Aziridine

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

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Principles of method if other than guideline:

BASF test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethylenimine

IUPAC Name:

Ethylenimine

Details on test material:

- Name of test material (as cited in study report): TH 14 151/OX "Rest aus Aethylenimin-Leitung"
- Physical state: liquid
- Composition: 94.1 % ethylenimin; 4.0 % water; 0.68 % low boiling fraction (ammonia, methylamine), 1.8 % higher boiling fraction (ethylenediamine, dimeric ethylenimine), < 0.001 % sulfur.

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMAL
- Weight at study initiation: Mean of 2 rabbits: 2.24 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent, saline treated eye of same animals served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl

Duration of treatment / exposure:

once

Observation period (in vivo):

4 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

2 animals

Time point:

other: 24-48-72 hrs

Score:

0.66

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

2 animals

Time point:

other: 24-48-72 hrs

Score:

3.5

Max. score:

3.5

Reversibility:

not reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

2 animals

Time point:

other: 24-48-72 hrs

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

2 animals

Time point:

other: 24-48-72 hrs

Score:

0

Max. score:

2

Reversibility:

other: no effects

Any other information on results incl. tables

Application of 0.05 mL of the undiluted test substance in the eye of rabbits caused corrosion of the cornea and death of the animals. Renal injuries (proteins, erythrocytes, leukocytes and renal epithelium in the urine, increase of blood urea, renal papillary necrosis) characteristic for the test substance were observed after application of the substance to the eye of rabbits.

Eye irritation scores (animal 1/2):

 

Observation After (h)	Erythema	Chemosis	Opacity	Iritis	Additional findings
1	2/2	2/2	2/2	0/0	blood discharge at the mucosa / blood discharge at the mucosa; yellow-red eye discharge
24	2/2	3-4/3-4	3/3	0/0	blood discharge at the eyelid margins (both animals)
48	0/0	3-4/3-4	3*/3*	0/0	Mucosa white and burned; necroses on both eye lids, ulcerous secretion / necroses on both eye lids, ulcerous secretion
72	0/0	3-4/3-4	3*/3*	0/0	Mucosa white and burned; necroses on both eye lids, ulcerous secretion / necroses on both eye lids, ulcerous secretion
96	-	-	-	-	Exitus / Exitus after 6 days

 * Due to severe swelling of the eyes, necroses on both eyelids, and ulcerous eye discharge, the etsimation of the degree of opacity posed some difficulties. Thus, it was assumed that the opacity score remained the same during the whole observation period of 72 hours.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information