### TRANSLATION 

### Report on.the study ofthe acute.irritation to the.eye ofwhite rabbits based on 

## OEco•• rabbit/eye Testing**f<;~cility:** Aim of the study: Test substance No.: Name oftest substance: Stable until: Application: Number of animals: 

# - - Observation period: Result:

This report consists of.6 pages. Sheet 1

Estimate of a possible irritating potential to the eye and to the eye mucosa

Single application to the conjunctival sac of the eyelid; the substance is not washed out 

# I I 8d Primary irritation Index

### =6

• Date ofthe original German report: Dec, 29, 1983 •• Method based on OECD Guideline (405) forTesting of Chemicals adopted May 12th, 1981 ***A detailed product characterization is included in the.raw data.



## -

--- --

- -- ---Results ofacute eye Irritation (OECD) Sheet 2 

## METHOD Animal species: Animal breeder: Type ofcage: No. ofanimals percage: Animal identification: Room temperature/relative humidity:

Day/night rhythm: Bedding: Diet:
Drinking water: Acclimatization period: Cage made ofstainless steelwith wire mesh walk floor; floor area: 40 em x 51 em 

# I Eartattoo (= animal No.) The animals were accommodated in fully airconditioned rooms, in which central air conditioning guaranteed a range of temperature of20- 24'C and a range.of relative humidity of 30-70%. There were no deviations from these specifications .tha.t would have impaired the test results. 12 h/12 h (6:00 -18:00 hours/ 18:00- 6:00 hours) No bedding in the cages; sawdust in the waste trays

About250 ml tap water per**;:~nimal** perd<')y At least 8 days before the beginning ofthe study in the skin laboratory; same housing conditions as during the studyResults of <!CUte eye Irritation (OECD) Sheet 3 Volume applied: Application site: Assessment:

Readings: Negative control: Storage ofthe report and raw data:**Date~** input: Data control: Date ofapplication: Mean weight (kg) 

# - - 0.1 ml (unchanged) Conjunctival sac ofthe right eyelid

1 h, 24 h, 48 h, 72 h and 8 d afterapplication Untreated eye On completion ofthe report, all raw data and study documents are retained at Product Safety of- 

# - • •Results of acute eye irritation (OECD} Sheet 4

Animal 1 2 3 Animal No. 0341 0322 03.30 Animal weight (kg) 2.82 2.79 2.91 Sex Female Male Male Read- Animal Cornea Iris Conjunctiva Signs Irritation lngs index Opac- Area Red- Swell- Dislty ness ing charge 1 h 1 0 0 0 2 1 1 8 2 0 0 0 2 1 1 8 3 0 0 0 

### 2 1 1 8 M 8 24h 1 

## a 0 0 2 1 0 6 2 0 0 0 2 1 1 8 3 0 0 0 2 1 0 6 M 7 48 h 1 0 0 0 2 1 0 RE 6 2 0 0 0 2 1 0 6 3 0 0 0 2 1 0 6 M 6 72 h 1 0 0 0 1 1 0 RE 4 2 0 0 0 2 1 0 6 3 0 0 0 2 1 0 6 M 5 8d 1 0 0 0 0 0 0 RE 0 2 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0
M 0 54 /9 

### =6 (rounded to the nearest whole number) Primary irritation index

# = 6Results of acute eye irritation (OECD) SCALE FOR SCORING OCULAR LESIONS 

### (1) Cornea A) Opacity- degree ofdensity (are"l most dense taken for reading) -No opacity

- Scattered ordiffuse area, details of iris clearly visible -Easilydiscernible translucent areas, details of

iris slightly obscured

- Opalescent areas, no details of iris visible, size

ofpupil barely discernible

- Opaque, iris invisible B) Area ofcornea involved

- One quarter (or tess) but not zero

- Greaterthan one quarter but less than half

- Greaterthan halfbut less than three quarters

- Greaterthan three quarters, up to whole area Sheet 5

0 1 

### 2 

### 3 

### 4 

### 1 2 

### 3 4 AxBx5 Total maximum= 80 (2) Iris A) Values -Normal 0

- Folds above normal, congestion, swelling, circumcorneal injection

(any or all ofthese orcombination of any thereof), iris still reacting to light (sluggish reaction is positive) 1

- No reaction to light, hemorrhage, gross destruction (any or all ofthese) 2 

### Ax5 Total maximum= 10 (3) Conjunctivae A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris) -Vessels normal -Vessels definitely injected above normal

- More diffuse, deepercrimson red, individual

vessels not easily discernible

- Diffuse beefy red 0 

### 1 

### 2 3

### Results of

### acute eye irritation (OECO) 

### Sheet!:) B) Chemosis

- No swelling -Anyswelling above normal (includes nictitating membrane)

- Obvious swo;lling with partial eversion of lids

- Swelling with Hds about halfclosed

- SweJling with lids <!bout halfclosed to completely closed C) Discharge 

### 0 

### 1 2 3 

### 4

- No discharge 0 -Any amount different from normal(does not include small amounts

observed in innercanthus of normal animals) 1

- Discharge with moistening ofthe lids and hairs

justadjacent to lids 2

- Discharge with moistening ofthe lids and hairs, and

considerable area around the eye 3 Score (A + B + C) X

### 2 Calculation ofthe irritation index: Forone animal per reading: A 

### = 5x opacity xarea B

# = 5 x iris C = 2 x (redness +swelling + discharge) Individual irritation index =A+ B + C Total maximum= 20

The primary irritation index is the total of all individual irritation indices from all animals and ofthe readings at 24 h, 48 h, 72 hdivided by S

## x numberofanimals. Key: h =hour .d =day M =mean Explanation ofsigns: RE = small retractions in the eyelid