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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is a screening test but followed international guidance requirements with acceptable restrictions.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : observation period of 14 days rather than 21 days, no certificae of analysis
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid
- IUPAC Name:
- Reaction mass of N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid
- Test material form:
- other: Amber liquid
- Details on test material:
- - Name of test material (as cited in study report): DV-2422N
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the lef untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable as the test item is instilled as supplied
VEHICLE
not applicable - Duration of treatment / exposure:
- No wash is performed
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no wash
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- within 72h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within:
- Remarks:
- 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 14 days
- Irritant / corrosive response data:
- Irreversible effects are observed in all three rabbits. See details in Table 7.3.2/1.
- Other effects:
- no other effects
Any other information on results incl. tables
Table 7.3.2/1:Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae redness |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
24 h |
1/2/2 |
1/1/1 |
2/2/2 |
2/3/3 |
48 h |
1/2/2 |
1/1/1 |
2/2/2 |
2/3/3 |
72 h |
1/2/2 |
0/1/1 |
2/2/2 |
2/3/3 |
7 days |
2/2/2 |
0/2/1 |
2/2/2 |
1/2/1 |
14 days |
2/2/2 |
0/2/1 |
1/2/2 |
0/2/1 |
Average 24h, 48h, 72h |
1/2/2 |
0.7/1/1 |
2/2/2 |
2/3/3 |
Reversibility*) |
n |
n |
n |
n.c |
Average time (day) for reversion |
N/A |
N/A |
N/A |
N/A |
*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the test conditions, Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is classified as Eye Dam. 1 (H318) according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R41 according to the Directive 67/548/EEC as irreversible effects on the eyes are observed in all 3 animals.
- Executive summary:
In an eye irritation study performed similarly to the OECD No. 405 guideline, 0.1 mL of undiluted Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide was instilled into the right eye of 3 Albino New Zealand Rabbits.
The eyes were not washed following the instillation of the substance.
Animals were then observed for 14 days for redness, chemosis and discharge of the conjonctiva, corneal opacity and iris lesion.
Eye irritation was assessed and scored according to the Draize scale at 24, 48 and 72 hrs after the instillation of the substance and then at days 7 and 14. The mean individual score were calculated within 3 scoring times (24, 48 and 72 hrs).
The mean individual scores were 1.0/2.0/2.0 for chemosis, 0.7/1.0/1.0 for iris lesion, 2.0/2.0/2.0 for conjunctival redness, and 2.0/3.0/3.0 for corneal opacity. All of these effects were not reversible within the termination of the study (14 days) in all animals.
Under the test conditions, Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is classified as Eye Dam. 1 (H318) according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R41 according to the Directive 67/548/EEC as irreversible effects on the eyes are observed in all 3 animals.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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