Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 - 17 November 1997
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Epyrron
- Physical state: Off white powder
- Composition of test material, percentage of components: Main component 55%; Other 22% and 18%
- Lot/batch No.: GV-1458 K1
- Expiration date of the lot/batch: 24 September 1998
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 6 weeks
- Weight at study initiation: 3.5 kg
- Housing: Individual cages with perforated floors
- Diet: 100 grams per day of standard laboratory rabbit diet (LKK-20, pellet, Hope Farms, Woerden, The Netherlands)
- Water: Free access to tap-water diluted with decalcified water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 48.6 g (approximately 0.1 mL)

Duration of treatment / exposure:
Single samples were instilled. Remnants of the test substance were present in the eyes of all rabbits up to 48-72 hours after installation.
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 50 mL of tap-water
- Time after start of exposure: 48 hours

SCORING SYSTEM:
See free text section below

TOOL USED TO ASSESS SCORE: 2% fluorescein in water for 24 hour observation of corneal epithelial damage.
All other examinations were completed using standard lighting or with the assistance of an ophthalmic examination lamp.

Results and discussion

In vivo

Irritant / corrosive response data:
Effects of irritation were observed within cornea, iris and conjunctivae.
Corneal injury consisted of opacity and epithelial damage (25-35% of corneal area).
Iridic irritation was observed in all rabbits exposed to test substance.
Irritation of conjunctivae consisted of redness, chemosis and discharge in all animals exposed to test substance.

There was no evidence of corrosion.
Other effects:
Remnants of the test substance were present in the eyes of all animals up to 48-72 hours after exposure.
No symptoms of toxicity were observed during test period, no mortality occurred.

Any other information on results incl. tables

 Individual Eye Irritation Scores                    
  Animal No. 1453 1479 1485
Time after dosing Tissue Findings Score  Comments Score  Comments Score  Comments
1 hour Corneal opacity 0 D 0 D 0 D
area 0   0   0  
Iris 1   1   1  
Conj.: redness 2(A)   2(A)   2(A)  
Chemosis 3(A)   3(A)   3(A)  
Discharge 2   2   2  
24 Hours Corneal opacity 0 25 D 0 35 D 0 25 D
area 1   2   1  
Iris 0   1   1  
Conj.: redness 3(A)   3(A)   3(A)  
Chemosis 2(A)   2(ABC)   2(ABC)  
Discharge 1   2   2  
48 Hours Corneal opacity 1 D 1 D 1 D
area 1   2   1  
Iris 0   1   0  
Conj.: redness 3(AC)   3(AC)   3(AC)  
Chemosis 1(ABC)   2(A)   2(A)  
Discharge 1   1   1  
72 Hours Corneal opacity 0 5 0 25 D 0 5 D
area 1   2   1  
Iris 0   0   0  
Conj.: redness 2(AC)   2(AC)   3(C)  
Chemosis 1(AC)   1(AC)   1(ABC)  
Discharge 0   1   1  
7 Days Corneal opacity 0 0 0 0 0 0
area 0   0   0  
Iris 0   0   0  
Conj.: redness 0   1(AC)   1(C)  
Chemosis 0   0   0  
Discharge 0   0   0  
14 Days Corneal opacity 0   0   0  
area 0   0   0  
Iris 0   0   0  
Conj.: redness 0   0   0  
Chemosis 0   0   0  
Discharge 0   0   0  
() Score given for: A=Eyelids
B=Nictitating membrane
C=Sclera
Comments
D - Remnants of the test substance in the eye

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was administered to 3 male rabbits and appears to be irritating to the eye at a dosage of 0.5 grams.