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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
Study period:
From January 13, 1997 to January 27, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cesium acetate
EC Number:
222-248-0
EC Name:
Cesium acetate
Cas Number:
3396-11-0
Molecular formula:
C2H4O2.Cs
IUPAC Name:
cesium acetate
Test material form:
liquid
Remarks:
Clear
Details on test material:
- Name of test material (as cited in study report): Cesium acetate
- Physical state: Clear liquid
- Analytical purity: 96%
- Storage condition of test material: Room temperature; protected from exposure to light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Naive
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry Incorporated (animals were purchased from a U.S.D.A. licensed supplier)
- Weight at study initiation: 2.460 to 2.851 kg
- Housing: Singly in wire mesh suspension cages
- Diet (e.g. ad libitum): Teklad Hi-Fiber Rabbit Diet (ad libitum)
- Water (e.g. ad libitum): Tap water (ad libitum)
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 61-72˚F
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 h light and 12 darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye, remaining untreated, served as a control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
unwashed (entire study)
Observation period (in vivo):
14 d
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
The test substance was placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were then gently held together for approximately one second, as possible, and the animal was released.

Eyes were examined and graded for ocular reaction approximately 1, 24, 48, and 72 h following treatment. Animals exhibiting irritation at the 72 h reading were held and examined for a total of 14 d or until all ocular effects subsided, whichever occurred first (Day 4, 7, and 14)

Scoring was conducted using the Draize method (refer to 'Any other information on materials and methods incl. tables' for Scale for Scoring Ocular Lesions)

With the exception of the 1 h scoring, all eyes were scored again for corneal opacity intensity and area using fluorescein except when precluded by extreme responses.

Body weights were measured for each animal on the Day of dosing

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 5
Max. score:
80
Reversibility:
fully reversible within: 48 h
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: 2-6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
10
Remarks on result:
other:
Remarks:
All 6 animals exhibited Score of 5 in 1 h reading
Irritation parameter:
conjunctivae score
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
ca. 6 - ca. 10
Max. score:
20
Reversibility:
fully reversible within: Day 14
Remarks on result:
positive indication of irritation
Remarks:
Conjunctivae score for 1 h reading was in range of 12-16
Irritation parameter:
chemosis score
Basis:
animal: 1-6
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
overall irritation score
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
ca. 6 - ca. 15
Max. score:
110
Reversibility:
fully reversible within: Day 14
Remarks on result:
positive indication of irritation
Remarks:
Overall score for 1 h reading was in range of 17-22

Any other information on results incl. tables

The test substance produced corneal opacity which was first observed at the 1 h reading and cleared by the 48 h reading, iritis which cleared by the 24 h reading, and conjunctival irritation which cleared by the Day 14 reading. Maximum total irritation scores for individual animals ranged from 17 to 22. Additional changes noted included a blistered appearance to the conjunctiva and/or nictitating membrane, areas of conjunctiva or nictitating membrane appear hemorrhagic, areas of purple discoloration on conjunctiva or nictitating-membrane, and areas of nictitating membrane appear blanched. All signs of irritation had cleared by the Day 14 reading. No evidence of corrosion was noted.

Primary Eye Irritation in Rabbits Following an Ocular Application of Undiluted Test Substance

Animal number, sex, and body weight   Cornea* Iris Conjunctiva*  
Reading A B C D E Total Score**

