Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 211-708-6 | CAS number: 688-84-6
- 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

Endpoint summary
Administrative data
Description of key information
2-ethylhexyl methacrylate is not an skin irritant and a very slight eye irritant.
2-ethylhexyl methacrylate is not expected to be irritating to the respiratory tract.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 15, 2017 - May 22, 2017 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted on 28 July 2015
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN™ - 0.38 cm2
- Tissue batch number(s): 17-EKIN-020
- Shipping date: 15 May 2017
- Delivery date: 16 May 2017
- Date of initiation of testing: 15 May 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature of post-treatment incubation: 37°C, 5% CO2 and saturated humidity
REMOVAL OF TEST MATERIAL AND CONTROLS
At the end of the exposure, each tissue was rinsed with approximately 25mL of sterile D-PBS,
filling and empting the tissue insert. The excess liquid was carefully removed and the sample
transferred in new wells pre-filled with 2mL/well of maintenance medium.
- Modifications to validated SOP: not indicated in the report
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2mL/well of MTT ready-to-use solution
- Incubation time: approximately 3 hours at 37°C, 5% CO2 and saturated humidity
- Wavelength: 595 nm
- Linear OD range of spectrophotometer: confirmed by MTT formazan calibration curve
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
Criteria Classification
Mean relative viability ≤ 50% UN GHS Category 2 or 1
Mean relative viability > 50% UN GHS No Category (for member states that do not adopt optional category 3) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL, NEGATIVE and POSITIVE CONTROL
- Amount(s) applied: 20 μL (i.e. approx. 53 µL/cm2) - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- A 42 ± 1 hour recovery period was allowed by incubation at 37°C, 5% CO2 and saturated humidity
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 95
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Viability range of three test item replicates: 84.7 - 103.3% ; standard deviation 9.4
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this GLP conform in vitro study according to OECD 439, the test item 2-EHMA is not irritant to the skin (UN GHS No Category).
- Executive summary:
The potential of the test item 2-EHMA to be irritant to the skin was investigated through an GLP conform in vitro skin irritation study according to OECD 439, using a commercial reconstructed human epidermis (RhE) model named EPISKIN™.
The blank, negative and positive controls gave acceptable results and the study was accepted as valid.
The mean cell viability of the test item treated tissues, after the blank subtraction, was 95%.
Based on the results obtained, the test item 2-EHMA is classified as not irritant to the skin (UN GHS No Category).
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959).
- Deviations:
- not specified
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2.5 kg
- Housing:
- Diet (e.g. ad libitum): Höing 222
- Water (e.g. ad libitum): tap water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-1
- Humidity (%): 50-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved or shaved/scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: two untreated areas (shaved and shaved/scarified) were used as the control
- Amount / concentration applied:
- undiluted; 0.5 ml
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24 and 72 hours post dosing
- Number of animals:
- 6
- Details on study design:
- Six New Zealand White rabbits were assigned to study. In order to investigate the reproducibility of the effects, each rabbit had two separate dose sites (shaved and shaved/scarified), which were treated with 0.5 ml of undiluted test material. In addition, two untreated areas (shaved and shaved/scarified) were used as the control. Only reactions which were different from those of the control were evaluated as positive reactions. For each treated dose site, 0.5 ml of undiluted test material was soaked onto a gauze patch (approx. 6 cm²/1 in²) which was held in place with adhesive tape on the shaved and shaved/scarified skin of the test animals. The animals were fixed in a holding device and their bodies were wrapped in a rubberised cloth for 24 hours. After this time dressing and adhesive tape were removed and the local reactions were examined. 72 hours after application, the examinations were repeated. The test result is the average of the scores of the 24- and 72-hour examinations.
- Irritation parameter:
- edema score
- Remarks:
- edema score shaved skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: occlusive, 4 h exposure, observation time 72 h, shaved intact skin, mean 24 + 72 h, 48 h was not evaluated.
- Irritation parameter:
- erythema score
- Remarks:
- erythema score scarified skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: occlusive, 4 h exposure, observation time 72 h, scarified skin, mean 24 + 72 h, 48 h was not evaluated.
