Registration Dossier
Registration Dossier
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EC number: 206-017-1 | CAS number: 288-13-1
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:
- other: Acceptable, well documented publication/ study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Patch-Test
- GLP compliance:
- no
Test material
- Reference substance name:
- Pyrazole
- EC Number:
- 206-017-1
- EC Name:
- Pyrazole
- Cas Number:
- 288-13-1
- Molecular formula:
- C3H4N2
- IUPAC Name:
- 1H-pyrazole
- Details on test material:
- no further data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Breeder: W. Ostrop / Meerbusch
The animals were caged single and had "mümmel z" (ssniff / Soest) for diet and water ad libitum.
Temperature 16 - 18 °C, Humidity 40 %
12 h light/12 h dark cycle
Acclimatization period 7 - 14 d.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- 500 mg in water
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 8 d
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- other: animals died
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- other: animals died
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 5.8
Any other information on results incl. tables
Pyrazole caused strong erythema and edema after a 24 h treatment. 72 h after application all animals were dead because of hematuria, splenic congestion, bloody intestine lymph nodes, petechia at the thymus, soaked liver - alltogether, a strong substance-related toxicity was found. The irritation index of 5.8 gives indication that the substance is strongly irritating to the skin.
Readings |
Animal |
|||
Erythema |
Edema |
Additional findings |
||
24 h |
1 |
4 |
3 |
|
2 |
2 |
3 |
||
3 |
2 |
2 |
||
72 h |
1 |
4 |
3 |
|
2 |
2 |
2 |
||
3 |
3 |
1 |
||
8 d |
1 |
dead |
dead |
|
2 |
dead |
dead |
||
3 |
dead |
dead |
||
Mean 24, 48, 72 h |
1 |
4 |
3 |
|
2 |
2 |
2.5 |
||
3 |
2.5 |
1.5 |
||
Mean 24, 48, 72 h |
1-3 |
2.8 |
2.3 |
|
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Regarding the results of the study the test substance Pyrazole is classified as irritating Cat. 2 following EG 1272/2008 (GHS) requirements.
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