Registration Dossier
Registration Dossier
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EC number: 811-357-4 | CAS number: 952-06-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 November 1997 to 4 December 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed in a GLP laboratory in accordance with EPA test guidance, no deviations 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:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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, in suspended, stainless steel cages
- Diet: A measured amount of High Fiber Rabbit Diet #7015 (Harlan Teklad).
- Water: ad libitum
- Acclimation period: at least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16° to 22°C
- Humidity (%): 50% ±20%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin of each animal will serve as its own control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g of test substance.
- Concentration (if solution): Test area was moistened with approx. 0.5 ml of distilled water before application. - Duration of treatment / exposure:
- 4-hours.
- Observation period:
- Within 30 to 60 minutes after removal of the test material. Subsequent examinations were made at 24, 48, and 72 hours.
- Number of animals:
- Three male and three female.
- Details on study design:
- TEST SITE
- Area of exposure: test material was applied to the intact skin site on each animal's back (approximate exposure area of 6.25 crn ')
- Type of wrap if used: overwrapped with Saran Wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Draize Scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- ca. 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0.2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Irritant / corrosive response data:
- Application of SC-66276 to the skin of rabbits under 4-hour semioccluded conditions
resulted in very slight erythema reactions in two animals. No other dermal irritation was
observed. All irritation cleared by the 48-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, under the conditions of this test, SC-66276 is considered to be slightly irritating to dermal tissue of the rabbit.
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