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Eye irritation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17th May 1993 to 10th June 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2477 to 3420 g
- Housing: Individual suspended mesh-bottom cages
- Diet: ad libitum
- Water: ad libitum, tap water
- Acclimation period: a minimum of 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24 °C
- Humidity (%): 42-84 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was not performed
SCORING SYSTEM:
1. Cornea:
(A) Opacity- Degree of density (area most dense taken for reading)
No ulceration or opacity – 0
Dulling of normal lustre, details of iris clearly visible – 1*
Easily discernible translucent areas, details of iris slightly obscured – 2*
Nacreous areas, no details of iris visible, size of pupil barely discernible – 3*
Opaque cornea, iris not discernible through the opacity – 4*
(B) Area of cornea involved
No ulceration or opacity – 0
One quarter or less but not zero – 1*
Greater than one quarter, but less than half – 2*
Greater than half, but less than three quarters – 3*
Greater than three quarters up to whole area – 4*
Score equals A X B X 5
Total Maximum = 80
2. Iris
(A) Values
Normal – 0
Markedly deepened rugae, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) – 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) – 2*
Score equals A X 5
Totally maximum = 10
Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Blood vessels normal – 0
Some blood vessels definitely hyperaemic (injected above) normal – 1
Diffuse, deeper crimson colour, individual vessels not easily discernible – 3*
Diffuse beefy red – 3*
(B) Chemosis (lids and/or nictitating membranes)
No swelling – 0
Any swelling above normal (includes nictitating membrane) – 1
Obvious swelling with partial eversion of lids – 2*
Swelling with lids about half closed – 3*
Swelling with lids more than half closed - 4*
(C) Discharge
No discharge – 0
Any amount of different from normal (does not include small amounts observed in inner canthus of normal animals) -1
Discharge with moistening of the lids and hairs just adjacent to the lids – 2
Discharge with moistening of the lids and hair, and considerable area around the eye – 3
Score equals (A + B + C) X 2
Total maximum = 20
Total maximum score possible = 110
* Indicates a positive reaction
TOOL USED TO ASSESS SCORE: Both eyes of all rabbits were examined for ocular abnormalities prior to study initiation. The pre-initiation examination was performed using sodium fluorescein and ultraviolet light. Only rabbits with no pre-existing ocular abnormalities were used.
Both eye of all rabbits were examined macroscopically for ocular irritation using a hand-held penlight at approximately one, 24, 48 and 72 hours after dosing and at 4, 7, 14 and 21 days. In addition, both eye of all animals were further examined at 72 hours and 7, 14 and 21 days with sodium fluorescein and ultraviolet light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- None of the rabits vocalised upon instillation of the test material.
There were no significant changes or differences observed in body weights during the study period (measured on day 0 and 21).
There were no unscheduled deaths during the study.
Any other information on results incl. tables
Table 1: Results
Animal |
Sex |
Observation |
Examination |
|||||||
1 hour |
24 hours |
48 hours |
72 hours |
4 days |
7 days |
14 days |
21 days |
|||
1 |
Male |
Cornea - opacity |
0 |
1 |
1 |
2 |
2 |
2 |
0 |
0 |
Cornea - area |
0 |
1 |
2 |
3 |
4 |
4 |
0 |
0 |
||
Iris |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
||
Conjunctivae - Redness |
2 |
3 |
2 |
3 |
2 |
2 |
1 |
1 |
||
Conjunctivae - Chemosis |
3 |
2 |
2 |
3 |
3 |
2 |
1 |
1 |
||
Conjunctivae - Discharge |
3 |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
||
2 |
Male |
Cornea - opacity |
1 |
1 |
1 |
1 |
2 |
2 |
2 |
1 |
Cornea - area |
2 |
3 |
4 |
4 |
4 |
4 |
2 |
1 |
||
Iris |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
||
Conjunctivae - Redness |
2 |
2 |
3 |
3 |
3 |
3 |
2 |
1 |
||
Conjunctivae - Chemosis |
3 |
3 |
3 |
3 |
3 |
4 |
3 |
2 |
||
Conjunctivae - Discharge |
3 |
2 |
1 |
1 |
2 |
1 |
1 |
1 |
||
3 |
Male |
Cornea - opacity |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
Cornea - area |
1 |
3 |
3 |
2 |
1 |
0 |
1 |
1 |
||
