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EC number: 222-492-8 | CAS number: 3495-36-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: NA
- Adequacy of study:
- key study
- Study period:
- From January 13, 1997 to January 21, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cesium formate
- EC Number:
- 222-492-8
- EC Name:
- Cesium formate
- Cas Number:
- 3495-36-1
- Molecular formula:
- HCO2.Cs, Cs+HCOO-, CH2O2.Cs
- IUPAC Name:
- Caesium formate
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): Cesium Formate
Physical state: Clear colorless liquid
Storage condition of test material: Room temperature
Constituent 1
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 (U.S.D.A. licensed supplier) 4678 Bethesda Road Thompson Station, TN 37179
- Age at study initiation: Adult
- Weight at study initiation: 2.470 to 2.708 kg
- Housing: Housed singly in wire mesh suspension cages
- Diet (e.g. ad libitum): Teklad Hi-Fiber Rabbit Diet
- Water (e.g. ad libitum): Tap water
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 61- 72 °F
- Humidity (%): 30- 70 %
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 h light/12 h 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): 0.1mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- Duration of treatment similar as observation period
- Observation period (in vivo):
- The eyes were examined for any ocular reaction approximately 1, 24, 48, and 72 h after the treatment. For animals exhibiting irritation at the 72 h reading, an additional ocular examination was conducted on Day 14 d or until all apparent ocular effects subsided.
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Not applicable
SCORING SYSTEM: According to Draize (1995). Appraisal of the safety of chemicals in food, drugs and cosmetics. Association of the food and drug officials of the United States. Austin, Texas.
TOOL USED TO ASSESS SCORE: Visualization of cornea was done under ultraviolet illumination after the application of Fluorescein Sodium Ophthalmic Solution U.S.P
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- iris score, conjunctiva score
- Basis:
- animal #1
- Time point:
- other: 1 h to Day 14
- Score:
- ca. 17
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- overall irritation score
- Remarks:
- iris score, conjunctiva score
- Basis:
- animal #2
- Time point:
- other: 1 h to Day 14
- Score:
- ca. 21
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Remarks:
- iris score, conjunctiva score
- Basis:
- animal #3
- Time point:
- other: 1 h to Day 7
- Score:
- ca. 15
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Remarks:
- iris score, conjunctiva score
- Basis:
- animal #4
- Time point:
- other: 1 h to Day 14
- Score:
- ca. 17
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Remarks:
- iris score, conjunctiva score
- Basis:
- animal #5
- Time point:
- other: 1 h to Day 14
- Score:
- ca. 17
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Remarks:
- iris score, conjunctiva score
- Basis:
- animal #6
- Time point:
- other: 1 h to Day 14
- Score:
- ca. 19
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- Irritation parameters examined in this study included cornea score, iris score and conjunctivae score. No evidence of corrosion was observed.
- Other effects:
- Additional observations included blistering, blanched or hemorrhagic appearance of areas of conjunctiva and nictitating membrane. These effects were also resolved by Day 14.
