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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:
2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Yellow powder
Specific details on test material used for the study:
- Expiration Date: May 18, 2021
- Lot # : 2757
- Stability under test conditions: stable for the duration of testing
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc. (USA)
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 - 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-83
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: June 6-16, 2011

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mL (0.03 mg)
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Prior to instillation, 2-3 drops of ocular anesthetic (Tetracaine Hydrochloride Ophthalmie Solution, 0.5%) were placed into both the treated and control eye of each animal. One-tenth of a milliliter (0.03 g) of the test substance was then instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
There was no corneal opacity or iritis observed in any treated eye during the study. Within one hour after test substance instillation, all three treated eyes exhibited minimal conjunctivitis. All animals were free of ocular irritation by 24 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met