Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nouan-8147 (2000)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Purity: 92.1%

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: 2225, 2383 and 2603 g
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors
- Diet: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 6 or 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 33-61%
- Air changes (per hr): 12 or 13.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of each rabbit remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 g
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: High-intensity white light in accordance with Draize, et al. The fluorescein dye evaluation procedure was used in the treated eye at 24 hours to verify the absence of corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
other: range
Time point:
other: 1-72 hours
Score:
0 - 2
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 hours
Irritation parameter:
other: discharge
Basis:
other: range
Time point:
other: 1-72 hours
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 hours
Irritant / corrosive response data:
All animals appeared active and healthy and gained body weight during the study. Apart from the eye irritation noted, there were no other clinical signs observed. There was no corneal opacity or iritis observed in any treated eye during the study. Conjunctival redness (score of 1 and 2), chemosis (score of 2 and/or 1) and discharge (score of 2 and/or 1) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 48 hours.

Any other information on results incl. tables

Table 1: Individual Scores for Ocular Irritation

 

Rabbit No.: 3401 (Female)

Rabbit No.: 3402 (Female)

Rabbit No.: 3403 (Female)

 

Hours

Hours

Hours

 

1

24

48

72

1

24

48

72

1

24

48

72

I. Cornea

A. Opacity

0

01

0

0

0

01

0

0

0

01

0

0

B. Area

4

4

4

4

4

4

4

4

4

4

4

4

II. Iris

A. Values

1

0

0

0

1

0

0

0

1

0

0

0

III. Conjunctivae

A. Redness

1

0

0

0

1

1

0

0

1

0

0

0

B. Chemosis

0

0

0

0

0

0

0

0

0

0

0

0

C. Discharge

1

0

0

0

1

1

0

0

1

0

0

0

12% ophthalmic fluorescein sodium used to verify the absence of corneal opacity. 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance caused slight irritation to the eye.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 0.05 mg ( 0.1 mL) of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours following administration. Conjunctival redness (score of 1 and 2), chemosis (score of 2 and/or 1) and discharge (score of 2 and/or 1) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 48 hours.