resorcinol; 1,3-benzenediol

Eye irritation

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1962

Reference 2

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

Test material information

Constituent 1

Reference substance name:

Resorcinol

EC Number:

203-585-2

EC Name:

Resorcinol

Cas Number:

108-46-3

Molecular formula:

C6H6O2

IUPAC Name:

resorcinol

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

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

105

Max. score:

110

Reversibility:

not reversible

Results 2

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

Results 3

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

Results 4

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

Results 5

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) based on GHS criteria

Conclusions:

The author concluded the substance to be a severe eye irritant. The results were evaluated in association with EC 1272/2008 (CLP) and the substance was determined to be classified corrosive to the eye due to the lack of improvement in the condition of the eyes over the 14 day observation period.

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.

Following evaluation based on the criteria in EC 1272/2008 (CLP) the substance was determined to be classified corrosive to the eye due to the lack of improvement in the condition of the eyes over the 14 day observation period.