Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
(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

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