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EC number: 202-597-5 | CAS number: 97-63-2
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- Endpoint summary
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- 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
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- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- DATA QUALITY: Study meets minimum scientific standards for an eye irritation study and provides sufficient information regarding the irritation potential of the test substance. However, there was a limited description of the substance (i.e. purity, CAS#, etc.) Thus, the results are regarded as reliable with restriction.
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 191.12, 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
- Details on test material:
- Ethyl methacrylate, purity not specified but typicallly > 99 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- 72 hour(s)
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six female NZ White rabbits, weighing 2-2.5 kg, were administered 0.1 ml (vol) of test compound into the everted lower lid of one eye of each rabbit; eyelids were closed and held shut for 1 second. Prior to administration the eyes of each rabbit were examined. Eyes remained unwashed. Eyes scored at 24, 48 and 72 hrs after administration with the aid of an ophthalmoscope and Fluorescein sodium. The eyes were unwashed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: scores are showing tendency in reversibility
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: scores are showing tendency in reversibility
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: scores are showing tendency in reversibility
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: scores are showing tendency in reversibility
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: scores are showing tendency in reversibility
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: scores are showing tendency in reversibility
- Irritant / corrosive response data:
- Conjunctival irritation, redness (max. grade 3 in 3/6 rabbits) and chemosis (max. grade 3 in 2/6 rabbits) at 24 hr. Irritation (redness and chemosis), grade 3, was still present at 48 hr in 3/6 rabbits. At 72 hrs the irritation (redness) was grade 2 in 1/6, grade 1 in 3/6; chemosis was grade 2 in 1/6, grade 1 in 1/6 and 0 in 4/6 rabbits. Slight irritation of the cornea was observed after 24 h in 2/6 animals which was reversible after 48 h. There was no involvement of the iris.
Any other information on results incl. tables
Animal No. |
Corneal opacity/Hornhauttrübung[Scores]
|
Mean Draize score |
||
after 24 h |
after 48 h |
after 72 h |
|
|
1) |
0 |
0 |
0 |
0,0 |
2) |
1 |
0 |
0 |
0,33 |
3) |
1 |
0 |
0 |
0,33 |
4) |
0 |
0 |
0 |
0,0 |
5) |
0 |
0 |
0 |
0,0 |
6) |
0 |
0 |
0 |
0,0 |
|
0,33 |
0,0 |
0,0 |
0,11 |
|
|
|
|
|
Animal No. |
Iritis/Regenbogenhautentzündung[Scores]
|
Mean Draize score |
||
after 24 h |
after 48 h |
after 72 h |
|
|
1) |
0 |
0 |
0 |
0 |
2) |
0 |
0 |
0 |
0,0 |
3) |
0 |
0 |
0 |
0,0 |
4) |
0 |
0 |
0 |
0,0 |
5) |
0 |
0 |
0 |
0,0 |
6) |
0 |
0 |
0 |
0,0 |
|
0,0 |
0,0 |
0,0 |
0,0 |
|
|
|
|
|
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores]
|
Mean Draize score |
||
after 24 h |
after 48 h |
after 72 h |
|
|
1) |
3 |
3 |
1 |
2,33 |
2) |
3 |
3 |
2 |
2,67 |
3) |
3 |
3 |
1 |
2,33 |
4) |
2 |
1 |
1 |
1,33 |
5) |
1 |
0 |
0 |
0,33 |
6) |
2 |
1 |
0 |
1 |
|
2,33 |
1,83 |
0,83 |
1,67 |
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores]
|
Mean Draize score |
||
after 24 h |
after 48 h |
after 72 h |
|
|
1) |
3 |
2 |
1 |
2 |
2) |
3 |
2 |
2 |
2,33 |
3) |
2 |
2 |
0 |
1,33 |
4) |
0 |
0 |
0 |
0,0 |
5) |
0 |
0 |
0 |
0,0 |
6) |
1 |
0 |
0 |
0,33 |
|
1,5 |
1 |
0,5 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Conclusions:
- Classification: not irritating
- Executive summary:
In an occular irritation test acc. the federal Hazardous Substances and Labelling Act Regulations, Section 191.12 published in the Federal Register - 29 F.R. 13009, 1964. Ethyl methacrylate (0.1 ml) was placed in the conjunctival sac of the right eye of six New Zealand White rabbits. The lids were then gently held together for one second. The test eyes were not washed out following the instillation. The left eye remained untreated for control. The eyes were examined at 1, 24, 48 and 72 hours. Eye irritation was scored for signs of corneal damage (density, area), iris reaction and lesions of the conjunctivae (erythema, chemosis). Additionally, the cornea was examined with the aid of fluorescein after recording the observations at 24 hours. No observation after 72 hrs. Scores were reevaluated acc. CLP criteria. Highest mean cornea score (24+48+72 h) was 0.33 in 2/6 animals, no animal showed iritis, 3/6 animals showed conjunctival erythema > 2 and 2/6 animals cunjunctival chemosis > 2. Scores showed clear tendency in rapid reversibility but during the short observation time (72 h) full reversibility could not be observed in all animals (scores in 2/6 animals were fully reversible).
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