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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 20 SEP 2007 to 14 Dec 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
2002

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
62037-80-3
Details on test material:
-Purity: 86%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: 2846 g
- Housing: singly in a stainless steel, wire-mesh cage suspended above a cage board.
- Diet: 125 grams of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22°C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: control was untreated eye of test animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
28 hours
Observation period (in vivo):
at dosing, 1, 24 and 28 hours
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: unwashed



SCORING SYSTEM: Draize Scale


TOOL USED TO ASSESS SCORE: illumination and magnification, fluorescein stain examinations were conducted on the day after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 28 hours
Remarks on result:
other: 1-28 h
Remarks:
because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 28 hours
Remarks on result:
other: 1-28 h
Remarks:
positive indication of irritation. because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 28 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 28 hours
Remarks on result:
other: 1-28 h
Remarks:
because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
2
Reversibility:
not fully reversible within: 28 h
Remarks on result:
other: 1-28 h
Remarks:
because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 28 hours
Remarks on result:
other: 1-28 h
Remarks:
because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 28 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 28 h
Remarks on result:
other: 1-28 h
Remarks:
because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h
Score:
0
Max. score:
3
Reversibility:
not fully reversible within: 28 h
Remarks on result:
other: Brown and white discoloration of the conjunctiva
Remarks:
1-28 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
not fully reversible within: 28 hours
Remarks on result:
other: Brown and white discoloration of the conjunctival membrane of the treated rabbit eye was observed at 1, 24, and 28 hours after instillation of the test substance.
Remarks:
1-28h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 28 h
Score:
0
Max. score:
3
Reversibility:
not fully reversible within: 28 h
Remarks on result:
other: Brown and white discoloration of the conjunctiva
Remarks:
1-28h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 28h
Remarks on result:
other: 1-28 h
Remarks:
because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 28 hours
Remarks on result:
other: 1-18 h
Remarks:
because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 28 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 28 h
Remarks on result:
other: 1-28 h
Remarks:
because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
Irritation parameter:
other: Discharge
Basis:
animal #1
Time point:
24 h
Score:
>= 2
Max. score:
3
Reversibility:
not fully reversible within: 28 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1
Score:
0
Max. score:
2
Irritant / corrosive response data:
Brown and white discoloration of the conjunctival membrane of the treated rabbit eye was observed at 1, 24, and 28 hours after instillation of the test substance. Corneal opacity (score of 2), iritis (score of 1), conjunctival chemosis (score of 2 or 4), and discharge (score of 2 or 3) were also observed. Fluorescein stain examinations were positive for corneal injury in the treated eye. The rabbit was euthanized the day after treatment for humane reasons.
The ocular scores from the animal with respect to observation time are presented in Table 1.

Any other information on results incl. tables

Table 1: Individual Animal Ocular Effects

 

 

Rabbit No.

Cornea

Iritis

Conjunctiva

Fluorescein Stain

Other

Opacity

Area

Redness

Chemosis

Discharge

1 Hour

279

2

4

0

0

2

3

NA

-

24 Hours

279

2

2

1

0

4

2

POS

*

28 Hours

279

2

4

1

0

4

2

POS

*

POS= positive for corneal injury

NA = not applicable

- = No other effects

* = Brown and white discoloration of the conjunctiva

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this study, the test substance produced ocular effects in a rabbit.
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
Executive summary:

An aliquot of 0.1 mL of test substance was administered to 1 eye of the animal. The treated and control eye remained unwashed following treatment. The conjunctiva, iris, and cornea of the treated eye were evaluated and scored according to a numerical scale approximately 1, 24, and 28 hours following administration of the test substance. Brown and white discoloration of the conjunctival membrane of the treated rabbit eye was observed at 1, 24, and 28 hours after instillation of the test substance. Corneal opacity (score of 2), iritis (score of 1), conjunctival chemosis (score of 2 or 4), and discharge (score of 2 or 3) were also observed. Fluorescein stain examinations of the treated eye were positive for corneal injury. The rabbit was euthanized the day after treatment for humane reasons. Under the conditions of this study, the test substance produced ocular effects in a rabbit.

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