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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:
weight of evidence
Study period:
1984-04-09 to 1984-04-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent or similar to OECD guideline, GLP

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984
Reference Type:
publication
Title:
Unnamed
Year:
1998
Reference Type:
publication
Title:
Eye Irritation : Updated Reference Chemicals Data Bank
Author:
Bagley, D. M.; Gardner, J. R.; Holland; Lewis, R. W.; Vrijhof, H. and Walker, A. P.
Year:
1999
Bibliographic source:
Toxicology in Vitro 13 (1999), 505-510

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
The study was based on the method described in the Journal Officiel de la Republique Francaise 21 April 1971 and 5 June 1973. The eyes of six New Zealand White rabbits were treated with the undiluted test substance to examine the eye irritating potential of the test substance.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington,Leics, and Rosemead Rabbits Ltd., Lea Valley, Essex
- Age at study initiation: approximately 12-16 weeks
- Weight at study initiation: 2.47 - 2.71 kg
- Housing: individually
- Diet: standard laboratory diet (Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire) ad libitum
- Water: free access to tap water
- Acclimation period: for a minimum period of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 25
- Humidity (%):Humidity was not controlled but remained within a range of 55-65 % RH recorded daily on a wet and dry bulb hygrometer.
- Air changes (per hr): approximately 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single treatment (no washing out conducted)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing conducted

SCORING SYSTEM: according to Draize J.H. 1959, Assoc. of Food and Drug Officials of the USA, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of a standard ophthalmoscope (Keeler). Observation of corneal opacity may be carried out under ultra-violet illumination (Mineralight UVSL-58) preceded by the instillation into the eye of 0.05 mL of fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5,
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3, #6
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4.0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #5, #6
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
The test material produced slight ocular irritation in 6/6 rabbits. A dulling of the normal lustre of the cornea was observed in two rabbits on Day 1 only. Iritis was observed in one rabbit on Day 1 only. Mild inflammation or a diffuse crimson-red colouration of the conjunctivae, with or without slight swelling was observed in all six rabbits on Day 1. The reactions had ameliorated in one rabbit by Day 2, in three further rabbits by Day 3 and in the two remaining rabbits by Day 4.

Any other information on results incl. tables

Cornea Iris Conjunctiva
Animal  Reading  Opacity Area involved Redness Chemosis Discharge
1 24 hrs 0 0 0 1 1 0
2 24 hrs 0 0 0 1 1 1
3 24 hrs D 1 0 1 1 0
4 24 hrs 0 0 0 1 0 0
5 24 hrs 0 0 0 2 1 1
6 24 hrs D 1 1 1 1 1
1 48 hrs 0 0 0 1 0 0
2 48 hrs 0 0 0 1 0 1
3 48 hrs 0 0 0 1 0 0
4 48 hrs 0 0 0 0 0 0
5 48 hrs 0 0 0 1 0 0
6 48 hrs 0 0 0 1 0 0
1 72 hrs 0 0 0 1 0 0
2 72 hrs 0 0 0 0 0 0
3 72 hrs 0 0 0 0 0 0
4 72 hrs 0 0 0 0 0 0
5 72 hrs 0 0 0 1 0 0
6 72 hrs 0 0 0 0 0 0
1 4 days 0 0 0 0 0 0
2 4 days 0 0 0 0 0 0
3 4 days 0 0 0 0 0 0
4 4 days 0 0 0 0 0 0
5 4 days 0 0 0 0 0 0
6 4 days 0 0 0 0 0 0
1 7 days 0 0 0 0 0 0
2 7 days 0 0 0 0 0 0
3 7 days 0 0 0 0 0 0
4 7 days 0 0 0 0 0 0
5 7 days 0 0 0 0 0 0
6 7 days 0 0 0 0 0 0
1 24/48/72 hrs 0   0 1 0.3  
2 24/48/72 hrs 0   0 0.7 0.3  
3 24/48/72 hrs 0   0 0.7 0.3  
4 24/48/72 hrs 0   0 0.3 0  
5 24/48/72 hrs 0   0 1.3 0.3  
6 24/48/72 hrs 0   0.3 0.7 0.3  
mean animal 1-3 24/48/72 hrs 0.0   0.1 0.8 0.3  
D = Dulling of the cornea

The test material produced a Maximum Mean Score of 5.8

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Allymethacrylate was not irritating according to EU-criteria in this eye irritation study.
Executive summary:

Allymethacrylate was not irritating according to EU-criteria in this eye irritation study.