Registration Dossier
Registration Dossier
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EC number: 443-400-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Novermber 1997 - 13 January 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was perfromed in a GLP laboratory, OECD or EU test guideline were not followed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 443-400-4
- EC Name:
- -
- Cas Number:
- 181696-73-1
- Molecular formula:
- C16H15NO2
- IUPAC Name:
- 4,5-Dihydro-5-methyl-3,4-diphenyl-5-isoxazolol
- Test material form:
- other: White solid
- Details on test material:
- White solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc.
- Age at study initiation: 19-21 weeks old
- Weight at study initiation: 2,550 to 2,802g
- Housing: individually housed in suspended, stainless steel cages.
- Diet (e.g. ad libitum): Measured amounts of High Fiber Rabbit Diet #7015 (Harlan Teklad).
- Water (e.g. ad libitum): free access to water
- Acclimation period: at least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16° to 22°C,
- Humidity (%): of 50% ±20%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each rabbit served as the untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of solid test material (not to exceed 0.1 g). - Duration of treatment / exposure:
- Group 1: Continuous
Group 2: 30-60 seconds after treatment. - Observation period (in vivo):
- Observations were made at approximately 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- Six, three male and three female animals.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group 1, no washing. Group 2, Washing was performed.
- Time after start of exposure: 30-60 seconds after treatment.
SCORING SYSTEM:
Draize scoring system.
TOOL USED TO ASSESS SCORE: Fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 1 (unwashed), average
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 1 (unwashed), average
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0.7
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 1 (unwashed), average
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 1 (unwashed), average
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 2 (washed), average
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 1.3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 2 (washed), average
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 2 (washed), average
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 2 (washed), average
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Irritant / corrosive response data:
- Both test groups exhibited signs of conjunctival redness which was fully reversible during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The test substance is considered to be minimally irritating in the treated eyes of rabbits that were unwashed after treatment and practically nonirritating in the treated eyes of animals receiving a washout after test material instillation.
- Executive summary:
The test substance is considered to be minimally irritating in the treated eyes of rabbits that were unwashed after treatment and practically nonirritating in the treated eyes of animals receiving a washout after test material instillation.
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