Iris |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
||
Conjunctivae - Redness |
2 |
3 |
3 |
3 |
2 |
1 |
2 |
1 |
||
Conjunctivae - Chemosis |
2 |
3 |
3 |
2 |
2 |
1 |
1 |
0 |
||
Conjunctivae - Discharge |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
4 |
Female |
Cornea - opacity |
1 |
1 |
1 |
2 |
3 |
3 |
3 |
2 |
Cornea - area |
1 |
3 |
4 |
4 |
4 |
4 |
4 |
2 |
||
Iris |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
0 |
||
Conjunctivae - Redness |
2 |
2 |
2 |
2 |
2 |
2 |
3 |
1 |
||
Conjunctivae - Chemosis |
2 |
2 |
2 |
2 |
2 |
3 |
3 |
2 |
||
Conjunctivae - Discharge |
2 |
2 |
2 |
2 |
2 |
0 |
1 |
0 |
||
5 |
Female |
Cornea - opacity |
1 |
1 |
1 |
1 |
2 |
2 |
2 |
2 |
Cornea - area |
3 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
||
Iris |
1 |
0 |
1 |
1 |
1 |
0 |
1 |
0 |
||
Conjunctivae - Redness |
2 |
3 |
3 |
3 |
3 |
3 |
2 |
2 |
||
Conjunctivae - Chemosis |
3 |
3 |
3 |
3 |
4 |
4 |
4 |
3 |
||
Conjunctivae - Discharge |
3 |
2 |
2 |
2 |
3 |
3 |
2 |
1 |
||
6 |
Female |
Cornea - opacity |
1 |
1 |
1 |
1 |
2 |
2 |
2 |
1 |
Cornea - area |
3 |
3 |
3 |
3 |
2 |
2 |
1 |
1 |
||
Iris |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae - Redness |
2 |
3 |
3 |
3 |
2 |
2 |
2 |
1 |
||
Conjunctivae - Chemosis |
3 |
3 |
2 |
3 |
3 |
3 |
1 |
1 |
||
Conjunctivae - Discharge |
3 |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
||
Total |
168 |
191 |
198 |
235 |
302 |
277 |
213 |
111 |
||
Mean |
28.0 |
31.8 |
33.0 |
39.2 |
50.3 |
46.2 |
35.5 |
18.5 |
||
Table 2: Individual observations
Animal |
Sex |
Time |
Observation |
1 |
Male |
1 hour |
b |
24 hours |
b,e(20 %) |
||
48 hours |
b,e(40 %),i(40 %) |
||
72 hours |
a,c,e(80 %),r(80 %) |
||
4 days |
b,e(80 %),j |
||
7 days |
b,e(40 %),j,r(40 %) |
||
14 days |
r(0 %) |
||
21 days |
r(0 %) |
||
2 |
Male |
1 hour |
b,e(25 %) |
24 hours |
b |
||
48 hours |
b |
||
72 hours |
a,r(90 %) |
||
4 days |
b,e(90 %),j |
||
7 days |
b,e(50 %),j,r(50 %) |
||
14 days |
b,e(20 %),k,r(20 %) |
||
21 days |
b,k,r(0 %) |
||
3 |
Male |
1 hour |
b,e(30 %) |
24 hours |
b,e(80 %) |
||
48 hours |
e(80 %) |
||
72 hours |
e(50 %),r(50 %) |
||
4 days |
e(40 %) |
||
7 days |
e(5 %),r(5 %) |
||
14 days |
e(20 %),k,r(20 %) |
||
21 days |
r(0 %) |
||
4 |
Female |
1 hour |
b,e(20 %) |
24 hours |
b,e(25 %) |
||
48 hours |
b |
||
72 hours |
b,e(85 %),r(85 %) |
||
4 days |
b,e(85 %),j |
||
7 days |
e(40 %),j,k,r(40 %) |
||
14 days |
a,e(35 %),k,r(35 %) |
||
21 days |
e(20 %),k,r(20 %) |
||
5 |
Female |
1 hour |
b,e(40 %) |
24 hours |
b,e(80 %) |
||
48 hours |
a,e(80 %) |
||
72 hours |
a,c,e(100 %),r(100 %) |
||
4 days |
b,e(100%),j |
||
7 days |
b,e(90 %),k,r(90 %) |
||
14 days |
b,e(70 %),k,r(70 %) |
||
21 days |
a,e(5 %),k,r(5 %) |
||
6 |
Female |
1 hour |
b,e(20 %) |
24 hours |
b,e(50 %) |
||
48 hours |
a,e(40 %) |
||
72 hours |
c,e(40 %),r(40 %) |
||
4 days |
b,e(40 %) |
||
7 days |
b,e(25 %),j,r(25 %) |
||
14 days |
e(20 %),k,r(20 %) |
||
21 days |
e(10 %),k,r(10 %) |
||
a = Purulent discharge |
|||
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of the test, positive irritation was present for all ocular tissues examined. Iridial irritation subsided by day 21 or earlier in all animals.Corneal irritation persisted throughout the study until termination in five rabbits. Conjunctival irritation for all animals includede positive reaction for three animals persisted through to the termination of the study. The test material was concluded to induce irreversible ocular irritation under the conditions of the test.
- Executive summary:
The eye irritation potential of the test material was evaluated in an in vivo study conducted in accordance with OECD 405, EU Method B.5 and EPA OPP 81 -4. Six albino rabbits (3 male and 3 females) were instilled with 0.1 mL undiluted test material and observed for 21 days. Under the conditions of the test, positive irritation was present for all ocular tissues examined. Iridial irritation subsided by day 21 or earlier in all animals.Corneal irritation persisted throughout the study until termination in five rabbits. Conjunctival irritation for all animals includede positive reaction for three animals persisted through to the termination of the study. The test material was concluded to induce irreversible ocular irritation under the conditions of the test.
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