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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline Study; Not GLP
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1962
Reference Type:
publication
Title:
The benzenediols: catechol, resorcinol and hydroquinone - a review of the industrial toxicology and current industrial exposure limits.
Author:
Flickinger, C.W.
Year:
1976
Bibliographic source:
American Industrial Hygiene Association Journal, 37:596-606.
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSLA
Principles of method if other than guideline:
The study was conducted in accordance with Federal Hazardous Substance Labeling Act (FHSLA), Federal Register Aug 12, 1961, p 7333-7341, Part 191 "Hazardous Substances Definitions and Procedural and Interpretative Regulations, Final Order".
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Resorcinol
EC Number:
203-585-2
EC Name:
Resorcinol
Cas Number:
108-46-3
Molecular formula:
C6H6O2
IUPAC Name:
benzene-1,3-diol
Details on test material:
Flaked and Industrial Grade Resorcinol

Flaked Grade (deep, ivory colored solid) and Industrial Grade (dark brown-colored solid), no purity data available

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Amount applied: 0.1 other: gm
Duration of treatment / exposure:
72 hour(s)
Number of animals or in vitro replicates:
6
Details on study design:
Six male albino rabbits were treated in determining the extent of injury that might be expected following accidental contamination of the eyes with each material. Two to four hours prior to the application of the material upon the cornea and into the conjunctival sac, the eyes were stained with fluorescein to assure the use of undamaged eyes. Since the material was water soluble, the standard test procedure was modified to test both the dissolved material and the semi-solid in its usual state. One tenth of a gram of the material was applied to one eye of each of six rabbits, the six untreated eyes serving as controls. The exposed eyes were not washed following application of the material. The eyes were examined and evaluated at 24 hours, 48 hours, and 72 hours after treatment for gross damage to the palpebral and bulbar conjunctivae, to the iris, and to the cornea. All damaged eyes were examined periodically thereafter for a maximum period of two weeks to evaluate the permanence of the damage and the rate and degree of repair.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
105
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
There was no significant difference in the response of the eyes of rabbits to Flaked or Industrial Resorcinol. Upon the application of 0.1 gm of either 
of the test materials into the eyes of male, albino rabbits, the conjunctivae became inflamed, the corneas opaque, and the rabbits gave evidence of 
marked discomfort.  Examination at 24 hours post exposure showed severe conjunctivitis, iritis, corneal opacities occluding most of the iris, and 
corneal ulcerations.  There was almost no perceptible improvement in the condition of the eyes during the observation period and by the 14th-day, 
all of the exposed eyes revealed kerataconus and pannus formation. The test substance, therefore, is an eye irritant as defined in the regulations
pursuant to the FHSLA.

Using Draize methods, a numerical evaluation of the eye injuries at 24, 48 and 72 hours gave a resultant total eye irritation scores of 105, 105 and 105, respectively, with a maximum obtainable score of 110 for each time period. Classified as an eye irritant.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The author concluded the substance to be a severe eye irritant. The results were evaluated in association with EC 1272/2008 (CLP). The substance was determined to be corrosive.
Executive summary:

Following the FHSLA protocol, six male albino rats were administered 0.1 gram of flaked and industrial grade resorcinol in a dissolved and semi-solid state into one eye with the other eye serving as the control (Flickinger, 1976; Koppers Company, 1962). At administration, the conjunctivae became inflamed, corneas were opaque and discomfort was observed.  At 24 hours post exposure, observations included severe conjunctivitis, iritis, corneal opacities occluding most of the iris and corneal ulcerations.  There was almost no perceptible improvement in the condition of the eyes during the observation period and by the 14thday, all of the exposed eyes revealed kerataconus and pannus formation.  Total eye irritation scores following Draize method were 105/110 at 24, 48 and 72 hours. Resorcinol was concluded to be a severe eye irritant.