Registration Dossier
Registration Dossier
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EC number: 226-166-6 | CAS number: 5308-25-8
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- xposure period was not 4 hours, but the test substance is corrosive
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (animals were used for a 3 minutes and 1 hour exposure; exposure period was not 4 hours, but the test substance is corrosive)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1-ethylpiperazine
- EC Number:
- 226-166-6
- EC Name:
- 1-ethylpiperazine
- Cas Number:
- 5308-25-8
- Molecular formula:
- C6H14N2
- IUPAC Name:
- 1-ethylpiperazine
- Details on test material:
- - Name of test material (as cited in study report): Ethylpiperazin, Partie 6, Abl.Nr. 64-6112
- Analytical purity: 98%
- PSN 88/0569
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany (female rabbit) and Savo, med. Versuchstierzuchten, Kissling/Germany (males)
- Weight at study initiation: 2.77 kg (female), 2.3 kg (males)
- Housing: singly
- Diet: Kliba 341, about 130 g/animal/day
- Water: tap water, about 250 mL/animal/day
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 3 minutes (right flank) and 1 hour (left flank)
- Observation period:
- 72 hours
- Number of animals:
- 1 female and 2 male animals
- Details on study design:
- TEST SITE
Clipping of the fur: at least 15 hours before the beginning of the study.
- Area of exposure: 2.5 x 2.5 cm, upper third of the back or flanks
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure period
SCORING SYSTEM:
based on J .H . Draize: Appraisal of the safety of chmemicals in foods, drugs and cosmetics. In dermal toxicity pp. 46 - 59, 1959 Austin, TEX.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: necrosis
- Basis:
- mean
- Time point:
- other: 3 minutes exposure
- Remarks on result:
- other: superficial/medium thickness scabbing was observed but no necrosis
- Irritation parameter:
- other: necrosis
- Basis:
- mean
- Time point:
- other: 1 hour exposure
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis was observed immediately after exposure and during the whole observation period; full thickness necrosis was confirmed 72 hours after exposure at gross pathology
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours post treatment
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: 3 minutes exposure; Erythema extending beyond the area of exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours post treatment
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: 3 minutes exposure; Edema extending beyond the area of exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours post treatment
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours post treatment
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: 1 hour exposure; Edema extending beyond the area of exposure
- Irritant / corrosive response data:
- 3 minutes exposure:
Edema and erythema extending beyond the area of exposure and hemorrhage was observed in the male animals up to 24 hours after exposure. Superficial scabbing/medium thickness scabbing was additionally observed 72 hours post exposure in the male test animals.
1 hour exposure:
Edema extending beyond the area of exposure was observed in all test animals at any time post exposure. Necrosis was observed one hour after exposure up to 48 hours, resulting in full thickness necrosis after 72 hours in the male animals and superficial scabbing in the female animal. Findings were confirmed by gross pathology examination.
Any other information on results incl. tables
Table 1: Erythema and Edema scores of animals treated for 3 minutes with the unchanged test substance
Observation time |
Animal |
Erythema |
Edema |
Add. information |
3 minutes |
1 |
2 |
0 |
|
|
2 |
2 |
2 |
Edema and erythema extending beyond the area of exposure |
|
3 |
4 |
0 |
hemorrhage |
24 hours |
1 |
2 |
0 |
|
|
2 |
3 |
1 |
Edema and erythema extending beyond the area of exposure |
|
3 |
4 |
2 |
hemorrhage |
48 hours |
1 |
3 |
0 |
|
|
2 |
4 |
1 |
|
|
3 |
3 |
2 |
|
72 hours |
1 |
2 |
0 |
|
|
2 |
3 |
1 |
Superficial scabbing |
|
3 |
3 |
2 |
Medium thickness scabbing |
Mean |
1 |
2.3 |
0 |
|
|
2 |
3.3 |
1 |
|
|
3 |
3.3 |
2 |
|
Mean |
|
3 |
1 |
|
Table 2: Erythema and Edema scores of animals treated for 1 hour with the unchanged test substance
Observation time |
Animal |
Erythema |
Edema |
Add. information |
1 hour |
1 |
3 |
1 |
Edema extending beyond the area of exposure |
|
2 |
4 |
3 |
Necrosis; Edema extending beyond the area of exposure |
|
3 |
4 |
3 |
Necrosis; Edema extending beyond the area of exposure |
24 hours |
1 |
3 |
2 |
Edema extending beyond the area of exposure |
|
2 |
4 |
2 |
Necrosis; Edema extending beyond the area of exposure |
|
3 |
4 |
2 |
Necrosis; Edema extending beyond the area of exposure |
48 hours |
1 |
3 |
1 |
Edema extending beyond the area of exposure |
|
2 |
4 |
2 |
Necrosis; Edema extending beyond the area of exposure |
|
3 |
4 |
2 |
Necrosis; Edema extending beyond the area of exposure |
72 hours |
1 |
3 |
1 |
Superficial scabbing; Edema extending beyond the area of exposure |
|
2 |
4 |
2 |
Full thickness necrosis; Edema extending beyond the area of exposure |
|
3 |
4 |
1 |
Full thickness necrosis; Edema extending beyond the area of exposure |
Mean |
1 |
3 |
1.3 |
|
|
2 |
4 |
2 |
|
|
3 |
4 |
1.7 |
|
Mean |
|
3.7 |
1.7 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
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