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EC number: 680-341-5 | CAS number: 41438-38-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, according to OECD 405
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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:
- other: EC 92/69/EEC, B.5, 31st July 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Mexoryl SBU
- Cas Number:
- 41438-38-4
- Molecular formula:
- C11H13N04
- IUPAC Name:
- Mexoryl SBU
- Reference substance name:
- diethyl pyridine-2,4-dicarboxylate
- EC Number:
- 680-341-5
- Cas Number:
- 41438-38-4
- Molecular formula:
- C11H13N04
- IUPAC Name:
- diethyl pyridine-2,4-dicarboxylate
- Details on test material:
- - Name of test material: MEXORYL SBU- The test material is the same than the one mentioned in section 7.2.1
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Sex: female- Source: CEGAV, Saint Mars d'Egrenne, France- Age at study initiation: 2 to 4 months- Weight at study initiation: 2.9±0.1 kg- Housing: individually- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18±3 °C- Humidity (%): 30 to 70- Air changes (per hr): 12 cycles- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye, which remained untreated, served as control.
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100 mg
- Duration of treatment / exposure:
- 1 single dose, the eyes were not rinsed after administration of the test item.
- Observation period (in vivo):
- 9 days (until complete reversibility)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): noSCORING SYSTEM: Chemosis: 0 to 4, Redness: 0 to 3, Discharge: 0 to 3, Iris lesions 0 to 2, Corneal lesions: 0 to 4, Area of opacity 1 to 4.TOOL USED TO ASSESS SCORE: UV lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- intensity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
Any other information on results incl. tables
Table 1. Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)
Rabbit number | Region of eye | Description of ocular reactions | Scores | Mean irritation score(1) | Interpretation (+) (-) | |||
1 h D1 | 2 h D2 | 48 h D3 | 72 h D4 | |||||
267 | Conjunctivae | Chemosis | 3 | 3 | 3 | 3 | 3.0 | (+) |
|
| Redness | 2 | 3 | 3 | 3 | 3.0 | (+) |
|
| Discharge | 2 | 2 | S | S | (2) | (+) |
| Iris |
| 0 | 1 | 1 | 1 | 1.0 | (+) |
| Corneal opacity | Intensity | 0 | 2 | 2 | 1 | 1.7 | (-) |
|
| Area | 0 | 3 | 2 | 1 | 2.0 |
|
| Other |
| * | * | * | * |
|
|
| Fluorescein |
| / | U | U | U |
|
|
268 | Conjunctivae | Chemosis | 3 | 2 | 1 | 1 | 1.3 | (-) |
|
| Redness | 2 | 2 | 2 | 2 | 2.0 | (-) |
|
| Discharge | 2 | 1 | 1 | 0 | 0.7 |
|
| Iris |
| 0 | 0 | 0 | 0 | 0.0 | (-) |
| Corneal opacity | Intensity | 0 | 2 | 2 | 1 | 1.7 | (-) |
|
| Area | 0 | 3 | 2 | 2 | 2.3 |
|
| Other |
| * | * | * | * |
|
|
| Fluorescein |
| / | U | U | U |
|
|
269 | Conjunctivae | Chemosis | 3 | 2 | 2 | 2 | 2.0 | (+) |
|
| Redness | 2 | 2 | 2 | 2 | 2.0 | (-) |
|
| Discharge | 2 | S | S | S | (2) |
|
| Iris |
| 0 | 1 | 1 | 1 | 1.0 | (+) |
| Corneal opacity | Intensity | 0 | 2 | 2 | 2 | 2.0 | (+) |
|
| Area | 0 | 3 | 3 | 3 | 3.0 | (+) |
| Other |
| * | ZB | ZB | ZB |
|
|
| Fluorescein |
| / | U | U | U |
|
|
Table 1 (continued)
Rabbit number | Region of eye | Description of ocular reactions | Scores | ||||
D5 | D6 | D7 | D8 | D9 | |||
267 | Conjunctivae | Chemosis | 2 | 1 | 0 | 0 | 0 |
|
| Redness | 2 | 1 | 1 | 1 | 0 |
|
|
|
|
|
|
|
|
|
| Discharge | 0 | 0 | 0 | 0 | 0 |
| Iris |
| 1 | 0 | 0 | 0 | 0 |
| Corneal opacity | Intensity | 1 | 0 | 0 | 0 | 0 |
|
| Area | 1 | 0 | 0 | 0 | 0 |
| Other |
| * | * | * | * | * |
| Fluorescein |
| U | U | / | / | / |
268 | Conjunctivae | Chemosis | 1 | 1 | 1 | 1 | 0 |
|
| Redness | 2 | 2 | 1 | 1 | 0 |
|
|
|
|
|
|
|
|
|
| Discharge | 0 | 0 | 0 | 0 | 0 |
|
|
|
|
|
|
|
|
| Iris |
| 0 | 0 | 0 | 0 | 0 |
| Corneal opacity | Intensity | 1 | 0 | 0 | 0 | 0 |
|
| Area | 1 | 0 | 0 | 0 | 0 |
| Other |
| * | * | * | * | * |
| Fluorescein |
| U | U | / | / | / |
269 | Conjunctivae | Chemosis | 2 | 1 | 1 | 0 | 0 |
|
| Redness | 2 | 1 | 1 | 1 | 0 |
|
| Discharge | S | 0 | 0 | 0 | 0 |
| Iris |
| 1 | 0 | 0 | 0 | 0 |
| Corneal opacity | Intensity | 1 | 0 | 0 | 0 | 0 |
|
| Area | 1 | 0 | 0 | 0 | 0 |
| Other |
| ZB | * | * | * | * |
| Fluorescein |
| U | U | / | / | / |
D = day; U = Fluorescein batch No. F777; / = Fluorescein not used; * = None; S = Whitish purulent discharge; ZB = White area on the conjunctivae
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Under applied experimental conditions, the test item Mexoryl SBU is irritant when administered by ocular route to rabbits.
- Executive summary:
The potential of the test item Mexoryl SBU to induce ocular irritation was evaluated in three rabbits accoding OECD and EC guidelines. The study was conducted in compliance with the principles of GLP. A single dose of 100 mg of the test item was introduced into the left conjunctival sac. The right not treated eye served as control. The eyes were not rinsed after administration of the test item. Occular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. Mean scores calculated for each animal over 24, 48 and 72 hours were 3.0, 1.3 and 2.0 for chemosis, 3.0, 2.0 and 2.0 for redness of the conjuctivae, 1.0, 0.0 and 1.0 for iris lesions and 1.7, 1.7 and 2.0 for corneal opacity.
Rabbit number
Region of eye
Description of ocular reactions
Scores
Mean irritation score
24 h
48 h
72 h
267
Conjuctivae
Chemosis
3
3
3
3.0
Redness
3
3
3
3.0
Iris
1
1
1
1.0
Corneal opacity
Intensity
2
2
1
1.7
268
Conjuctivae
Chemosis
2
1
1
1.3
Redness
2
2
2
2.0
Iris
0
0
0
0.0
Corneal opacity
Intensity
2
2
1
1.7
269
Conjuctivae
Chemosis
2
2
2
2.0
Redness
2
2
2
2.0
Iris
1
1
1
1.0
Corneal opacity
Intensity
2
2
2
2.0
Under applied experimental conditions, the test item Mexoryl SBU is irritant when administered by occular route to rabbits.
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