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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
study duration was 72h instead of 21 days
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Physical description: yellow liquid
- Sample No. UN1760
- Storage temperature: room temperature in the dark
- Test material received: on June 2, 1995

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kohican Valley Rabbitry, Loudonville, Ohio
- Weight at study initiation: 3588 g
- Housing: suspended stainless steel cage
- Diet: PMI Feeds, Inc. Lab Diet, The Richmond Standard, Laboratory Rabbit Diet HF, ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-70 (16 - 21 °C)
- Humidity (%): 40-60
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

Observations on the behaviours of the rabbit were made at 5, 15 and 30 minutes and at 1, 2, 3, 4, 24, 48 and 72 hours after instillation of the test material. The animal was observed twice daily for mortality and moribundity during the study

SCORING SYSTEM: the Draize system
Observations for irritation and ocular lesions were performed at approximately 1, 24, 48 and 72 hours after treatment

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
other: test was terminated after 72h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
other: test was terminated after 72h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
other: test was terminated after 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
other: test was terminated after 72h
Irritant / corrosive response data:
The test material elicited ocular effects in the one rabbit following test material administration. Corneal opacity was observed in the one rabbit from the 1-hour interval through the 72-hour interval of the study. An epithelial lesion was observed in the rabbit from the 1-hour interval through the 72-hour interval of the study. The results of the eye examinations using fluorescein indicated significant corneal epithelial effects involving up to approximately 100% of the corneal surface in the rabbit at 24, 48 and 72 hours.

Iridal effects (congestion and swelling, grade 1) were observed in the rabbit from the 1-hour interval through the 72-hour interval of the study. Conjunctival redness, chemosis and discharge were observed in the one rabbit by the 1-hour interval. Draize grades of 2 to 3 were observed in the rabbit at the 1-hour interval, a Draize grade of 3 at the 24-hour interval, and Draize grades of 2 to 3 at the 48 and 72-hour intervals. Conjunctival blanching was noted in the rabbit from the 1-hour interval through the 72-hour interval. Conjunctival petechial hemorrhage was observed in the rabbit from the 24-hour interval through the 72-hour interval. Purulent discharge was noted in the rabbit from 48 hours through 72 hours of the study.
Other effects:
The one rabbit survived the study period. No abnormal clinical signs were observed in the rabbit during the study.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria