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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not required
Duration of treatment / exposure:
3min; 1h and 4h
Observation period:
1h; 24h; 48h; 72h and 7 days
Number of animals:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
0
Remarks on result:
other: No macroscopically visible skin changes were found at the administration sites.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Remarks on result:
other: No macroscopically visible skin changes were found at the administration sites
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
0
Remarks on result:
other: No macroscopically visible skin changes were found at the administration sites
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Remarks on result:
other: No macroscopically visible skin changes were found at the administration sites
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Remarks on result:
other: No macroscopically visible skin changes were found at the administration sites

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test substance BIBR 1048 Nitril is considered not to be skin irritating or caustic.