Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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: Study pre-dates GLPs

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CPSC guidelines in CFR 16
Principles of method if other than guideline:
The procedure employed was that prescribed by THE CONSUMER PRODUCT SAFETY COMMISSION OF THE U.S.A. in the CODE OF FEDERAL REGULATIONS, TITLE 16, SECTION 1500.42, and in THE JOURNAL DE LA REPUBLIQUE FRANCAISE, APRIL 21, 1971. Only three animals were used instead of six.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Albino rabbits

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml test item
Duration of treatment / exposure:
1 time
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
The eyes are examined and the grade of ocular reaction i s recorded at 24, 48 and 72 hours. Reading of reaction i s facilitated by use of a binocular loupe, hand slit-lamp, or other expert means.
After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. For this optional test, one drop of fluorescein sodium ophthalmic solution U.S.P. or equivalent is dropped directly on the cornea. After flushing out the excess fluorescein with sodium chloride solution U.S.P. or equivalent, injured areas of the cornea appear yellow; this is best visualized in a darkened room under ultra-violet illumination. Any or all eyes may be washed with sodium chloride solution U.S.P. or equivalent after the 24 hour reading.

Results and discussion

In vivo

Results
Irritation parameter:
other: totality of effects
Basis:
other: all animals
Time point:
other: Day 3
Score:
39 - 78
Max. score:
78
Reversibility:
not reversible
Remarks on result:
other: test was terminated after three days since signs of necrosis were observed
Irritant / corrosive response data:
see below
Other effects:
CORNEAL OPACITIES WERE OBSERVED IN ALL THREE ANIMALS (TWO HAD COMPLETE CORNEAL OPACITY AND GROSS DESTRUCTION OF THE CORNEA WAS OBSERVED IN THE THIRD ANIMAL). IRITIS WAS OBSERVED IN ALL THREE ANIMALS. A DIFFUSE CRIMSON TO BEEFY AND COLORATION OF THE CONJUNCTIVA AND CONSIDERABLE SWELLING WITH THE EYELIDS ABOUT HALF CLOSED WERE OBSERVED IN ALL THREE ANIMALS. THE NICITATING MEMBRANE SHOWED AREAS OF NECROSIS IN ALL THREE ANIMALS. THE MAXIMUM AVERAGE SCORE (MM) = 58.

Applicant's summary and conclusion

Conclusions:
Test item was extremely irritating to the rabbit eye and is probably corrosive.
Executive summary:

  WITHIN THE LIMITATIONS OF THE ABOVE ABBREVIATED TEST PROCEDURE TEST ITEM GAVE A POSITIVE TEST FOR EYE IRRITATION. FINAL CLASSIFICATION ACCORDING TO THE PROCEDURE IN THE OFFICIAL JOURNAL WAS NOT POSSIBLE, AS ONLY THREE ANIMALS WERE USED, AND THE TEST WAS TERMINATED ON DAY THREE.