N-(2-aminoethyl)-1,3-propanediamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976 - 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment

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:

0.05 ml of intilled test substance

Principles of method if other than guideline:

BASF-Test, see details in remarks on material and methods.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-aminoethyl)-1,3-propanediamine

EC Number:

236-882-0

EC Name:

N-(2-aminoethyl)-1,3-propanediamine

Cas Number:

13531-52-7

Molecular formula:

C5H15N3

IUPAC Name:

N1-(2-Aminoethyl)-1,3-propanediamine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 2.71 kg; male: 3.32 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as saline control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.05 mL

Duration of treatment / exposure:

8 days

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM: similar to OECD

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1h-8 days

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1h-8 days

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1h-24h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

The test substance caused irreversible effects under the conditions of the study.

Other effects:

Necrosis, staphyloma were also observable and not reversible.

Any other information on results incl. tables

Time	Animal	Erythema	Opacity	Chemosis
1h	No 1	-	3	2
	No 2	-	2	1
24 h	No 1	2	3	2
	No 2	2	3	2
8 days	No 1	-	-	-
	No 2	2	4	2

The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information