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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:
50 µl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2-Propylendiamin
- 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: 2.74 and 2.89 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
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: 1 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 8 d
Score:
4
Max. score:
4
Reversibility:
not reversible

Any other information on results incl. tables

The application of the test substance caused corrosion to the exposed eyes predominantly expressed by severe corneal opacity and chemosis.

Severe corneal opacity is considered to be an irreversible effect to ophthalmic tissue. At the end of the observation period after 8 days beginning staphyloma, corneal opacity, partially necrotic lid margins and suppuration was noted.

The original gradings were 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
Conclusions:
Under the conditions of this study the test substance caused severe damage to the rabbit eye.
Executive summary:

In an eye irritation study (internal test method) in rabbits, 50 µL of the undiluted test substance were applied to the conjunctival sac of one eye in 2 rabbits. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours.

The application of the test substance caused corrosion to the exposed eyes predominantly expressed by severe corneal opacity and chemosis.

At the end of the observation period after 8 days beginning staphyloma, corneal opacity, partially necrotic lid margins and suppuration were noted.