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Registration Dossier
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EC number: 690-722-8 | CAS number: 494799-36-9
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:
- 2 005
- 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
- Reference substance name:
- 3-cyclopentyl-1H-indole-6-carboxylic acid
- Cas Number:
- 494799-36-9
- Molecular formula:
- C14 H15 N O2
- IUPAC Name:
- 3-cyclopentyl-1H-indole-6-carboxylic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): CD 6002 SE
- Physical state: white powder
- Storage condition of test material: room temperature, protected from light
- Analytical purity: 99.7 %
- Lot/batch No.: TSA-05-003
Constituent 1
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: 2502 - 2717 g
- Housing: Animals were individually housed in suspended stainless-steel racks
- Diet (e.g. ad libitum): Certified High 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 ) : 0.0272 - 0.0273 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): physiological saline
- Time after start of exposure: 24 h
TOOL USED TO ASSESS SCORE: sodium fluorescein dye
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all animals
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2359 , 2360
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2358
- Time point:
- other: 24 h
- Score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: all animals
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h / 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2358
- Time point:
- other: 1 h
- Score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2359, 2360
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h / 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all animals
- Time point:
- other: 1 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2358, 2359
- Time point:
- other: 24 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2360
- Time point:
- other: 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2358, 2359
- Time point:
- other: 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal: all animals
- Time point:
- other: 1 h
- Score:
- 13.7
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 6002 SE was mildly 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 6002 SE to one eye each in three male albino rabbits.
On the day of dosing approximately 0.0273 g of CD 6002 SE 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. There was no irriation present at the
72-hours examination; therefore, no additional observation were conducted. Mortality, clinical observations, and body weight were also assessed.
All rabbits survived to study termination. There were no test article-related changes in clinical observations or body weights.
Approximately 1 minute after test article instillation, one animal exhibited vocalization. At 1 hour postinstillation, test article was present in the treated eye of all animals. All three animals were noted with findings in the iris. Findings in the conjunctivae included redness, chemosis, and discharge. At 24 hour postinstillation, test article was still present in the treated eye of one animal. Corneal opacity and the area involved was present for one animal. One animal was noted with findings in the iris. Conjunctivae redness and chemosis were also noted. At 48 hour postinstillation, redness was noted in tow animals, the corneal opacity seen at 24 hour postinstillation was no longer present. By 72 hour postinstillation, all signs of irritation had resolved.
The maximum primary irritation score was 13.7 at 1 hour postinstillation. All signs of irritation resolved by 72 hours postinstillation. There was no evidence of corrosion in any of the treated eyes.
CD 6002 SE was mildly irritating and non-corrosive to the eyes of the rabbits under the test conditions.
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