Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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

Constituent 1
Chemical structure
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:
N,N'-bis(3-aminopropyl)ethylenediamine
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
1.5
Max. score:
3
Reversibility:
not reversible
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