Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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

Data source

Referenceopen allclose all

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
Reference Type:
study report
Title:
Unnamed
Year:
1962

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSLA
Principles of method if other than guideline:
Method: other: Federal Hazardous Substances 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 grade Resorcinol

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

Test animals

Species:
rabbit

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
physiological saline
Amount / concentration applied:
Concentration: 500 mg
Duration of treatment / exposure:
24 hour(s)
Number of animals:
6
Details on study design:
The irritation produced by a single contact of each material with the skin was measured by a patch-test technique on the abraded and intact skin bellies of male, albino rabbits, clipped free of fur. One-half of a gram of the material was moistened with physiological saline and applied, under one-inch-square gauze patches to three intact and three abraded areas randomly distributed over the bellies of six male, albino rabbits. The patches were secured in place by adhesive tape and the trunks of the animals were wrapped in impervious plastic films to further secure the patches and retard the evaporation of the chemical. Following a 24-hour period of exposure, during which the rabbits were confined in stocks, the patches were removed and the skin reactions were evaluated on the basis of erythema, edema, and necrosis. The exposed areas were again evaluated after 72 hours. Areas of the skin which were damaged by the material were kept under observation for a maximum period of two weeks.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Score:
4.4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
1.03
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Remarks on result:
other: 48 h value was considered to be the same as the 72 h value as worst case approach
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 2 weeks
Remarks on result:
other: 48 h value was considered to be the same as the 72 h value as worst case approach

Any other information on results incl. tables

Flaked Grade: Not a primary irritant

Evaluation Time (hours)         Effect on skin
                        Erythema                    Edema
                 A. Intact        B. Abraded        C. intact        D. Abraded
24                 0.7                2.7*                 1.3                 3.0*
72                 1.2                3.5*                 1.5                 3.5*
Total              1.9                6.2*                 2.8                 6.5*

Primary Irritation score [(A+B+C+D)/4]: 4.4
*Based upon necrotic areas being scored 4.0, the maximum score possible, for both eythema and edema.

The contact of 0. 5 gm of the test material with the intact and abraded areas of the skin of male, albino rabbits for a maximum period of 24 hours produced responses, the most severe of which were: Intact, moderate irritation; Abraded, necrosis; primary
irritation score, 4. 4 for the Flaked Grade.

In general, after 72 hours exposure, the effects of the skin were more prevalent than at 24 hours following exposure.

After 14 days the necrotic areas were still encrusted or scarred but other areas were free of any signs of irritation.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: other: EC 1272/2008
Conclusions:
The primary irritation score was calculated to be 4.4 for the Flaked Grade and is considered  by the author to no be an irritant. When evaluated in association with EC 1272/2008 (CLP), the substance is considered a Category 2 Irritant.
Executive summary:

A twenty four-hour, occluded application of flaked and industrial grade resorcinol at 500 mg to the bellies of male albino rabbits (strain not specified) resulted in moderate irritation on intact skin and necrosis on abraded sites with flaked grade resorcinol (Flickinger, 1976 and Koppers Company, 1962; RL=2 (provides basic data)).  Industrial grade resorcinol results varied after 24 hours from slight to severe irritation of the intact areas and from severe irritation to necrosis of the abraded areas.  After the 14 day recovery period the necrotic areas were either still encrusted or scarred but the other areas were free of any signs of irritation.  The primary irritation scores for flaked and industrial grade resorcinol were 4.4 and 5.4, respectively