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EC number: 947-930-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-29 to 2003-06-01
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris(2-ethylhexyl) 2-hydroxypropane-1,2,3-tricarboxylate
- EC Number:
- 230-457-3
- EC Name:
- Tris(2-ethylhexyl) 2-hydroxypropane-1,2,3-tricarboxylate
- Cas Number:
- 7147-34-4
- Molecular formula:
- C30H56O7
- Test material form:
- other: Colourless liquid
- Details on test material:
- Bernel Ester TCC (Tricapryl Citrate), Lot #P1585
Colourless lliquid stored at room temperature
100%. Test substance was expected to be stable for the duration of testing
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- New Zealand Albino, three male young adults. They were housed singly. Temperature 18-22 C with 12/12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL was instilled into the conjunctival sac of the right eye of 3 healthy rabbits by pulling the lower lid way from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimise loss of the test subtsance. The left eye remained untreated and served as a control.
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Ocular irritation was evaluated using a high-intensity white ligh in accordance with Draize et al. at 1, 24, 48 and 72 hours post-installation. The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 13.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 13.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 13.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 14
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 14
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 12
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
Any other information on results incl. tables
Incidence of Irritation
|
| Time Post Instillation (Hours) | Severity of Irritation - Mean Score |
| 1 | 13.3 |
| 24 | 10.0 |
| 48 | 4.0 |
| 72 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Executive summary:
0.1 mL of the test substance was instilled into the right eye of 3 healthy rabbits by pulling the lower lid way from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimise loss of the test subtsance. The left eye served as a control. Occular irritation was evaluated by the Draize et al. method. Ocular irritation was evaluated using a high-intensity white ligh in accordance with Draize et al. at 1, 24, 48 and 72 hours post-installation. The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra.
All animals appeared active and healthy. Apart from the eye irritation described below, there were no signs of gross toxicity, adverse phamacologic effects or abnormal behaviour.
No corneal opacity ot iritis was noted for any treated eye during the study. One hour after test substance installation, all three treated eyes exhibited conjunctivitis. The overall severity of irritation decreased with time. All animals were free of occular irritiation within 72 hours.
The Maximum Mean Total Score was 13.3 and is therefore classified as mildly irritating to the eye under these study conditions.
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