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EC number: 225-730-9 | CAS number: 5036-48-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January - February 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Method: Short-term test: 3 min, 1 h exposure (Draize-Test)
- GLP compliance:
- no
Test material
- Reference substance name:
- 1H-imidazole-1-propylamine
- EC Number:
- 225-730-9
- EC Name:
- 1H-imidazole-1-propylamine
- Cas Number:
- 5036-48-6
- Molecular formula:
- C6H11N3
- IUPAC Name:
- 3-(1H-imidazol-1-yl)propan-1-amine
- Details on test material:
- - Name of test material (as cited in study report):N-(3-aminopropyl)-imidazol
- Physical state: liquid
- Analytical purity: 99.7 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach
- Housing: 1 animal per cage (stainless steel cage)
- Diet (e.g. ad libitum): Kliba 341 (130 g per animal per day)
- Water (e.g. ad libitum): 250ml per day per animal
- Acclimation period: at least 8 days before
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 C°
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Duration of treatment / exposure:
- 3 min, 1 h
- Observation period:
- 72 h
- Number of animals:
- 3 min: 2 males, 1 female
1 h: 2 males, 1 female - Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/Water (1:1)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Full Thickness Necrosis after 3 min exposure
- Basis:
- other: 3 animals
- Time point:
- other: within 72 h
- Remarks on result:
- other: No full thickness necrosis
- Irritation parameter:
- other: Full Thickness Necrosis after 1 h exposure
- Basis:
- other: 3 animals
- Time point:
- other: within 72 h
- Remarks on result:
- other: Full thickness necrosis at day 3
- Irritation parameter:
- erythema score
- Remarks:
- 3 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 3 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 1 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 1 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
Any other information on results incl. tables
Readings |
Animal |
R |
ED |
Symptoms |
3 min |
1 |
2 |
1 |
HE |
2 |
1 |
0 |
|
|
3 |
1 |
0 |
|
|
24 h |
1 |
3 |
0 |
HE |
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
48 h |
1 |
3 |
0 |
HE |
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
72 h |
1 |
3 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
|
|
|
ME 24/48/72 h |
1 |
3.0 |
0.0 |
|
ME 24/48/72 h |
2 |
0.0 |
0.0 |
|
ME 24/48/72 h |
3 |
0.0 |
0.0 |
|
ME |
|
1.0 |
0.0 |
|
HE: Hemorrhage
Readings |
Animal |
R |
ED |
Symptoms |
1 h |
1 |
4 |
2 |
N |
2 |
4 |
2 |
N |
|
3 |
4 |
2 |
N |
|
24 h |
1 |
4 |
1 |
N |
2 |
4 |
2 |
N |
|
3 |
4 |
2 |
N |
|
48 h |
1 |
4 |
0 |
N |
2 |
4 |
1 |
N |
|
3 |
4 |
1 |
N |
|
72 h |
1 |
4 |
0 |
N/S2/+ |
2 |
4 |
1 |
N/S2/+ |
|
3 |
4 |
1 |
N/S2/+ |
|
ME 24/48/72 h |
1 |
4.0 |
0.3 |
|
ME 24/48/72 h |
2 |
4.0 |
1.3 |
|
ME 24/48/72 h |
3 |
4.0 |
1.3 |
|
ME |
|
4.0 |
1.0 |
|
N: Necosis; S2: Full Thickness Necrosis; +: Findings confirmed by Gross-Path. Examin.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Conclusions:
- Classification: corrosive (causes burns)
- Executive summary:
Skin corrosion was investigated in an pre-OECD Guideline and pre-GLP study (BASF AG, 1986). Three rabbits were semiocclusively exposed to N-(3 -Aminopropyl)-imidazole for 3 min and 1 h. Readings for edema and erythema scores were done within 1 h after exposure and at day 1, 2, and 3. After 3 min of exposure only 1 of 3 animals showed erythema and no edema were observed. After 1 h of exposure clinical signs of necrosis were observed in all 3 animals, which were confirmed by gross-pathological examination after incision of the skin. Therefore, N-3 -Aminopropyl)-imidazole is considered to be corrosive to the skin.
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