Registration Dossier
Registration Dossier
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EC number: 690-920-4 | CAS number: 494799-38-1
Skin irritation / corrosion
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:
- 2 005
- 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
- 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
Constituent 1
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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