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Registration Dossier
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EC number: 443-400-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 December 1997 - 13 January 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Performed in a GLP laboratory.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal 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: Solid
- Details on test material:
- - Name of test material (as cited in study report): SC-66285
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., Kalamazoo, Michigan
- Age at study initiation: 14-18 weeks of age
- Weight at study initiation:
ANIMAL; SEX; Pre-Dose Weight (g)
F65378; F; 2,356
F65379; F; 2,500
F65381; F; 2,302
F65354; M; 2,574
F65383; F; 2,642
F65356; M; 2,409
After receipt, the animals were acclimated for a period of at least 7 days. During acclimation and throughout the study, the animals were individually housed in suspended, stainless steel cages. Environmental controls for the animal room were set to maintain a temperature of 16° to 22°C, a relative humidity of 50% ±20%, and a 12-hour light/12-hour dark cycle. In cases where variations from these conditions existed, they were documented and considered to have had no adverse effect on the study outcome.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Remarks:
- Test area was moistened with 0.8 ml of distilled water prior to application.
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g in 0.8 ml of water (used to moisten the test area) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 rabbits
- Details on study design:
- Untreated
TEST SITE
- Area of exposure: 2.5 cm x 2.5 CM
- Type of wrap if used: Seran Wrap and Elstoplast tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours from initiation of treatment.
SCORING SYSTEM:
Draize Scoring System:
(1) Erythema and Eschar Formation
No erythema...........................................................................O
Very slight erythema (barely perceptible)..........................1
Well-defined erythema..........................................................2
Moderate to severe erythema....................................................3
Severe erythema (beet redness) to slight eschar formation (injuries in depth)..4
Highest possible erythema score .4
(2) Edema Formation
No edema.......................................................................O
Very slight edema (barely perceptible).........................................1
Slight edema (edges are well defined by definite raising)......................2
Moderate edema (raised approximately 1 mm) :...................................3
Severe edema (raised approximately 1 mm and extending beyond area of exposure).4
Highest possible edema score............ 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- ca. 0.2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0
- 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:
- Reversible effects were observed in one female animal. The effects were fully reversible within a 24 hour period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Under the conditions of this test, SC-66285 is considered to be nonirritating to dermal tissue of the rabbit.
- Executive summary:
The test substance is determined not to be a skin irritant under the conditions of this test.
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