
The absorbance was measured in triplicate of MTT extract. The ùeasured absorbances were proportional to the number of living cells.
Treatment of the results : The results were expressed as a viability percentage compared with the negative control.
Evaluation and interpretation of the results :
The OD values obtained for the test item were used to calculate a percentage of viability relative to the negative control, which was arbitrarily set at 100%. The cut-off values for the prediction of corrosion associated with the epiSC model were as follows :
-Viability < 50% after 3 min exposure: Corrosive (1A)
-Viability > or = 50% after 3 min exposure AND < 15% after 60 min exposure: Corrosive (1B/1C)
-Viability > or = 50% after 3 min exposure AND > or = 15% after 60 min exposure: Non-Corrosive
Acceptability criteria :
-Negative control: mean OD of the tissue replicates should be > or = 0.8 and < or = 2.8 for epiSC model for every exposure time
-Positive control: mean viability of the tissue replicates expsed for 1 hour, expressed as % of the negative control, should be < 20% for epiCS model
-Test item: in the range 20-100% viability, and for ODs < or = 0.3, difference of viability between the two tissue replicates should not exceed 30% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied, as supplied, at the dose of 50 µl at room temperature
- Duration of treatment / exposure:
- 3 min, 1 hour
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min
- Run / experiment:
- treated
- Value:
- 101.47
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 4.11%
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 1 hour
- Run / experiment:
- treated
- Value:
- 122.61
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 0.83%
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- Based on these results, 3,3,5 -trimethylcyclohexylmethacrylate is not classified as skin corrosive.
- Executive summary:
The aim of the study was to evaluate the possible corrosive effects of the test item after topical administratin on in vitro human reconstituted epidermis (epiCS, CellSystems).
The test item 3,3,5 -trimethylcyclohexylmethacrylate was applied as supplied, at the dose of 50 µl, to 2 Human skin modekl surfaces (epiCS, CellSystems) during 3 minutes and 1 hour, followed by a rinse with 20 ml of DPBS. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The experimental protocol was established in accordance with the OECD TG 431.
Three minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 101.47% and 122.61% when compared with the negative control (considered as 100%), versus 4.11% and 0.83%, respectively, with the positive control item (potassium hydroxide 8N).
All the acceptability criteria were met. This study is validated.
Based on these results, 3,3,5 -trimethylcyclohexylmethacrylate is not classified as skin corrosive.
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