Registration Dossier

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965
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

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
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
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
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