Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline corfirmed study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS New Zealand White rabbits
- Source: Myrtle's Rabbitry, Thompson Station, TN
- Age at study initiation: adult
- Weight at study initiation: not mentioned
- Housing: housed individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 33-35
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: 7.-14..3.2000

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.0510 g
(0.1 mL weight equivalent)
Duration of treatment / exposure:
The test article was instilled into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eye. Following instillation, the eyelids were gently held together for approximately one second in order to limit test article loss and the animal was returned to its cage. The eyes were macroscopically examined with the aid of an auxiliary light source for signs of irritation at 1, 24, 48 and 72 hours and up to 7 days after dosing
Observation period (in vivo):
7d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- no removal

SCORING SYSTEM: Draize system

TOOL USED TO ASSESS SCORE: fluorescein

The test article was instilled into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eye. Following instillation, the eyelids were gently held together for approximately one second in order to limit test article loss and the animal was returned to its cage. The contralateral eye remained untreated to serve as a control.

Ocular Observations
The eyes were macroscopically examined with the aid of an auxiliary light source for signs of irritation at 1, 24, 48 and 72 hours and up to 7 days after dosing according to the Ocular Grading System which is based on Draize. Following macroscopic observations at the 24-hour scoring interval, the fluorescein examination procedure was repeated on all test and control eyes and any residual test article was gently rinsed from the eye at this
time (if possible) using physiological saline.

Clinical Observations
Any unusual observations and/or mortality were recorded. General health/mortality checks were performed twice daily (in the morning and in the
afternoon).

Body Weights
Individual body weights were obtained for each animal prior to dosing on day 0 and prior to euthanasia.

Scheduled Euthanasia
Each animal was euthanized by an intravenous injection of sodium pentobarbital following its final observation interval. Gross necropsy examinations were not required for these animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all time points
Score:
0.1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: all time points
Score:
0.65
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: all time points
Score:
0.45
Max. score:
3
Reversibility:
fully reversible
Irritant / corrosive response data:
Exposure to the test article produced iritis in 1/3 test eyes at the 1-hour scoring interval. The iridal irritation resolved completely in the affected test eye by the 48-hour scoring interval. Conjunctivitis (redness, swelling and discharge) was noted in 3/3 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in all test eyes by study day 7. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The potential irritant and/or corrosive effects were evaluated on the eyes of New Zealand White rabbits. Each of three rabbits received a 0.0510 g (0.1 mL weight equivalent) dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 7 days following dosing. Exposure to the test article produced iritis in 1/3 test eyes at the 1-hour scoring interval. The iridal irritation resolved completely in the affected test eye by the 48-hour scoring interval. Conjunctivitis (redness, swelling and discharge) was noted in 3/3 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in all test eyes by study day 7.