Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to same study

Data source

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

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
Details on test animals and environmental conditions:
according to guideline

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0,5 g (per animal) moistened with 0.5 ml water
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 h;
Number of animals:
3
Details on study design:
according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h, 48 h, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h, 48 h, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
substance is not subject of classification and labeling