Registration Dossier

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:
Jan 27 - March 25, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Feb 24, 1987
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source:
Kaninchenhof Süstedt, Alter Pohl 8, 27305 Süstedt
Animal selection:
random
Animal identification:
with individual ear tags; cage labelled with ear tag no., sex, date of study initiation, project no.
Housing:
individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
Illumination:
artificial lighting (120 lux) from 7.00 a.m. -7.00 p.m.
Temperature:
20 +/- 3°C
Relative humidity:
30-70%
measurement:
twice daily

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 g of the test item
Observation period (in vivo):
Ocular reactions were assessed 1, 24, 48 and 72 h after treatment and thereafter once daily up to day 12 post applicationem. On each occasion, ocular irritation and/or corrosion were scored according to the scheme presented on the next two pages. At 48 h p.a., secretions had to be removed from the treated eye with warm saline to make an assessment possible.
Number of animals or in vitro replicates:
1 animal
Details on study design:
24 h before treatment, the eyes of the animal were examined for potential ocular lesions. Since the animal showed no evidence of ocular abnormalities it was used in the test.
The test article was administered in the original state.
0.1 g of the test article was introduced into the conjunctival sac of the left eye, while the right eye served as control. Because of the pain reaction of the animal immediately after the introduction of the test article, a local anaesthetic was used.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 12 days
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
3
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 12 days
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 12 days
Remarks on result:
probability of severe irritation
Irritant / corrosive response data:
Immediately after administration the test article caused unreasonable pain in the animal, so that a local anaesthetic (Novesine@, Wander 1 %) was used. Moderate to severe redness and swelling of the conjunctiva were observed during the entire observation period. Hyperemia of the iris was seen 1 h p.a. and was still apparent up to day 9 p.a. On the following days, irritation of the iris could not be evaluated because
of the extreme corneal opacity. Moderate to extreme corneal opacity was observed from 1 h p.a. up to the end of the observation period. Additionally, there was a strong formation of milky secreta 48 and 72 h p.a..
The observed findings persisted and were not reversible until day 12 p.a. On this day the animal was sacrificed because of the severe findings and the incipient destruction of the eyeball.
Other effects:
No other toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test for acute eye irritation/corrosion according to OECD Guideline No. 405 was performed with the test item.
Under the conditions of the present study, a single ocular application of the test item to rabbit at a dose of 0.1 g produced severe effects. The observed findings were not reversible up to the killing for animal protection reasons at day 12 p.a..
Executive summary:

The potential toxicity of the test item was assessed in an acute eye irritation/corrosion test on one albino rabbit. 0.1 g of the test article was introduced into the conjunctival sac of one eye, the untreated eye serving as control. Both eyes were examined at 1,24,48 and 72 h post applicationem and thereafter once daily up to day 12 post applicationem. For reasons of severe fmdings, the test was terminated on day, 12 p.a. and the animal was sacrificed.