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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:
1987
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
Single exposure without rinsing.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored by the attached system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Additional readings are made, if necessary, at 14 and 21 days. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.

SCALE FOR SCORING OCULAR LESIONS
Cornea:
A. Opacity--degree of density (most dense area taken for reading)
No opacity------------------------------------------------------- 0
Scattered or diffuse area, iris details clearly visible---------- 1
Easily discernible translucent areas, iris details slightly obscured------------------------------------------- 2
Opalescent areas, iris details not visible, pupil size barely discernible------------------------------------------ 3
Opaque, iris invisible------------------------------------------- 4
B. Area of cornea involved
One-quarter or less, but not zero-------------------------------- 1
Greater than one-quarter, but less than half--------------------- 2
Greater than half, but less than three-quarter------------------- 3
Greater than three-quarter, up to whole area--------------------- 4

Iris:
A. Normal----------------------------------------------------------- 0
Folds above normal, congestion, swelling, circumcomeal injection (any or all), iris still reacting to light-------- 1
No reaction to light, hemorrhage, gross destruction-------------- 2

Conjunctivae :
A. Vessels normal--------------------------------------------------- 0
Vessels definitely injected above normal------------------------- 1
Diffuse, deep crimson red, individual vessels not readily discernible------------------------------------- 2
Diffuse beefy red-------------------------------------- 3
B. No chemosis------------------------------------------------------ 0
Any swelling above normal (includes nictitating membrane)-------- 1
Obvious swelling with partial eversion of lids------------------- 2
Swelling with lids about half closed----------------------------- 3
Swelling with lids about half closed to completely closed-------- 4
C. No discharge------------------------------- 0
Any amount of discharge different from normal-------------------- 1
Discharge with moistening of the lids and hairs adjacent to lids--------------------------------------- 2
Discharge with considerable moistening around the eyes----------- 3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: All animals
Time point:
24/48/72 h
Score:
0
Other effects:
No corneal injury in any of the 6 eyes, minor transient irititis in 3 eyes at 1 hour after application, minor transient conjunctival irritation in 6 from 50 mg at 1 and 4 hour time points. All healed by 24 hr.

Any other information on results incl. tables

See details of scores in Attachments

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Executive summary:

Instillation of 50 mg of sample (equivalent of 0.1 ml) into rabbit eyes resulted in no corneal injury in any of 6 animals. Iritis was apparent in 3 animals and minor conjunctival irritation developed in 6 rabbits. Substantial ocular discharge was evident in 3 animals. After 24 hours, all rabbit eyes exhibited a normal appearance.