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: Well documented and reported study fully adequate for assessment. The study was conducted according to an internationally accepted technical guideline and in compliance with GLP in a recognized contract research organization.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
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:
TEST ANIMALS
- Species, Strain: albino rabbits, Hra:(NZW)SPF
- Source: Hazleton Research Products, Inc., Denver PA
- Weight prior to dosing (Day 1): 2006 - 2224 g
- Husbandry and housing: individually in screen-bottom cages; according to standards outlined in the "Guide for the Care and Use of Laboratory" (NIH Publication.86-23 (revised 1985)).
- Diet (ad libitum): measured amount of High Fiber Rabbit Chow® 5326, Purina Mills, Inc.,
- Water(ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 23.3
- Humidity (%): 48 - 70

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1-ml dose, 0.03 g
Duration of treatment / exposure:
Eyes kept unwashed.
Observation period (in vivo):
observations: 1, 24, 48, and 72 hours after treatment
Number of animals or in vitro replicates:
3 male, 3 female rabbits
Details on study design:
SCORING SYSTEM: Irritation was graded and scored according to the Draize technique.

TOOL USED TO ASSESS SCORE: At the 72-hour reading, sodium fluorescein was used to aid in revealing possible corneal injury.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over 6 animals and 4 time points
Time point:
24/48/72 h
Score:
0
Max. score:
320
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 6 animals
Time point:
24 h
Score:
1.7
Max. score:
10
Reversibility:
fully reversible within: 48-72 h
Remarks on result:
other: 3 of 6 animals concerned
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 6 animals
Time point:
48 h
Score:
0.8
Max. score:
10
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 3 of 6 animals concerned
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 6 animals
Time point:
72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over 6 animals
Time point:
24 h
Score:
6.7
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 2 animals: symptom "discharge" resolved
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over 6 animals
Time point:
48 h
Score:
6
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness of conjunctivae remained in all animals, chemosis only in 1 animal
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over 6 animals
Time point:
72 h
Score:
0
Max. score:
20
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over 6 animals
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over 6 animals
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over 6 animals
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test material produced iridal involvement and moderate conjunctival irritation when instilled into the eyes of six albino rabbits.
All ocular irritation cleared within 72 hours after instillation of the test material.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating