Registration Dossier
Registration Dossier
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EC number: 205-438-8 | CAS number: 140-88-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to standards. Original document not available.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report for SIAM 18 (Ethyl acrylate).
- Author:
- OECD SIDS
- Year:
- 2 004
- Bibliographic source:
- SIDS, April 20-23, 2004 Paris.
Materials and methods
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethyl acrylate
- EC Number:
- 205-438-8
- EC Name:
- Ethyl acrylate
- Cas Number:
- 140-88-5
- Molecular formula:
- C5H8O2
- IUPAC Name:
- ethyl acrylate
- Details on test material:
- - Name of test material (as cited in study report): Ethyl acrylate
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent eye of each rabbit remained untreated and served as control.
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL undiluted sample
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.07
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.07
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritant / corrosive response data:
- Mild to severe conjunctival inflammation and some corneal opacity and iritis was observed at 24 hours. One animal was terminated due to the severity of the lesions. The eyes of the other five animals either cleared or had reduced irritation by 72 hours. The mean score was calculated in only 5 animals where results of all time-points were available.
Any other information on results incl. tables
The following table summarizes the individual observations:
Rabbit No. |
Time (h) |
Cornea |
Iris |
Conjuctivae |
|
Redness |
Chemosis |
||||
5 |
24 |
0 |
0 |
3 |
2 |
48 |
0 |
0 |
3 |
1 |
|
72 |
0 |
0 |
1 |
0 |
|
Mean Score |
0 |
0 |
2.33 |
1 |
|
6 |
24 |
0 |
0 |
1 |
0 |
48 |
0 |
0 |
1 |
0 |
|
72 |
0 |
0 |
2 |
0 |
|
Mean Score |
0 |
0 |
1.33 |
0 |
|
7 |
24 |
1 |
0 |
3 |
2 |
48 |
0 |
0 |
2 |
2 |
|
72 |
0 |
0 |
2 |
1 |
|
Mean Score |
0.33 |
0 |
2.33 |
1.67 |
|
8 |
24 |
0 |
0 |
2 |
1 |
48 |
0 |
0 |
1 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Mean Score |
0 |
0 |
1 |
0.33 |
|
9 |
24 |
0 |
1 |
3 |
2 |
48 |
0 |
0 |
3 |
2 |
|
72 |
0 |
0 |
3 |
2 |
|
Mean Score |
0 |
0.33 |
3 |
2 |
|
10 |
24 |
4 |
2 |
3 |
3 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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