Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1999

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(7-ethyl-1H-indol-3-yl)ethanol
EC Number:
431-020-1
EC Name:
2-(7-ethyl-1H-indol-3-yl)ethanol
Cas Number:
41340-36-7
Molecular formula:
C12H15NO
IUPAC Name:
2-(7-ethyl-1H-indol-3-yl)ethan-1-ol

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: bi-distilled water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
mean score 1,2,3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
mean score 1,2,3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occured.

No signs of irritation were observed.

Reversible light brown staining by the test article of the treated skin was observed in all animals until 24 hours after treatment.

The body weight of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

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