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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: Acceptable, well documented report which meets basic scientific principles.

Data source

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

Materials and methods

Principles of method if other than guideline:
BASF-Test, see details in remarks on results.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.87 and 2.92 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Duration of treatment / exposure:
8 days (single application)
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h -72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days

Any other information on results incl. tables

Findings animal1/2:

 Time   Opacity  Iritis    Erythema   Chemosis              
1h 1/3 0/0 2/2 2/2              
24h 1/3 0/0  2/2 2/2              
48h 1/1 1/2  2/2 1/1              
72h 3/3 1/2  2/2 1/2              
 8d 3/3 0/2 0/2  0/2              

Mean values over 24h, 48h and 72h:

Animal1: Opacity: 1.7; Iritis: 0.7; Erythema: 2; Chemosis: 1.3;

Animal2: Opacity: 2.3; Iritis: 1.3; Erythema: 2; Chemosis: 1.7;

The application of the test substance caused moderate to severe corneal opacity, irritis, moderate erythema and slight to moderate chemosis.

At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted. Severe corneal opacity, is considered to be an irreversible effect to ophthalmic tissue.

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

Applicant's summary and conclusion