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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:
February 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Consumer Product Safety Commission of the USA in the Code of Federal Regulations, Title 16, Section 1500.42.
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): H6XDI (Takenate 600;1,3-bis (isocyanatomethyl)cyclohexane)

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino rabbits

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as concurrent control
Amount / concentration applied:
0.1mL
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
96 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM:
Grades for ocular lesions were given according to "Illustrated Guide for Grading Eye Irritation by Hazardous Substances", U.S. Department of Health, Education and Welfare, Food and Drug Administration, Washington, D.C. 20402 (comparable to Draize scoring system).

TOOL USED TO ASSESS SCORE: binocular loupe, hand-slit lamp, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Remarks:
The corneal reactions could not be assessed due to severity of the reaction at 24 and 48 hours.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Remarks:
The corneal reactions could not be assessed due to severity of the reaction at 24 and 48 hours.
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Remarks:
The corneal reactions could not be assessed due to severity of the reaction at 24 and 48 hours.
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Remarks:
The corneal reactions could not be assessed due to severity of the reaction at 24, 48 and 72 hours.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Remarks:
The iris score could not be assessed due to severity of the reaction at 24 and 48 hours.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal: #4 and #6
Time point:
24/48/72 h
Max. score:
2
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Remarks:
The iris score could not be assessed due to severity of the reaction at 24, 28 and 72 hours.
Irritation parameter:
iris score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Remarks:
The iris score could not be assessed due to severity of the reaction at 24 and 48 hours.
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: #1, #2, #3, #4, #6
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: Animals were killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #1, #4, #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: Animals were killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #2, #5
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
other: Animals were killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
other: Animal was killed due to the severity of the reaction after 7 days.
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Due to the severity of the reaction it was impossible to assess corneal and iridial lesions on a number of occasions in three animals, and in one other animal no assessment of corneal damage could be made at any reading.
Corneal opacities were observed in five animals.
Iritis was observed in three animals but the iris could not be observed in two other animals.
A diffuse, crimson to beefy-red colouration of the conjunctivae accompanied by considerable swelling with the eye about half or almost completely closed was seen in all six animals.
Other effects:
Due to the severity of the reactions the animals were killed after the four days observation.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Conclusions:
An eye irritation study was conducted comparable to OECD guidance. As severe effects were seen, 1,3H6XDI is classified cat. 1 for eye damage.
Executive summary:

An eye irritation study was conducted comparable to OECD guidance. 1,3H6XDI was instilled in one eye of 6 rabbits. Due to the severity of the reaction it was impossible to assess corneal and iridial lesions on a number of occasions in three animals, and in one other animal no assessment of corneal damage could be made at any reading. Corneal opacities were observed in five animals. Iritis was observed in three animals but the iris could not be observed in two other animals. A diffuse, crimson to beefy-red colouration of the conjunctivae accompanied by considerable swelling with the eye about half or almost completely closed was seen in all six animals. Due to the severity of the reactions the animals were killed after the four days observation.

As severe effects were seen, 1,3H6XDI is classified cat. 1 for eye damage.