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Toxicological information

Eye irritation

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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:
1989
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

Constituent 1
Reference substance name:
Reaction mass of N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid
EC Number:
934-058-1
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

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.