Registration Dossier
Registration Dossier
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EC number: 811-357-4 | CAS number: 952-06-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 November 1997 - 11 December 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Performed in a GLP laboratory, no deviations from the study protocol were noted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (Z)-N-(1,2-diphenylethylidene)hydroxylamine
- EC Number:
- 811-357-4
- Cas Number:
- 952-06-7
- Molecular formula:
- C14 H13 N O
- IUPAC Name:
- (Z)-N-(1,2-diphenylethylidene)hydroxylamine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): SC-66276
- Physical state: White powder
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: Adult
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended, stainless steel cages
- Diet (e.g. ad libitum): measured amount of High Fiber Rabbit Diet #7015 (Harlan Teklad).
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): of 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: 60 mg - Duration of treatment / exposure:
- Group 1: Unwashed
Group 2: Test eyes were washed between 30 and 60 seconds of material instillation. - Observation period (in vivo):
- 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- Three male and three female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Group 1 remained unwashed.
Group 2 washed 30 to 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)
- Basis:
- mean
- Time point:
- other: 1 Hour
- Score:
- ca. 3.3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 1 (unwashed)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 1.3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 1 (unwashed)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0.7
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 1 (unwashed)
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Group 1 (washed)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 1.3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0
- Irritant / corrosive response data:
- No positive ocular reactions were observed in the three animals with washed eyes.
SC-66276 produced slight conjunctiva! irritation (all three animals) in treated eyes that were unwashed after treatment. All treated eyes in this group returned to a normal appearance by 72 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, according to the Kay and Calandra(3) classification, SC-66276 is considered to be mildly 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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