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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
Study period:
28 August 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
Reference Type:
other: TSCATS OTS053
Title:
Unnamed
Year:
1992
Report Date:
1992

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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.79 - 3.5 kg


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye was left untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: undiluted

Duration of treatment / exposure:
24 h, eyes were not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:



SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
55.8
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
3.2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.75
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3.6
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
The application of the test substance caused severe damage of ophthalmic tissue including corneal opacity. Due to severe edema, eyeball was not assessable at all readings. After 8 days, the study was terminated since reversibility of the findings was not expected.

Any other information on results incl. tables

Table 1: Eye irritation scores:

24 h  48 h   72 h  8 days
Cornea 4/3/3  */3/*   */3/* */*/*
Iris */1/0  */1/*   */1/*  */*/*
Conjunctiva 2/2/2  */2/*   */2/*  */*/*
Chemosis  3/4/3 4/4/3  4/4/3  3/3/3 

* severe edema, eyeball not assessable,

The application of the test substance caused severe damage of ophthalmic tissue including corneal opacity. Due to severe edema, eyeball was not assessable at all readings. After 8 days, the study was terminated since reversibility of the findings was not expected.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria