Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 404 (1992)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Dastib 845
IUPAC Name:
Dastib 845

Test animals

Species:
other: rbt, New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: Der Versuchsartikel wurde gemahlen und unverdunnt verwendet.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
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:
1.7
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
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: 10 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:
1.7
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
edema score
Max. score:
2
Remarks on result:
other: Max. duration: 8 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 11 days
Other effects:
Hautrotungen und Odeme zeigten sich bei allen Tieren bis
9-10 Tage nach Entfernung der Pflaster. Es wurde keine
weiteren giftigen Auswirkungen festgestellt.

Applicant's summary and conclusion

Interpretation of results:
other: not classified