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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: 92/69/EWG, B.5
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Nature of substance: Feststoff; purity: 99.7%, light yellow powder

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Source: CHR. FRED Leuschner & CO., D-24601 Löhndorf/Post Wankendorf
- Weight at study initiation: 2.0-2.3 kg
- Acclimation period: at least 20 adaptation days
- Housing: single, in special restrainers which allowed free movement of the head
- Diet: ad libitum
- Water: ad libitum




Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
1 test day and a follow-up period of 72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
TOOL USED TO ASSESS SCORE: fluorescein, fluorescein SE Thilo eye drops (Alcon Pharma GmbH, D-79108 Freiburg).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
Weiße Ablagerungen (möglicherweise Eiter) im Augenlid.
"ENGLISH"
Withish deposits (probably jus) in the conjunctival sac.

Any other information on results incl. tables

A single application of 100 mg Vulcuren Trial product KA 9188 per animal into the conjunctival sac of the right eye of three rabbits caused the following changes:

Cornea opacity (grad 1) was observed in animal no. 1 and 2 at the examination time points 1 and 24 hours after instillation. The effect was fully reversible within 24 h.

The iris and conjunctivae were not affected by instillation of the test compound.

In addition, whitish deposits (probably pus) were observed in the conjunctival sac in animal no. 2 and 3 24 and 48 hours after instillation.

There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Vulcuren Trial product KA 9188 was not irritating to the eyes.
Executive summary:

A single application of 100 mg Vulcuren Trial product KA 9188 per animal into the conjunctiva sac of the right eye of three rabbits caused very slightly cornea opacity effects (grad 1) in 2/3 animals 1 and 24 h after instillation (mean score 0.3). The effect was reversible within 24 hours. Based on these findings, the author assessed the test material Vulcuren Trial product KA 9188 as not irritating to eyes (LPT 1999).