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Diss Factsheets

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:
2012
Report date:
2012

Materials and methods

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

Test material

Constituent 1
Test material form:
solid
Details on test material:
- Purity: 99.9%

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: 2475, 2511 and 2483 g
- Housing: 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
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 59-69%
- Air changes (per hr): 12 to 13/hour
- Photoperiod: 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.06 g (0.1 mL)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
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: fluorescein, ultraviolet light source

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
other: range
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
other: range
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no cornea effects
Irritation parameter:
iris score
Basis:
other: range
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no iris effects
Irritation parameter:
chemosis score
Basis:
other: range
Time point:
24/48/72 h
Score:
0 - 2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: discharge
Basis:
other: range
Time point:
other: 1 hour
Score:
1 - 2
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
There was no corneal opacity or iritis observed in any treated eye during the study. Conjunctival redness (score of 1 and/or 2), chemosis (score of 1 and/or 2) and discharge (score of 1 and/or 2) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 72 hours.

Any other information on results incl. tables

Table 1: Individual Animal Ocular Effects

 

Rabbit No.

Cornea

Iritis

Conjunctiva

Fluorescein Stain

Opacity

Area

Redness

Chemosis

Discharge

1 Hour

3401

0

4

0

1

1

1

NA

3402

0

4

0

1

2

2

NA

3403

0

4

0

1

1

2

NA

24 Hours

3401

0

4

0

0

0

0

Checked

3402

0

4

0

2

1

0

Checked

3403

0

4

0

1

0

0

Checked

48 Hours

3401

0

4

0

0

0

0

NA

3402

0

4

0

1

1

0

NA

3403

0

4

0

0

0

0

NA

72 Hours

3401

0

4

0

0

0

0

NA

3402

0

4

0

0

0

0

NA

3403

0

4

0

0

0

0

NA

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Slightly irritating
Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 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. There was no corneal opacity or iritis observed in any treated eye during the study. Conjunctival redness (score of 1 and/or 2), chemosis (score of 1 and/or 2) and discharge (score of 1 and/or 2) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 72 hours.