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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:
1999
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

Constituent 1
Chemical structure
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

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.