Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
