Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: The purity of the test substance is unknown. Exposure duration was 24 h instead of 4 h. Observations were evaluated according to the scoring of Draize.

Data source

Reference
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(10), 596-606.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize test
Deviations:
not specified
Principles of method if other than guideline:
Federal register (1961) pp.7333-7341, Part 191- Hazardous Substances: definitions and Procedural and Interpretative Regulations, Final Order. Scoring performed according to Draize.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyrocatechol
EC Number:
204-427-5
EC Name:
Pyrocatechol
Cas Number:
120-80-9
Molecular formula:
C6H6O2
IUPAC Name:
pyrocatechol
Details on test material:
Koppers Company, Inc, Catechol C.P. Crystal Lot 68-1.

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mg of catechol on bellies of rabbits.
Duration of treatment / exposure:
24 hour(s)
Observation period:
14 days
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
5.5
Max. score:
32
Reversibility:
other: see results
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.95
Reversibility:
other: see results
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.7
Reversibility:
other: see results
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24 and 72 hours
Reversibility:
not specified
Remarks on result:
other: no individual data
Irritant / corrosive response data:
- Intact skin:
The contact of catechol produced slight to moderate erythema (score 2.2) and slight oedema (score 1.2) after 24 h. 
The irritation was less marked 72 h after exposure (erythema: 1.7 and oedema: 1.0) . 
After 14 days, the intact areas were free of irritation.

- Abraded skin:
The contact of catechol produced necrosis after 24 h. After 14 days, the necrotic areas were incrusted and beginning to slough.

Any other information on results incl. tables

Primary Irritation scores, Intact and abraded skin on rabbits (0.5 g, 24h period):

 

Erythema

Edema

 

Intact

Abraded

Intact

Abraded

24 hours

2.2

4

1.2

4

72 hours

1.7

4

1

4

Total

3.9

8

2.2

8

Primary Irritation score: 5.5

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:

Catechol causes skin irritation in EU GHS.
Executive summary:

In a primary dermal irritation study (Flickinger, 1976), 6 albino rabbits were dermally exposed to 0.5 mg of Catechol for 24 hours to bellies. No indication was done concerning dressing. Skin of animals was abraded or intact. Animals then were observed for 14 days. Irritation was scored by the method of Draize.

 

The contact of catechol produced slight to moderate erythema (score 2.2) and slight oedema (score 1.2) after 24 hours on intact skin.

The irritation was less marked 72 h after exposure (erythema: 1.7 and oedema: 1.0).

In this study, Catechol is irritating to the skin based on Draize scoring.