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EC number: 278-140-9 | CAS number: 75214-72-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- September/October, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD method 003
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium
- EC Number:
- 278-140-9
- EC Name:
- Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium
- Cas Number:
- 75214-72-1
- Molecular formula:
- C52H40CoN18Na3O16S4
- IUPAC Name:
- Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- Animal facilities were designed and maintained as to exclude sawdust, wood chips, or other extraneous materials that might produce eye irritation.
Both eyes of each animal in the test group were examined before testing, and only those animals without eye defects or irritation were used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 90 mg
- Duration of treatment / exposure:
- A single installation into one eye of each animal
- Observation period (in vivo):
- 24, 48 and 72 h and 7 d after instillation of the test item
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- TREATMENT
The animal was held firmly but gently until quiet. The test item 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 one second and the animal is released.
SCORING SYSTEM
CORNEA: Opacity degree of density (area most dense taken for reading)
- No opacity: 0
- Scattered or diffuse area, details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
- Opaque, iris invisible 4
CORNEA: Area of cornea involved
- 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
IRITIS
- Normal: 0
- Folds above normal, 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
CONJUNCTIVAE: Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Vessels normal: 0
- Vessels definitely injected above normal: 1
- More diffuse, deeper crimson red, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
CONJUNCTIVAE: Chemosis
- 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 about half closed to completely closed: 4
CONJUNCTIVAE: Discharge
- No discharge 0
- Any amount different from normal (does not in inner lids and hairs include small amounts observed canthus of normal animals): 1
- Discharge with moistening of the just adjacent to lids: 2
- Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- A diffuse, crimson red colouration of the conjuctivae, with or without slight swelling was observed in two animals. Slight discharge was seen in one other animal at the 24 h reading only. Three animals did not show any observable response to treatment throughout the seven days observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: not eye irritating
- Conclusions:
- The test item was found to be not irritating to the rabbit eye.
- Executive summary:
The eye irritation potential of the test item was evaluated in an experimental study according to the ETAD Method No. 003, similar to OECD Guideline 405. 90 mg of test item was applied to one eye of 6 rabbits and was monitored for corneal opacity/area, iritis and conjunctival redness/chemosis/discharge for 7 days.
Under the conditions of this study, application of the test item resulted in no adverse effects on corneal opacity and iris: mean values at 24, 48 and 72 h for were 0 in all animals. Adverse effects on the conjunctivae resulted in 2 animals: mean values at 24, 48 and 72 h were 1.3 for redness in one animal and 1 for redness and 0.33 for chemosis in the other animal. These effects were reversible within 7 d in the first animal and within 72 and 48 h for redness and chemosis respectively in the other animal. The mean values for conjunctive in the other animals were 0.
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