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Toxicological information

Skin irritation / corrosion

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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:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):N-(3-aminopropyl)-imidazol
- Physical state: liquid
- Analytical purity: 99.7 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals 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.