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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 June 2010 - 24 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP- Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material : J-37
- Substance type: red powder
- Physical state: powder
- Analytical purity: 99.3%
- Lot/batch No.: 91116
- Expiration date of the lot/batch: 16th April 2011
- Storage condition of test material: at room temperature in the dark in desiccators
- Stability under test conditions: stable
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Belton, Leics, England.
- Age at study initiation: 6 weeks old
- Weight at study initiation: At least 1.0 kg
- Housing: animals were indvidually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32x 23 cm).
- Diet : pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab- BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water : free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (Actual range: 19.0 - 23.4)
- Humidity (%): 40 - 70 (Actual range: 38 - 81)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artifical fluorescent light and 12 hours darkness per day.
IN-LIFE DATES: From: 14th June 2010 To: 24th June 2010
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): animals were treated by instillation of, on average, 32.3 mg (range 32.2 -32.5) of the test substance ( a volume of approximately 0.1 mL) as the maximum required amount in the conjuctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. - Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- The eye of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.
SCORING SYSTEM: accoridng to Draize (1944).
TOOL USED TO ASSESS SCORE: fluorescein. Immediately after the 24- hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted tp pH 7.0) was instilled into both eyes of each animal to quantitavely determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Instillation of approximately 32 mg of the test substance (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation grade 1 was observed in all animals and had resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 48 hours in one animal and within 72 hours in the other two animals (Table 1).
Treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
Remnants of the test substance were present in the eye on Day 1 and on the outside of the eyelids throughout the observation period. Red/purple staining of the fur on the head and paws, caused by the test substance, was noted throughout the observation period.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Table 1. Individual eye irritation scores
Animal |
Time after dosing |
Cornea |
Iris |
Conjunctivae |
Comments |
||||
Opacity (0-4) |
Area (0-4) |
Fluor area (%)2 |
(0-2) |
Redness (0-3) |
Chemosis (0-4) |
Discharge (0-3) |
Comments |
||
4341 |
1 Hour |
0 |
0 |
- |
1 |
2 |
1 |
2 |
b,e,c |
24 Hour |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
e,c |
|
48 Hour |
0 |
0 |
- |
0 |
1 |
0 |
0 |
e,c |
|
72 Hour |
0 |
0 |
- |
0 |
0 |
0 |
0 |
e,c |
|
440 |
1 Hour |
0 |
0 |
- |
1 |
1 |
1 |
1 |
b,e,c |
24 Hour |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
e |
|
48 Hour |
0 |
0 |
- |
0 |
0 |
0 |
0 |
e |
|
72 Hour |
0 |
0 |
- |
0 |
0 |
0 |
0 |
e |
|
442 |
1 Hour |
0 |
0 |
- |
1 |
2 |
1 |
1 |
b,e,c |
24 Hour |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
e |
|
48 Hour |
0 |
0 |
- |
0 |
1 |
0 |
0 |
e |
|
72 Hour |
0 |
0 |
- |
0 |
0 |
0 |
0 |
e |
|
1Sentinel,2Green staining after fluorescein treatment (percentage of total corneal area)
Comments:
b: Remnants of the test substance in the eye, c: Remnants of the test substance on the outside of the eyelids and e: Red/ purple staining of the head and paws by the test substance.
Table 2. Mean value eye irritation scores.
Animal |
Mean 24, 48 and 82 Hours |
|||
Corneal opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
|||
434 |
0.0 |
0.0 |
0.7 |
0.0 |
440 |
0.0 |
0.0 |
0.3 |
0.0 |
442 |
0.0 |
0.0 |
0.7 |
0.0 |
Table 3: Animal Specifications
Animal |
Sex |
Age at start (weeks) |
Body weight (grams) |
|
Prior to application |
At termination |
|||
434 |
M |
12 |
2525 |
2601 |
440 |
M |
7-9 |
1643 |
1749 |
442 |
M |
7-9 |
1543 |
1636 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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