1H-imidazole-1-propylamine

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:

1986

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

Test material information

Constituent 1

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 %

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

Results

Results 1

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

Results 2

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

Results 3

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Results 4

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Remarks:

1 h exposure

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Results 6

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.