Registration Dossier
Registration Dossier
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EC number: 700-424-2 | CAS number: 6872-10-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- methyl 1,3,3-trimethyl-2-methylidene-2,3-dihydro-1H-indole-5-carboxylate
- EC Number:
- 700-424-2
- Cas Number:
- 6872-10-2
- Molecular formula:
- C14 H17 N O2
- IUPAC Name:
- methyl 1,3,3-trimethyl-2-methylidene-2,3-dihydro-1H-indole-5-carboxylate
- Details on test material:
- - Name of test material (as cited in study report): Carboxytrimethylbase, roh, feucht
- Lot/batch No.: 1H
- Appearance: black liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, United Kingdom
- Strain: HC: NZW
- Sex: female
- Weight at study initiation: mean 3.3 kg
- Housing: individually in stainless steel cages
- Diet and water: ad libitum
- Acclimation period: at least 14 days the animals were kept in the quarantine station
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): approx. 50%
- Air changes (per hr): 10 times
- Photoperiod: 12 hours light/ dark cycle; artificial illumination
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated and served as control.
- Amount / concentration applied:
- 100 µL
- Duration of treatment / exposure:
- Test substance was instilled into the conjunctival sac of the rabbits eye. The lids were then gently held together for about one second. The treated eye was washed out with physiological sodium chloride solution 24 hours after instillation of the test substance.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- PROCEDURE: The test substance was instilled into the conjunctival sac of one eye of each of three rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was washed out with physiological sodium chloride solution 24 hours after instillation of the test substance.
SCORING SYSTEM: Draize-scale for signs of cornea, iris, conjunctivae and discharge; according to McDonald and Shadduck (Eye irritation. in: Marzulli and Maibach, Dermatotoxicology and Pharmacology, 3rd ed. (series: Advances in Modern Toxicology, Vol. 4), Wiley, New York, London, 1987, 641) for aqueous humor
TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein, evaluation was made by means of UV (area) and diffuse white illumination (intensity)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1, #2, #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Not reported.
Applicant's summary and conclusion
- Executive summary:
An OECD TG 405 -study for evaluating eye irritation/ corrosion properties of the test substance was conducted on 3 female rabbits. Scores were determined according to Draize 24, 48 and 72 hours after instillation of 100 µL test substance in the conjunctival sac of one eye of each rabbit and after washing of the treated eye 24 hours after instillation with physiological sodium chloride solution.
The study showed that the test substance was not irritating to the eye of rabbits.
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