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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:
2007
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

Constituent 1
Chemical structure
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 )

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 .