Registration Dossier
Registration Dossier
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EC number: 204-427-5 | CAS number: 120-80-9
Skin irritation / corrosion
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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- 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:
- 1 976
- 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
- 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.
Constituent 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:
- 24/48/72 h
- Score:
- 5.5
- Max. score:
- 32
- Reversibility:
- other: see results
- Remarks on result:
- other: The result is the mean 24/72h (no data available at 48h).
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.95
- Reversibility:
- other: see results
- Remarks on result:
- other: The result is the mean 24/72h (no data available at 48h).
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- other: see results
- Remarks on result:
- other: The result is the mean 24/72h (no data available at 48h).
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No individual data is available.
- 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.
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