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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole
Cas Number:
198480-21-6
Molecular formula:
C44 H46 N2 O3
IUPAC Name:
1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole
Test material form:
solid: particulate/powder

In vitro test system

Vehicle:
unchanged (no vehicle)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Amount / concentration applied:
Application of 0.5 g to the intact left flank of each of three young adult rabbits.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removal of the dressing.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times.
The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not induce significant or irreversible damage to the skin. TSE 8 is considered to be not irritating to rabbit skin.