Registration Dossier

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 guideline study

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)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits, strain HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd, Wyton Huntingdon, England
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 2 weeks

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one untreated eye of test animals served as control
Amount / concentration applied:
Amount: 0.1 ml

Duration of treatment / exposure:
after placing the test substance into the conjunctional sac of the rabbits eye the lids were held together for about one second. 24 hours after treatment the treated eye was rinsed with saline.
Observation period (in vivo):
1, 24, 48, 72 hours and 7, 14, and 21 days post application. 
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The eye was rinsed at 24 hours after instillation

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: area of cornea opacity: more than 3/4 up to complete surface
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Other effects:
There were no systemic intolerance reactions recorded.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information
Conclusions:
severely irritating to the eye


Classification: not irritating
Executive summary:

In an eye irritation test on rabbits according to OECD 405, the test substance led to marked inflammatory reactions of the corna, iris and conjunctivae in one animal. Discharge was observed. Corneal and conjunctival signs and discharge did not prove to be reversible within 21 days. No systemic intolerance reactions were recorded. Due to animal welfare reasons no further animals were treated. The test substance was shown to induce severely irritating effects to the eye of rabbits.