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Diss Factsheets

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
Report date:
2002

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
EC Number:
926-072-1
Cas Number:
198479-63-9
Molecular formula:
C29H25NO2
IUPAC Name:
3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Description: solid
Batch Number: 0010211968
Purity: 98.1%
stability of test item: Stable under storage conditions
Expiry date: 03-Mar-2002
Storage conditions: In the original container, at room temperature (range of 17-23°C), away from direct sunlight.
Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Duration of treatment / exposure:
4 hours
Observation period:
The scoring of skin reactions was performed 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

Any other information on results incl. tables

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

The test item did not elicit any skin reactions at the application site of any animal at anyof the observation times (all scores 0).

No staining by the test item of the treated skin was observed.

No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), TSE 2 is considered to be "not irritating" to rabbit skin.

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