- Irritation parameter:
- erythema score
- Remarks:
- erythema score shaved skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: occlusive, 4 h exposure, observation time 72 h, shaved intact skin, mean 24 + 72 h, 48 h was not evaluated.
- Irritation parameter:
- edema score
- Remarks:
- edema score scarified skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: occlusive, 4 h exposure, observation time 72 h, scarified skin, mean 24 + 72 h, 48 h was not evaluated.
- Irritant / corrosive response data:
- Shaved skin: 24 hours after application 5 of 6 animals showed well defined erythema. 72 hours after application 3 animals had well defined erythema while the other 3 had very slight erythema. Slight edema (and in two cases very slight edema) was present in all animals 24 hours after application. After 72 hours, no edema was observed except for one animal with very slight edema.
Shaved and scarified skin: 24 hours after application all animals showed well defined erythema. 72 hours after application the well defined erythema was still present in 5 of 6 animals while in one case it had developed to moderate to severe erythema. Slight edema (and in one case moderate edema) was present in all animals 24 hours after application. After 72 hours, very slight edema was observed in all animals. - Interpretation of results:
- other: slightly irritating
- Remarks:
- Not classified: Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Executive summary:
The cutaneous irritation that could be induced by 2-ETHYLHEXYL METHACRYLATE was evaluated in the rabbit according to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959). 2-ETHYLHEXYL METHACRYLATE was applied as supplied, at the dose level of 0.5 ml per animal, under an occlusive patch for 24 hours, to the intact and abraded skin of six New-Zealand albino rabbits. The cutaneous reactions were observed when the patches were removed and were again made at 72 hours. On the shaved skin, 24 hours after application 5 of 6 animals showed well defined erythema. 72 hours after application 3 animals had well defined erythema while the other 3 had very slight erythema. Slight edema (and in two cases very slight edema) was present in all animals 24 hours after application. After 72 hours, no edema was observed except for one animal with very slight edema. On the shaved and scarified skin, 24 hours after application all animals showed well defined erythema, 72 hours after application the well defined erythema was still present in 5 of 6 animals while in one case it had developed to moderate to severe erythema. Slight edema (and in one case moderate edema) was present in all animals 24 hours after application. After 72 hours, very slight edema was observed in all animals. For the shaved skin, the mean scores over 24 and 72 h were 1.66 and 0.9 for erythema and oedema, respectively. Under these experimental conditions, 2-ETHYLHEXYL METHACRYLATE was considered as an slight irritant when applied 24 hours to the rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets minimum scientific standards for a dermal irritation study and provides sufficient information for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Labeling Act Regulations, Section 191.12, Federal Register: 29, 13009 (1964)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24 and 72-h post dosing
- Number of animals:
- 6
- Details on study design:
- Six NZ White rabbits were restrained in stocks and the fur removed by clipping. Half of the exposed area was abraded and the other half remained intact. 0.5 ml(vol) of test compound was applied to the shaved intact and abraded skin sites and covered with surgical gauze. The area was then wrapped with impervious tape and a stockinette sleeve. Test material remained in contact for 24 hrs and then removed. Irritation scores were determined at 24 and 72 hours after patch removal.
- Irritation parameter:
- erythema score
- Remarks:
- erythema score
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Remarks:
- erythema score
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: scarified skin
- Irritant / corrosive response data:
- The reactions displayed at the first reading interval ranged from barely perceptible to moderate reddening and swelling of the skin, at both intact and abraded sites. Evidence of irritation persisted to the end of the test period in each animal. Examples of a general increase in turgor, discolouration and induration were also identified in this study.
- Interpretation of results:
- other: slightly irritating
- Remarks:
- Not classified: Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Executive summary:
The cutaneous irritation that could be induced by 2-ETHYLHEXYL METHACRYLATE was evaluated in the rabbit according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register (USA) -29 F.R. 13009, 1964.
2-ETHYLHEXYL METHACRYLATE was applied as supplied, at the dose level of 0.5 ml per animal, under an occlusive patch for 24 hours, to the intact and abraded skin of six New-Zealand albino rabbits. The cutaneous reactions were observed when the patches were removed and were again made at 72 hours.
