Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
study report
Title:
Unnamed
Year:
2004
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of the present study, BIBR 1048 OXA-AMIDIN DIACETATE was well tolerated subsequent to topical application on rabbit skin.
There were no macroscopic signs of irritation or corrosion. In addition, there were no signs of systemic side effects or of skin alterations beyond the area of exposure. Thus, according to the Globally Harmonized Hazard Classification and Labeling Scheme (GHS), the test item
BIBR 1048 OXA-AMIDIN DIACETATE is not classified.