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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:
1990-10-23 to 1990-10-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D271

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 3.8 kg
- Housing: individually
- Diet: ad libitum (Altromin 2123), hay
- Water: ad libitum (deionised, chlorated water)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg

Duration of treatment / exposure:
single treatment, the eye was washed out after 24 hours with physiological saline
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
1 animal
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Yes (physiological saline solution)
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
24 h up to 7 days p.a. the animal exhibited a swollen and reddened conjunctiva and a reddened iris. Eyelids were more than halfly closed. Clear-clourless to whitish discharge was observed. On day 7, the cornea surface appeared uneven and the conjunctiva was partly detaching.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test item is considered to cause serious eye damage in the rabbits' eye.
Executive summary:

The acute eye irritation study of the test item was performed in one New Zealand White rabbit according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 100 mg of the test item was placed into the conjunctival sac of the left eye. The untreated right eye served as control. The treated eye of the test animal was washed out 24 hours after application. The eye was examined at 1, 24, 48, and 72 hours after the application. From 24 h up to 7 days after treatment the animal exhibited a swollen and reddened conjunctiva and a reddened iris. Eyelids were more than halfly closed. Clear-clourless to whitish discharge was observed. On day 7, the cornea surface appeared uneven and the conjunctiva was partly detaching. The animal was sacrificed on day 7. Based on these findings the test item was considered to cause serious eye damage.