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EC number: 202-597-5 | CAS number: 97-63-2
- Life Cycle description
- Uses advised against
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Irritation / corrosion
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- 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 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
- Remarks:
- Study meets minimum scientific standards for a dermal irritation study and provides sufficient information regarding the irritation potential of the test substance. Exposure longer (24 h) than current guideline standard (4 h).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Labelling Act Regulations, Section 191.11, Federal Register: 29, 13009 (1964)
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethyl methacrylate
- EC Number:
- 202-597-5
- EC Name:
- Ethyl methacrylate
- Cas Number:
- 97-63-2
- Molecular formula:
- C6H10O2
- IUPAC Name:
- ethyl methacrylate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: half abraded/half intact
- Vehicle:
- not specified
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- up to 72 hrs
- 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 measuring 2.5 x 2.5 cm² 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.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean 24+72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean 24+72 h
- Score:
- 1.34
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #5
- Time point:
- other: mean 24+72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- erythema score
- Basis:
- animal: #2,#4
- Time point:
- other: mean 24+72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- erythema score
- Basis:
- animal: #3, #6
- Time point:
- other: mean 24+72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #5
- Time point:
- other: mean 24+72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: mean 24+72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24+72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: mean 24+72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24+72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritant / corrosive response data:
- Either slight or well defined erythema and from barely perceptible to moderate edema of the skin at 24 hrs.
Evidence of irritation persisted at 72 hrs.
Any other information on results incl. tables
Reevaluated according CLP criteria
Shaved skin:
Animal Nr. |
Erythema 24 h |
Erythema 48 h |
Erythema 72h |
Mean Erythema |
Edema 24 h |
Edema 48 h |
Edema 72 h |
Mean Edema |
1 |
1 |
- |
0 |
0.5 |
1 |
- |
0 |
0.5 |
2 |
2 |
- |
1 |
1.5 |
2 |
- |
2 |
2 |
3 |
2 |
- |
2 |
2 |
3 |
- |
3 |
3 |
4 |
2 |
- |
1 |
1.5 |
2 |
- |
3 |
2.50 |
5 |
1 |
- |
0 |
0.5 |
1 |
- |
0 |
0.50 |
6 |
2 |
- |
2 |
2 |
1 |
- |
2 |
1.5 |
Comparison with CLP criteria:
Remark: Exposure time was higher than 4 hours, observation time only 72 hours.
Two scores were > 2.3 but observation time too short. The highest mean erythema score is 2 for 3/6 animals. The highest edema score is 3 for 1/6 animals. The observation time was too short to demonstrate reversibility.
Shaved and scarifized skin (not used for evaluation):
Animal Nr. |
Erythema 24 h |
Erythema 48 h |
Erythema 72h |
Mean Erythema |
Edema 24 h |
Edema 48 h |
Edema 72 h |
Mean Edema |
1 |
1 |
- |
0 |
0.5 |
1 |
- |
0 |
0.5 |
2 |
2 |
- |
1 |
1.5 |
2 |
- |
2 |
2 |
3 |
2 |
- |
2 |
2 |
3 |
- |
3 |
3 |
4 |
2 |
- |
1 |
1.5 |
2 |
- |
3 |
2.50 |
5 |
1 |
- |
1 |
1 |
1 |
- |
1 |
1 |
6 |
2 |
- |
2 |
2 |
1 |
- |
2 |
1.5 |
Reevaluated acc. DSD criteria
|
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Conclusions:
- Classification: irritating
- Executive summary:
In a primary dermal irritation study according to “Federal Hazardous Substances Labelling Act Regulations, Section 191.11, Federal Register: 29, 13009 (1964), 6 young adult New Zealand White rabbits were dermally exposed to 0.5 mL of EMA for 24 hours to 2.5x 2.5 cm body surface area of the shaved/scarified skin. Animals then were observed for 3 days. Irritation was scored by the Draize method. This scoring system is similar to OECD guideline 404.
Only animals with the shaved intact skin were evaluated for C&L purposes.
24 h after application 2 animals showed very slight (score1) and 4 animals well defined (score 2) signs of erythema and 3 animals very slight (score 1), 2 animals slight (score 2) and 1 animal moderate (score 3) edema. 72 h after application 2 animals showed no erythema (score 0), 2 animals very slight (score 1) and 2 animals well defined erythema (score 2). No edema were observed after 72 h in 2 animals, slight edema (score 2) in 2 animals and moderate (score 3) in 2 animals. Acc. CLP criteria in 2/6 animals mean edema scores (24 +72h) were > 2.3. As observation time was only 72 h and reversibility could not be observed EMA is considerd as irriating to skin.
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