Registration Dossier
Registration Dossier
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EC number: 935-121-6 | CAS number: 1253789-90-0
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 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- EC Number:
- 935-121-6
- Cas Number:
- 1253789-90-0
- Molecular formula:
- C18 H23 N O2
- IUPAC Name:
- propan-2-yl 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): CD00006066XX ( BI 207127SE )
- Physical state: yellow powder
- Storage condition of test material: room temperature
- Lot/batch No.: 7330-038-2
- Expiration date of the lot/batch: Feb. 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 weeks
- Weight at study initiation: 2.3 - 2.4 kg
- Housing: Animals were 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 - Duration of treatment / exposure:
- 72 h
- 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 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: all animals
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: all animals
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 91, 93
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 92
- Time point:
- other: 1, 24 and 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
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. CD00006066XX, was found to be slightly irritant to the eyes of rabbits with a MMTS score of 2.0.
- Executive summary:
Objective
The purpose of this study was to determine the potential irritant and/or corrosive effects of CD00006066XX on eyes of rabbits.
Methods
The test article, CD00006066XX, was instilled onto the corneal surface of the right eye of each of three male New Zealand White rabbits at 10 mg/eye. Upon instillation, each eye was held closed for ~ 1second to prevent loss of material. The left eye was untreated and served as control. Both eyes of all animals were examined and scored to 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 or iris was observed in the test-treated eyes during the study. Non-positive conjunctival redness was observed in 3 of 3 animals at 1 hour and one animal at 24 and 48 hours. No sings of irritation were observed in any of the animals at 72 hours post treatment.
Conclusion
Under the conditions of the study, CD00006066XX, was found to be slightly irritant to the eyes of rabbits with a MMTS score of 2.0.
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