1
Male
(2460g)

 1 h 0 0 1 IL 3 3 19
24 h 1/1 1/1 0 2L 2 1 15/15
48 h 0/0 0/0 0 2LSR 2 0 8/8
72 h 0/0 0/0 0 2SRE 1 0 6/6
Day 4 0/0 0/0 0 2SR 1 0 6/6
Day 7 0/0 0/0 0 1S 1 0 4/4
Day 14 0/0 0/0 0 0 0 0 0/0
2
Male
(2851g)		 1 h 0 0 1 1L 2 3 17
24 h 0/0 0/0 0 2L 2 1 10/10
48 h 0/0 0/0 0 2L 2 0 8/8
72 h 0/0 0/0 0 2 1 0 6/6
Day 4 0/0 0/0 0 1 1 0 4/4
Day 7 0/0 0/0 0 1 1 0 4/4
Day 14 0/0 0/0 0 0 0 0 0/0
3
Male
(2580g)		 1 h 0 0 1 1L 3 3 19
24 h 0/0 0/0 0 2L 2 1 10/10
48 h 0/0 0/0 0 2LS 2 0 8/8
72 h 0/0 0/0 0 2LSR 2 0 8/8
Day 4 0/0 0/0 0 1SR 1 0 4/4
Day 7 0/0 0/0 0 1S 1 0 4/4
Day 14 0/0 0/0 0 0 0 0 0/0
4
Female
(2830g)		 1 h 1 1 1 1L 2 3 22
24 h 0/0 0/0 0 2L 2 1 10/10
48 h 0/0 0/0 0 2LS 2 0 8/8
72 h 0/0 0/0 0 2LS 1 0 6/6
Day 4 0/0 0/0 0 1SR 1 0 4/4
Day 7 0/0 0/0 0 1 1 0 4/4
Day 14 0/0 0/0 0 0 0 0 0/0
5
Female
(2838g)		 1 h 0 0 1 2LTH 3 3 21
24 h 0/0 0/0 0 2LH 2 1 10/10
48 h 0/0 0/0 0 2LSU 2 1 10/10
72 h 0/0 0/0 0 2LSU 1 0 6/6
Day 4 0/0 0/0 0 2SR 1 0 6/6
Day 7 0/0 0/0 0 1S 1 0 4/4
Day 14 0/0 0/0 0 0 0 0 0/0
6
Female
(2700g)		 1 h 0 0 1 1L 2 3 17
24 h 0/0 0/0 0 2L 1 0 6/6
48 h 0/0 0/0 0 2LS 1 0 6/6
72 h 0/0 0/0 0 2LS 1 0 6/6
Day 4 0/0 0/0 0 2S 1 0 6/6
Day 7 0/0 0/0 0 1S 0 0 2/2
Day 14 0/0 0/0 0 0 0 0 0/0
*A = Degree of Opacity; B =Area Affected; C = Erythema; D = Swelling; and E = Discharge
**Total Score is the sum of the following three sub-totals, with a maximum score of 110; = score without/with sodium fluorescein:
1. Degree of opacity x area involved x 5
2. Iris score x 5
3. (Sum of scores for erythema, swelling, and discharge) x 2

E = Area of purple discoloration on conjunctiva.
P = Animal phonated for a short period of time following dosing.
L = Blistered appearance to the conjunctiva.
S = Areas of nictitating membrane appear blanched.
R = Areas of nictitating membrane appear haemorrhagic.
T = Blistered appearance to nictitating membrane.
H = Area of conjunctiva appears haemorrhagic.
U = Small areas of purple discoloration on nictitating membrane.

Author concluded that based on study results, test substance was classified in FIFRA Toxicity Category II (40 CFR 156, Proposed)

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the study conditions, test substance was irritating to rabbit eye.
Executive summary:

A study was conducted to determine the eye irritation potential of the test substance according to OECD 405 Guideline, in compliance with GLP. Six rabbits (3/sex) were used for the study, in which 0.1mL of the test substance was instilled in the conjunctival sac of right eye of each animals. Eyes were not rinsed and observed for irritation as per Draize method. The test substance produced corneal opacity which was first observed at the 1 h reading and cleared by the 48 h reading, iritis which cleared by the 24 h reading, and conjunctival irritation which cleared by the Day 14 reading. Maximum total irritation scores for individual animals ranged from 17 to 22. Additional changes included a blistered appearance to the conjunctiva and/or nictitating membrane, areas of conjunctiva or nictitating membrane appearing hemorrhagic, areas of purple discoloration on conjunctiva or nictitating membrane, and areas of nictitating membrane appearing blanched. All signs of irritation were cleared by Day 14. No evidence of corrosion was noted. Under the study conditions, the test substance was irritating to rabbit eye (Harrod, 1997).