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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:
July 20, 1982 to August 10, 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Study conducted according to GLP and was equivalent or similar to OECD 405 guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
impurity
Specific details on test material used for the study:
The test material is a UVCB

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Rabbits were housed individually in cages sized in accordance with the 'Guide for the Care and Use of Laboratory Animals' of the Institute of Laboratory Resources. Waste material was removed daily. Cages and feeders were sanitized every two weeks. Food and water was provided ad libitum, checked daily and added or replaced as needed.

ENVIRONMENTAL CONDITIONS

Temperature: 20 ◦C ± 3 ◦C
Relative Humidity: 30-70%
Light cycle: 12 hours light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL of neat test material
Duration of treatment / exposure:
Test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup. The upper and lower lids were then held together for one seconf to prevent loss of material
Observation period (in vivo):
Up to 21 days post dosing
Number of animals or in vitro replicates:
six animals (3 males, 3 females)
Details on study design:
Twenty four hurs prior to the application of the test material, the eyes of the rabbits were examined using 2% sodium fluorescein stain. Animals showing preexisting corneal injury were eliminated from the study. The test susbtance was placed in the right eye of each animal by gently pulling the lower lid away from hte eyeball (conjunctival cul de sac) to form a cup. The upper and lower lids were then gently held together for one seconf to prevent loss of material. The contralateral eye remained untreated and served as a control. The eyes were examined at 1, 24, 48 and 72 hours and 7, 14 and 21 days after treatment. The grades of ocular reaction were recorded at each examination

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
2.973
Reversibility:
not fully reversible within: 21 days
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1.86
Reversibility:
not fully reversible within: 21 days
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.996
Reversibility:
not fully reversible within: 21 days
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3.16
Max. score:
4
Reversibility:
not fully reversible within:
Remarks:
21 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the results of this study, the test material is considered to cause irreversible damage to the eye. Therefore, under the criteria set forth in the CLP guidance document, this substance should be classified as Eye Damage, H318.
Executive summary:

The test article was instilled in the right eye of six rabbits. Positive ocular responses were observed at 1, 24, 48 and 72 hours, and on Days 7, 14 and 21 after treatment. Blistering and ulceration of the cornea, pannus and keratoconus were observed during the study. Based upon the observations made in the Acute Eye Irritation Test in Rabbits, the test substance was determined to be corrosive to the eye under CLP classification criteria.