Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03. Jan 1967 - 11. Jan 1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test, see details in remarks on material and methods.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Morpholine
EC Number:
203-815-1
EC Name:
Morpholine
Cas Number:
110-91-8
Molecular formula:
C4H9NO
IUPAC Name:
morpholine
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.82 and 2.97 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 50 µL


Duration of treatment / exposure:
Single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.6
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h

Any other information on results incl. tables

Findings animal1/animal2 (50 µL):

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

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

Animal1: Opacity: 1.3; Chemosis: 0; Erythema: 1.3; Iritis: 0

Animal2: Opacity: 1; Chemosis: 0; Erythema: 2; Iritis: 0

The application of 50 µL test substance caused initially chemosis and moderate opacity and erythema. The corneal opacity and erythema effects were not reversible within the 8 day observation period. One animal developed ingrowing vessels at the end of the observation period.

Findings animal1/animal2 (100 µL):

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

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

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

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

The applicaton of 100 µL test substance caused moderate to severe corneal opacity, erythema and chemosis. After 48 hours iritis and after 6 days staphyloma was noted. The effects were not reversible within the 8 day observation period Severe corneal opacity and iritis are considered to be irreversible effects to ophthalmic tissue.

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