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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
Cas Number:
494799-38-1
Molecular formula:
C16 H19 N O2
IUPAC Name:
methyl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): CD 6003 XX
- Physical state: light yellow powder with chunks
- Storage condition of test material: room temperature, protected from light
- Analytical purity: 99.7 %
- Lot/batch No.: T1031

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Convance Research Products,Inc., Denver, Pennsylvania
- Age at study initiation: ca. 20 weeks
- Weight at study initiation: 1998 - 2100 g
- Housing:Individually housed in suspended stainless-steel racks
- Diet (e.g. ad libitum):Certified Hi-Fiber Rabbit Diet #5325 ; ca. 150 g of diet/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30 - 70
- Air changes (per hr): minimum of 10
- Photoperiod (hrs dark / hrs light): 12 : 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4449 - 0.5001 g


VEHICLE
- Amount(s) applied (volume or weight with unit): ca. 0.65 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: gauze patch, paper tape, Saran Wrap, Elastoplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water and paper towels
- Time after start of exposure: 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal: all animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: all animals
Time point:
other: 1, 24, 48, 72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The primary irritation index ( PDII ) of CD 6003 was 0.0 ; therefore, the test article was non-irritating / non-corrosive to the skin of the rabbits under the conditions of the study.
Executive summary:

This study assessed the relative level of primary skin irritation/corrosion of CD 6003 XX in three male albino rabbits under semioccluded conditions.

On the day of dosing the moistened neat test article was applied to the intact skin area and covered with a semiocclusive dressing. Approximately 4 hours after application, patches were removed, and residual test article was taken off the skin( as thoroughly and gently as possible ) using tap water and paper towels.The untreated skin of each animal served as its own control.

The degree of erythema and edema was evaluated approximately 60 min and 24, 48 an 72 hours after unwrapping. There were no signs of erythema or edema at any observation interval; therefore, after the 72 h examination, no additional observations were conducted and the study was terminated. Mortality, clinical observations and body weights were also assessed.

All animals survived to study termination. There were no test article-related changes in clinical observations or body weights during the study.

The primary irritation index ( PDII ) of CD 6003 was 0.0 ; therefore, the test article was non-irritating / non-corrosive to the skin of the rabbits under the conditions of the study.

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