Registration Dossier
Registration Dossier
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EC number: 936-073-9 | CAS number: 1253791-42-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- propan-2-yl 2-bromo-3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- EC Number:
- 936-073-9
- Cas Number:
- 1253791-42-2
- Molecular formula:
- C18 H22 Br N O2
- IUPAC Name:
- propan-2-yl 2-bromo-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): CD00006062XX ( BI 207127SE )
- Physical state: white powder:
- Storage condition of test material: room temperature
- Lot/batch No.:BIC 11008957 ( Exp. Mar 2007 )
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Oxford ,MI
- Age at study initiation: 12 weeks
- Weight at study initiation: 2.4 - 2.5 kg
- Housing: Individually housed
- Diet (e.g. ad libitum): All animals had access to PMI Certified Hi-Fiber Rabbit Diet #5325
- Water (e.g. ad libitum): Tap water was available ad libitum, to each animal via an automatic watering device.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19- 22
- Humidity (%): 32 - 80
- Photoperiod (hrs dark / hrs light): 12:12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 L - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ~ 5 cm x 5 cm
- Type of wrap if used: gauze patch, which was held in contact with the skin with a sheet of rubber dam; elastic bandage dressing + non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water and gauze
- 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: 30 min, 60 min,24,48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: all animals
- Time point:
- other: 30 min, 60 min, 24,48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: all animals
- Time point:
- other: 30 min, 60 min, 24,48 and 72 hours
- Score:
- 0
- Max. score:
- 8
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of this study, CD00006062XX, was found to be a non-irritant to the skin of rabbits with a Primary Irritation Index score of 0.
- Executive summary:
Objective
The purpose of this study was to determine the potential irritant and/or corrosive effects of CD00006062XX on the skin of rabbits.
Methods
The test article was applied to one site on the clipped dorsal trunk of three female New Zealand White rabbits. The total exposure period was 4 hours. Observations for dermal irritation and corrosivity were recorded for each site 30 - 60 min after patch removal and at 24, 48 and 72 hours after unwarp. Grading of irritation was according to the method of Draize.
Results
The Primary Irritation Index (PII) was calculated and determined to be 0.
Exposure Observation Period Dermal Observations 4 h 30 -60 min through 72 h No erythema and no edema Conclusion
Under the conditions of this study, CD00006062XX, was found to be a non-irritant to the skin of rabbits with a Primary Irritation Index score of 0.
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