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Administrative data

Endpoint:
eye 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:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute 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:
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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Convance Research Products,Inc., Denver, Pennsylvania
- Age at study initiation: ca. 16 weeks
- Weight at study initiation: 2532 - 2543 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

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0442 - 0.0446 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): saline
- Time after start of exposure: 24 h

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
Irritation parameter:
iris score
Basis:
animal: 2361
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 2362, 2363
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal: all animals
Time point:
other: 1,24 h
Score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: all animals
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal: all animals
Time point:
other: 1 h
Score:
8.7

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
In conclusion, CD 6003 XX was minimally irritating and non-corrosive to the eyes of the rabbits under the conditions of the study.
Executive summary:

This study assessed the relative level of ocular irritation/corrosion produced following a single dose exposure of CD 6003 XX to one eye each in three male albino rabbits.

On the day of dosing approximately 0.444 g of CD 6003 XX was placed into the everted lower lid of the right eye; the left served as the untreated control. The animals were evaluated for an obvious pain response ( e.g. vocalization and/or excessive pawing of the treated eye) upon instillation of the test article. Approximately 24 h after insitllation , the treated eyes were examined for residual test article; the residual ( if any ) test article was gently washed out using room-temperature physiological saline.

Eye irritation was evaluated and scored approximately 1, 24, 48 and 72 hours after instillation.

All rabbits survived to study termination. There were no test article-related changes in clinical observations or body weights.

There were no indication of pain in any animal upon instillation of the test article or shortly thereafter. At 1-hour postinstillation, test article was present in the treated eyes of all animals.Two animals were noted with findings in the iris.Findings in the conjunctivae including redness and chemosis in all animals , and discharge in two animals. At 24 hour postinstillation conjunctival redness was noted in all animals. At 48 hours postinstillation, all sings of irritation had resolved.

The maximum mean primary irritation score was 8.7 at 1 hour postinstillation. There was no evidence of corrosive or effects of the cornea in any treated eye.

CD 6003 XX was minimally irritating and non-corrosive to the eyes of the rabbits under the conditions of the study.

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