Registration Dossier

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 - Guideline study.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guideline 402
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: New Zealand White Rabbit

Test system

Type of coverage:
occlusive
Vehicle:
other: Test material moistened with physical saline
Amount / concentration applied:
2000mg
Duration of treatment / exposure:
24h
Number of animals:
10

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0d; Max.value at end of observation period:0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0d; Max.value at end of observation period:0
Other effects:
see section 4.1.3. Cutaneous (dermal) administration for signs of toxicity related to dose levels used, time of onset and duration

Applicant's summary and conclusion