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:
1997-12-15 until 1998-01-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: Hra:(NZW)SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc. (Denver, PA)
- Age at study initiation: young adult (at least three month old)
- Weight at study initiation: at least 200g grams at the start of the study
- Housing: singly, in suspended, stainless-steel mesh cages. Cages and racks were washed once a week.
- Diet: Certified High Fiber Rabbit Diet (PMI #5325) was available ad libitum
- Water: municipal drinking water, regularly assayed
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-21°C
- Humidity: 41-55 %
- Photoperiod: 12 hours of artificial light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied 0.1 mL of test item as such was pplaced into conjunctival sac of one eye (right)
Duration of treatment / exposure:
First animal: The treated eye of one animal was immediately washed after instillation.
Second animal: The treated eye of one animal was not washed after instillation.
Observation period (in vivo):
Observation: immediately after instillation of the test substance and at 1, 24, 48, 72 and 96 hours and at 7, 14 and 21 days after instillation of the test substance.
Number of animals or in vitro replicates:
2
Details on study design:
TREATMENT
The right eyes of two animals were treated. The left eyes were not treated.

REMOVAL OF TEST SUBSTANCE
- Washing:The treated eye of one animal was washed with runing water
- The treated eye of the second animal was not wahsed after exposure
- Time after start of exposure: Immediately after instillation

SCORING SYSTEM: OECD system as specified in OECD 405

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #1
Remarks:
(not irrigated)
Time point:
other: 24 - 48 -72 h
Score:
1.67
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #2
Remarks:
(irrigated)
Time point:
other: 24-48-72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #1
Remarks:
(not irrigated)
Time point:
other: 24 - 48 -72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #2
Remarks:
(irrigated)
Time point:
other: 24 - 48 -72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #1
Remarks:
(not irrigated)
Time point:
other: 24 - 48 -72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #2
Remarks:
(irrigated)
Time point:
other: 24 - 48 -72 h
Score:
2.67
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #1
Remarks:
(not irrigated)
Time point:
other: 24 - 48 -72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #2
Remarks:
(irrigated)
Time point:
other: 24 - 48 -72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

Animal

 

Irrigated

Corneal Opacity, Iris Effects, Redness, Chemosis

1 h

24 h

48h

72h

96h

Day 7

Day 14

Day 21

1

No

0,0,2,3

1a,1,3,3

2a,1,3,3

2a,1,3,3

3a,x,3,3

3a,x,3,3

3a,X,2,2

2a,0,2,1

2

Yes

0,0,1,3

1a,1,2,3

1a,1,3,3

2a,1,3,3

1a,1,3,3

0,0,3,1

0,0,2,0

0,0,1,0

 

X) Due to opacity, iris details were obscured.

a) Greater than three-quarters up to the whole area of the cornea was involved

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU