1H-Indole-6-carboxylic acid, 3-cyclopentyl-1-methyl-, methyl ester

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: all animals

Time point:

other: 1,24,48,72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal: 2361

Time point:

other: 1 h

Score:

0

Results 3

Irritation parameter:

iris score

Basis:

animal: 2362, 2363

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible within: 24 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: all animals

Time point:

other: 1,24 h

Score:

1

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

chemosis score

Basis:

animal: all animals

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible within: 24 h

Results 6

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.