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EC number: 273-386-3 | CAS number: 68959-00-2
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Boiling point
- Density
- Particle size distribution (Granulometry)
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
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- Specific investigations
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- Additional toxicological data
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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
- Principles of method if other than guideline:
- Test conducted following Code of Federal Regulations, Title 16, section 1500.42
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Orange 116
- IUPAC Name:
- Acid Orange 116
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.2 kg
- Housing: individual cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 - 14 d
ENVIRONMENTAL CONDITIONS
- Temperature: 16-18 °C
- Humidity: 40 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Single application of 100 µl bulk volume of amorphous substance in conjunctiva of right lower eyelid. The eyelids were then gently held together for 1 second.
- Duration of treatment / exposure:
- The eye was not rinsed after application.
- Observation period (in vivo):
- 24, 48, 72 h up to 8 d.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
Corneal opacity
0 no opacity
1 opacity on scattered districts. Details of the iris clearly visible
2 easily recognizable, translucent districts of opacity. Details of the iris slightly darkened
3 pearly-like opacity. No details of the iris visible. Size of the pupil barely distinguishable
4 complete corneal opacity. Iris invisible
Iris
0 normal
1 conspicuous deep-drawn wrinkles, hyperaemia, swelling, circumcorneal vascular drawing (any or all of these symptoms or combination of them). Iris still reacts to light (sluggish reaction to light is considered positive)
2 no reaction to light, bleeding, gross destruction of the iris (any or all of these symptoms)
Conjunctivae redness
0 vessels normal
1 vessels clearly injected
2 diffuse, crimson reds. Individual vessels not easily distinguishable
3 diffuse, fleshy redness
Conjunctivae chemosis
0 no swelling
1 slight swelling (any swelling above normal).
2 distinct swelling with partial lifting of the lid (ectropion)
3 swelling, with the eyelids half closed
4 swelling with more than half to fully closed eyelids
TOOL USED TO ASSESS SCORE: ophthalmoscope. The corneal findings were confirmed with the fluorescein test after 8 days (instillation of 1 drop of fluorescein solution in ophthalmological preparation directly onto the cornea. After rinsing with physiological saline solution, corneal damage appears yellow-green, UV light or cobalt blue filter).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,#2,#3,#5,#6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
rabbit no. | 24 h | 48 h | 72 h | 8 d | ||||||||||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | |
cornea opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
conjunctivae redness | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
conjunctivae chemosis | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not eye irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to rabbit eye.
- Executive summary:
Method
Eye irritation assessement based on Code of Federal Regulations, Title 16, section 1500.42. Test substance was placed in one eye of 6 rabbits, while the other eye served as control. Treated eye was not rinsed. Observations were done after 24 h , 48 h, 72 h and up to 8 d after starting of experiment.
Results
Neither corneal opacity nor iritis were noted in rabbits; slight chemosis was noted in 1/6 rabbits, that however was reversible within 48 h. Slight conjunctivae redness was noted in 6/6 rabbits, that was reversible within 48 h.
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