Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2000-01-18 into 2000-02-02
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC, B.4 Acute toxicity (Skin irritation) OECD 404
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test batch: No.: 7/99

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Rabbit vhite NZW - male and female , body weight over 2,5 kg.Zvieratá boli ustajnené individuálne v samostatnom zverinci a boli krmené ad libitum štandardnou komerčne vyrábanou kŕmnou zmesou.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,5 ml
Duration of treatment / exposure:
14 days / exposure 4 h
Observation period:
1 hour after removing of bandage
then on period of 24 ,48 a 72 hours and next in 24 hour intervals up to total skin recovering
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.25
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
erythema score
Max. score:
2
Remarks on result:
other: Max. duration: 6 d; Max. value at end of observation period: (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
1
Remarks on result:
other: Max. duration: 4 d; Max. value at end of observation period: (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 14 days
Irritation Index: 1,16
Other effects:
In 1 hour after application very mild repletion without oedema was found out at the 1st animal, in 24 hours after application no changes were found out. In 48 and 72 hours after application the mild repletion without oedema was found out. On the 5th day after application the increased separating of skin surface coats, the mild repletion without oedema were found out. On the next days the repletion became milder, the reaction was quite lost on the 9th day after application. In 1 hour after application the very mild repletion without oedema was found out at the 2nd and the 3rd animal, in 24 hours no changes were found out, in 48 hours the very mild repletion was found out and in 72 hours after application the mild repletion and very mild oedema were found out. On the 4th and the 5th day - mild repletion without oedema, on the 6th day - mild repletion and separating of skin surface coats without oedema. After 10th day at the 2nd animal and after 14th day at the 3rd animal their skin was quite healed without the changes.

Applicant's summary and conclusion

Interpretation of results:
other: not classified