TRANSLATION 

Report 

on the study of the acute irritation/corrosion to the intact dorsal skin of white 

rabbits based on OECD** 

rabbit/skin 

Testing facility: 

Aim of the study: 

Test substance No.; 

Name of test substance: 

Stable until: 

Form of application: 

Exposure period: 

Number ofanimals: -

Opservation period: 

-

Responsible for correct translation: 

This report consists of 6 pages. 

-

-

-

I 

I 

• 

••• 

M.ethodand assessment based pn OECD Guideline (404) for Testing of Chemicals adopted 

May 12th, 1981. 

A detailed product characterization is included in the raw data . 

Sheet1 
Results of acute skin irritation/corrosion {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: 

Clipping of the fur: 

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 air· 

conditioned 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 that 

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 

OVA TOR SOLJKANIN 4 mm; 

(about 130 g per animal per day) 

About 250 ml tap water per animal per day 

About 8 days before the beginning of the 

study in the skin laboratory; same housing 

conditions as during the study 

At least 15 hours before the beginning of the 

study 
Results of acute skin. irritation/corrosion (OECD) Sheet 3 

Application are<~: 

Volume applied: 

Application site: 

Removal of the test substance: 

Readings: 

Negative .control: 

2.5 em x 2 .. 5 em 

Dipping ofthe test patch into the undiluted 

test substance. (In the case of an edge 

length of .2.5 em, apout 0.5 ml of the test 

liquid is absorbed.) 

Upper third of the back or flank 

At the end qf the exposure period with· Lutrol 

and Lutrol/water ( 1: 1) 

30 - 60 minutes after removal of the test 

patches and 24 h,48 h, 72 h and 8 d after 

the beginning of application 

Untreated skin sites of the same animal 
Results of acute s~in irritation/corrosion (OECD) Sheet 4 

Additional examinations: 

Pathology: 

Storage of the report and. raw 

data: 

Data input: 

Data control: 

Date of application: 

Mean weight (kg) male: 

female: 

After sacrifice, the animals are examined by 

gross pathology. If there are clinical signs of 

necroses, these are confirmed by grosspathological examination after incision of the 

skin. (lfthere .are differences between the 

clinical and pathological assessments, only 

the latter is included In the final report.) 

2.61 

3.15 
Results of acute skin .irritation/corrosion (OECD) .Sheet 5 

Exposure period: 4 hours 

Animal 1 2 3 

Animal No. 0449 0482 0453 

Animal weight(kg) 2.80 3.15 2.41 

Sex Male Female Male 

Readings Animal Intact skin 

Erythema Edema Signs 

4h 1 2 2 ER:e/ED:e 

2 2 1 ER:e/ED:e 

3 2 2 ER:e/ED:e 

24 h 1 3 3 ER:e/ED:e 

2 3 2 ER:e/ED:e 

3 2 2 ER:e 

/ 

48 h 1 3 3 ER:e/ED:e 

2 3 2 ER:e/ED:e 

3 2 2 ER:e 

72 h 1 2 2 ER:e/ED:e 

2 3 2 ER:e/ED:e 

3 3 2 ER:e 

Bd 1 0 0 S/+ 

2 1 1 S:se/+ 

3 1 0 S/+ 
Results of acute skin Irritation/corrosion (OECD) 

Grading of erythema (ER) and edema (ED): 

0 = no erythema or edema 

1 = questionable 

2 =slight 

3 =marked 

4 =severe 

Key: 

h =hour 

d =day 

Explanation of signs: 

ED:e = edema extending beyond the area of exposure 

ER:e = erythema extending beyond the area of exposure 

S =scaling 

S:se = severe scaling 

+ =finding confirmed by gross-pathological examination 

Sheet 6