Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 936-073-9 | CAS number: 1253791-42-2
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye 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 ( BI207127SE )
- Physical state: withe powder:
- Storage condition of test material: room temperature
- Lot/batch No.: BIC 11008957 ( Exp. Mar 2007 )
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Oxford, MI
- Age at study initiation: 11 - 12 weeks
- Weight at study initiation: 2.1 - 2.4 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): 16 - 22
- Humidity (%): 32 - 80
- Photoperiod (hrs dark / hrs light): 12 : 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg - Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all animals
- Time point:
- other: 1,24,48,72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: all animals
- Time point:
- other: 1,24,48,72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all animals
- Time point:
- other: 1,24,48,72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: all animals
- Time point:
- other: 1,24,48,72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal: all animals
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 1
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 non-irritation to the eyes of rabbits with a MMTS score of 0.0 .
- Executive summary:
Objective
The purpose of this study was to determine the potential irritant and/or corrosive effects of CD00006062XX on eyes of rabbits.
Methods
The test article,CD00006062XX, was instilled on to the corneal surface of the right eye of each of the three male New Zealand White rabbits at 10 mg/eye. Upon instillation each eye was held closed for ~ 1 s to prevent loss of material. The left eye was untreated and served as control. Both eyes of all animals were examined and scored for ocular irritation prior to dose, 1 hour after dose and at 24,48 and 72 hours post dose.
Results
No ocular irritation involving the cornea, iris or conjunctivae was observed in the treated eyes during the study.
Conclusion
Under the conditions of this study, CD00006062XX, was found to be non-irritation to the eyes of rabbits with a MMTS score
of 0.0 .
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