Barely perceptible to moderate reddening and swelling of the skin were exhibited 24 hours following application. Reactions persisted to 72 hours. For the intact skin, the mean scores over 24 and 72 h were 1.9 and 2.2 for erythema and oedema, respectively.
Under these experimental conditions, 2-ETHYLHEXYL METHACRYLATE was considered as an slight irritant when applied 24 hours to the rabbit skin.
Referenceopen allclose all
Tabulated results
Blank | Negative Control | |||||
OD | sample | OD | OD-blank | mean | Viability (%) | |
0.037 | N1-1 | 0.696 | 0.6590 | |||
0.037 | N1-2 | 0.627 | 0.5900 | 0.6245 | 98.7 | |
0.036 | N2-1 | 0.702 | 0.6650 | |||
0.037 | N2-2 | 0.673 | 0.6360 | 0.6505 | 102.8 | |
0.038 | N3-1 | 0.675 | 0.6380 | |||
0.037 | N3-2 | 0.647 | 0.6100 | 0.6240 | 98.6 | |
mean | 0.037 | 0.7 | 0.6 | 100 | ||
SD | 0.001 | 0.03 | 0.02 | 2.4 | ||
CV (%) | 1.7 | 4.3 | 2.4 | 2.4 | ||
Positive Control | ||||||
sample | OD | OD-blank | mean | Viability (%) | ||
P1-1 | 0.081 | 0.0440 | ||||
P1-2 | 0.075 | 0.0380 | 0.0410 | 6.5 | ||
P2-1 | 0.068 | 0.0310 | ||||
P2-2 | 0.065 | 0.0280 | 0.0295 | 4.7 | ||
P3-1 | 0.086 | 0.0490 | ||||
P3-2 | 0.081 | 0.0440 | 0.0465 | 7.3 | ||
mean | 0.1 | 0.04 | 6 | |||
SD | 0.01 | 0.01 | 2.4 | |||
CV (%) | 10.8 | 22.2 | 22.2 | |||
Test item | ||||||
sample | OD | OD-blank | mean | Viability (%) | ||
A1-1 | 0.653 | 0.6160 | ||||
A1-2 | 0.632 | 0.5950 | 0.6055 | 95.7 | ||
A2-1 | 0.592 | 0.5550 | ||||
A2-2 | 0.554 | 0.5170 | 0.5360 | 84.7 | ||
A3-1 | 0.710 | 0.6730 | ||||
A3-2 | 0.672 | 0.6350 | 0.6540 | 103.3 | ||
mean | 0.6 | 0.6 | 95 | |||
SD | 0.06 | 0.06 | 9.4 | |||
CV (%) | 8.8 | 9.9 | 9.9 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. The test followed recognized toxicology testing procedures and recognized scoring procedures of the results.
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation:
- Weight at study initiation: 2.4-2.6 kg
- Housing: no data
- Diet (e.g. ad libitum): Mümmel Z, Plange
- Water (e.g. ad libitum): tap water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Not rinsed
- Observation period (in vivo):
- 24, 48 and 72 h, and 4, 5, 6 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six New Zealand White rabbits had 0.1 ml of undiluted test material instilled into the conjunctival sac of the left eye. The right eye of each rabbit, which remained untreated, served as a control. Animals were observed for irritating effects of the cornea, iris, conjunctivae 24, 48 and 72 hours and 4, 5, 6 and 7 days after treatment.
SCORING SYSTEM: Draize scale - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Mean 24 + 72 h, 48 h was not evaluated.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Mean 24 + 72 h, 48 h was not evaluated.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Mean 24 + 72 h, 48 h was not evaluated.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Mean 24 + 72 h, 48 h was not evaluated.
- Irritant / corrosive response data:
- Except for some initial redness, none of the animals showed any effects of the treatment.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Conclusions:
- Based on the results of this non GLP conform in vivo study according to recommendations of the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959), the test item 2-EHMA is not irritant to the eye (UN GHS No Category).
