N,N'-bis(3-aminopropyl)ethylenediamine

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:

other: Acceptable study comparable to guideline (non GLP; occlusive conditions; 1 min, 5 min, 15 min or 20 hours treatment duration; applied volume of TS preparation: 1 mL, up to 8 days observation period)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Acceptable study comparable to guideline (non GLP; occlusive conditions; 1 min, 5 min, 15 min or 20 hours treatment duration; applied volume of TS preparation: 1 mL, up to 8 days observation period)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis(3-aminopropyl)ethylenediamine

EC Number:

234-147-9

EC Name:

N,N'-bis(3-aminopropyl)ethylenediamine

Cas Number:

10563-26-5

Molecular formula:

C8H22N4

IUPAC Name:

(3-aminopropyl)({2-[(3-aminopropyl)amino]ethyl})amine

Details on test material:

- Name of test material (as cited in study report): N-4 Amin
- Analytical purity: > 97 %

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Weight at study initiation: 2.85 kg (mean)
- Diet: Ssniff

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL

Duration of treatment / exposure:

1, 5, 15 minutes, 20 hours

Observation period:

8 days
reading time points: 24 h and 8 days

Number of animals:

2 per treatment

Details on study design:

TEST SITE: area of test sites: 2.5 x 2.5 cm² on the animal back.

SCORING SYSTEM: Draize

2 animals were treated for 1, 5, 15 minutes and 2 other animals for 20 hours with undiluted test substance using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with test substance on a patch. In addition, skin from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals which had been treated for 20 hours were not washed after removal of the substance patch. The animals were observed 8 days and skin changes were recorded on working days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: necrosis

Basis:

animal #1

Remarks:

1 minute exposure

Time point:

other: 24 h

Reversibility:

fully reversible

Remarks on result:

other: smooth necrosis

Results 2

Irritation parameter:

other: necrosis

Basis:

animal #2

Remarks:

1 minute exposure

Time point:

other: 72 h

Reversibility:

no data

Remarks on result:

other: laminar necrosis was observed on day 3

Results 3

Irritation parameter:

other: necrosis

Basis:

animal #1

Remarks:

5 minute exposure

Time point:

other: 24, 48, 72 h

Reversibility:

not reversible

Remarks on result:

other: leathery necrosis

Results 4

Irritation parameter:

other: necrosis

Basis:

animal #2

Remarks:

5 minute exposure

Time point:

other: 24, 48, 72 h

Reversibility:

not reversible

Remarks on result:

other: laminar necrosis

Results 5

Irritation parameter:

other: necrosis

Basis:

animal #1

Remarks:

15 minute exposure

Time point:

other: 24, 48, 72 h

Reversibility:

not reversible

Remarks on result:

other: parchmentary necrosis

Results 6

Irritation parameter:

other: necrosis

Basis:

animal #2

Remarks:

15 minute exposure

Time point:

other: 48, 72 h

Reversibility:

not reversible

Remarks on result:

other: parchmentary necrosis

Results 7

Irritation parameter:

other: necrosis

Basis:

mean

Remarks:

20 hour exposure

Time point:

other: 24, 48, 72 h

Reversibility:

not reversible

Remarks on result:

other: parchmentary necrosis on day 1 after exposure which developed to leathery necrosis on day 2 and 3

Irritant / corrosive response data:

Laminar necrosis was found directly after 15 minute exposure in one animal which was still seen until animal died.

Any other information on results incl. tables

Undiluted N-4-Amin gave indication of slight edema and slight necrosis as a result of an exposure period of 1 minute. After application of the test substance for 5, 15 min and 20 hours, respectively, erythema and necrosis were observed.

Necropsy findings of the animals that died comprised enteritis and peritonitis with agglutinations. All findings were not reversible within 6 days.

Animal	Readings	Exposure period: 15 minutes
		Erythema	Edema	Additional findings
01	24 h	2	2
	48 h	2	2	parchment-like necrosis
	72 h	2	2	parchment-like necrosis
	Mean score	2	2
02	24 h	2	2
	48 h	2	2	parchment-like necrosis
	72 h	2	2	parchment-like necrosis
	Mean score	2	2

 

 

Animal	Readings	Exposure period: 20 hours
		Erythema	Edema	Additional findings
01	24 h	2	3	parchment-like necrosis
	48 h	2	2	hard, relocatable necrosis
	72 h	2	3	hard, relocatable necrosis
	Mean score	2	2.7
02	24 h	2	2	parchment-like necrosis
	48 h	2	2	leather-like necrosis
	72 h	2	2	leather-like necrosis
	Mean score	2	2

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information