Registration Dossier
Registration Dossier
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EC number: 203-142-3 | CAS number: 103-76-4
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (occlusive conditions, exposure period up to 20 hours)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-piperazin-1-ylethanol
- EC Number:
- 203-142-3
- EC Name:
- 2-piperazin-1-ylethanol
- Cas Number:
- 103-76-4
- Molecular formula:
- C6H14N2O
- IUPAC Name:
- 2-piperazin-1-ylethanol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.02 and 3.05 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted test item applied on dorsal skin
- Duration of treatment / exposure:
- 1, 5 and 15 min and 20 h
- Observation period:
- 8 days
- Number of animals:
- 2 males
- Details on study design:
- TEST SITE
A cotton pad (2.5x2.5 cm) was covered with the undiluted liquid test substance and was applied under occlusive conditions onto the skin of the back.
REMOVAL OF TEST SUBSTANCE
- Washing: 1x Lutrol and 1x 50% Lutrol
- Time after start of exposure: Immediately after 1, 5 and 15 min exposure.
SCORING SYSTEM: The original BASF grading was converted into the numerical grading according the OECD Draize system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 1, 5 or 15 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 1, 5 or 15 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 20 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- 20 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Other effects:
- No mortality occurred and there were no signs of systemic toxicity from the dermal exposure.
Any other information on results incl. tables
Mean erythema score after 24, 48 and 72 h (animal1/2)
| Exposure time | 24 h | 48 h | 72 h | mean |
| 1 min | 0/0 | 0/0 | 0/0 | 0/0 |
| 5 min | 0/0 | 0/0 | 0/0 | 0/0 |
| 15 min | 0/0 | 0/0 | 0/0 | 0/0 |
| 20 h | 3/3 | 3/3 | 3/3 | 3/3 |
Mean edema score after 24, 48 and 72 h (animal1/2)
| Exposure time | 24 h | 48 h | 72 h | mean |
| 1 min | 0/0 | 0/0 | 0/0 | 0/0 |
| 5 min | 0/0 | 0/0 | 0/0 | 0/0 |
| 15 min | 0/0 | 0/0 | 0/0 | 0/0 |
| 20 h | 2/2 | 2/2 | 2/0 | 2/1.3 |
20 h treatment: erythema patchy or extending beyond the area of exposure, bleeding, incrustation, scaling.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
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