- Executive summary:
The ocular irritation that could be induced by 2-ethylhexyl methacrylate was evaluated in the rabbit according to the recommendations of the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959). A single application of 0.1 ml of 2-ethylhexyl methacrylate in its original form was placed into the conjunctival sac of one eye of six New-Zealand white rabbits. The ocular reactions were observed at 24, 48 and 72 hours and up to 7 days after the instillation. Mean values (24+48+72 h) for ocular irritation were: 0.0 for chemosis, enanthema, congestion and opacity. Under these experimental conditions, 2-ethylhexyl methacrylate was considered as not irritating when administered to the rabbit by ocular route.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Labeling Act Regulations, Section 191.12, Federal Register: 29, 13009 (1964)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Not rinsed
- Observation period (in vivo):
- 24, 48 and 72 hours post dosing
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: opthalmoscope and 2.0% fluoroscein sodium solution - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Conclusions:
- Very sligthly irritating
- Executive summary:
The ocular irritation that could be induced by 2-ETHYLHEXYL METHACRYLATEwas evaluated in the rabbit according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.12, published in the Federal Register (USA) -29 F.R. 13009, 1964.A single application of 0.1 mlof 2-ETHYLHEXYL METHACRYLATE in its original form was placed into the conjunctival sac of one eye of six New-Zealand white rabbits. The ocular reactions were observed at 24, 48 and 72 hours after the instillation. Mean values (24+48+72 h) for ocular irritation were 0.11 for chemosis, 0.33 for enanthema and 0.00 for congestion and opacity. Under these experimental conditions, 2-ETHYLHEXYL METHACRYLATE was considered as very slightly irritating when administered to the rabbit by ocular route.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
In vitro
For clarification of the available in vivo studies described below, the potential of 2-EHMA to be irritant to the skin was investigated through an in vitro skin irritation study using a commercial reconstructed human epidermis (RhE) model named EPISKIN™. The experimental procedures are based on the OECD Guideline for testing of chemicals no. 439. The test item, as well as controls, were tested for their ability to impair cell viability after an exposure period of 15 minutes followed by a 42 ± 1 hour recovery period. The final endpoint of the assay is the colorimetric measurement of MTT reduction (blue formazan salt) in the test system, being this reaction an index of cell viability. The compatibility of the test item with the test system was confirmed in a preliminary test, where no colouring potential was recorded.
In the Main Assay, the test item was applied as supplied in three replicates at the treatment level of 20 μL/epidermis unit, each measuring 0.38cm2 (treatment level: 53 μL/cm2). Positive and negative controls [a 5% (w/v) sodium dodecyl sulphate solution in water and Dulbecco’s phosphate buffered saline (D-PBS), respectively] were concurrently tested, in the same number of replicates and test conditions at the treatment level of 20 μL/epidermis unit.
In the Main Assay, the negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability [Standard Deviation (SD) of % viability lower or equal to 18], in agreement with the guideline indications. According to the method, the negative control mean value is considered the baseline value of the experiment and thus represents 100% of cell viability. The positive control caused the expected cell death (6% of cell viability when compared to the negative control) and variability (SD of % viability equal to 1.4). Based on the stated criteria (mean viability ≤ 40% and SD of % viability ≤ 18), the assay was regarded as valid. The test item did not induce cell death in any replicate, the mean cell viability after the blank subtraction was 95% when compared to the negative control. Intra-replicate variability was acceptable with a SD of % viability value equal to 9.4 (lower than 18, as stated in the Study Protocol). Based on the results obtained, the test item Visiomer ® EHMA is classified as not irritant to the skin (UN GHS No Category).
Earlier in vivo studies
The cutaneous irritation that could be induced by 2-ethylhexyl methacrylate was evaluated in the rabbit according to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959) (Sterner, 1977). 2-ethylhexyl methacrylate was applied as supplied, at the dose level of 0.5 ml per animal, under an occlusive patch for 24 hours, to the intact and abraded skin of six New-Zealand albino rabbits. The cutaneous reactions were observed when the patches were removed and were again made at 72 hours. On the shaved skin, 24 hours after application 5 of 6 animals showed well defined erythema. 72 hours after application 3 animals had well defined erythema while the other 3 had very slight erythema. Slight oedema (and in two cases very slight oedema) was present in all animals 24 hours after application. After 72 hours, no oedema was observed except for one animal with very slight oedema. On the shaved and scarified skin, 24 hours after application all animals showed well defined erythema, 72 hours after application the well defined erythema was still present in 5 of 6 animals while in one case it had developed to moderate to severe erythema. Slight oedema (and in one case moderate oedema) was present in all animals 24 hours after application. After 72 hours, very slight oedema was observed in all animals. For the shaved skin, the mean scores over 24 and 72 h were 1.66 and 0.9 for erythema and oedema, respectively. Under these experimental conditions, 2-ethylhexyl methacrylate was considered as a slight irritant when applied 24 hours to the rabbit skin.
