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:
from 1996-06-07 to 1996-08-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Lot No.: 0998603612
Purity: 59.6 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: adult
- Weight at study initiation: approximately 2.0 to 3.5 kg
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rabbit Chow #5322 (Purina Mills, Inc.) was provided ad libitum to the animals throughout the study.
- Water: Municipal tap water treated by reverse osmosis was available ad libitum throughout the study.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 20 °C (67 - 68 °F)
- Humidity (%): 62 - 85
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
100 % concentration; 0.1 g substance were instilled
Duration of treatment / exposure:
Single dosage with no rinse.
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
1 female rabbit
Details on study design:
The test article was instilled into the conjunctival sac of the right eye of the 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Max. score:
2
Remarks on result:
not determinable
Remarks:
due to degree of opacity
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Max. score:
2
Remarks on result:
not determinable
Remarks:
due to degree of opacity
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: conjunctival redness
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: conjunctival redness
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: conjunctival redness
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: conjunctival swelling
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: conjunctival swelling
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: conjunctival swelling
Irritant / corrosive response data:
Exposure to the test article produced corneal opacity in the test eye at the 1 hour scoring interval. The corneal injury was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. Iritis was observed in the test eye at the 1 hour scoring interval. Conjunctivitis (redness and swelling) was noted in the test eye at the 1 hour scoring interval. Additional ocular findings of blanching of nictating membrane, blanching of conjunctival tissue, ocular discharge-yellow and head tilt were noted in the test eye. Due to the severe irritation noted, the animal was euthanized following the 72 hour score.
No corneal opacity, iritis or conjunctivitis was observed in the control eyes.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the initial rabbit dosed, the test item is considered to be a corrosive to the ocular tissue of the rabbit.
Executive summary:

The potential irritant and/or corrosive effects of the test item were evaluated on the eyes of New Zealand White rabbits. One rabbit received a 0.1000 g (0.1 mL weight equivalent) dose of the test item in the conjunctival sac of the right eye. The contralateral eye of the animal remained untreated and served as a control. The test and control eye was examined for signs of irritation for up to 72 hours following dosing. Due to the amount of irritation noted in the initial rabbit, the remaining animals were not dosed.

Exposure to the test article produced corneal opacity in the test eye at the 1 hour scoring interval. The corneal injury was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. Iritis was observed in the test eye at the 1 hour scoring interval. Conjunctivitis (redness and swelling) was noted in the test eye at the 1 hour scoring interval. Additional ocular findings of blanching of nictating membrane, blanching of conjunctival tissue, ocular discharge-yellow and head tilt were noted in the test eye. Due to the severe irritation noted, the animal was euthanized following the 72 hour score.

Based on the initial rabbit dosed, the test item is considered to be a corrosive to the ocular tissue of the rabbit.