Any other information on results incl. tables
Table showing the scores of irritation parameters in test animals:
Animal No. and sex |
Reading |
Cornea A B |
Iris |
Conjunctiva C D E |
|||
1-22 Male |
1 h |
0 |
0 |
1 |
IL |
2 |
3 |
24 h |
0/0 |
0/0 |
0 |
2L |
2 |
2 |
|
48 h |
0/0 |
0/0 |
0 |
2LS |
1 |
0 |
|
72 h |
0/0 |
0/0 |
0 |
2LS |
1 |
0 |
|
Day 4 |
0/0 |
0/0 |
0 |
2S |
1 |
0 |
|
Day 7 |
0/0 |
0/0 |
0 |
1 |
1 |
0 |
|
Day 14 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
|
2-23 Male |
1 h |
0 |
0 |
1 |
2LTH |
3 |
3 |
24 h |
0/0 |
0/0 |
0 |
2L |
2 |
3 |
|
48 h |
0/0 |
0/0 |
0 |
2LS |
2 |
1 |
|
72 h |
0/0 |
0/0 |
0 |
2SR |
1 |
0 |
|
Day 4 |
0/0 |
0/0 |
0 |
1SR |
1 |
0 |
|
Day 7 |
0/0 |
0/0 |
0 |
1S |
1 |
0 |
|
Day 14 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
|
3-24 Male |
1 h |
0 |
0 |
1 |
1L |
2 |
2 |
24 h |
0/0 |
0/0 |
0 |
2L |
2 |
2 |
|
48 h |
0/0 |
0/0 |
0 |
2L |
1 |
0 |
|
72 h |
0/0 |
0/0 |
0 |
1 |
1 |
0 |
|
Day 4 |
0/0 |
0/0 |
0 |
1 |
1 |
0 |
|
Day 7 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
|
4-49 Female |
1 h |
0 |
0 |
1 |
1LT |
2 |
3 |
24 h |
0/0 |
0/0 |
0 |
2L |
2 |
2 |
|
48 h |
0/0 |
0/0 |
0 |
2LHS |
2 |
0 |
|
72 h |
0/0 |
0/0 |
0 |
2LSR |
1 |
0 |
|
Day 4 |
0/0 |
0/0 |
0 |
1SR |
1 |
0 |
|
Day 7 |
0/0 |
0/0 |
0 |
1S |
1 |
0 |
|
Day 14 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
|
5-50 P Female |
1 h |
0 |
0 |
1 |
1L |
2 |
3 |
24 h |
0/0 |
0/0 |
0 |
2L |
2 |
1 |
|
48 h |
0/0 |
0/0 |
0 |
2LR |
2 |
1 |
|
72 h |
0/0 |
0/0 |
0 |
2SR |
1 |
0 |
|
Day 4 |
0/0 |
0/0 |
0 |
1SR |
1 |
0 |
|
Day 7 |
0/0 |
0/0 |
0 |
1S |
1 |
0 |
|
Day 14 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
|
6-51 Female |
1 h |
0 |
0 |
1 |
2LH |
2 |
3 |
24 h |
0/0 |
0/0 |
0 |
2L |
2 |
1 |
|
48 h |
0/0 |
0/0 |
0 |
2LS |
2 |
0 |
|
72 h |
0/0 |
0/0 |
0 |
2S |
1 |
0 |
|
Day 4 |
0/0 |
0/0 |
0 |
1S |
1 |
0 |
|
Day 7 |
0/0 |
0/0 |
0 |
1S |
1 |
0 |
|
Day 14 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
|
A - Degree of opacity
B - Area affected
C - Erythema
D - Swelling
E - Discharge
L - Blistered appearance to conjunctiva
T - Blistered appearance to nictitating membrane
H - Areas of conjunctiva appears hemorrhagic
S - Areas of nictitating membrane appears blanched
R - Areas of nictitating membrane appears hemorrhagic
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the study conditions swelling (chemosis) of the conjunctivae with a mean score equal to or above 2, persisting for more than 24 h was observed.
- Executive summary:
A study was conducted to determine the primary eye irritation potential of the test substance in New Zealand White rabbits according to OECD Guideline 405, in compliance with GLP. 0.1 mL of undiluted test substance was applied to the right eye of three male and three female rabbits. The left untreated eye served as control. Animals were examined for ocular reactions approximately 1, 24, 48 and 72 h after treatment. For animals exhibiting irritation at the 72 h reading, an additional ocular examination was conducted on Day 14 or until all apparent ocular effects subsided. Scoring was conducted according to the Draize method. No corneal opacity was produced. Iritis was cleared by 24 h and conjunctival irritation was cleared by Day 14. Blistering, hemorrhage and blanched appearance was observed in the conjunctiva and/or the nictitating membrane and all the signs were resolved by Day 14. No evidence of corrosion was observed.Under the study conditions swelling (chemosis) of the conjunctivae with a mean score equal to or above 2, persisting for more than 24 h was observed (Harrod, 1997).
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