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EC number: 289-550-2 | CAS number: 89923-62-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate
- EC Number:
- 289-550-2
- EC Name:
- Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate
- Cas Number:
- 89923-62-6
- Molecular formula:
- C23H19N3O6S.Na
- IUPAC Name:
- sodium 1-amino-9,10-dioxo-4-[(3-propanamidophenyl)amino]-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Code No.: FAT 20242/E
Batch No.: EN 1500.52
Contents of active ingredients: 100%
Validity: April 1991
Description: Solid/powder; Solubility in water: Approx. (10g/L at 20°C, pH 7.3)
Safety precautions : Golve and face masks.
Test article received: June 2, 1986.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: between 2200 to 2510 g
- Housing: The animals were housed individually in metal cages, identified with individually numbered ear tags.
- Diet: The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eye of each rabbit remained untreated and served as a control.
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- One single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- 0.1 ml of FAT 20242/E was placed into the conjunctival sac of the right eye of each animal after gently pulling away the lower lid from the eyeball.
The lids were then held together for about one second in order to prevent loss of the test material. The left eye was kept untreated and served as a control.
The animals were checked daily for systemic symptoms and mortality.
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20242/E according to the OECD scoring system.
TOOL USED TO ASSESS SCORE: A slit-lamp was used to facilitate the evaluation.
SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading).
- No ulceration or opacity:...................................................................................................................................... 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible:................ 1
- Easily discernible translucent area, details of iris slightly obscured:......................................................................... 2
- Nacrous area, no details of iris visible, size of pupil barely discernible:..................................................................... 3
- Opaque cornea, iris not discernible through the opacity:......................................................................................... 4
IRIS
- Normal:............................................................................................................................................................... 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any 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, cornea and iris)
- Blood vessels normal:............................................................................... 0
- Some blood vessels definitely hyperaemic (injected):................................... 1
- Diffuse, crimson colour, individual vessels not easily discernible:................... 2
- Diffuse, beefy red:..................................................................................... 3
Chemosis: lids and/or nictitating membranes
- No swelling..................................................................................... 0
- Any swelling above normal (includes nictitating membranes)............... 1
- Obvious swelling with partial eversion of lids....................................... 2
- Swelling with lids about half closed.................................................... 3
- Swelling with lids more than, half closed............................................. 4
Results and discussion
In vivo
Resultsopen allclose all
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Reversibility:
- other: expected to be not fully reversible within 21 days
- Remarks on result:
- other: Because of maximal opacity of the cornea in animals No. 66 and 67, the evaluation of possible iris reactions was impeded
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Animal number 66
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Score:
- 3.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Animal number 67
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Animal number 68
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: No evaluation possible because of maximal opacity of cornea
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: No evaluation possible because of maximal opacity of cornea
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- test eye
- 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
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 1 hour after application: Blue-staining (substance related)
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 1 hour after application: Blue-staining (substance related)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- test eye
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritant / corrosive response data:
- Cornea and conjunctiva of the treated eye of animals No. 66 and 67 and the cornea of animal No. 68 were blue-stained (substance-related) one hour after the application of the test compound.
Because of maximal opacity of the cornea in animals No. 66 and 67, the evaluation of possible iris reactions was impeded.
FAT 20242/E induced maximal irritant effects in animals No. 66 and 67 which were expected not be reversible within 21 days. The animals were sacrificed for protective reasons 72 hours after instillation of the test compound. - Other effects:
- None
Any other information on results incl. tables
Body weight:
| Animal no. | 66/F | 67/F | 68/F |
| At start of test | 2200 | 2380 | 2510 |
| After 3 days (end) | 2270 | 2500 | 2570 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- FAT 20242/E is concluded to pose risk of serious damage to eyes.
- Executive summary:
An acute eye irritation/corrosion study was performed to determine the irritant or corrosive potency of FAT 20242/E. This test was conducted based on the OECD Guideline No. 405. The substance was tested undiluted to determine the irritant potency on 3 female rabbit eyes.
0.1 ml of FAT 20242/E was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control.
Cornea and conjunctiva of the treated eye of animals No. 66 and 67 and the cornea of animal No. 68 were blue-stained (substance-related) one hour after the application of the test compound. Because of maximal opacity of the cornea in animals No. 66 and 67, the evaluation of possible iris reactions was impeded. FAT 20242/E induced maximal irritant effects in animals No. 66 and 67 which were expected not be reversible within 21 days. The animals were sacrificed for animal protective reasons 72 hours after instillation of the test compound. Hence it can be concluded that, under the experimental conditions employed, FAT 20242/E induced strong irritation of the cornea and conjunctiva. The test compound possess the risk of serious damage to the eyes
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