Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- and Guidelinestudy with minor deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(4-aminophenyl)-2,5-dihydro-1,2,4-oxadiazol-5-one
EC Number:
917-912-8
Cas Number:
864680-71-7
Molecular formula:
C8 H7 N3 O2
IUPAC Name:
3-(4-aminophenyl)-2,5-dihydro-1,2,4-oxadiazol-5-one
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Species: rabbits, 3 females
Strain: Chbb:NZW (New Zealand White)
Age on day of application: approximately 5 months
Body weight range: 2.8 - 3.4 kg (day of application)
Supplier: Biological Laboratory Service of Boehringer Ingelheim Pharma GmbH & Co. KG.

Rabbits were housed individually in solid wire cages. The bottom of the cages were changed at least once a week and cleaned.
Conditions in the animal room were standardized:
Temperature: 22±2°C
Relative humidity: 45-75%
Light/darkness cycle: 12/12 h, with light cycle from 6.00 h to 18.00 h
Average illumination: approximately 60 lx (depending on cage position), which can be increased to 450 lx during working time.
Air circulation: approximately 10 air changes per h

Dry food (KLIBA 3413.0.25 , Provimi Kliba AG, Kaiseraugst, Schweiz) and municipal drinking water were supplied ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1-72 h
Score:
0 - 0.33
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Except for a very slight erythema observed 24 h after a 4 h exposure in one single animal, BIBR 1048 Oxa-Amin had no irritating or corrosive effect on rabbit skin subsequent to dermal application. No alterations of the rabbits' general appearance was observed subsequent to local administration of the test item. In addition, no skin reaction beyond the area of exposure was observed. In addition, administration of BIBR 1048 Oxa-Amin did not result in any effect on body weight development.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study, BIBR 1048 Oxa-Amin was well tolerated subsequent to topical application on rabbit skin. Except for a very slight
erythema observed 24 h after a 4 h exposure in one single animal, 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 Labelling
Scheme (GHS) the test item BIBR 1048 Oxa-Amin is not classified.