Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-OECD study, non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Off white waxy solid
Details on test material:
TK 12 146
ZK 502
3942
opl/76 K-650

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. ( + 1°) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Single exposure (The eyelids were held closed for 1 second.)
Observation period (in vivo):
The rabbits were examined 1, 24, 48 and 72 hours after application cf the test compound
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
The eyes of the experimental animals were examined and found normal prior to the test. 100mg of the test compound were instilled into the conjunctiual sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 200 ml. of warm water.
The rabbits were examined 1, 24, 48 and 72 hours after application cf the test compound

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Con.junctiva.
A very slight reaction was seen in 3/3 unwashed and 1/3 washed eyes. one hour after the application of the compound.
Only one washed eye was still showing a reaction at 24 hours, but this had returned to normal by 48 hours.

Cornea.
Slight opacity with damage to the surface epithelium was seen transiently at one hour only in one unwashed eye.
Generally, there was uery little difference seen in the reactions between washed and unwashed eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
TK 12 146 is a minimal eye irritant in the albino rabbit.
Executive summary:

Three male rabbits and three female rabbits were used in the test. 100mg of the test compound were instilled into the conjunctiual sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 200 ml. of warm water.

The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound.

A very slight reaction (redness of the conjunctivae) was seen in 3/3 unwashed and 1/3 washed eyes one hour after the application of the compound.

Only one washed eye was still showing a reaction at 24 hours, but this had returned to normal by 48 hours.

Slight corneal opacity with damage to the surface epithelium was seen transiently at one hour only in one unwashed eye.

Generally, there was uery little difference seen in the reactions between washed and unwashed eyes.