The cutaneous irritation that could be induced by 2-ethylhexyl methacrylate was evaluated in the rabbit according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register (USA) -29 F. R. 13009, 1964 (Poole, 1981). 2-ethylhexyl methacrylate was applied as supplied, at the dose level of 0.5 ml per animal, under an occlusive patch for 24 hours, to the intact and abraded skin of six New-Zealand albino rabbits. The cutaneous reactions were observed when the patches were removed and were again made at 72 hours. Barely perceptible to moderate reddening and swelling of the skin were exhibited 24 hours following application. Reactions persisted to 72 hours. For the intact skin, the mean scores over 24 and 72 h were 1.9 and 2.2 for erythema and oedema, respectively. Under these experimental conditions, 2-ethylhexyl methacrylate was considered as a slight irritant when applied 24 hours to the rabbit skin.
By analogy to the other esters of the category, for which reversibility has been established, it is assumed that the skin irritation caused by 2 -EHMA will be reversible.
The observation period with 24 hrs occlusive exposure of the two available studies was too short to establish reversibility.
Eye irritation
The ocular irritation that could be induced by 2-ethylhexyl methacrylate was evaluated in the rabbit according to the recommendations of the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959) (Sterner, 1978). A single application of 0.1 ml of 2-ethylhexyl methacrylate in its original form was placed into the conjunctival sac of one eye of six New-Zealand white rabbits. The ocular reactions were observed at 24, 48 and 72 hours and up to 7 days after the instillation. Mean values (24+48+72 h) for ocular irritation were: 0.11 for chemosis, 0.33 for erythema and 0.00 for congestion and opacity. Under these experimental conditions, 2-ethylhexyl methacrylate was considered a very slight irritant when administered to the rabbit by ocular route.The ocular irritation that could be induced by 2-ethylhexyl methacrylate was evaluated in the rabbit according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.12, published in the Federal Register (USA) -29 F. R. 13009, 1964 (Poole, 1981). A single application of 0.1 ml of 2-ethylhexyl methacrylate in its original form was placed into the conjunctival sac of one eye of six New-Zealand white rabbits. The ocular reactions were observed at 24, 48 and 72 hours after the instillation. Mean values (24+48+72 h) for ocular irritation were 0.11 for chemosis, 0.33 for erythema and 0.00 for congestion and opacity. Under these experimental conditions, 2-ethylhexyl methacrylate was considered as very slightly irritating when administered to the rabbit by ocular route.
The data support that 2-EHMA is not classified as an eye irritant, while it would be regarded as a member of the Index no. 607-134-00-4 (monoalkyl or monoaryl or monoalkylaryl esters of methacrylic acid with the exception of those specified elsewhere in Annex VI) whose members are classified aseye irritants, category 2.
Respiratory tract irritation
Based on the studies summarized above classification as Cat. 3 respiratory irritants (H335) is proposed for MMA, EMA, n- and i-BMA, consistent with their Annex VI entries, while based on its low vapour pressure 2-EHMA is not expected to be irritating to the respiratory tract and no classification is proposed, contrary to the alkyl methacrylate group listing (Index no. 607-134-00-4).
Effects on skin irritation/corrosion: not irritating (effects below GHS classification level) Effects on eye irritation: slightly irritating (GHS Cat 3; no classification according to CLP)
Justification for classification or non-classification
According to CLP criteria no classification is warranted for the skin, eye and respiratory tract irritation based on the key studies provided based on data and physico-chemical properties,contrary to the alkyl methacrylate group listing (Index no. 607-134-00-4).
According to the criteria of UN-GHS(2009) 2-EHMA is not regarded as skin irritant; no classification for eye irritation.
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