Registration Dossier

Toxicological information

Eye irritation

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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. Purity of the test material was not listed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-aminoethanol
- pH 12
- no further data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.65-2.89 kg
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent eye (physiological NaCl-solution)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
Duration of treatment / exposure:
not applicable (tests substance was not washed out)
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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hrs
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hrs
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hrs
Score:
0.66
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hrs
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hrs
Score:
1.33
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hrs
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Chemical burnings, scars on upper eyelid, purulent secretion, bloody discharge, conjunctival bleedings, iritis, staphyloma, ciliar injections

Any other information on results incl. tables

 

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

1

-

0

0

0

-

cornea black-red coloured, bloody secretion, constricted pupil, strong secretion

2

3

-

0

0

0

-

cornea black-grey coloured, bloody secretion, constricted pupil, strong secretion

3

3

-

0

0

0

-

cornea brown-red coloured, chemical burnings, brown-red secretion

24 h

1

3

-

0

2

1

-

chemical burnings

2

3

-

0

1

2

 

chemical burnings

3

3

-

0

0

2

-

cornea brown-red coloured, chemical burnings, brown-red secretion

48 h

1

3

-

2

2

1

-

crust formation (eyelids)

2

3

-

-

1

2

-

chemical burning of the eyeball and eyelid

3

3

-

2

0

2

-

purulent secretion

72 h

1

3

-

2

2

0

-

purulent secretion

2

3

-

0

0

0

-

purulent secretion, conjunctiva covered with purulent fur

3

3

-

2

0

2

-

purulent secretion,

8 d

1

3

-

2

2

0

-

purulent secretion

2

3

-

0

0

0

-

loss of hair

3

3

-

2

0

0

-

Staphyloma, ciliar injections, conjunctiva white and chemically burned, scar on upper eyelid

Mean

24 -72 h

1

3

-

1.33

2

0.66

-

 

2

3

-

0

0.66

1.33

-

 

3

3

-

1.33

0

2

-

 

Mean

24-72 h

1-3

3

-

0.88

0.89

1.33

-

 

- endpoint not addressed

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information