Registration Dossier

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:
04/16/1996-05/07/1996
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material was stored at room temperature and reported as clear, yellow liquid with lot no. C1829-10

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 Incorporated
- Age at study initiation: young adult
- Weight at study initiation: 2.346-2.608 kg
- Housing: Individually in wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-26.1
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Group 1 (6 animals) unrinsed
Group 2 (3 animals) rinsed with water after 30 sec of contact
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6 (non rinsed) and 3 (rinsed)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with 200 ml of lukewarm tap water was done on Group 2 (3 rabbits)
- Time after start of exposure: 30 seconds


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: Fluorescein sodium ophthalmic solution U.S.P. followed by UV illumination

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.67
Reversibility:
not reversible
Remarks on result:
other: Non-rinsed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.22
Reversibility:
fully reversible
Remarks on result:
other: Rinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Non-rinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.22
Reversibility:
fully reversible
Remarks on result:
other: Rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2.22
Reversibility:
not reversible
Remarks on result:
other: Non-rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2
Reversibility:
fully reversible
Remarks on result:
other: Rinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2.78
Reversibility:
not reversible
Remarks on result:
other: Non-rinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2.11
Reversibility:
fully reversible
Remarks on result:
other: Rinsed
Irritant / corrosive response data:
For Group 1 (unrinsed), the test material produced corneal and conjunctival irritation which persisted through Day 21 and iritis which cleared by Day 14. Maximum total irritation scores ranged from 36 to 61. The 24h mean Draize score was 43/110 and 46/110 for eyes scored without and with sodium fluorescein, respectively. Additional observations included a blistered appearance to the conjunctiva and/or nictitating membrane and areas of nictitating membrane were blanched. Corneal vascularization became apparent at Day 7 and persisted through Day 21. No evidence of corrosion was noted.

For Group 2 (rinsed) animals, the test material produced corneal irritation which cleared by Day 7, iritis which cleared by Day 3, and conjunctival irritation which cleared by Day 21. Maximum total irritation scores ranged from 24 to 36. The 24h mean Draize score was 28/110 for eyes scored with and without sodium fluorescein. Additional observations included blistering to the conjunctiva and/or nictitating membrane. No evidence of corrosion was noted.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Test substance, when applied to the eyes of albino rabbits, produced irreversible eye irritation when observed for 21 days. Test substance, when applied to the eyes of albino rabbits and water-rinsed after 30 sec of contact, produced eye irritation reversible within 21 days.
Executive summary:

A 0.1 ml aliquot of test material was applied to the right eye of each of nine New Zealand White rabbits. Group 1 animals (6/9) were not rinsed following administration. Group 2 animals (3/9) were rinsed 30 seconds following administration with approximately 200 ml lukewarm tap water. For Group 1 (unrinsed), the test material produced corneal and conjunctival irritation which persisted through Day 21 and iritis which cleared by Day 14. Maximum total irritation scores ranged from 36 to 61. The 24h mean Draize score was 43/110 and 46/110 for eyes scored without and with sodium fluorescein, respectively. Additional observations included a blistered appearance to the conjunctiva and/or nictitating membrane and areas of nictitating membrane were blanched. Corneal vascularization became apparent at Day 7 and persisted through Day 21. No evidence of corrosion was noted. For Group 2 (rinsed) animals, the test material produced corneal irritation which cleared by Day 7, iritis which cleared by Day 3, and conjunctival irritation which cleared by Day 21. Maximum total irritation scores ranged from 24 to 36. The 24h mean Draize score was 28/110 for eyes scored with and without sodium fluorescein. Additional observations included blistering to the conjunctiva and/or nictitating membrane. No evidence of corrosion was noted.