TRANSLATION 

Report 

on .the study of the acute.irritation to the .eye of white rabbits based on OEco•• 

rabbit/eye 

Testing f<;~cility: 

Aim of the study: 

Test substance No.: 

Name of test 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 of the original German report: Dec, 29, 1983 

•• Method based on OECD Guideline (405) for Testing of Chemicals adopted May 12th, 1981 

***A detailed product characterization is included in the. raw data. 

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Results of acute eye Irritation (OECD) Sheet 2 

METHOD 

Animal species: 

Animal breeder: 

Type of cage: 

No. of animals per cage: 

Animal identification: 

Room temperature/relative 

humidity: 

Day/night rhythm: 

Bedding: 

Diet: 

Drinking water: 

Acclimatization period: 

Cage made of stainless steel with wire mesh 

walk floor; floor area: 40 em x 51 em 

I 

Ear tattoo (= animal No.) 

The animals were accommodated in fully airconditioned rooms, in which central air 

conditioning guaranteed a range of 

temperature of 20- 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 per d<')y 

At least 8 days before the beginning of the 

study in the skin laboratory; same housing 

conditions as during the study 
Results of <!CUte eye Irritation (OECD) Sheet 3 

Volume applied: 

Application site: 

Assessment: 

Readings: 

Negative control: 

Storage of the report and raw 

data: 

Date~ input: 

Data control: 

Date of application: 

Mean weight (kg) -

-

0.1 ml (unchanged) 

Conjunctival sac of the right eyelid 

1 h, 24 h, 48 h, 72 h and 8 d after application 

Untreated eye 

On completion of the 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 = 6 
Results of acute eye irritation (OECD) 

SCALE FOR SCORING OCULAR LESIONS 

(1) Cornea 

A) Opacity- degree of density (are"l most dense taken for reading) 

-No opacity 

- Scattered or diffuse area, details of iris clearly visible 

-Easily discernible translucent areas, details of 

iris slightly obscured 

- Opalescent areas, no details of iris visible, size 

of pupil barely discernible 

- Opaque, iris invisible 

B) Area of cornea involved 

- One quarter (or tess) but not zero 

- Greater than one quarter but less than half 

- Greater than half but less than three quarters 

- Greater than 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 of these or combination of any thereof), iris still reacting 

to light (sluggish reaction is positive) 1 

- No reaction to light, hemorrhage, gross destruction (any or all of these) 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, deeper crimson red, individual 

vessels not easily discernible 

- Diffuse beefy red 

0 

1 

2 

3 
Results of acute eye irritation (OECO) Sheet!:) 

B) Chemosis 

- No swelling 

-Any swelling above normal (includes nictitating membrane) 

- Obvious swo;lling with partial eversion of lids 

- Swelling with Hds about half closed 

- SweJling with lids <!bout half closed 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 inner canthus of normal animals) 1 

- Discharge with moistening ofthe lids and hairs 

just adjacent to lids 2 

- Discharge with moistening of the lids and hairs, and 

considerable area around the eye 3 

Score (A + B + C) X 2 

Calculation of the irritation index: 

For one animal per reading: 

A = 5 x opacity x area 

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 of the readings at 24 h, 48 h, 72 h divided by S x number of animals. 

Key: h =hour 

.d =day 

M =mean 

Explanation of signs: 

RE = small retractions in the eyelid