Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well conducted and documented study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: In general the techniques of tests as published by the FDA af the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Gosmet. Industr. 71 (1952) 36) are followed.
Principles of method if other than guideline:
Principles according to Draize
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
TRIMETHYLOLPROPANETRIACRYLATE II was used

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Ihe animais are caged individually and receive no hay or other extranous material that might enter the eyes

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye serves as control
Amount / concentration applied:
- undiluted
- 100µL
Duration of treatment / exposure:
Treatment: After installtion the upper and lower eye lid are then carefully clased and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye remaining untreated, serves as a control.The eyes are not washed following instillation and the animals
are released immediately.
Observation period (in vivo):
The eyes are examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material.
Number of animals or in vitro replicates:
2
Details on study design:
Ocular reactions are judged using the scoring seale as published by Draize and Kelley (Drug. Gosmet. Industr. 71 (1952) 36)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: highest value of 3 after 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: highest value of 3 after 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: highest value of 3 after 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
no corrosive effects reported

Applicant's summary and conclusion

Interpretation of results:
other:
Conclusions:
From the present results it can be coneluded that the compound na. 77/767 is moderately irritating to the eye.
Executive summary:

A eye irritation study according to the general techniques as published by the FDA of the(Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Gasmet. Industr. 71 (1952) 36) was conducted to assess the eye irritation potential of TMPTA.

Therefore two New Zealand White albino rabbits received 100 milligrams of the test substance. No washout followed the instillation and the eyes are examined at one hour, 24, 48, 72 hours and 7 days. Ocular reactions are judged using the scoring scale as published by Draize and Kelley (Drug. Gosmet. Industr. 71 (1952) 36)

During the first day after instillation the eyes showed slight corneal damage, slight iritis and moderate to severe lesions of the conjunctivae.

In the course of the seven-day observation period the degree of corneal

damage increased. After seven days the following ocular lesions were observed: moderate or moderate-severe corneal opacity, slight iritis and moderate conjunctivitis.

Results are summarized as follows: eye irritation score (two animais used): 44

The author concluded that, according to the classification used, the test material is moderately irritating to the eye.