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

Eye irritation

Administrative data

Endpoint:

eye 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 (no GLP, 50 µl TS, 8-day 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

50 µl TS, 8-day 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 / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data
- Weight at study initiation: 3.02 kg (mean)
- Diet: Ssniff

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye was treated with a physiological solution of sodium chloride and served as a control.

Amount / concentration applied:

0.05 ml

Duration of treatment / exposure:

unspecified

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp
The animals were observed several times on the treatment day and 8 days afterwards, and findings were recorded on working days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72 h

Score:

1.5

Max. score:

3

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Any other information on results incl. tables

One hour after the application of indiluted N-4-Amin slight to moderate edema, moderate corneal opacity and bloody secretion were observed. In the course of 8 days, severe corrosion of the conjunctiva and cornea occurred. All findings were not reversible within 8 days.

Animal	Readings	Cornea	Iris	Conjunctivae		Additional findings
				Redness	Chemosis
01	24 h	2	1	2	2	staphyloma
	48 h	Readings were not perfomed
	72 h	2	1	0	2	staphyloma
	8 d					staphyloma
	Mean score	2	1	1	2
02	24 h	2	1	2	2
	48 h	Readings were not perfomed
	72 h	2	1	2	2	staphyloma
	8 d					staphyloma
	Mean score	2	1	2	2

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information