Registration Dossier

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:
2008

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

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:
water
Controls:
yes
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Reversibility:
other: no effects were observed
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
0
Reversibility:
other: no effects were observed
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
other: no effects were observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Reversibility:
other: no effects were observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
0
Reversibility:
other: no effects were observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
other: no effects were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU