Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other:

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other:
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other:
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other:
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other:
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other:
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other:
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other:
Score:
1.5

Applicant's summary and conclusion