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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed and documented in a robust manner (adopted from OECD SIDS; however, results are not reported in sufficient detail for classification)

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
1986
Report Date:
1986
Reference Type:
publication
Title:
No information
Author:
PPG Ind. Inc.
Year:
1987
Bibliographic source:
TSCATS, OTS 0513463, Doc. I.D. 89-878000001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity of test material was not analytically confirmed. It was used as received from PPG Industries. Purity of that material is listed as > 98% on the MSDS

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated left eye served as a control.
Amount / concentration applied:
100 µL
Duration of treatment / exposure:
In 3/9 animals the treated eyes were washed out after 30 sec; in all other animals, washing was not performed
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
9
Details on study design:
A test with fluorescein showed that the eyes were normal prior to testing. Test material (0.1 ml) was placed into the conjunctival sac of the right eye of each of 9 animals. The lids were held together for one second. Three of the nine treated eyes were each washed with room temperature deionized water for 1 minute, 30 seconds after treatment.
The treated eyes were examined for irritation 1, 24, 48 hours and 4, 7, 10, 14, 17 and 21 days after treatment. The corneas were re-examined after treatment with 0.2% fluorescein sodium ophthalmic solution after the 24 hour observation time. If staining was observed, staining was repeated after each subsequent evaluation time until staining no longer occurred.

Eyes were scored on scales of 0-4 for corneal opacity, area of cornea involved, fluorescein staining, corneal stippling, and conjunctival chemosis; a scale of 0-2 for iridial effects; and scales of 0-3 for conjunctival redness and discharge, for total maximum corneal, iridial and conjunctival scores of 80, 10 and 20 (total maximum of 110).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
unwashed eyes
Time point:
other: 1 h
Score:
21.8
Max. score:
110
Reversibility:
not specified
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
washed eyes
Time point:
other: 1 h
Score:
13.3
Max. score:
110
Reversibility:
not specified
Irritant / corrosive response data:
Positive staining occurred in four nonwashed eyes, which resolved by 48 hours. Positive staining did not occur in any of the washed eyes. The scores are consistent with a rating of "mildly irritating".

Since corneal involvement and/or conjunctival irritation cleared in 7 days or less, the test material was categorized as Toxicity Category III.

Applicant's summary and conclusion